2012 HIV Sourcebook for the Primary Care Provider

Transcription

1
2
2012
HIV Sourcebook for the Primary Care Provider
Whitney Starr, MS, FNP
Clinical Education Coordinator, Mountain Plains AETC
Instructor, Division of Infectious Diseases, School of Medicine
University of Colorado Denver
Steven C. Johnson, MD
Medical Director, Mountain Plains AETC
Professor of Medicine, Division of Infectious Diseases, School of Medicine
Donna Sweet, MD
Principal Investigator and Director, Kansas AETC
Professor, Department of Internal Medicine
University of Kansas School of Medicine – Wichita
Lucy Bradley-Springer, PhD, RN, ACRN, FAAN
Principal Investigator, Mountain Plains AETC
Associate Professor, Division of Infectious Diseases, School of Medicine
3
The Mountain Plains Regional AIDS Education and Training Center affiliated states participating in the
development and distribution of this sourcebook include Colorado, Kansas, Nebraska, New Mexico, North
Dakota, South Dakota, Utah, and Wyoming.
The information included in this document is intended to give an overview of HIV care for adults and
adolescents and is not all-inclusive. The material is based on the DHHS guidelines available at the time of
publication. The guidelines change frequently, and readers are encouraged to access updates at:
http://aidsinfo.nih.gov/guidelines/
To access consultation with a clinician who specializes in HIV care, contact the National HIV/AIDS Clinicians’
Consultation Center at:
HIV Medical Consultation: (800) 933-3413
Post-Exposure Consultation: (888) 448-4911
Perinatal HIV Consultation: (888) 448-8765
www.nccc.ucsf.edu
Published 2012
Cover Photograph: Whitney Starr
Design: Lucy Bradley-Springer
4
The 2012 HIV Sourcebook for the Primary Care Provider offers updated information about HIV infection for professionals who
work in today’s health care system. The content in this sourcebook will be useful for providers participating in various aspects
of HIV care including the AIDS Education and Training Center (AETC) targeted providers (advanced practice nurses, dental
professionals, nurses, pharmacists, physicians, and physician assistants), as well as other essential members of the health care
team (case managers, dietitians, mental health professionals, midwives, social workers, and others). The sourcebook provides
basic information about the pathophysiology of HIV infection and its modes of transmission, as well as how to recognize and
diagnose HIV in the primary care setting. The basics of care for treating people living with HIV (PLWH) are included. We
also address ongoing primary care issues that often arise with this patient population and are of increasing importance as HIV
therapies have improved.
The sourcebook is not intended to be a textbook on HIV infection, but rather a convenient reference for some of the most
common issues encountered in daily practice. The recommendations herein should not be interpreted as practice guidelines
or a standard of care that a clinician must follow in order to be considered competent, although the content has been derived
from current testing, treatment, prophylaxis, and prevention guidelines. The authors have no authority to develop formalized
approaches to the care of PLWH. As with any health care intervention, the needs of the individual patient are paramount. And,
as with any chronic and difficult-to-treat condition, clinicians are encouraged to consult with and refer to specialists in the field
as needed. To this end, lists of resources that can be easily accessed in local settings are provided at the end of the text.
Guidelines and recommendations related to antiretroviral therapy (ART), treatment of opportunistic infections (OI), HIV testing
and counseling, prevention of perinatal transmission, and post-exposure prophylaxis (PEP) are cited within this sourcebook.
Reference publications may be obtained from any of the AIDS Education and Training Centers (AETCs), the Centers for
Disease Control and Prevention (CDC), or at www.aidsinfo.nih.gov, the on-line site for official federal guidelines. Complete
information for accessing these resources is provided in the resource section of this sourcebook.
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Table of Contents
page
Considerations for Primary Care............................................................................................................1
History of HIV Infection..............................................................................................................................................1
Epidemiology...............................................................................................................................................................1
HIV Transmission........................................................................................................................................................2
Risk Assessment..........................................................................................................................................................3
Risk Reduction.............................................................................................................................................................5
Testing
........................................................................................................................................................................5
Caring for the HIV-Infected Patient.......................................................................................................9
Pathophysiology of HIV Infection...............................................................................................................................9
Acute HIV Infection..................................................................................................................................................10
Initial Assessment...................................................................................................................................................... 11
Antiretroviral Therapy...............................................................................................................................................13
Prophylaxis for Opportunistic Infections...................................................................................................................18
Complications Associated with HIV Infection and ART...........................................................................................20
Symptom Evaluation in the HIV-Infected Patient.....................................................................................................21
Primary Care and Disease Prevention..................................................................................................25
Considerations for an Aging Population....................................................................................................................25
Immunizations...........................................................................................................................................................26
Cardiovascular Complications and HIV....................................................................................................................27
Malignancies and HIV...............................................................................................................................................27
Bone Loss and HIV....................................................................................................................................................27
Women’s Health.........................................................................................................................................................28
Sexually Transmitted Infections................................................................................................................................28
Drugs and HIV...........................................................................................................................................................28
Mental Health Issues in the Care of the HIV-Infected Patient...................................................................................29
7
Bibliography............................................................................................................................................31
Appendices and Resources.....................................................................................................................35
Appendix A. Occupational Post-Exposure Prophylaxis (PEP) Guidelines...............................................................37
Non-Occupational Post-Exposure Prophylaxis (nPEP) Guidelines.....................................................39
Appendix B. Antiretroviral Therapy..........................................................................................................................40
Appendix C. List of Abbreviations............................................................................................................................47
Appendix D. National AIDS Services, Hotlines, and On-Line Resources................................................................48
Appendix E. Patient Assistance Programs for HIV Medications..............................................................................49
Appendix F. Regional and National AETC Programs...............................................................................................50
Appendix G. Mountain Plains AETC Regional Office and Local Performance Sites...............................................51
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Considerations
for Primary Care
The human immunodeficiency virus (HIV) epidemic
presents opportunities and challenges for primary care
practitioners. For many patients in the United States, HIV
is a treatable chronic infection with complex and frequently
changing care considerations. Like most chronic
conditions, health care needs are often complicated by
social, economic, and mental health conditions. Education
and prevention, routine primary care, and management of
co-morbidities are key factors in the continuum of care.
Table 1 lists primary care activities and major
responsibilities as they relate to HIV infection.
Most clinicians routinely perform risk assessments as they
screen patients for new or developing problems related to
sexual practices or drug use. The practice of routine testing
for at-risk populations allows for early identification of
people infected with HIV (PLWH) and timely linkage to
care. All clinicians need a basic level of understanding
about HIV infection in order to enhance clinical skills,
provide prevention education, and make informed decisions
about care and referral.
The prognosis for a person infected with HIV in the United
Table 1. Primary Care Activities Related to HIV Infection
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Evaluate risk for HIV infection
Provide education on prevention strategies
Refer to risk-reduction and social service programs as needed
Counsel patients about testing options
Diagnose HIV infection as early as possible
Evaluate stage of HIV infection at clinical presentation
Encourage health-promoting behaviors
Counsel patients to prevent further spread of HIV infection
Assess social and emotional support and arrange referrals as
needed
Screen for mental health illness, past and present, particularly
suicidal ideation
Encourage early initiation of antiretroviral therapy (ART)
Support patients in adherence to ART
Provide basic primary care
Provide routine health maintenance services
With appropriate collaboration, consultations, and referrals:
• Support prescribed regimen of ART
• Assist in managing troublesome symptoms associated with
ART – diarrhea, nausea, metabolic complications, and body
shape changes
• Monitor and recognize signs and symptoms of OIs
• Administer recommended prophylaxis against OIs
• Monitor for complications of ART
• Provide post-exposure prophylaxis
States has improved significantly over the past decade.
The average lifespan for many PLWH has neared that of
the general population. Ongoing primary care including
providing vaccinations, managing cardiovascular risk,
identifying and treating mental illnesses, and offering
general health maintenance, has become critical to the
optimal health of PLWH, especially as this population
lives longer and ages with HIV. Treating HIV infection
may necessitate or require consultation and additional
resources for many primary care providers. It is the goal of
this sourcebook to present basic information necessary for
primary care clinicians to evaluate risk for infection with
HIV, diagnose HIV infection, and assist in the management
of clinical care, as well as offer a framework for primary
care activities of specific concern to PLWH.
History of HIV Infection
The Centers for Disease Control and Prevention (CDC)
first published reports of a syndrome that led to the
development of rare opportunistic infections (OIs) in 1981.
The term acquired immunodeficiency syndrome (AIDS)
was coined following several reports of Pneumocystis
pneumonia (PCP) in previously healthy young men. These
cases were seen in clusters around the United States, mostly
in young men having sex with men (MSM) and on both
coasts. AIDS was manifested by rare forms of infections
previously seen only in those with severely suppressed
immune systems, such as transplant recipients and
cancer patients. Recurrences of OIs were common, and
AIDS was associated with high mortality rates. Within
15 months, more than 500 cases of AIDS had been
documented. Cases of AIDS were mostly found in major
metropolitan areas, with the majority in Los Angeles,
San Francisco, and New York City. The syndrome was
soon seen not only in MSM but in other populations as
well, including people with hemophilia, pregnant women,
Haitian refugees, and injection drug users (IDUs). In
addition to unexpected infections, several malignancies,
including Kaposi’s sarcoma (KS), became associated
with AIDS. In 1983, HIV was recognized as the virus that
caused AIDS.
Epidemiology
According to the United Nations Joint Programme on
HIV/AIDS Report on the Global AIDS Epidemic
(UNAIDS, 2010), in 2009, an estimated 33.3 million
people were living with HIV, 2.6 million new cases of
HIV developed, and 1.8 million HIV-related deaths
occurred. The epidemic has stabilized since 2000, with
decreasing death rates and fewer new infections.
1
Most of
of the
the epidemic
epidemic burden
burden continues
continues to
to be
be borne
borne by
by
Most
countries
in
Sub-Saharan
Africa.
The
global
epidemic
is
countries in Sub-Saharan Africa. The global epidemic is
spread
predominantly
by
heterosexual
transmission
with
spread predominantly by heterosexual transmission with
women making
making up
up half
half of
of all
all cases
cases of
of HIV
HIV infection
infection around
around
women
the
world.
the world.
In the United States, an estimated 55,000-60,000 new
In theofUnited
States,
anthan
estimated
new
cases
HIV and
more
16,00055,000-60,000
deaths from HIVcases
of
HIV
and
more
than
16,000
deaths
from
HIVrelated conditions occur each year. The majority of PLWH
related
conditions
eachto
year.
The majority
PLWH
in the United
Statesoccur
continue
be MSM,
althoughofincreases
in
the
United
States
continue
to
be
MSM,
although
in women with HIV infection, especially women of color,
increases
women
withthe
HIV
especially
women
have beeninnoted
during
pastinfection,
decade. Minority
populations
of
color,
have
bee
noted
during
the
past
decade.
Minority
are disproportionately affected in the United States. African
populations
are Hispanics/Latinos
disproportionatelyaccounted
affected inforthe
United
Americans and
44%
and
States.
African
Americans
and
Hispanics/Latinos
accounted
20%, respectively, of new HIV diagnoses in 2009. During
for
20%,
new HIV
this44%
sameand
time,
therespectively,
rate of AIDS of
diagnoses
fordiagnoses
African in
2009.
During
this
same
time,
the
rate
of
AIDS
diagnoses
American women was 15 times that of white women.
Asians
for
African
American
account for 2% of new infections and American Indians and
Alaska
Natives
account for less thanwomen
1%. was 15 times
HIV
Transmission
that of White women.
Mechanisms
Asians account for 2%
Transmission
Contact withHIV
HIV-infected
of new infections and
blood, semen, vaginal
American
Indians
and
HIV is primarily transmitted through
exposure
to infected
secretions, or breast milk
Alaska
Natives
account
fluids, predominantly blood, semen, vaginal secretions,
Major means of
less than 1%.include
and breast milk. The major means for
of transmission
transmission:
unprotected anal and/or vaginal intercourse, sharing
• Unprotected anal or
intravenous
drug
paraphernalia, and perinatally during birth
vaginal
intercourse
HIV
Transmission
or
through
breast milk
• HIV
Sharing
used injection
Transmission
(see
Figure
1). While
HIV is primarily
equipment
Mechanisms
we
know
that
HIV can
transmitted through
• Perinatal transmission
be
found
in
other
body
exposure to infected
Contact with HIV-infected
fluids,
such
as
peritoneal
blood,
semen,
vaginal
fluids, predominantly blood, semen, vaginal secretions, and
fluid, cerebrospinal
secretions,
breast means
milk of transmission
breast
milk. Theormajor
include
fluid, urine,
saliva,
Major
means
of
unprotected anal and/or vaginal intercourse,
sharing
sweat,
and
tears,
no birth
transmission:
intravenous drug paraphernalia, and perinatally during
documented
cases
•
Unprotected
anal
or
or through breast milk (see Figure 1). While we knowofthat
HIV such
transmission
have
intercourse
HIV can vaginal
be found
in other body fluids,
as peritoneal
occurred
after
exposure
•
Sharing
used
injection
fluid, cerebrospinal fluid, urine, saliva, sweat, and tears, no
equipment
to these
fluids
unlessafter
documented
cases of HIV transmission
have
occurred
• Perinatal transmission
blood
was
also
present.
exposure to these fluids unless blood was also present.
DrugUse
Use
Drug
Peoplewho
whouse
useillicit
illicitdrugs
drugsare
areatatrisk
riskofofacquiring
acquiringHIV
HIVifif
People
theyshare
shareused
useddrug
drugparaphernalia
paraphernaliawith
withinfected
infectedpartners.
partners.
they
Paraphernaliainclude
includeneedles,
needles,syringes,
syringes,cookers,
cookers,and
andrinse
rinse
Paraphernalia
waterused
usedfor
fordrug
druginjection;
injection;pipes
pipesused
usedtotosmoke
smokedrugs;
drugs;
water
andstraws
strawsused
usedtotosnort
snortdrugs.
drugs.Hepatitis
HepatitisBBand
andCCviruses
viruses
and
(HBVand
andHCV)
HCV)are
arealso
alsotransmitted
transmittedthrough
throughinfected
infected
(HBV
bloodand
andsexual
sexualcontact.
contact.HCV
HCVisisprimarily
primarilytransmitted
transmitted
blood
throughinjection
injectiondrug
druguse,
use,but
butthere
thereare
arereports
reportsofofsexual
sexual
through
transmission
of
HCV
in
MSM.
Almost
one-third
of
PLWH
transmission of HCV in MSM. Almost one-third of PLWH
are
co-infected
with
HCV.
A
diagnosis
of
HBV
or
HCV
is
are co-infected with HCV. A diagnosis of HBV or HCV is
a
compelling
reason
to
also
test
for
HIV
infection.
a compelling reason to also test for HIV infection.
Perinatal Transmission
Perinatal Transmission
Perinatal transmission of HIV infection can occur at any
Perinatal
transmission
HIV
infection
point
during
pregnancy,ofbut
is most
likelycan
to occur
occur at
in any
the
pointand
during
pregnancy,
butIfisthe
most
likely
tonot
occur
in the
labor
delivery
process.
mother
has
been
labor and with
delivery
If thenot
mother
hasappropriate
not been
diagnosed
HIVprocess.
and/or does
receive
diagnosed
HIV and/or
doesofnot
receive appropriate
ART
duringwith
pregnancy,
the risk
transmission
to her
ART during
risk
of transmission
to her
infant
is aboutpregnancy,
25%. The the
good
news
is that perinatal
infant is about
25%.
TheUnited
good news
that perinatal
transmission
rates
in the
Statesishave
decreased to
transmission
in thedocumented
United States
haveper
decreased
less
than 2% orrates
100-200
cases
year. to
less thantransmission
2% or 100-200
documented
cases per
year.to (a)
Perinatal
decreases
are directly
related
Perinatal
transmission
decreases
are directly
related ART
to (a)
HIV
screening
for all pregnant
women;
(b) effective
HIV screening
for to
allHIV-infected
pregnant women;
(b) during
effective ART
protocols
provided
women
protocols provided
todelivery;
HIV-infected
women
pregnancy,
labor, and
and (c)
ART during
prophylaxis
pregnancy,
labor,
and delivery;
and (c)the
ART
for
perinatally
exposed
infants during
firstprophylaxis
6 weeks of
for perinatally
exposed
during
thetofirst
6 weeks
life.
Because breast
milkinfants
has been
shown
contain
HIVof
life.
Because
breast
milk
has
been
shown
to
contain
and because post-natal transmissions have occurred asHIV
a
and because
post-natalHIV-infected
transmissionsmothers
have occurred
as a
result
of breastfeeding,
are counseled
result
of breastfeeding, HIV-infected mothers are counseled
not
to breastfeed.
not to breastfeed.
Sexual Transmission
Sexual Transmission
The most common method of HIV transmission is through
The most common
method of HIV
unprotected
sexual intercourse.
Analtransmission
intercourse is
is through
the most
unprotected
sexual
intercourse.
Anal
intercourse
is theOral
most
risky sexual activity followed by vaginal intercourse.
risky
sexual
activity
followed
by
vaginal
intercourse.
Oral
sex has some risk, but is considered to be significantly less
sex has some risk, but is considered to be significantly less
risky than unprotected anal or vaginal penetration. Genital
risky than unprotected anal or vaginal penetration. Genital
ulcer disease, including herpes simplex virus (HSV)
ulcer disease, including herpes simplex virus (HSV)
infection, syphilis, and chancroid, is correlated with an
infection, syphilis, and chancroid, is correlated with an
increased risk for acquisition of HIV infection. People who
increased risk for acquisition of HIV infection. People who
become symptomatic with a sexually transmitted infection
become symptomatic with a sexually transmitted infection
(STI) often present for treatment, and any patient
(STI) often present for treatment, and any patient
presenting with STI symptoms should be tested for HIV.
presenting with STI symptoms should be tested for HIV.
Mountain Plains AIDS Education and Training Center
CDC, 2009 HIV Incidence Data. Retrieved from
http://www.cdc.gov/hiv/topics/surveillance/
incidence.htm
Occupational
Exposure
Occupational
Exposure
Therisk
riskofofexposure
exposuretotoblood
bloodand
andblood-borne
blood-bornepathogens
pathogensisis
The
slightly
greater
for
health
care
personnel
than
for
people
slightly greater for health care personnel than for people
who
don’t
work
around
blood.
Risks
in
clinical
settings
who don’t work around blood. Risks in clinical settings
includepercutaneous
percutaneousinjuries,
injuries,such
suchasasaaneedle
needlestick
stickororaa
include
2012 Sourcebook p. 2 2
cut with a sharp object that has been in contact with
infected blood, or contact with infected blood on mucous
membranes, non-intact skin, tissues, or other body fluids.
Urine, feces, sweat, and saliva have not posed a risk of HIV
transmission, but semen and vaginal secretions are
considered potentially infectious.
The risk of infection from an occupational exposure to HIV
is small. A percutaneous exposure to HIV-infected blood
without post-exposure prophylaxis (PEP) results in
infection approximately 0.3% of the time or 1 in 300. The
risk of transmission from blood or body fluid contact with a
mucous membrane is estimated to be significantly lower at
0.09%. Many factors have to be considered when
determining the risk of a specific occupational exposure,
including the size of the device (sharp), the amount of
potentially infectious fluids in the exposure, the severity of
the injury to the worker, and whether the HIV status of the
source patient is known. Policies from the CDC and the
Occupational Safety and Health Administration require that
employees be protected from exposures to infectious fluids
in the work setting. Practicing Universal Precautions
(including Body Substance Isolation) with the use of
Personal Protective Equipment such as gloves, gowns,
boots, eyewear, and masks as appropriate for patient care,
decreases the risk of direct contact with blood and body
fluids, thereby decreasing the risk of infection with all
blood-borne pathogens.
The CDC recommends PEP based on the nature and
severity of exposure, the exposure source, and the available
antiretroviral drugs. The availability of treatment to further
decrease the risk of transmission after occupational
exposure makes the reporting of all risky exposures
extremely critical and increases the need for clinicians to
know PEP treatment basics. As always, expert consultation
should be considered as needed. For further information
regarding occupational exposure and PEP, see Appendix A.
Risk Assessment
All health care providers – regardless of clinical care
setting – play an important role in HIV prevention and
early detection. Routine risk assessments, screening, and
testing for HIV can help health care providers:
•
•
•
•
identify patients who are at risk for HIV infection,
provide targeted prevention education,
diagnose patients who are infected with HIV, and
educate PLWH about protecting their own health
while decreasing the risk of transmission to others.
Most cases of HIV are transmitted through sexual activity
and sharing used drug paraphernalia. Many care providers
find that these are difficult topics to address with their
patients, but careful risk assessment is essential in the
clinical care setting.
Discovery of a
patient’s risk
behaviors helps to
identify areas that
need to be addressed
in discussions about
risk reduction and
the need for HIV
testing. Certain
behaviors are
associated with a
higher risk of
exposure to HIV, and
a careful history may
provide direction for
further risk
assessment and
targeted education
and risk reduction
counseling. The
number of sexual
partners, the sexual
history of the
partner(s), trading
sex for money or
drugs, having
concurrent partners,
or having sex with
significantly older
partners are all
associated with a
higher risk of HIV
acquisition and
transmission.
Table 2. History Items
to Assess Risk
for HIV Infection
Sexual History
• Unprotected sexual intercourse
(vaginal, anal, oral)
• Sexual contact with an HIVinfected person or a person at
risk for HIV infection
• Multiple sex partners
• History of sexual abuse
• STI or related signs and
symptoms
• Abnormal Pap smear
Substance Abuse/Social History
• Injection drug use (IDU)
• Drug-using sexual partners
• Cocaine or methamphetamine
use
• Sharing drug paraphernalia
• Alcohol dependence or
detoxification
• Psychiatric hospitalizations
• Domestic violence
• History of incarceration
• Homelessness
Clinical History
• Flu-like illness, weight loss
• Infections such as thrush,
pneumonia, shingles,
tuberculosis (TB)
• Hepatitis
• Persistent generalized
lymphadenopathy (PGL)
• Children born to infected
mothers
• History of transfusion or
transplant
• Hemophilia or coagulation
disorders
• Occupational exposure to
human blood, body fluids, or
tissues
The purposes of a
comprehensive risk
assessment are to (a)
discover behaviors
that can be modified
to improve patient
health and (b) assist
with HIV diagnosis.
It is critical that
clinicians identify people at risk for HIV infection as early
as possible because early diagnosis has been associated
with:
• timely entry into care and treatment,
• better long term outcomes for the health of the
individual with HIV infection, and
• decreased risk of HIV transmission to the
individual’s sex and drug-using partners
3
People with identified risks are more likely to be
counseled about prevention measures and tested for HIV
infection. Risk is best assessed by investigating health
and social histories. Risk assessments provide useful
information for patient care. They should be completed
during the initial work up of a new patient and then
implemented as a regular component of clinical care.
Specific history items should relate to modes of
transmission and risks associated with HIV infection, as
noted in Tables 2 and 3.
Conditions Associated with HIV Infection
Signs and symptoms of HIV infection are frequently
subtle and can be easily missed if an HIV diagnosis is not
considered. For example, a young man with a persistent
cough and a menopausal woman with difficult-to-treat
vaginal candidiasis may each be demonstrating a
manifestation of immune suppression related to HIV.
Early identification of HIV infection depends on
clinicians who are alert to the signs and symptoms of
HIV. Common clinical conditions associated with HIV
infection are listed in the final section of Table 2. This list
is by no means exhaustive, but if signs and symptoms are
unusual or indicate immune suppression, the clinician
should consider HIV in the differential diagnosis.
Risk Behaviors
Major risk factors for HIV acquisition are unprotected
sexual activity and sharing drug-using paraphernalia.
While discussions around sexual practices and drug use
can be difficult for providers and their patients, these
conversations form the basis of appropriate and
comprehensive health care. Inquiring about sexual
behavior and drug use should be included in every
comprehensive risk assessment. In addition to uncovering
risk behaviors, the risk assessment can:
• Provide baseline information about the patient’s
behaviors
• Provide information about the patient’s understanding
of HIV transmission and prevention
• Open the door for further discussions
• Determine the need for prevention education
• Assist with testing decisions
• Strengthen the patient-provider relationship
The value of risk assessment in the overall process of
health care should not be underestimated. Table 3
provides key points for the risk assessment interview.
Table 3. Key Points for the Risk Assessment Interview
Risk assessments should be completed on every new patient and
updated on a regular basis because circumstances and behaviors
change.
Arrange for a private and quiet space for the assessment. It is
generally better to assess risk in a one-on-one interview between
the clinician and the patient.
Assure patient confidentiality and explain the importance of the
risk assessment.
Sexual and drug related risk assessment should be ascertained
within the context of an overall risk assessment that includes
questions about seat belt use, domestic violence, and other health
issues.
A comprehensive risk assessment related to HIV, STIs, and
hepatitis should focus on:
• Substance use risks
• Sexual risk
• Clinical indicators of risk
The following general recommendations can be applied during
each part of the risk assessment:
• Start with less threatening topics. “How often do you use
alcohol or tobacco?” before “Do you inject drugs?” and
“When did you start having sex?” before “Have you ever
exchanged sex for money, drugs, or a place to sleep?”
• Be non-judgmental.
• Be aware of your word choices.
o Avoid pejorative words such as “junkie,” “promiscuous,”
“unfaithful,” etc.
o Labels such as “gay” or “homosexual” may not apply to
individuals who have same-sex sex but who do not
identify as gay. It is better to use other terms such as “men
who have sex with men” or “women who have sex with
women.”
• Don’t assume anything. For example, being married does not
guarantee that a person is monogamous or heterosexual and
identifying as gay does not guarantee that a person has never
had heterosexual sex.
• Use a variety of questioning techniques to gather
information. Different people respond to different styles.
o Direct questions about a behavior. “Are you sexually
active?” “Do you have sex with men, women, or both?”
“Have you ever injected drugs or other substances?”
o Exploratory questions. “How easy is it to get condoms?”
“Do you have friends who use drugs?”
o Normalizing questions. “Sometimes people have anal
intercourse. Have you ever had anal intercourse?”
o Presumptive questions. “Tell me about your alcohol
use.” “How do you protect yourself from sexually
transmitted diseases?”
Respect a patient’s choice to not answer a question. This
increases the chances that s/he will provide the information at a
later date. “I can see this is uncomfortable for you. Let’s move on.”
At the end of the risk assessment, summarize the patient’s
responses to be sure he/she understood what was said.
Once risks are identified, implement risk reduction interventions
and screen for HIV, STIs, and hepatitis as needed.
4
acceptable, and attainable steps.
Risk Reduction
Risk reduction counseling can educate patients about ways
to change risky behaviors. Risk reduction is a philosophical
base that acknowledges the challenges associated with
behavior change and embraces pragmatic approaches to
this sometimes-difficult process. The risk reduction
approach respects human value and dignity through
nonjudgmental, supportive, and individually focused
interventions that allow patients to make their own
decisions. A central concept of risk reduction is that any
movement toward healthier, safer, or less risky behavior is
positive even if absolute protection is not attained. A risk
reduction approach maintains that behavior change is best
accomplished through a series of small, personally
Clinicians begin to implement risk reduction by helping
patients assess and acknowledge individual risk. Responses
are then used to discuss healthier, safer, and less risky
behaviors that are acceptable to the patient. This tactic
provides a spectrum of choices while reaffirming the
patient’s control over personal life events.
Table 4 reviews sexual- and drug-related HIV prevention
measures from a risk reduction perspective, creating a
continuum from safe (behaviors that eliminate risk) to risk
reducing (behaviors that decrease, but do not eliminate,
risk). Clinicians should provide education and referrals
specific to the patient’s chosen risk-reducing behaviors and
goals. For example, it does little
Table 4. Risk Reduction for Prevention of HIV Infection
good to discuss complete
cessation of substance use with a
Sexual Transmission
Drug Use Transmission
Perinatal
patient who is not ready to quit
Transmission
using drugs. In this situation,
offering strategies to use drugs
SAFE
Abstain from sex.
Don’t use drugs.
Prevent HIV in
in a safer manner (e.g., accessing
BEHAVIOR women.
Limit sex to activities in
Don’t inject drugs: if
sterile syringes and needles or
no risk of
which the penis, vagina,
drugs are used, smoke,
In HIV-infected
changing from injecting to
HIV
mouth, and/or rectum have snort, swallow, or apply
women:
smoking the drug of choice) or
transmission
no contact with the
to oral or rectal mucosa
less often may be more helpful.
• Use birth
partner’s penis, vagina,
instead.
control to
And, because transmission from
mouth, and/or rectum
Use only clean
prevent
HIV-infected drug users to their
(outer-course).
equipment that has not
pregnancy.
sexual partners is a common
Have sex only in a
been used by anyone
• Terminate
route of infection, all counseling
mutually monogamous
else. This includes
pregnancy.
to drug users should include
relationship with an
needles, cookers, pipes,
information about safer sexual
uninfected partner.
straws, etc.
practices.
RISK
REDUCING
BEHAVIOR decrease but
do not
eliminate
risk
Use barriers consistently
and correctly:
• Oral intercourse on
male: use nonlubricated condoms.
• Oral intercourse on
female: use dental
dams, plastic wrap, or
condoms that have been
cut open.
• Vaginal intercourse:
use male or female
condoms.
• Anal intercourse: use
male condoms or
female condoms with
inner ring removed.
Engage in care for HIV
infection:
• Establish and adhere to
effective ART regimen
to lower viral load
Clean used injecting
equipment before use:
• Rinse used needle
and syringe with tap
water.
• Fill syringe and
needle with fullstrength bleach,
shake for 30 seconds,
squirt bleach out;
repeat twice.
• Rinse twice with tap
water.
• Do not reuse or share
bleach or rinse water.
Engage in care for HIV
infection:
• Establish and adhere
to effective ART
regimen to lower
viral load
Plan pregnancy
when mother’s
viral load is low
and the CD4+ T
cell count is
relatively high.
Treat HIV-infected
mother with
appropriate ART
during pregnancy,
labor, and delivery;
consider elective
Cesarean section,
especially if viral
load is detectable;
treat newborn after
birth (see DHHS
treatment
guidelines for
pregnancy).
Testing
Approximately one in five
persons with HIV infection in the
United States is unaware of
being infected and, unfortunately,
many patients are still diagnosed
late in the course of the disease;
indeed, many who are newly
diagnosed with HIV progress
to AIDS within 1 year. Early
detection of HIV infection is
important: it allows infected
people to enter into treatment
and helps to reduce the risk of
HIV transmission and new
infections. In 2006, the CDC
published revised
recommendations for HIV
testing, with the goal of
increasing the number of people
5
who were aware of their HIV status. Please note that when
state laws and individual facility policies and procedures on
HIV testing do not match current CDC recommendations,
state and individual facility regulations take precedence.
Testing Methods
The most common screening methods for HIV infection
use an enzyme immunoassay (EIA or ELISA), a highly
sensitive, low-cost test that screens for HIV antibodies.
Testing is considered to be either rapid (on site) or
conventional (sent to a reference lab). Figure 2 shows a
graphic depiction of the testing process.
The CDC recommends that voluntary opt-out testing be
part of routine clinical care in all health care settings and
for all patients, regardless of the individual’s risk factors.
Screening should be offered to all individuals ages 13-64,
Rapid HIV tests use whole blood, plasma, or oral fluid to
and especially to patients in treatment for TB, patients
detect antibodies. Specimens are analyzed in an officein care for STIs, women considering contraception or
based lab with appropriate CLIA waiver. Test results are
pregnancy, pregnant women, and women who present in
usually available within 20 minutes. Because patients do
labor with no documented HIV test. Health care providers
not have to return to clinic on another day to receive results,
should inform each patient about the recommendation to
rapid testing increases the number of people who receive
test all patients for HIV. Opt-out testing is recommended.
results. They also increase opportunities for timely access to
In opt-out testing, the patient is informed, either in a verbal
counseling and treatment services. Rapid tests are especially
discussion or in writing, that the test will be performed
helpful in time-sensitive situations, such as a case of
unless the patient declines. Opportunity should be provided
occupational exposure or a woman presenting in labor with
for discussion as requested by the patient. A separate
an unknown HIV status. Although rapid results are accurate
consent form for HIV testing is not recommended; the
enough to provide immediate, preliminary results to the
general consent for medical care is sufficient. For those
patient, positive results should be confirmed with a more
individuals at high risk for acquiring HIV, testing is
specific test, such as a Western Blot or immunoflourescence
recommended on at least an annual basis. Individuals at
assay (IFA). This will require a blood sample and off-site
high risk for aquiring HIV include IDUs and their sex
laboratory analysis.
partners, people who have sex with more than one partner
or whose sex partner has sex
Conventional EIA tests
with more than one partner,
(non- rapid) can be done on
Figure 2. HIV Testing Protocol
people who exchange sex for
oral fluid, blood, or urine.
drugs or money, and sex partners
Results may not be available
HIV-1/HIV-2 Antibody Test by
of individuals known to have
ELISA
for several days to weeks,
If concerned
HIV.
about acute
depending on the reference
HIV infection,
lab used. If the EIA is
Universal screening has been
consider HIV
positive for HIV antibody,
RNA testing.
routinely implemented for
Negative
it should also be confirmed
all blood donors, and has
Positive
by a more specific test,
almost completely eliminated
such as the Western Blot
the risk of acquiring HIV
or IFA, before concluding
With
recent
through transfusions. Likewise,
risk exposure,
that the patient is infected
Confirm w/
Negative
testing for HIV infection has
retest with HIV
Western Blot or IFA
with HIV. The lab will
ELISA up to
become the standard of care
generally complete this step
6
months
after
for pregnant women, allowing
exposure
on the original specimen
these women to make informed
before reporting back to the
decisions about clinical care and
Positive
Indeterminate
provider who ordered the
Retest for HIV antidramatically reducing the rate of
body or HIV RNA;
test.
perinatal transmission.
consider risk factors
for HIV-2
HIV Infection
If Western Blot or IFA
Systems need to be in place
results are negative
at testing centers to provide
or indeterminate, it is
appropriate follow-up care
recommended that the test
by linking newly diagnosed and high-risk individuals to
be
repeated
4
weeks
after
the
initial
test or, if there is high
treatment and prevention services. Linking individuals
risk
for
HIV
infection,
to
immediately
test for HIV RNA,
to care early in the course of the disease is beneficial for
which
will
diagnose
HIV
based
on
viremia.
RNA tests
the health of the individual as well as for the health of
are
expensive
and
should
only
be
used
after
indeterminate
the community. The majority of PLWH change their risk
screening test results in the context of likely infection. An
behavior profiles after they become aware of being infected,
HIV screening test that detects both antibodies and p24
and this behavior change can lead to a dramatic reduction in
antigen, a protein from the virus, has been recently licensed.
new infections.
It is known as the 4th generation HIV assay, and it has the
6
potential to enhance the sensitivity of screening for patients
who are in the earliest stages of HIV infection.
• Discuss ways to limit transmission of the disease to
others.
• Discuss ways to avoid exposure to other infectious
Appropriate recommendations for further testing and risk
diseases, including TB, hepatitis, and STIs.
prevention depend on an understanding of the testing
• Review safer sexual and drug use practices.
“window period” and the patient’s risk history. Rapid and
• Encourage patients to disclose to high-risk contacts
conventional screening tests for HIV detect antibodies
who may also need to be tested. Offer anonymous/
rather than actual virus (antigen) and may, therefore,
alternate methods for disclosure, especially when the
not detect a recent infection. It takes 2-12 weeks after
patient feels there are dangers with disclosure.
infection for the individual’s immune system to produce
• Set up a return appointment within 1 to 3 weeks to
enough antibodies to register a positive test result. During
initiate care, continue education, and, if possible, be
the window period, a negative test does not rule out HIV
connected with a specialist.
infection. In fact, recently infected people usually have high
levels of viremia, and are at greater risk of infecting others
When negative test results are delivered, the risk for false
even while testing negative for HIV. People who have
negative results, based on the window period and assessed
had a potential for or an actual exposure to HIV should
risk for the individual, should be discussed. High-risk
be encouraged to take precautions to decrease the risk of
behavior anytime during the previous 6 months will
HIV transmission during the
The window period is the time
indicate the need for another HIV test in 4 weeks to 3
window period. A negative
between infection with HIV and
months. Reinforcing ways to reduce risk behaviors is
test in a person with a recent
having enough HIV antibodies to
also appropriate.
exposure or continuing risk
be detected through testing.
should, therefore, have a repeat
test in a few weeks. In settings
where recent infection is a significant concern, diagnostic
Suicide assessment. It is important to determine
testing for acute HIV infection via plasma RNA testing
the suicide risk of an individual newly diagnosed with HIV
should be ordered.
and throughout the course of care, as the rate of suicide is
Communicating test results. According to the
2006 CDC recommendations for HIV testing, all patients
should be provided with oral or written information
about HIV testing, the meaning of positive and negative
test results, how results will be communicated, and an
opportunity to ask questions. The CDC recommends
testing without risk assessment and prevention counseling,
especially in busy clinical settings where time is a barrier
to testing. However, testing may provide an opportunity for
discussions about HIV, transmission, risk, and prevention.
If the patient refuses the test, this should be documented in
the medical record, and testing should be offered at the next
clinic appointment.
Test results should be discussed in private to insure patient
confidentiality. Post-test counseling is recommended for
every positive result and should take place when results are
delivered. A positive test result can be difficult to disclose
and clinicians should be prepared for an emotional response
from the patient. Some patients become understandably
distressed about a positive test and it is appropriate to assess
support systems (e.g., friends, family, access to mental
health services) and to make referrals as needed. Post-test
counseling should be individualized to the patient, but
needs to include the following:
three times higher in PLWH than the general population.
A pre-existing psychiatric illness increases an individual’s
risk for suicide. It is important to screen for depression and
suicidal ideation when disclosing positive test results and
when establishing care. Previous suicide attempts are strong
predictors of future behaviors, especially during times of
extreme stress. Certain situations are associated with high
stress in HIV, including the time of initial diagnosis and
with signs or symptoms of advancing disease. Biological
and social factors (e.g., state of health, social support)
should be assessed when determining the suicide risk of
someone newly diagnosed with HIV. Alcohol often plays
a role in suicide attempts, and has been documented as a
factor in up to 50% of all cases.
The first step in suicide prevention is to initiate a dialogue
about the patient’s mental wellbeing. Asking a patient
about tendencies or thoughts of suicide does not increase
the risk that someone will attempt suicide and is part of
providing comprehensive care. Referrals are appropriate
when a patient is suicidal, has faced previous challenges
with mental health problems, would like support related
to mental health concerns, or needs additional assistance
adjusting to a diagnosis of HIV infection.
• Remind the patient that HIV infection, while not
curable, is treatable and that many people remain well
for prolonged periods of time.
7
8
Caring for the HIV-Infected
Patient
An understanding of the pathophysiology of HIV is
important when caring for patients with HIV infection.
Knowing about the HIV replication process can help
providers and patients understand the basic principles of
treatment and prevention.
Pathophysiology of HIV Infection
As with all viruses, HIV is an obligate parasite: It cannot
survive and replicate unless it is inside a living cell. HIV is
an RNA virus and it is one of several retroviruses that can
cause human disease. Retroviruses replicate by using an
RNA template to create a DNA strand. Each virion contains
two copies of HIV RNA, enzymes and other proteins
needed for replication, and a viral capsid. The enzymes,
including reverse transcriptase, integrase, and protease,
are the targets for many licensed antiretroviral agents. A
phospholipid bilayer membrane with protein complexes
embedded in the membrane surrounds the viral capsid.
These protein complexes allow the membrane to fuse or
bind to specific receptor sites on cells, including the CD4
receptor and co-receptor sites on CD4+ T lymphocytes.
This binding enables the virus to insert genetic material
and enzymes into the cell. Once inside the cell, viral RNA
is transcribed into proviral DNA with the assistance of
reverse transcriptase. The proviral DNA is then integrated
into the most active regions of the genetic material of the
cell with the help of the enzyme integrase. The proviral
Figure 3. Natural Progression of HIV Infection
Without intervention, viral load will continue to increase as CD4+T
cell counts decline.
CD4+ T Cells
Acute
infection*
Days/Weeks
HIV Viral Load
(HIV RNA)
Years
*Acute HIV infection often manifests as a mononucleosis-like
illness. During this stage, the patient will test negative until sufficient HIV antibodies have been produced.
DNA in the genome then directs viral replication in the
cell. Activation of the cell produces a long strand of viral
RNA that migrates into the cytoplasm of the cell. These
long strands are cleaved into smaller, viable strands with the
assistance of the enzyme protease. New virions containing
RNA and essential enzymes can then be assembled. New
virions bud from the host cell, taking a piece of the cell’s
membrane to form the new viral envelope.
Although HIV can infect several types of human cells,
immune dysfunction results predominantly from the
destruction of helper T cells, more appropriately called
CD4+ T lymphocytes (or CD4+ T cells). These cells
play a pivotal role in the human immune response by
(a) recognizing infectious and neoplastic processes and
(b) secreting cytokines that initiate the body’s defense
mechanisms. CD4+ T cells are targeted by HIV because
they have more CD4 receptor sites on their surfaces than
other cells. The number of CD4+ T cells is the primary
marker for immune function in HIV and is the main
determinant of risk for developing opportunistic disease.
Opportunistic diseases rarely occur early in the course of
HIV disease when the CD4+ T cell count is near normal at
≥ 500 cells/mm³. As the disease progresses and the number
of CD4+ T cells falls, the risk of opportunistic disease
increases. Furthermore, when the CD4+ T cell count falls
below 200 cells/mm³, the patient is considered to have a
diagnosis of AIDS.
HIV is a dynamic disease, with billions of virions produced
daily. During the first few weeks after infection, the virus
replicates rapidly, producing a high level of viremia in the
peripheral blood and other body fluids including vaginal
secretions and semen. During this initial phase, persons
infected with HIV are extremely infectious to others.
Initial (or acute) infection is associated with a significant
drop in CD4+ T cells and an increased viral load. An
immune response is triggered, leading to rapid CD4+ T cell
replacement and HIV-specific antibody production. Most
HIV screening tests detect the presence of these antibodies,
which can take several days to weeks to develop. The viral
load drops as the immune response is established. (See
Figure 3.)
HIV infection is typically a slowly progressing illness.
The effects of the virus are often not seen for several years
even in the absence of treatment. However, HIV is quick
to establish a persistent infection in reservoirs, mostly in
lymphatic tissues. HIV infection will usually progress
over several years, although virulence of the strain of virus
as well as individual host factors may vary the course of
disease. On average, untreated HIV infection will lead
to severe immune suppression and death in 8-12 years.
Clinical manifestations depend on the stage of infection and
the extent of immune dysfunction.
9
AIDS is a specific diagnosis that indicates
progressive or advanced disease. The 1993
AIDS surveillance case definition is still used;
it includes all PLWH with (a) < 200 CD4+ T
cells/mm³, or (b) a CD4+ T cell proportion
(CD4%) < 14% of total lymphocytes, or (c)
one of the other AIDS-defining conditions
listed in Table 5.
Acute HIV Infection
Table 5. Conditions in the 1993 AIDS Surveillance Case Definition
CD4+T cell count of < 200
cell/mm3 or percentage < 14%
Candidiasis of esophagus, bronchi,
trachea, or lungs
Cervical cancer, invasive
Coccidioidomycosis, disseminated
or extrapulmonary
Cryptococcosis, extrapulmonary
Cryptosporidiosis, chronic
intestinal (> 1 month duration)
Cytomegalovirus (CMV) disease
(other than liver, spleen, or nodes)
CMV retinitis (with loss of vision)
HIV encephalopathy
HSV: chronic ulcers (> 1 month
duration); or bronchitis,
pneumonitis, or esophagitis
Histoplasmosis, disseminated or
extrapulmonary
Isosporiasis, chronic intestinal (>1
month duration)
KS
Lymphoma, Burkitt's (or
equivalent term)
Acute HIV infection, also known as acute
retroviral syndrome, primary HIV infection,
or acute seroconversion illness, refers to a
syndrome experienced by many individuals
when they become infected with HIV. During
acute infection, symptoms can range from
mild to severe. Patients may experience
fever, headache, diffuse lymphadenopathy,
arthralgia, diarrhea, pharyngitis, or rash (see
Table 6). This mononucleosis-like illness
usually occurs 2-12 weeks after exposure
to HIV and symptoms can last 2-3 weeks
or longer. Some patients also experience
meningitis or encephalitis. The onset of
symptoms has been shown to coincide with peak viremia.
Lymphoma, immunoblastic (or
equivalent term)
Lymphoma, primary in brain
Mycobacterium avium complex
(MAC), or M. kansasii,
disseminated or extrapulmonary
Mycobacterium tuberculosis
(MTB/TB), any site (pulmonary or
extrapulmonary)
Mycobacterium, other species or
unidentified species disseminated
or extrapulmonary
Pneumocystis jiroveci (formerly
known as P. carinii) pneumonia
(PCP)
Pneumonia, recurrent bacterial (
2 episodes in 12 months)
Progressive multifocal
leukoencephalopathy (PML)
Salmonella septicemia, recurrent
Toxoplasmosis of brain
Wasting syndrome due to HIV
ability of the virus to establish reservoirs in these distant
sites. If diagnosed during this phase, the patient should
be considered for immediate treatment and referral to or
consultation with an HIV-expert provider is encouraged to
assure cutting-edge, evidence-based treatment.
Unfortunately, patients and providers often mistakenly
attribute acute infection and its associated symptoms to
a transient viral infection such as the flu. As a result, few
people with HIV are diagnosed during acute infection.
Diagnosis during the acute stage of infection is also
Acute HIV infection should be included in the differential
important for the public health. Individuals with acute
diagnosis for all at-risk patients who present with a flu- or
HIV infection typically have high levels of HIV in their
mononucleosis-like illness or with unexplained aseptic
blood (often > 1,000,000 copies/mL). During this stage,
meningitis. See Tables 2
blood, semen, and vaginal secretions are highly
Table 6: Signs and Symptoms
and 3 for information on
infectious. Identification of patients with acute
of Acute HIV-1 Infection
patients at risk for HIV
HIV infection provides an opportunity for early
Signs and Symptoms
% of Patients
and areas of key interest
counseling and prevention education, which have
in a risk assessment for
Fever
> 80-90
the potential to reduce risky behaviors and prevent
HIV.
Fatigue
> 70-90
HIV transmission to others.
Diagnosis during acute
HIV infection can
be important to the
individual’s health.
During the first few days
to weeks of infection,
HIV establishes
reservoirs, first in the
local tissues of the
host exposure site,
and then in lymphatic
tissues through systemic
circulation. Treating HIV
early in the infectious
process could limit the
Rash
> 40-80
Pharyngitis
50-70
Myalgia or arthralgia
50-70
Lymphadenopathy
40-70
32-70
Headache
Night sweats
50
Thrombocytopenia
45
40
Leukopenia
24
Aseptic meningitis
Elevated hepatic liver enzymes
21
Oral ulcers
10-20
Genital ulcers
5-15
Adapted from: Kahn, J.O., & Walker, B.D.
(1998). Acute human immunodeficiency virus
type 1 infection. NEJM, 339(1), 33-39.
Tests used to diagnose individuals with acute
HIV infection include the HIV antibody test and
the HIV viral load (HIV PCR) assay (see Part
1). During acute infection, the antibody test is
usually negative because the patient is in the
window period. A patient who tests negative on
initial screening with an ELISA test (see Figure
2) and presents a history of high risk behaviors
and/or symptoms of acute infection, should
be offered an HIV viral load test. If diagnostic
testing is initiated, it is important to have contact
information for the patient and to schedule an
appointment to discuss the test results, which
may not be available for several days. Counsel
patients that they may be highly infectious and
10
that, until results are known, they should minimize the
dependence on tobacco, alcohol, and other recreational
risk of transmission to others. Recommendations will
drugs should be evaluated as well. Addictions can have
vary from patient to patient, but patients who are sexually
serious consequences on the physical and social wellbeing
active should abstain from sex or use condoms and patients
of patients that can ultimately affect outcomes of treatment.
who use drugs should not share drug-using equipment
Patients with active substance abuse issues should be
with others. The clinician who orders the test must be
referred to treatment.
able to initiate counseling or to refer the patient to an
Sexual history. A careful sexual history should
easily accessible professional colleague who can provide
elicit
information about past and current sexual practices,
counseling and education.
protection from STIs, preferred method of
Table 7. Initial History
contraception, current STIs, and the history
After HIV Diagnosis
and treatment of previous STIs. Patients with
Initial Assessment
a diagnosis of HIV infection may have taken
History of previous HIV testing and
considerable sexual risks that have affected their
An individualized treatment plan
test results
physical and emotional health.
for a patient with HIV infection
Past exposure to related infections
is based on medical history,
Hepatitis
Family history. A family medical history
physical exam, and laboratory
Other STIs
can
help to establish an appropriate primary care
TB
analysis. Baseline assessments
screening
program for those infected with HIV.
Other potentially chronic
provide information that will help
Questions
should elicit information regarding
infections such as
to determine treatment options.
risks
for
early
development of malignancies,
histoplasmosis,
As with any patient, health care
cardiovascular
disease, and atherosclerotic
coccidiodomycosis
maintenance is an important aspect
disease.
A
history
of myocardial infarction in a
History
of
recurrent
infections
of ongoing care.
first-degree male relative before the age of 55
such as pneumonia, vaginal
and before the age of 65 in a female relative
candidiasis
History of present illness,
helps to determine cardiovascular risk factors.
History
including:
Weight loss, fever, chills, night
sweats
Changes in mentation
Headaches
Changes in vision
Pain in mouth, pharynx
Difficulty swallowing
Shortness of breath, cough,
chest discomfort
Diarrhea, nausea, vomiting
Numbness, tingling, weakness
in extremities
Changes in skin/rash
Vaginal or urethral discharge,
lesions, or dysuria
Rectal/anal lesions or bleeding
Medical history. A
comprehensive medical history
should be completed at the initial
visit. A focused history of the
patient’s HIV infection (including
identification of risk factors, date
of positive HIV test, history of
negative HIV tests, history of
signs and symptoms of acute HIV
infection, history of treatment
with ART, adverse effects of
ART, and any history of OIs or
other infections, including HBV
infection and HCV infection) is
needed. For patients with a history
of HIV treatment, information
about previous CD4+ T cell counts and viral loads is useful.
A focused review of symptoms is important at every visit
to elicit signs and symptoms of HIV infection or OIs. Acute
and chronic health conditions need to be identified and a
family medical history should be obtained as well. Table
7 lists some important questions to ask during the medical
history.
Social history. A thorough social history, including
housing, finances, employment, and social support, should
be obtained. These factors may affect the patient’s ability to
access care and to adhere to treatment.
Substance Use History. Substance use and
Physical Examination
A complete physical examination is required
for all patients with a diagnosis of HIV
infection, even if no symptoms are present.
Immunodeficiency may allow infections to
become established without early symptoms.
Careful inspection of the oral cavity, skin, and
lymph nodes is especially important. Table
8 lists important physical findings in PLWH,
along with their potential causes. Because
HIV is a chronic disease, it is also necessary to
continue all age-appropriate screening exams.
Laboratory Tests
Of the many laboratory tests used to support diagnosis and
therapy in HIV infection (see Table 9), two are critical:
the HIV viral load assay and the CD4+ T cell count. The
combination of HIV viral load and CD4+ T cell testing
provides the best information for initiating, monitoring,
and changing ART. The HIV viral load indicates the level
of virus circulating in the blood and the ability of the virus
to multiply. The CD4+ T cell count measures the ability of
the immune system to protect the body from infections. For
both tests, it is important to use the same laboratory test
over time and, if possible, to avoid testing on days when the
patient is acutely ill.
11
Table 8. Physical Examination
of the HIV-Infected Person
System
General
Skin
Oral
Mucosa
Eyes
Chest
Anogenital
Nodes
CNS
Physical Signs
Weight loss,
cachexia, fever,
chills, fatigue, night
sweats
Pigmented lesions of
recent onset,
ulceration, erythema,
exfoliation
Whitish plaques,
ulceration, poor
dentition, pigmented
lesions
Diminished
peripheral vision,
retinitis, changes in
visual acuity,
funduscopic
abnormalities
Cough, fine rales,
tachypnea, cyanosis,
hemoptysis,
abnormal chest x-ray
Ulceration, fissures,
discharge, lesions
Enlargement,
especially
noninguinal
Dementia, focal
deficits, meningitis
Potential Etiology
HIV infection, OI, or
malignancy
KS, HSV infection,
varicella zoster virus
(VZV) infection,
impetigo, seborrheic
dermatitis, folliculitis,
xeroderma
candidiasis, HSV, KS,
oral hairy leukoplakia
(OHL), gingivitis
CD4+ T cell count. The CD4+ T lymphocyte count is
the best marker for the immune deficiency associated with
HIV infection. The absolute CD4+ T cell count reflects the
number of CD4+ T cells/mm³; the percentage of CD4+ T
cells is a subset of all lymphocytes (CD4%). Depending
on the laboratory, the normal reference range for an adult
CD4+ T cell count absent of disease would be about 8001200 cells/mm³. The normal range for CD4% will vary
depending on the lab, but > 29% corresponds with a CD4+
T cell count > 500 cells/mm³ and < 14% (which qualifies as
an AIDS diagnosis) corresponds with a CD4+ T cell count
< 200 cells/mm³. The absolute CD4+ T cell count can vary
in the same individual depending on the time of day the
blood is drawn, the laboratory used, the presence of acute
illness, or other factors. Concomitant medication, such as
corticosteroids or interferon, can also lower the CD4+ T cell
count.
CMV retinitis, syphilis,
HSV retinitis/uveitis,
VZV retinitis, syphilis,
HIV retinopathy
bacterial, viral, atypical,
or fungal pneumonia;
PCP; TB; pulmonary
KS; CMV pneumonitis
Candidiasis, syphilitic
chancre, HSV infection,
human papillomavirus
(HPV) infection
MAC, lymphoma, TB,
HIV infection
PML, toxoplasmosis,
lymphoma, syphilis,
cryptococcosis
HIV viral load testing (HIV RNA Assay). Viral
replication in HIV infection is rapid and continuous. From
the time of infection, billions of new viral copies are
produced daily. HIV viral load is a quantitative measure
of HIV viral RNA in the plasma. A stable level or set
point occurs after primary infection and remains relatively
constant in the absence of disease progression, therapeutic
effect, and/or disease exacerbation. Plasma HIV RNA
quantitation is the best determinant of treatment efficacy,
and is also related to the level of infectivity. Several
different assays are currently available to measure plasma
HIV RNA. While correlation between plasma HIV RNA
levels is high between methods, each is a distinct technique
with different reference standards. Each technique has
a different definition of “undetectable,” none of which
indicate a total absence or clearance of virus. Providers
should become familiar with the assay most frequently used
in their laboratories.
Table 9. Initial Laboratory Evaluation
of the HIV-Infected Person
The Basics
CBC with differential
Platelet count
Chemistry profile (with
LFTs, BUN, and creatinine)
PPD test or IGRA
Cervical pap smear
Lipid profile and blood
glucose
Chlamydia and gonorrhea
testing as appropriate
Urinalysis
HIV Specific Tests
CD4+ T cell count (absolute
and percentage)
HIV viral load (HIV plasma
RNA)
HIV resistance testing
(genotype at baseline and
change of therapies,
phenotype in treatmentexperienced patients prior to
changing therapy)
Screening for Hepatitis
Co-infection
Hepatitis A: Hep A Ab
Hepatitis B: HBsAb,
HBsAg, HBcAb
Hepatitis C: Hep C Ab
Screening for OIs &
Other Infections
PPD or IGRA
AFB blood cultures*
Screening for STIs
Syphilis serology**
Toxoplasma serology
G6PD***
Other Testing to Guide
ART
Tropism assay (only
if use of maraviroc is
being considered)
HLA-B*5701 testing
(if use of abacavir is
being considered)
*Consider testing for MAC if CD4+ T cell count < 50
cells/mm3
** Baseline syphilis testing is important in areas of high
prevalence. If positive, consult expert guidelines regarding
treatment and CSF examination if indicated.
***Consider testing in high-risk populations, including
Mediterranean or African descent
12
HIV resistance testing. Resistance to antiretroviral
medications is a major clinical concern. Resistance leads to
treatment failure and the risk of transmitting drug-resistant
virus. Resistance testing is used to determine the presence
of a drug-resistant strain of HIV in order to prevent the
use of medications likely to be ineffective. Two types of
laboratory assays are available to help determine resistance:
(a) genotypic resistance testing identifies mutations in the
genetic code of HIV that are associated with drug resistance
and (b) phenotypic resistance testing determines if the
patient’s HIV can replicate in the presence of specific
antiretroviral agents (similar to antibiotic sensitivity
testing). Baseline resistance testing with a genotype is
recommended before the initiation of ART and is ideally
performed during the patient’s initial visit. If ART is
deferred, genotypic resistance testing should be repeated
prior to starting therapy.
Additional Laboratory Evaluation. Laboratory
tests should be used to identify HIV-related complications
or co-infections (syphilis serology; tuberculin skin test
or interferon gamma release assay [IGRA]; gynecologic
exam with Pap smear; hepatitis A, B, and C virus serology;
and toxoplasmosis IgG serology). Baseline metabolic
parameters, including a fasting lipid panel should also be
obtained. Other tests should be performed as clinically
indicated (e.g. chest x-ray, ophthalmologic exam). Prior to
initiating a regimen containing abacavir, a patient should
be screened for HLA-B*5701. This mutation is associated
with a hypersensitivity reaction to abacavir; any patient
who is HLA-B*5701 positive should, therefore, not receive
abacavir and should have abacavir listed as a drug allergy.
A tropism assay is also needed prior to starting therapy with
the CCR5 antagonist, maraviroc, as this medication is only
effective if the patient has a CCR5-using HIV strain.
Figure 4. Proportion of HIV-Infected Individuals
in the United States at Each Stage of Care
Treatment options for HIV infection have advanced rapidly
since 1995. Today’s ART has fewer side effects than
older regimens. In addition, the dosing of ART has been
simplified to either once or twice daily regimens, and the
majority of patients are able to successfully tolerate and
adhere to their ART regimens. PLWH with a comprehensive
treatment plan can live for many years and most have the
potential to live normal life spans. Despite advances in
treatment, of the 1.1 million PLWH in the United States,
only 28% are in consistent care, on an ART regimen, and
have a suppressed viral load (see Figure 4). These data
imply that the existence of effective combination ART is
necessary, but not sufficient, for treatment success. Other
requirements for success include access to care, retention in
long-term care, consistent access to ART, and the ability to
adhere to the treatment protocol.
ART has been shown to slow disease progression and
to improve survival and quality of life for PLWH. The
goal of ART is to decrease viral replication for as long as
possible, thus reducing the chance of viral mutations and
drug resistance. Combination drug regimens have proven
effective in dramatically reducing the quantity of circulating
virus in the blood, often to levels below detection by most
lab assays. It is important to note, however, that not all
patients can tolerate or adhere to combination therapies, and
10-20% or more of patients will not be able to achieve the
goal of an undetectable viral load.
It is also important to remember that an undetectable viral
load does not mean the virus has been eliminated nor that
the patient is cured. “Below the level of detection” indicates
that the viral load in a peripheral blood sample is too low
to be detected with current tests. It does not reveal the
level of HIV that remains in the tissues. The initiation of
ART should be based on the patient’s clinical presentation,
potential for disease progression, treatment history, desire
to start lifelong therapy, and understanding of adherence
parameters. See Table 10 for a list of the benefits and risks
of early initiation of ART.
100%
80%
40%
62%
20%
41%
480.395
60%
426,590
725,302
1,178,350
80%
941,950
100%
Antiretroviral Therapy
36%
328,475
28%
0%
infected
diagnosed
care
care
viral load
<200 copies/mL
Source: CDC
13
Table
10.10.
Benefits
andand
Risks
Table
Benefits
Risks
of Early
HIV
Treatment
of Early HIV Treatment
Potential Benefits
Potential Benefits
• Maintain higher CD4+ T cell count and prevent potentially
• Maintain higher CD4+ T cell count and prevent potentially
irreversible damage to the immune system
irreversible damage to the immune system
• Decrease risk for HIV-associated complications that occur
• Decrease risk for HIV-associated complications that occur
more often at CD4+ T cell count > 350 cells/mm (TB, certain
more often at CD4+ T cell count > 350 cells/mm (TB, certain
malignancies, and HIV-associated cognitive impairment)
malignancies, and HIV-associated cognitive impairment)
• Decrease risk of non-opportunistic complications, including
• Decrease risk of non-opportunistic complications, including
CVD, renal disease, liver disease, malignancies, and
CVD, renal disease, liver disease, malignancies, and
infections
infections
• Decrease risk of HIV transmission to others
• Decrease risk of HIV transmission to others
Potential Risks
Potential Risks
• Treatment-related side effects and toxicities
• Treatment-related side effects and toxicities
• Drug resistance with incomplete viral suppression, resulting in
• Drug resistance with incomplete viral suppression, resulting in
loss of future options for therapy
loss of future options for therapy
• Increase total time on medication with greater chance of
• Increase total time on medication with greater chance of
treatment fatigue
treatment fatigue
• Transmission of drug-resistant virus by patients who do not
• Transmission of drug-resistant virus by patients who do not
maintain full virologic suppression
maintain full virologic suppression
Antiretroviral Recommendations
With the advent of combination treatment regimens, ART
has become quite complex. A panel of experts periodically
publishes revised principles and recommendations for
treatment of HIV infection. The Guidelines for the Use
of Antiretroviral Agents in HIV-1 Infected Adults and
Adolescents recommend that clinicians with limited HIV
care experience seek the consultation of clinicians with
more experience in this complex and rapidly evolving field.
Most primary care clinicians use consultation services
for other complex disease processes and this is a critical
component of HIV care.
Specific guidelines (Public Health Service
Recommendations for Use of Antiretroviral Drugs in
Pregnant HIV-1 Infected Women for Maternal Health and
Interventions to Reduce Perinatal HIV-1 Transmission
in the United States) are also available for using ART
in pregnant women and for prevention of perinatal
transmission.
Refer to the guidelines for concerns and specific issues
regarding the use of ART in patients with drug resistance
or in specific populations including adolescents; IDUs;
patients who are co-infected with hepatitis B, hepatitis C, or
TB; and women of child-bearing age. Complete principles
and guidelines are available from the AETCs and other
resources (see resources section). Federal HIV Guidelines
can be accessed at http://www.aidsinfo.nih.gov/guidelines
Initiating ART: Acute HIV Infection
Clinicians and patients should be aware that therapy for
acute HIV infection is based on theoretical benefits and
is, therefore, optional. Potential benefits and risks of
treating acute HIV infection should be considered prior to
initiating therapy (see Table 11). If the clinician and patient
choose to treat acute HIV infection, resistance testing
prior to treatment is recommended. The goal of therapy
should be to suppress plasma HIV RNA levels to below
detectable levels. Routine testing for plasma HIV RNA
levels, CD4+ T cell counts, and toxicity screening should be
performed as with other patients on ART. As with all ART
regimens, consultation with an HIV-experienced clinician is
recommended.
Initiating ART: The Chronically HIV-Infected
Patient
Starting or changing therapy should be based on clinical
status, HIV viral load assays, HIV resistance testing, CD4+
T cell counts, and individual patient issues. Viral load tests
should be performed within the first 2-8 weeks of therapy to
assess effectiveness.
Table
11.11.
Potential
Benefits
andand
Risks
Table
Potential
Benefits
Risks
of Treating
Acute
HIV
Infection
of Treating Acute HIV Infection
Potential Benefits
Potential Risks
Potential Benefits
Potential Risks
Reduce viral replication
Drug toxicities
Reduce viral replication
Drug toxicities
Reduce symptoms of acute
Drug resistance
Reduce symptoms of acute
Drug resistance
HIV infection
Need for continuous
HIV infection
Need for continuous
Alter viral set point, affecting
therapy
Alter viral set point, affecting
therapy
progression
Adverse effect on
progression
Adverse effect on
Reduce rate of viral mutations
quality of life
Reduce rate of viral mutations
quality of life
Reduce risk of viral
Reduce risk of viral
transmission
transmission
Reduce immunologic damage
Reduce immunologic damage
Adapted from: Guidelines for the Use of Antiretroviral Agents
Adapted from: Guidelines for the Use of Antiretroviral Agents
in HIV-1-Infected Adults and Adolescents. Available at
in HIV-1-Infected Adults and Adolescents. Available at
http://www.aidsinfo.nih.gov/guidelines
http://www.aidsinfo.nih.gov/guidelines
Nearly all individuals with HIV infection are candidates
for treatment, if desired by the patient. Current guidelines
for initiating ART are outlined in Table 12. Early treatment
may be considered based on the patient’s individual risk for
immunologic decline, disease progression, and motivation
to begin therapy. Decisions regarding the initiation of ART
must be individualized to the patient after appropriate
patient education regarding disease stage, drug side effects,
long-term toxicity, co-morbidities, and adherence issues.
Regardless of CD4+ T cell count, current guidelines
also recommend ART be initiated in several conditions
including: pregnancy, an AIDS-defining condition, chronic
co-infection of HBV or HCV, and if there are signs of
HIV-associated nepropathy. ART is also used to limit
transmission in serodiscordant couples.
14
Table 12. Indications for Initiation of Antiretroviral Therapy for HIV-1 Infection
This table provides general guidance rather than absolute recommendations for an individual patient. Before initiating therapy,
patient counseling and education should be provided with a focus on the benefits and risks of therapy, adverse effects, and adherence.
Clinical Conditions
•
•
•
•
•
•
•
•
•
All HIV-infected individuals*
History of AIDS-defining illness**
Pregnant women***
Persons with HIV-associated nephropathy
Persons co-infected with hepatitis B virus
(HBV), when HBV treatment is indicated
(Treatment with fully suppressive antiviral
drugs active against both HIV and HBV is
recommended.)
Recommendations
ART should be initiated.
*Treatment is recommended for all HIV-infected individuals. All decisions regarding initiation of antiretroviral therapy should
include evaluation of immune suppression as determined by the CD4+T cell count and clinical presentation, the potential benefits
and risks of starting treatment, and the willingness of the patient to commit to lifelong antiretroviral therapy.
**AIDS-defining illness per CDC, 1993
***For women who do not require ART for their own health, consideration can be given to discontinuing antiretroviral drugs
postpartum. For more informatioin, please refer to the Public Health Service Reccomendations for Use of Antiretroviral Drugs
in Pregnant HIV-1-Infected Women and Interventions to Reduce Perinatal HIV-1 Transmission in the United States.
Table adapted from Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents; DHHS
March 27, 2012, available at http://aidsinfo.nih.gov/guidelines
Inflammatory Response
Treatment of patients with ART who have an underlying,
recognized or unrecognized OI, can occasionally elicit an
inflammatory response. This syndrome, often referred to as
immune reconstitution syndrome or immune reconstitution
inflammatory syndrome (IRIS), presents with a fever and
worsening of OI symptoms weeks after starting ART.
Use of non-steroidal anti-inflammatory drugs (NSAIDS)
or corticosteroids can help alleviate this inflammatory
reaction.
Medication Adherence
Adherence to treatment regimens is an important
therapeutic concern. Incomplete adherence can lead
to treatment failure, drug resistance, and the risk for
transmission of drug-resistant virus, making this a critical
topic for patient education. Patient readiness is key to
medication adherence, and it is important to allow the
patient time to make the decision to initiate therapy.
Treatment regimens have become much easier in recent
years (once- or twice-a-day dosing, fewer pills, fewer side
effects), but adherence to what will be a life-long course of
therapy is still difficult for many patients.
Medication adherence can be a challenge for even the most
motivated patients. While 100% adherence is optimal,
missed doses should be an expected part of treatment.
Clinical studies indicate that best results are achieved with
adherence rates of > 95%. PLWH who choose to initiate
ART will need continuous support to maintain therapy.
Judgmental and punitive approaches to less-than-optimal
adherence should be avoided, as they are likely to decrease
the patient’s willingness to share accurate information with
the clinician. Table 13 lists some factors to consider when
addressing adherence concerns with a patient. Adherence
interventions should be individualized and consistent with
the current treatment guidelines.
Currently Available Antiretroviral Drugs
Many antiretroviral agents are now approved for use in the
United States, with more in development. Antiretroviral
drugs fall into 6 classes: nucleoside/nucleotide reverse
transcriptase inhibitors (NRTIs/NtRTIs), non-nucleoside
reverse transcriptase inhibitors (NNRTIs), protease inhibitors
(PIs), integrase inhibitors, and two types of entry inhibitors:
fusion inhibitors and CCR5 antagonists (see Appendix B).
15
Nucleoside/Nucleotide Reverse Transcriptase
Inhibitors (NRTI/NtRTIs)work at an early stage in viral
replication. They block reverse transcriptase, an enzyme
required for the virus to multiply, by mimicking nucleosides
or nucleotides in the growing DNA chain. Once the DNA
chain is terminated, the individual virus can no longer
replicate, and damage to the immune system is slowed.
NRTIs are the cornerstone of combination therapy.
Non-nucleoside Reverse Transcriptase
Inhibitors (NNRTI) also block reverse transcriptase.
Resistance develops quickly to NNRTIs when used
alone, making it extremely important that they be used in
maximally suppressive combination therapies. NNRTIs are
often used in combination with NRTIs.
Protease Inhibitors (PIs) work against HIV in a late
stage of the viral replication process by interfering with the
protease enzyme’s ability to make new copies of HIV, thus
producing viruses that are incapable of infecting new cells.
The PIs, when used in combination with other antiretroviral
agents, offer potent anti-HIV activity.
Entry Inhibitors prevent HIV entry into the target
cell through a variety of mechanisms. Enfuvirtide (T20), a
fusion inhibitor, interferes with the process of viral binding
(fusion) to the cell membrane by binding to proteins on
the surface of the cell, which then prevents the virus from
binding to the target cell. Maraviroc (MVC) prevents entry
by blocking CCR5, a co-receptor on the cell, necessary for
viral attachment. This drug is a CCR5 antagonist. Some
viral strains use CXCR4, an alternate co-receptor, for entry.
A tropism assay is needed to confirm that the patient’s virus
uses only CCR5 for entry.
Integrase Inhibitors block viral replication by
preventing the incorporation of viral DNA into the host
genome. Integrase inhibitors decrease the ability of
the enzyme integrase to facilitate this vital step in HIV
replication.
Investigational antiretroviral therapies. The list
of antiretroviral agents continues to grow as clinical trials
provide new options for treatment. Information on clinical
trials can be obtained from resources listed in the back of
this sourcebook.
ART Regimens
Combination therapy with at least 3 active antiretroviral
agents is currently recommended for HIV treatment.
Preferred and alternate regimens are outlined in Table
14. Patients need to be aware that multi-drug regimens
function as a whole, and that missing or stopping any of the
medications can seriously jeopardize treatment
Table 13. Medication Adherence
Strategies to increase adherence
Establish patient-provider rapport
Educate and review goals of treatment, significance of labs
(CD4+ T cells and viral load), and issues of resistance in the
context of adherence
Assess and monitor for depression, active drug or alcohol
use, and other mental health issues
Inquire routinely about social issues including housing,
employment, and relationships
Ask which medications the patient is taking and how they
are taken at each appointment (use pictures of medications
whenever possible)
Ask about missed doses at each appointment and why doses
were missed
Do not be punitive or judgmental about missed doses,
instead, use it as an opportunity to strategize with the
patient
Use pill boxes, monitor prescription refills, and/or consider
pill counts if patient agrees
Integrate HIV medications into the patient’s daily routines
Simplify regimens whenever possible
Prepare patient for potential side effects
Ask about issues of cost and access to medications
Consider eliciting the help of a pharmacist and make other
referrals as appropriate
Use peer educators and/or treatment advocates
Major factors that decrease adherence
Mental health issues
Active dependence on drugs and alcohol
Undesirable or intolerable side effects
effectiveness and future options. Complex decisions
about when and how to initiate ART are best made during
clinician-patient interactions. A careful assessment of
patient readiness, goals, barriers, support, ability to adhere
to treatment, and clinical status are important in this
process. Providers with limited HIV experience should
consult a specialist before initiating therapy.
Not all patients can tolerate, adhere to, or achieve an
undetectable viral load with combination therapy. Partial
viral suppression (i.e., more than one-half log reduction
in viral load) has been shown to provide clinical benefit,
although partial suppression supports the development
of drug resistance that can ultimately lead to treatment
failure and disease progression. Monotherapy and dual
therapy provide only partial suppression over time and
are, therefore, not recommended. Factors that contribute
to resistance include pre-existing resistance, inappropriate
drug combinations, previous exposure to ART agents
(especially in partially suppressive regimens), and patient
non-adherence. Specific recommendations regarding dosing
considerations are discussed in Appendix B.
16
Drug interactions can occur between many of the
antiretroviral agents. Assessments for toxicities
should be ongoing. See the guidelines or consult a
specialist for details on drug interactions.
Evaluating Therapy
Response to treatment should be assessed 2-8 weeks
after initiation of ART with a CD4+ T cell count and
viral load analysis. Adjustments should be made if
the viral load does not decrease during that time
period. Fully successful regimens should reduce
HIV levels to undetectable within 4-6 months.
Viral loads should be monitored every 3-4 months
in the stable patient. Current viral load assays may
detect small amounts of virus in some patients;
these low levels may not be indicative of risk for
treatment failure. Virologic failure is defined in the
DHHS guidelines as a confirmed and sustained HIV
viral load of greater than 200 copies/mL. CD4+
T cell counts are generally measured at the same
time. Monitoring intervals are recommendations;
individual circumstances may require flexibility.
Table 14. ART Regimens Recommended
for Treatment of HIV-1 Infection in ART-Naïve Patients
Regimens are based on combination therapy, and generally contain 1
NNRTI with 2 NRTIs – OR – a single ritonavir-boosted PI with 2 NRTIs
Preferred Regimens (adapted from DHHS 2011 Guidelines Table 5a)
Preferred regimens for non-pregnant patients are arranged by order of
FDA approval of components other than nucleosides, thus, by duration of
clinical experience. Recommended dosing regimens illustrated.
NNRTI-based regimen:
EFV (QD) efavirenz
PI-based regimens:
ATV/r (QD) atazanavir + ritonavir
DRV/r (QD, if ART naïve) darunavir + ritonavir
+
TDF/FTC
tenofovir/
emtricitabine
Integrase Inhibitor-based regimen:
RAL (BID) raltegravir
Principles for use of ART in pregnant women
• Start prior to second trimester, if possible
• Continue prior regimen if effective and well-tolerated
• Include 1 or more NRTIs with high levels of transplacental passage
• Account for teratogenicity and results of resistance testing
• Commonly used: LPV/r (BID) + ZDV/3TC lopinavir/ritonavir +
zidovudine/lamivudine
Over the course of treatment, some patients with an
initial good response to therapy may begin to show
*Preferred regimens listed above. Alternative regimens may be considered
decreases in CD4+ T cell counts and increases in
based on resistance profile, tolerability, and patient preference. A list of
HIV viral loads, indicating a failure of the
alternative and acceptable regimens can be found at
therapeutic regimen. Viral load assessments can
http://aidsinfo.nih.gov/contentfiles/AdultandAdolescentGL.pdf
be used as indirect measures of drug failure from
resistance, patient non-adherence, inadequate
Changing therapy can be a complex process, but general
absorption (e.g., due to vomiting or diarrhea), or adverse
recommendations are presented in Table 15. When
drug interactions. Discussions with the patient should
changing or modifying ART regimens, clinicians are
include an honest appraisal of adherence to the medication
urged to be conservative and take the time needed to
regimen and adverse effects. The patient’s medications
make well-informed decisions with their patients based on
should be reviewed to identify or rule out potential drug
treatment guidelines and in consultation and collaboration
interactions that could reduce ART efficacy or exacerbate
with HIV-experienced clinicians. Ideally, a new regimen
adverse effects.
should consist of three or more active drugs from at least
Table 15. Guidelines for Changing an ART Regimen with Suspected Drug Failure
Criteria for changing therapy:
• Suboptimal reduction in plasma viremia after initiation of therapy
•
• After suppression to undetectable levels, repeated detection of viremia > 200 copies/mL •
Declining CD4+ T cell count
Clinical deterioration
Clinical considerations:
• Distinguish between the need to change a regimen due to drug intolerance or inability to adhere vs. failure to sustain viral
suppression.
• Multiple factors should be considered when changing regimens, including results from resistance testing and medication history.
• Resistance testing may provide valuable information as new regimens are considered. Timing of resistance tests is important for
interpretation.
• Although an undetectable viral load is the goal, some patients have limited options for new regimens; in some of these cases it is
rational to continue a prior regimen if partial viral suppression was achieved and if alternatives are limited.
• For patients with limited options (resistance or intolerance), combinations of 4 or more medications are sometimes used.
• Cross-resistance may be seen with a number of drugs in the same class.
• Clinicians with less HIV-care experience should consult with HIV specialists when initiating or adjusting ART regimens.
17
two different classes. Remember: using a “new” agent for
a patient does not always mean it will be effective due to
cross-resistance of medications. Patient ART history, HIV
viral load, and amount of drug resistance all contribute to
decisions regarding management of the failing regimen.
Criteria for the interpretations of genotypic and phenotypic
resistance tests evolve constantly and consultation with an
HIV expert is recommended.
Prophylaxis for Opportunistic
Infections
This section contains general prophylaxis recommendations
for common OIs. Some clinicians also advocate prophylaxis
for a variety of other OIs. Referral to expert clinicians
and review of the DHHS Guidelines is recommended (see
Bibliography). Figure 5 shows CD4+ T cell counts at which
various OIs typically occur.
An effective response to ART provides important protection
Prophylaxis can be discontinued in patients once the
CD4+ T cell count is > 200 cells/mm³ for 3 months. All
patients who have had prior PCP should be on secondary
prophylaxis. The guidelines for secondary prophylaxis may
vary from those of primary prophylaxis and it is best to
refer to the guidelines (see Bibliography). Prophylaxis is
also initiated for any occurrence of PCP with CD4+ T cells
> 200 cells/mm³.
The preferred primary prophylactic intervention for PCP
is oral trimethoprim-sulfamethoxazole (TMP-SMZ), one
double strength tablet QD or one single-strength tablet QD.
For patients with CD4+ T cell counts < 100 cells/mm³ and
positive toxoplasmosis serology, one double-strength TMPSMZ will also provide protection against toxoplasmosis.
If TMP-SMZ cannot be tolerated, alternatives for PCP
prophylaxis include dapsone, aerosolized pentamidine,
or atovaquone. Dapsone should not be administered if a
patient is G6PD deficient.
Approximately 25% of patients will not tolerate TMP-SMZ
and may develop rash, fever, or elevated liver enzymes.
Gradual initiation has been shown to decrease the
incidence of rash. It may be preferred to initiate TMPSMZ prior to starting ART as both interventions may
be associated with adverse events and the etiology may
be difficult to determine if both are started at the same
time.
Some patients will experience bronchospasm following
pentamidine therapy. This can usually be treated
symptomatically, but is occasionally severe enough to
require discontinuation of the drug. Repeated exposure
to pentamidine may be harmful for administering
clinicians. Inhalation therapy should be done in a
respiratory therapy setting that can provide safe
containment of aerosolized and exhaled pentamidine.
Inhaled pentamidine using alternate nebulization
devices for administration is not recommended.
from OIs. In situations where patients do not respond well
to ART, or where the CD4+ T cell count is below certain
thresholds, prophylaxis with other medications is indicated.
In many cases, once immune reconstitution has occurred
and is sustained, prophylaxis can be discontinued. See Table
16 for some of these guidelines.
Pneumocystis jiroveci Pneumonia (PCP)
Primary prophylaxis is intended to prevent the first episode
of PCP and is begun or reintroduced when the CD4+ T
cell count is ≤ 200 cells/mm³ or with a history of PCP.
Prophylaxis should be considered if the CD4+ T cell
proportion is < 14%, or if an AIDS-defining illness occurs.
Herpes Simplex Virus (HSV) Infection and
Varicella Zoster Virus (VZV) Infection
Patients who have frequent or severe recurrences of HSV
may benefit from suppressive therapy with acyclovir,
famciclovir, or valacyclovir. If exposed to chickenpox or
shingles, patients with no previous history of chickenpox
or shingles or without detectable VZV antibody, should
receive prophylaxis with varicella zoster immune globulin
(VZIG). This should be administered as soon as possible
but within 96 hours of close contact with chickenpox or
shingles. Although there is now a zoster vaccine, it is a livevirus vaccine and not currently used in HIV care (see Table
20 in Part 3).
18
Table 16. Prevention of Opportunistic Infections
Infection
P. jiroveci
pneumonia
(PCP)
M. avium
complex
(MAC)
T. gondii toxoplasmosis
Indication to
Initiate
CD4+ < 200
cells/mm³ or
CD4% < 14%,
history of thrush
or AIDS-defining
illness
CD4+ < 50
cells/mm³
Immunoglobulin
G antibody to
toxoplasma and
CD4+ < 100
cells/mm³
M. tuberculosis
(MTB, TB)
Positive PPD, ≥ 5
mm without
active TB or clear
history of
untreated positive
PPD, or + IGRA
*The distinction
between active vs.
latent TB must be
made prior to
initiating
treatment
Herpes simplex
(HSV)
Frequent or severe
recurrences
Indication to
Discontinue
CD4+ > 200
cells/mm³ for >
3 months
Preferred Prophylaxis
Alternate Prophylaxis
TMP/SMZ one double strength
tablet QD
TMP/SMZ one single strength
tablet QD
Dapsone 100 mg QD
Aerosolized pentamidine 300
mg/monthly
Atovaquone 1500 mg QD
CD4+ > 100
cells/mm³ for >
3 months
CD4+ > 200
cells/mm³ for >
3 months
Azithromycin 1200 mg weekly
Clarithromycin 500 mg QD
See guidelines
INH 300 mg QD + pyridoxine
50 mg QD x 9 months not
under direct observational
therapy (DOT)
INH 900 mg twice weekly +
pyridoxine 100 mg twice
weekly, DOT x 9 months
INH 15 mg/kg rounded to
nearest 50 or 100 mg; max 900
mg + rifapentine (≥ 50.0 kg,
use 900 mg) once weekly, DOT
x12 weeks*
*The use of INH +RPT weekly x
12 weeks under DOT is limited to
otherwise healthy PLWH not
currently on ART.
Acyclovir 400 mg BID
Famciclovir 250 mg BID
Azithromycin 5 mg/kg (max
250 mg) QD
Rifabutin 300 mg QD
TMP/SMZ one single strength
tablet QD
Dapsone 50 mg QD +
pyrimethamine 50 mg weekly
+ leucovorin 25 mg weekly
Dapsone 200 mg weekly +
pyrimethamine 75 mg weekly
+ leucovorin 25 mg weekly
Atovaquone 1500 mg QD ±
pyrimethamine 25 mg QD +
leucovorin 10 mg QD
See guidelines
TMP/SMZ one double strength
tablet QD
Mycobacterium avium Complex (MAC)
The incidence of MAC infection increases about 20%
each year after an AIDS-defining diagnosis in patients not
receiving ART with CD4+ T cell counts < 50 cells/mm³.
Individuals with CD4+ T cell counts < 50 cells/mm³ should
be started on primary prophylaxis. Prophylaxis should be
discontinued when CD4+ T cell counts increase to > 100
cells/mm³ for more than 3 months.
Current guidelines recommend prophylaxis for individuals
who meet the above criteria with azithromycin 1200 mg
by mouth once a week or clarithromycin 500 mg by mouth
BID. Many specialists prefer the former because of ease of
Valacyclovir 500 mg BID
dosing, lower cost, and fewer drug interactions with
PIs. Alternatives include rifabutin, or azithromycin plus
rifabutin. Seek consultation when using rifabutin, as its use
is limited by multiple drug interactions.
M. tuberculosis (MTB, TB)
Active TB may develop relatively early in HIV infection
and has a predilection for extrapulmonary sites. Because of
this, any patient with (a) a positive PPD of at least 5 mm
induration, or (b) a positive result on IGRA who does not
have active TB, or (c) a clear history of an untreated
19
positive PPD, should receive treatment for latent TB
infection. This may be accomplished with isoniazid (INH)
daily for 9 months without DOT. For patients where
adherence to a daily regimen is not possible, DOT of INH
twice weekly is an alternative regimen. For individuals
not currently on ART, the use of INH with rifapentine
once weekly with DOT for 12 weeks can be considered.
Pyridoxine should be co-administered with INH because
of the risk of peripheral neuropathy. If there is resistance to
INH, a 4-month regimen of either rifampin or rifabutin may
be used. The decision to use a regimen containing either
rifampin or rifabutin should be made with consideration
of potential drug interactions with ART. The treatment
of resistant latent TB or active TB should be done in
conjunction with a specialist.
T. gondii
Prophylaxis against toxoplasmosis is appropriate for
patients who have antibodies to the organism when CD4+
T cell counts are below 100 cells/mm³. Prophylaxis against
both toxoplasmosis and PCP consists of TMP-SMZ, one
double strength tablet QD. Alternatives include TMP-SMZ,
one single strength tablet by mouth QD; dapsone, 50 mg by
mouth QD plus pyrimethamine, 50 by mouth weekly plus
leucovorin, 25 mg by mouth weekly; or atovaquone, 1500
mg by mouth QD with or without pyrimethamine, 25 mg
by mouth daily plus leucovorin, 10 mg by mouth QD. Once
patients respond to ART and their CD4+ T cell counts are
> 200 cells/mm³ for more than 3 months, prophylaxis can
be stopped. It should be restarted if the CD4+ T cell counts
drops to < 100-200 cells/mm³.
Complications Associated
with HIV Infection and ART
contribute to the problem. Physical body changes are
distressing to many patients, but problems associated with
lipodystrophy are more than cosmetic. Any side effect can
have an adverse effect on adherence to ART, especially
changes that affect body image. In addition, truncal obesity
in uninfected populations is associated with increased
rates of cardiovascular morbidity and mortality (problems
that are also seen in patients with chronic HIV infection),
and dorsocervical fat accumulation (“buffalo hump”) can
compress the cervical spine, resulting in pain and the need
for surgical removal of excess fat.
Lipid Abnormalities
Chronic HIV infection, genetic factors, lifestyle, and
ART all contribute to dyslipidemia in PLWH. Certain
ART medications are associated with increased levels of
triglycerides, total cholesterol, and low-density lipoprotein
(LDL) cholesterol, as well as decreased levels of highdensity lipoprotein (HDL) cholesterol. All patients should
have fasting lipid profiles prior to beginning or changing
ART. Profiles should be repeated 3-6 months after starting
or switching therapy, and annually thereafter. Routine
periodic assessments of these clinical parameters should be
used to guide therapeutic decisions. In general, guidelines
from the National Cholesterol Education Program can
be used to manage dyslipidemia in PLWH. For patients
with dyslipidemia, a combination of therapeutic lifestyle
changes and medication may be needed to reach lipid
goals. Fenofibrate, gemfibrozil, and omega-3 fatty acids
can be used to lower triglycerides. Statins are effective
for lowering LDL, but many statins interact with ART,
especially the PIs. Pravastatin and atorvastatin have the
fewest drug interactions and should be used in patients on
PIs with elevated LDL. Patients should be started on the
lowest dose and monitored carefully for liver toxicity and
rhabdomyolysis.
Various morphologic and metabolic abnormalities have
been described in PLWH. This is a heterogeneous group of
conditions of varying etiologies. Prior to the initiation of
Hyperglycemia and Insulin Resistance
ART, patients should be counseled about potential body fat
Hyperglycemia and insulin resistance are
and metabolic changes. Emphasis should
be placed on the benefit of ART despite the Clinicians should develop and use associated with ART (specifically PIs),
potential for metabolic problems.
consultation and referral systems lifestyle, and genetic factors. Fasting
or random plasma glucose should be
with specialists in HIV care to
assessed prior to starting ART and every
improve diagnosis of HIV-related 3-4 months after initiating therapy.
Fat Redistribution Disorders
conditions and the quality and
When diabetes occurs in the setting of
A variety of morphological changes
HIV treatment, therapy as indicated
quantity of patients’ lives.
related to fat distribution have occurred
in non-HIV clinical settings should be
in conjunction with HIV infection. These
considered and initiated. Diet and exercise
body fat changes can include the loss of subcutaneous fat
regimens can be prescribed, but medications, including oral
in the face, extremities, and/or buttocks, as well as truncal
medications or injected insulin, may be required. Patients
fat and/or dorsocervical fat accumulations. The etiology
with diabetes, dyslipidemia, and hypertension should be
is multifactorial, but ART and long-term HIV infection
treated and ideally meet target levels for diabetics. Refer to
an endocrinologist as needed.
20
Weight Loss
Weight loss is a multifactorial problem related to inadequate
energy intake, metabolic dysregulation, side effects of
medications, malabsorption syndrome, and/or infectious
processes related to HIV and opportunistic diseases. All
PLWH need nutritional assessment and counseling. Referral
to a dietician early in the disease process helps many
patients deal with nutrition issues. Other referrals (i.e.,
for mental health counseling or economic assistance) may
also be needed. If body fat is proportionally low in relation
to total body mass, simply increasing the daily caloric
intake may improve the situation. Dietary supplements and
appetite stimulation agents, such as megestrol acetate or
dronabinol, may be helpful.
Symptom Evaluation
in the HIV-Infected Patient
Diagnosis and treatment of opportunistic conditions
associated with HIV can be difficult. Common causes of
signs and symptoms seen in PLWH are listed in Table 17.
Pulmonary
Manifestations
As a general rule, any pulmonary
symptom, even if mild, warrants
evaluation. The CD4+ T cell
count influences the extent of
the evaluation. Influenza, viral
infections, fungal infections,
mycobacterial infections, and
non-infectious causes, such as
congestive heart failure and
pulmonary embolism, should
be included in the differential
for evaluation of pulmonary
symptoms. A chest x-ray is usually
recommended. It is important
to consider that more than one
pathogen might be present.
Induced sputum samples can aid in
the identification of the infectious
organism. Other conditions, such
as pulmonary KS, will require a
lung biopsy for diagnosis.
Patients with a CD4+ T cell count
below 200 cells/mm³ are at an
increased risk for acquiring PCP.
The introduction of prophylactic
medications and widespread use
of ART has greatly reduced the
incidence of PCP, however, it
remains the most common OI in persons infected with HIV.
The symptoms of PCP are often subacute and include lowgrade fevers, dyspnea, and dry cough. A chest x-ray will
usually reveal diffuse infiltrates. In mild cases, the chest
x-ray may even be normal.
Bacterial pneumonias also occur much more frequently in
this patient population, and often present differently than
PCP. High fever, productive cough, and symptoms with
an acute onset are characteristic of bacterial pneumonia.
A chest x-ray in this case will reveal focal infiltrates. As
there can be several causes of pulmonary symptoms in
persons infected with HIV, evaluation for pulmonary TB
is necessary for both public health and personal health
reasons.
It is appropriate to treat patients empirically for suspected
pulmonary conditions. For a person with a very low CD4+
T cell count and evidence of pneumonia, it is appropriate to
begin empiric treatment for PCP and bacterial pneumonia
while awaiting lab results or making referral arrangements.
In settings when the patient is very ill and diagnostic
procedures are not immediately available, it is appropriate
to begin broad-spectrum empiric coverage for PCP and
bacterial infection (and even fungal infection, if suspected)
until a more definitive diagnosis can be established.
Table 17. Common Causes of Signs and Symptoms in HIV
Cutaneous Diseases
Eosinophilic
Syphilis
folliculitis
KS
Folliculitis
Tinea
“Itchy red bump”
HSV infection
disease
VZV infection
Molluscum
Viral warts
contagiosum
Neurologic Diseases
CMV encephalitis
PML
HIV-associated
Syphilis
dementia
T. gondii
Peripheral neuropathy
encephalitis
Primary CNS
lymphoma
Ocular Diseases
CMV retinitis
Syphilis
HSV infection
VZV infection
Diseases Causing Lymphadenopathy
Disseminated cat
MAC
scratch disease
infection
HIV infection
TB
Lymphoma
Oropharyngeal Diseases
Mucocutaneous
Gingivitis
candidiasis
HSV infection
Aphthous ulcers
OHL
Pulmonary Diseases
Coccidioidomycosis
KS
Lymphoid interstitial
Cyptococcal
pneumonitis in
pneumonia
children
TB
CMV pneumonitis
PCP
Histoplasmosis
Bacterial pneumonia
Diseases Causing Diarrhea
Bacterial pathogenic
Giardiasis
diseases
Isosporiasis
Clostridium difficile
KS
Cryptosporidiosis
CMV colitis
Strongyloidiasis
MAC, disseminated
Esophageal Diseases
Mucocutaneous
HSV
candidiasis
esophagitis
CMV esophagitis
Diseases Causing General Wasting
TB
CMV
Strongyloidiasis
infection
MAC, disseminated
HIV infection
Anal/Perianal and Genital Diseases
Chlamydial infection
HPV infection
Genital warts
Syphilis
Mucocutaneous
HSV infection
candidiasis
Gonorrhea
21
Neurologic Presentations
Ocular Involvement
It is estimated that more than 50% of PLWH develop some
type of neurological disease, causing changes in affect,
behavior, and/or cognition, particularly in late stages of
HIV infection (see Table 18). Neurologic symptoms can,
however, present early in the course of disease and are the
chief presenting complaint in about 20% of cases. Minor
cognitive impairment occurs in 20-40% of HIV-infected
asymptomatic patients; more severe impairment may be
seen in people with AIDS-defining illness.
CMV infection is the most common cause of retinitis
and sight-threatening ocular disease associated with
HIV. It occurs most often in patients with severe
immunosuppression or CD4+ T cell counts < 50 cells/mm³.
The incidence of this OI greatly declined with the advent
of more effective combinations of ART. Other causes of
retinitis include VZV, T. gondii, and HSV. Anterior uveitis
can be a complication of syphilis. Diagnosis is usually
established through a dilated eye exam performed by an
HIV-experienced ophthalmologist.
Evaluation of global CNS dysfunction should generally
include imaging (either CT or MRI brain scan) to look for
evidence of mass lesions or cortical atrophy, the latter of
which is seen in HIV encephalopathy. A lumbar puncture
following a CT may also help to determine etiologies.
Cutaneous Manifestations
The incidence of dermatologic manifestations in persons
infected with HIV is close to 100%. Recurrent HSV and
Successful treatment of HIV, in general, is the most
VZV are frequent causes of morbidity in HIV infection.
effective treatment for HIV-associated cognitive deficits,
Because of impaired immune response, the appearance of
dementia, and encephalopathy. Opportunistic infection
these conditions may be unusual, sometimes
or malignancy, however,
forming chronic, extensive, superficial
should always be considered.
Table 18. Neurologic Manifestations
ulcerated areas. Confirmation of the diagnosis
Altered mental status can
Clinical
Etiologic Agent or Disease
by culture should be completed if available.
also be a manifestation of
Syndrome
Prolonged prophylaxis with oral acyclovir,
fungal meningitis, particularly Cerebrovascular
CMV
famciclovir, or valacyclovir may prevent
coccidiodomycosis or
disease
HIV
outbreaks, as lesions tend to recur when
cryptococcal meningitis. In
Infective endocarditis with
prophylactic medications are stopped.
addition, clinicians should
emboli
always consider syphilis and a
Minor afflictions of the skin are commonly
TB
number of viral pathogens in
Treponema pallidum
seen in people with HIV infection. Cutaneous
the differential diagnosis.
VZV
mycoses (tinea) are diagnosed and treated
Dementia
HIV
in the usual way. Xerosis is managed
Space occupying lesions in
Treponema
pallidum
symptomatically. Seborrheic dermatitis is
the brain can manifest as
Encephalitis
acute
HIV
infection
very common in this population, especially
focal findings on physical
CMV
on the face. Ketoconazole or itraconazole
examination. The most
HSV
cream applied topically may be effective for
common causes include
West Nile virus
chronic seborrheic dermatitis. Molluscum
CNS lymphoma, CNS
Mass lesion in
T. gondii
contagiosum and veruccae may be extensive
toxoplasmosis, and PML.
the brain
JC virus (the cause of
and are generally removed by excision or
A presumptive diagnosis of
PML)
cryosurgery.
CNS toxoplasmosis may be
Primary CNS lymphoma
made by a positive serum
KS is a proliferative condition of cells of
Meningitis
Cryptococcus neoformans
toxoplasmosis IgG serology
vascular origin. It is seen almost exclusively
HIV
plus the characteristic ringin MSM and is caused by human herpes
TB
enhancing lesion on CT. A
virus type 8 (HHV8). The appearance of
Treponema pallidum
brain biopsy is the definitive
purplish subcutaneous nodules is usually
Myelopathy/
CMV
diagnostic procedure, but
typical enough to permit a clinical diagnosis,
radiculopathy
HIV
not always necessary. CNS
but a biopsy is the definitive test if there is
VZV
lymphoma often presents as
doubt about the nature of the lesion. The
Peripheral
Medications
a single lesion and is seen
cutaneous form is seldom fatal, but visceral
neuropathy
Toxins (alcohol, etc.)
more frequently in patients
involvement, particularly gastrointestinal or
Vitamin deficiencies
with advanced HIV disease.
pulmonary disease, carries a poor prognosis.
(B12, folate)
PML will usually demonstrate
Potent combination ART will often improve
several lesions involving the white matter. Other causes of
or resolve cutaneous KS without additional treatment.
brain lesions should be included in the differential such as
However, some cutaneous KS can be extensive, obstructing
brain abscesses and neoplasm metastases.
lymphatic flow and causing disfigurement. For extensive
22
lesions, further intervention is often needed. Several
treatments are available, including radiation therapy,
direct lesion injection with chemotherapy, and systemic
chemotherapy. A decision to treat and selection of treatment
modalities must be individualized with consideration of the
patient’s wishes and prognosis.
Oral Manifestations
Dental health professionals play an important role in
comprehensive health care for PLWH; they are essential
members of the treatment team. Several conditions
associated with HIV, including candidiasis, OHL, and KS,
can first appear inside the mouth. Because of this, dental
professionals may be the first to suspect HIV infection and
are instrumental in providing appropriate referrals for HIV
testing, counseling, and clinical care. In fact, dental offices
are often ideal sites for initial HIV antibody testing.
Aggressive prophylactic oral care can reduce difficulties
related to oral pathology, medical, nutritional,
psychological, and social complications; it can also improve
immune function. In HIV disease, oral health can decline
as a result of systemic illness, in conjunction with drug
use, or when socioeconomic factors prevent access to care.
A combination of active oral disease and lack of dental
care can cause debilitating oral pain, impaired nutrition,
aesthetic concerns, and the need for emergency treatment.
Delays in oral health care can lead to tooth loss in
immune compromised patients who will also be at risk for
complications from invasive oral procedures. All of these
may lead to negative repercussions to the patient’s overall
health, self-esteem, independence, or ability to work.
Advances in ART have been associated with better oral
health in PLWH. While this is encouraging, it does not
decrease the need for proactive dental care, routine
prophylactic appointments, and aggressive intervention for
developing problems. As always, consultation and referral
are appropriate when caring for PLWH with complex
pathologies.
23
24
Primary Care and Disease
Prevention
are imperative. Patients should be advised of appropriate
weight management, diet, exercise, and health care
maintenance. Important considerations for PLWH include
treatment fatigue and feeling overwhelmed by chronic
and complex medical conditions. Consistent support and
In the United States, the
availability of effective ART
and access to health care has
extended the life span for
many PLWH. With longevity,
however, comes a need to
address primary care issues
including, but not limited
to, vaccinations, cancer
screenings, and screening for
and management of CVD
and diabetes. Primary care
providers play an integral
role in assuring that PLWH
receive appropriate and timely
care. In general, guidelines
for uninfected patients should
also be followed for PLWH.
Special considerations are
necessary for vaccinations,
cervical cancer screening,
anal cancer screening, and
for patients on ART. Table
19 addresses health care
maintenance for patients with
HIV.
Considerations
for an Aging
Population
In the United States, the
population of PLWH is
aging, highlighting the need
for ongoing primary care
management. Many patients
who were initially infected in
their 30s and 40s are aging
into their 50s and 60s and,
as a result, are experiencing
illness associated with aging,
long-term HIV infection, and
co-morbidities.
Considerations for this
aging population are similar
to those of people without
HIV infection and, as with
all populations, routine
prevention and screening
25
education from an integrated health care team including
physicians, nurses, pharmacists, dental professionals, social
workers, and mental health professionals can improve
coping skills and alleviate stress.
and HCV respectively. Being infected with one type of
hepatitis is not a contraindication for being vaccinated
against others. PLWH co-infected with HBV and/or HCV
should be vaccinated against HAV, and those co-infected
with HCV should receive the HBV vaccine if not immune.
PLWH who are hepatitis co-infected should be counseled to
avoid alcohol and educated about risk behaviors and ways
Immunizations
to reduce transmission. A discussion of the HIV-infected
Primary prevention of infectious diseases through
person who is co-infected with chronic HBV and HCV is
immunization is recommended
beyond the scope of this sourcebook (see resources).
in many cases, as significant
Table 20. Recommended Vaccines Treatment of HBV and HCV can be complex and
morbidity and mortality
should prompt consultation and/or referral to a
in HIV-infected Adults
in PLWH is associated
specialist.
with preventable illnesses
Recommended for ALL HIV-Infected
(see Table 20). In general,
Adults
inactivated vaccines are safe,
Tetanus and diphtheria (Td)/Tetanus,
Influenza – inactivated, currently
but live virus vaccines are
only in intramuscular injection
diphtheria, acellular pertussis (Tdap)
often restricted in patients
formulation (annually)
with a CD4+ T cell count
Td and Tdap vaccines are safe in PLWH. For
Pneumococcal polysaccharide
< 200 cells/mm³. Typically,
patients due for a booster, Tdap should be given in
(every 5 years)
patients have the best response
place of Td.
Tetanus, diphtheria, acellular
to immunizations when the
pertussis (Tdap; every 10 years)
CD4+ T cell count is > 200
Hepatitis A (test for previous
cells/mm³. Administration
exposure and immunity)
Measles
of immunizations prior to
Hepatitis B (test for previous
Measles vaccine is a live virus vaccine, but it
immune reconstitution or when
exposure, acute infection, and
appears safe to administer to certain PLWH who
the CD4+ T cell count is < 200
immunity)
are not immune to measles. It is not recommended
cells/mm³ is not recommended
Hepatitis A/B (Twinrix –
in patients with a history of an AIDS-defining
with the exception of the
combination vaccine, series of 3
illness, with symptoms of HIV, or a CD4+ T cell
annual influenza vaccine.
injections)
count < 200 cells/mm³. A complete discussion
of the appropriate age groups for whom measles
Recommended for SOME HIVInfected
Adults
immunization is recommended is beyond the scope
Influenza and
Meningococcal (with appropriate
of this sourcebook, but the information can be
Pneumococcus
risk factors)
readily obtained from a local health department.
Measles, mumps, rubella (MMR;
Immunization with
with appropriate risk factors)
pneumococcal polysaccharide
Varicella
(CD4+ T cell count > 200
vaccine and inactivated
Varicella
cells/mm³)
influenza vaccine (in season)
The varicella vaccine is a live attenuated vaccine
is appropriate at all stages of
used
for
the prevention of varicella infection. Current
HIV. In more advanced HIV disease, the immune response
guidelines
state that varicella vaccine may be considered
to these antigens may be less than that of an immune
in
adults
and
children older than 8 years of age or with
competent person, but the immunizations should still be
a
CD4+
T
cell
count > 200 cells/mm³ who have no
given. If the pneumococcal vaccine was initially given
evidence
of
previous
VZV infection. PLWH who are VZV
when the patient’s CD4+ T cell count was < 200 cells/mm³,
seronegative
and
exposed
to a person with chickenpox or
revaccination is recommended once the CD4+ T cells are >
shingles
should
receive
post-exposure
prophylaxis with
200 cells/mm³.
VZV immune globulin (VZIG) within 96 hours of exposure.
Hepatitis
Hepatitis can be a major contributor to the morbidity
and mortality of co-infected individuals. Immunization
should be offered to all at-risk patients without evidence
of immunity to HAV and/or HBV. Approximately 10%
and 15-30% of PLWH are chronically infected with HBV
Zoster
The zoster vaccine is a live attenuated vaccine used to
prevent herpes zoster infection. There is a lack of data
on the use of this vaccine in persons with HIV and it is
currently not recommended for persons with HIV.
26
Cardiovascular Complications
and HIV
Prevention
As PLWH continue to age, there is growing need to
evaluate cardiovascular risk and implement primary
prevention measures. Estimating cardiovascular risk
helps in the clinical management of patients at risk
for cardiovascular events. Focus should be given to
modifiable risk factors, including tobacco use, blood
pressure, and cholesterol levels. The benefits of aspirin
therapy in prevention of CVD should be assessed in men
ages 45-79 and women ages 55-79. The potential harms
of implementing this therapy should also be evaluated,
including the risk of gastrointestinal hemorrhage,
particularly in persons using NSAIDs regularly or with a
history of gastric ulcers.
Metabolic Syndrome
The increased prevalence of metabolic syndrome in PLWH
has drawn attention to the need for providers to identify
individuals at risk for the development of CVD. Metabolic
syndrome is comprised of (a) elevated fasting triglycerides,
(b) low HDL cholesterol levels, (c) increasing abdominal
obesity, (d) elevated fasting glucose levels, and (e)
hypertension. Over time, ART is thought to induce insulin
resistance, particularly when PIs are used. Longer exposure
to ART and increased survival times contribute to the
development of metabolic syndrome.
Dyslipidemia
Dyslipidemia is an important risk factor that needs to
be addressed as part of the primary care of PLWH. An
association between many antiretroviral agents and
dyslipidemia has been found, particularly with PIs, although
the effect varies greatly between medications within this
class. Ritonavir, particularly at higher dosages, has been
associated with significant elevations in triglycerides. The
use of simvastatin or lovastatin is contraindicated for those
receiving ART, and caution should be used with several
other lipid-lowering agents, as there can be significant
drug-drug interactions. As recommended for uninfected
people, lifestyle modifications are first-line treatments
that should be implemented prior to or concurrently with
pharmacologic interventions. Such modifications include
limiting saturated fat, decreasing dietary cholesterol, and
increasing physical activity. Fish oil is often used for
the treatment of dyslipidemia in this population as it is
well tolerated with minimal drug-drug interactions. An
endocrinologist with experience treating dyslipidemia in
PLWH should be consulted if available.
Malignancies and HIV
PLWH are at increased risk of developing cancers and
should be screened accordingly. While the risk is higher for
KS, non-Hodgkin lymphomas, and cervical cancer, all of
which are classified as AIDS-defining cancers by the CDC,
the number of cases of AIDS-defining cancers has been
steadily declining with the advent of highly effective ART.
In contrast, the rates of non-AIDS defining malignancies,
including anal and oropharyngeal cancers, liver cancer,
lung cancer, and Hodgkin lymphoma have been steadily
increasing in PLWH. There is an association between nonAIDS defining malignancies and infections. For instance,
anal and oropharyngeal cancers are associated with HPV,
and liver cancer with HBV and HCV. Likewise, smoking is
more common in PLWH, placing them at a higher risk of
developing lung cancer.
While impaired immunity seems to play a role in the
development of certain malignancies, the extent to which
immune suppression influences the development of cancer
has yet to be determined. Prolonged immune suppression
seems to be associated with an increase in the incidence
of cancer, but the level of immune suppression at which
risk is increased is unknown. Traditional risk factors,
including tobacco and alcohol use, sun exposure, and age
also contribute to higher incidences of cancer. Primary care
providers should focus on early detection and prevention.
Recommendations for screening as used in the general
population should be followed. Age- and gender-specific
recommendations for screening and early detection are
available from the U.S. Preventative Task Force. Prevention
methods are also similar to those offered to uninfected
patients. The focus here is on smoking cessation and
prevention and treatment of underlying infections such as
HBV, HCV, and HPV.
U.S. Preventive Task Force recommendations for
screening and early detection can be found at http://www.
uspreventiveservicestaskforce.org/adultrec.htm#cancer
Bone Loss and HIV
The relationship between HIV infection, ART, and bone
loss has become an issue of concern for providers caring for
PLWH. Bone loss, including osteopenia and osteoporosis,
is associated with an increased risk of fractures. Several
studies have demonstrated low bone mineral density (BMD)
in PLWH, but the cause remains unclear. The effect of ART
on bone loss is unknown, but there is general consensus
that some BMD loss can be expected in the first 18 months
of ART before reaching a point of stabilization. Traditional
risk factors, such as body mass index (BMI), vitamin D
deficiency, and age are also predictors of lower BMD in
PLWH. Social and medical histories should be taken into
account as lifestyle factors can also contribute to lower
BMD, including smoking, alcohol use, and effects of
27
medications. Research is currently addressing the effect of
HIV infection on bone loss, as well as causal relationships
between specific drug therapies and bone loss. Similar
to minimizing cardiovascular risk in this population,
modifiable factors should be addressed until more definitive
conclusions have been drawn as to the effect of specific
ART on bone loss. Vitamin D synthesis and metabolism
are also disrupted in this population through multiple
mechanisms, including HIV infection itself, and the use
of certain antiretroviral agents. As vitamin D deficiency is
associated with heart disease, dyslipidemia, and diabetes,
health care providers should consider screening PLWH
for vitamin D insufficiency or deficiency. Screening for
osteoporosis should be done according to guidelines for
uninfected patients.
Treatment for osteopenia in females, if indicated, should
include calcium and vitamin D supplementation, weightbearing exercise, and modification of risk factors. If
osteoporosis is present, consideration should be given to
bisphosphonate therapy.
U.S. Preventive Task Force recommendations for
screening for osteoporosis can be found at http://www.
uspreventiveservicestaskforce.org/uspstf10/osteoporosis.
htm
Women’s Health
Providers caring for women infected with HIV must address
HIV-related health concerns across the lifespan. The risk
of vertical transmission, or maternal-to-child transmission
(MTCT) of HIV, has decreased dramatically over the last
several years because of targeted HIV testing and treatment.
Family planning and reproductive health issues need to be
addressed consistently with all HIV-infected women. Other
gynecologic issues, including abnormalities in menstrual
cycles, STIs, neoplasias, and menopause, also need to
be addressed. A work-up for irregular menses should be
similar to that in uninfected women, taking into account
the many causes of menstrual abnormalities including, but
not limited to, pregnancy, dysfunction in the hypothalamicpituitary-ovarian system, menopause, drug use, stress, BMI,
hematologic abnormalities, infection, and the direct effects
of HIV.
Invasive cervical cancer is an AIDS-defining illness.
HIV-infected women have a greater prevalence of cervical
dysplasia and monitoring through Pap smears should occur
at more frequent intervals than are used for uninfected
women. Many factors can contribute to the increase in
cervical dysplasia, including immune suppression, and an
increased prevalence in all types of HPV. Even in women
who are not sexually active, HPV reactivation from past
exposure can occur particularly with lower CD4+ T cell
counts and elevated viral loads; all HIV-infected women
should, therefore, be screened regularly, regardless of
whether they are sexually active or not. The current
recommendation is for women to be screened with Pap
smears at 6-month intervals during the first year after
an HIV diagnosis, and annually thereafter if cytology is
normal.
Contraception choices for women with HIV should protect
them from other STIs, minimize unplanned pregnancies,
and limit the risk for HIV transmission. Hormonal
contraceptives should be used cautiously and drug
interactions taken into account, particularly with ART; if
possible, more than one method of contraception should
be used. Intrauterine devices do not have the same risk of
drug interactions as seen with oral contraceptives and are
one option for contraception. Barrier methods should be
encouraged to limit HIV transmission risks to the woman’s
sex partner(s).
Menopause issues are also of concern as the population
of HIV-infected women continues to age. Hormone
replacement therapy should be used cautiously, similarly
to uninfected women. While women may find relief from
hot flashes, irritability, and sleep disturbances, there is
also an increased risk for breast cancer, stroke, pulmonary
embolism, and CVD. Progestin-only regimens may
help with hot flashes, although the long-term effects are
unknown. The use of non-hormonal lubricants can assist
with urogenital atrophy. For women with osteoporosis,
bisphosphonates should be considered to minimize risk of
fractures.
Sexually Transmitted Infections
Screening for STIs should be performed annually with all
PLWH, and more frequently if warranted. Genital ulcer
disease can facilitate the transmission of HIV infection, and
should, therefore, be identified and treated as appropriate.
HSV and syphilis are associated with increased rates of HIV
transmission. The risk of developing pelvic inflammatory
disease (PID) in women is similar to the general population;
however, the level of immune suppression in women with
HIV may complicate the course of treatment.
Drugs and HIV
Drug use continues to be associated with the spread of
HIV infection. Drug use and abuse contributes to the
transmission of the virus as drug networks and sexual
circles often overlap. HIV is then readily spread by sharing
contaminated drug-use paraphernalia and by high-risk
sexual behavior with other IDUs or with sex partners who
do not inject drugs. A higher prevalence of STIs, such
as gonorrhea, chlamydia, and syphilis, is notable among
IDUs and can facilitate transmission of HIV. Co-morbid
conditions are often identified in individuals who use drugs
28
and are infected with HIV, including HCV, HBV, STIs,
and psychiatric conditions. Clinical management can be
complicated by these often chronic, co-morbid conditions.
Interventions should address addiction and psychiatric
conditions, and medical co-morbidities simultaneously for
the best health outcomes.
Substance abuse, including drugs and alcohol, is
consistently associated with poorer outcomes in HIV
infection. Drug dependence is important to recognize and
treat as appropriate. The barriers to maintaining good
virologic control are often different than in non-users.
Socioeconomic factors, transient lifestyles, and lack of
social support create challenges that are important to
address as these problems can decrease patient abilities to
engage and stay in care, adhere to medication protocols,
and use measures to decrease the risks of HIV transmission
to others. Psychotherapy, planning for relapse, and
pharmacologic management of co-morbid psychiatric
conditions can contribute to a more successful patientprovider relationship.
Mental Health Issues
in the Care of the HIV-Infected
Patient
be encouraged to maintain or re-establish relationships
with mental health professionals. Newly diagnosed patients
may have an exacerbation of a pre-existing mental illness.
Patients who develop mental health issues while in care for
HIV infection should be referred to a mental health provider
for evaluation. When available, it is important to use the
expertise of mental health providers experienced in treating
PLWH.
Depression is often present in this patient population,
with the prevalence estimated to be 19-45%. Depression
can be difficult to recognize, as many of the symptoms of
depression can be confused with side effects of medications
or with a grief reaction to the HIV diagnosis and/or the
change in life circumstances. Treatment of depression is
similar to treatment in uninfected patients, and no clear
delineation has shown that one antidepressant is superior
to another. Attention should be given to the side effect
profiles of antidepressants, drug interactions, and desired
effects.Treating depression is paramount to maintaining
long-term adherence to therapy. There is also evidence that
the immune response is blunted in PLWH with untreated
depression.
Insomnia may be a symptom of stress, anxiety, depression,
or an adverse effect of ART. Patients should be screened
for these conditions and educated about appropriate sleep
hygiene (routines before bed, reduce stimulants, etc.). Sleep
aids may be appropriate for some patients; however, caution
should be used as patients can quickly develop dependency
and tolerance to some medications. Medications such
as diphenhydramine or trazodone have a low risk of
dependency.
Similar to other chronic diseases, HIV infection can be
complicated by mental illness. A thorough mental health
history should be taken during the initial visit, including
a history of a diagnosed mental illness, medications,
hospitalizations, suicidal ideation and attempted suicide,
trauma, and assessment of current symptoms.
See Table 21 for common psychosocial
Table 21. Psychosocial Issues for the Patient with HIV Infection
issues commonly faced by PLWH.
Physical
Addressing the mental health needs of
loss of physical
finding professional providers
changes and
PLWH is a critical measure to optimize
strength
adherence to treatment
disturbances in body
patient outcomes following an HIV
hospitalization(s)
regimens
image
diagnosis. Patients experience a time of
sexuality
fatigue
substance use
increased stress and anxiety following the
Emotional
initial diagnosis of HIV, which can lead to
self-esteem
depression
shock
self-destructive behaviors and cause delays
hopelessness/despair
sadness
grief
in seeking care. Many patients, particularly
uncertainty
fear
denial
when newly diagnosed, will have complex
anxiety
loss of dreams and future
body image
feelings about the diagnosis. An estimated
embarrassment
plans
guilt
13-20% of PLWH have symptoms of postanger
independence/control
self-blame
traumatic stress disorder (PTSD) following
Social
an HIV diagnosis.
finances
leisure
social support
relationships
friends/family/community
discrimination
Some PLWH will present with anxiety
sexuality
stigma
disorders, panic disorders, depression,
personality disorders, or psychosis. Mental
Spiritual
health needs can be complex and exacerbated
meaning of life
acceptance/hope
forgiveness
by the HIV diagnosis and having to cope
death
spiritual practice
suicide
with a chronic illness. PLWH with an
spiritual connection
established diagnosis of mental illness should
29
Cognitive dysfunction, including HIV-associated dementia,
is associated with severe immune suppression and a number
of AIDS-defining conditions. Dysfunction can manifest
in subtle ways and is easily missed by providers. The
presence of minor difficulties with simple tasks, such as
reading, basic math skills, or tasks requiring fine motor
control, may not be obvious in typical clinical assessments.
Effective ART is currently the best method to improve these
symptoms.
A model that incorporates integrated mental health services
is preferred to support the psychiatric needs of this patient
population. Mental illness and psychosocial stresses create
barriers to consistent adherence to treatment regimens and
clinical care. Clinicians must be constantly aware of these
issues in order to assess problems and work with the client
and the care team to find solutions. Consultation with and
referral to mental health specialists should occur routinely.
30
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34
Appendices
&
Resources
35
36
Appendix A. Occupational Post-Exposure Prophylaxis (PEP) Guidelines
Treat exposure site. Wash areas exposed to potentially
infectious fluids with soap and water as soon as possible
after the exposure. Do NOT apply caustic agents or inject
antiseptics or disinfectants into the wound. Exposed mucous
membranes should be flushed with water and exposed eyes
should be flushed with saline solution.
Report and document. Report all occupational
exposures immediately. Reports need to document the
following:
• Date and time of exposure
• Details of the incident: where and how the exposure
occurred, exposure site(s) on the body; if related to
sharp device, the type and brand of device should be
recorded
• Details of the exposure: type and amount of fluid or
material, severity of the exposure
• Counseling, post-exposure management, and follow-up
Large Volume large blood splash
Small Volume a few drops
Exposure Type
HIV PEP for Mucous Membrane and Non-Intact Skin Exposures
HIVInfected
Class 1
e.g.,
asymptomatic
HIV infection
or viral load
< 1,500 RNA
copies/mL
Consider
basic 2-drug
PEP
Recommend
basic 2-drug
PEP
Infectious Status of Source
HIV-Infected
Unknown
Unknown
Class 2
HIV status
source
HIVNegative
e.g.,
symptomatic
HIV infection,
AIDS, acute
seroconversion,
or known high
viral load*
e.g., source
patient
refuses
testing or is
unavailable
e.g., blood
spill or
bloody
equipment
that cannot
be traced to
a patient
e.g., source
patient
known to be
uninfected
Recommend
basic 2-drug
PEP
Generally no
PEP
warranted;
consider
basic 2-drug
PEP¹ for
source with
HIV risk
factors²
Generally no
PEP
warranted;
consider
basic 2-drug
PEP¹ in
settings
where
exposure to
HIV likely
No PEP
warranted
Generally no
PEP
warranted;
consider
basic 2-drug
PEP¹ for
source with
HIV risk
factors²
Generally no
PEP
warranted;
consider
basic 2-drug
PEP¹ in
settings
where
exposure to
HIV likely
No PEP
warranted
Recommend
expanded 3drug PEP
¹The designation “consider PEP” indicates that PEP is optional and should be based on
an individualized decision between the exposed person and the treating clinician.
²If PEP is initiated and the source is later determined to be uninfected, PEP should be
discontinued.
*Seek expert consultation if drug resistance is a concern. Initiation of PEP should NOT
be delayed pending expert consultation.
•
Details about the exposure source:
whether the source material
is known to contain HIV; if source
patient is HIV infected, determine
stage of disease, viral load, history
of ART, and antiretroviral
resistance information
•
Details about the exposed
individual: HBV vaccination and
vaccine-response status, other
medical conditions, allergies, and
medications
•
Record circumstances of the
exposure and PEP management
in the exposed person’s
confidential medical record.
Evaluate exposure. Evaluate the
exposure for the potential to transmit
HBV, HCV, or HIV based on the
type of body substance involved and
the route and severity of exposure.
Exposures to any of the following
through percutaneous injury or
contact with a mucous membrane are
situations that cause a risk for bloodborne transmission and require further
evaluation:
•
Amniotic fluid
•
Blood
•
Cerebrospinal fluid
•
Pericardial fluid
•
Peritoneal fluid
•
Pleural fluid
•
Semen
•
Synovial fluid
•
Vaginal secretions
37
Assess need for follow up. Consider the following
factors when assessing the need for follow-up:
• Type of exposure
• Type and amount of fluid/tissue
• Infection status of source patient
• Susceptibility of exposed individual
Evaluate exposure source. If the source patient is
known, test for HBsAg, HCV antibody, and HIV antibody.
The use of a rapid HIV antibody test facilitates decisionmaking about the use of PEP within hours of the exposure.
For patients who cannot be tested, consider medical
diagnoses, clinical symptoms, and history of risk behaviors.
If source patient is NOT known, evaluate the likelihood
of high-risk exposure. Do not test discarded needles for
bloodborne pathogens, as the reliability of these findings is
not known.
Baseline testing. Perform baseline HIV antibody
testing, HbsAb, and anti-HCV of the exposed individual as
soon as possible after an exposure. If PEP is anticipated, a
CBC and LFTs should also be done.
PEP management. Start HIV PEP immediately (optimal
timeframe is 1-4 hours after exposure). If treatment is
delayed more than 36 hours, seek expert consultation.
PEP should continue for 28 days, if tolerated, or until
source is determined to be uninfected with HIV. Anticipate
medication side effects and provide counseling and
appropriate symptomatic management.
Selection of PEP regimen should include drugs with
activity at different stages in the viral replication process.
The addition of a third agent should be considered with
higher risk exposures; however, with the addition of a
third agent comes higher rates of non-completion of the
regimen for the full 28-days course. Other considerations
include co-morbidities, pregnancy status, medication
interactions, tolerability of the drugs, and the possibility
of drug resistance. The use of a PI-based regimen should
be considered if there is concern for drug resistance (i.e., a
treatment-experienced source patient).
Treatment decisions should be made based in part on
information about the source patient including use of ART
and response to therapy (viral load, CD4+ T cell count,
current disease state, and any data on HIV resistance
testing). Delays in getting information should NOT delay
initiation of PEP; modifications can be made at a later
date. Expert consultation is strongly encouraged (see PEP
resources below).
Follow-up. HIV-antibody testing should be repeated at
6 weeks, 3 months, and 6 months post-exposure. Extended
follow-up (12-months) is recommended for exposed
individuals who become infected with HCV following an
exposure to a source co-infected with HIV and HCV. If
PEP is given, the exposed individual should be monitored
for drug toxicity. CBC, serum creatinine, and LFTs (ALT,
AST, bilirubin, and alkaline phosphatase) should be done
at baseline (within 72 hours) and at 2 weeks. Exposed
individuals should refrain from donating blood, plasma,
organs, tissue, or semen.
Exposed individuals should be counseled to protect sex- and
needle-sharing partners until HIV infection has been ruled
out. Harm reduction techniques, including latex barriers
during sex and not sharing injection equipment, can be taught
during counseling. Patients should also be counseled about
the signs and symptoms of acute HIV infection (flu-like
syndrome), the need to report it, and to come in for followup testing at the time symptoms appear. Mental health
counseling should be offered as needed.
Special considerations. Expert consultation in providing
HIV PEP is recommended in the following situations:
• Delayed exposure report (later than 24-36 hours)
• Unknown source (e.g., needle from sharps container)
• Known or suspected pregnancy of exposed HCP.
While most drugs used in HIV therapy have not been
found to be a problem in pregnancy, information on the
safety of ART in pregnancy is incomplete. Guidelines
currently recommend that efavirenz, ddI, and d4T not
be used in pregnant women. Consultation with an HIV
expert clinician is recommended. Pregnancy does not
preclude the use of optimal PEP regimens, nor should
PEP be denied solely on the basis of pregnancy.
• Resistance of the source virus to antiretroviral
agents. Resistance testing of the source patient’s virus
at the time of exposure is not recommended. Selection
of drugs to which the source patient’s virus is unlikely
to be resistant is recommended if the source patient’s
virus is known or suspected to be resistant to more
than one of the drugs considered for the standard PEP
regimen.
• Toxicity of the initial PEP regimen. Adverse
symptoms such as diarrhea, nausea, fatigue, and
headaches are common with PEP. These can often
be managed without changing the PEP regimen by
recommending over-the-counter agents or providing
prescriptions as needed. Consultation may be needed
when side effects are difficult to manage. The use
of nevirapine-containing regimen is not currently
recommended for post-exposure prophylaxis.
38
PEP Resources
National Clinicians’ Post-Exposure Prophylaxis Hotline (PEPline)
National HIV Telephone Consultation Service
HIV Antiretroviral Pregnancy Registry
Food and Drug Administration (FDA): Report unusual or severe toxicity to
antiretroviral agents
AIDSinfo
1-888-448-4911
1-800-933-3413
1-800-258-4263
1-800-332-1088
www.nccc.ucsf.edu
www.nccc.ucsf.edu
www.apregistry.com
www.fda.gov/medwatch
www.aidsinfo.nih.gov
Non-Occupational Post-Exposure Prophylaxis (nPEP) Guidelines
Non-occupational post-exposure prophylaxis (nPEP) may
be offered after a non-occupational exposure to fluids that
are potentially infectious. When an exposure presents a
significant risk of transmission, guidelines recommend a
28-day course of ART. If the HIV status of the source is
unknown, the guidelines offer no recommendation. Therapy
should be initiated as soon as possible, ideally within 72
hours after exposure. Initiation of therapy can be considered
for persons who present to care more than 72 hours after
the exposure, but the efficacy of prophylaxis is diminished,
and must outweigh the risks associated with therapy. Expert
consultation is advised. Testing is recommended at baseline,
4-6 weeks, 3 months, and 6 months after exposure. Signs
and symptoms of acute seroconversion should be reviewed.
Individuals should be counseled about risk-reducing
behaviors during the course of nPEP, as it is not 100%
effective in preventing HIV transmission. Multiple studies
have shown that approximately 15% of those who present
to care requesting nPEP present again within 12 months.
Risk assessment and risk reduction counseling should be
performed at each visit.
39
Appendix B. Antiretroviral Therapy
Generic Name
Abbreviation
Trade Name®
abacavir
(ABC)
Ziagen®
didanosine
(ddI)
Videx EC®
Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTI/NtRTI)
Available
Dosage
Forms
300 mg
tablets
Usual Dose*
Special Dosing Considerations
Adverse Effects
300 mg BID or 600
mg QD
Take with or without food. Alcohol
increases abacavir levels 41%;
abacavir has no effect on alcohol.
Hypersensitivity reaction (may be
fatal): signs/symptoms may include
rash, fever, nausea, vomiting, malaise,
fatigue, loss of appetite, respiratory
symptoms (sore throat, cough,
shortness of breath). Screening with a
genetic test, HLA-B*5701, greatly
reduces the risk of this reaction
nausea, body fat changes†
20 mg/mL
oral solution
125, 200,
250 or 400
mg
Body wt. 60 kg:
400 mg QD
With TDF: 250 mg
QD
Body wt. 60 kg:
250 mg QD
With TDF: 200 mg
QD
emtricitabine
(FTC)
Emtriva®
lamivudine
(3TC)
Epivir®
stavudine
(d4T)
Zerit®
200 mg
capsule
10 mg/mL
oral solution
150, 300 mg
tablets
10 mg/mL
oral solution
15, 20, 30,
and 40 mg
capsules
1 mg/mL
oral solution
200 mg QD or 240
mg (24 mL) oral
solution QD
Body wt. > 50 kg:
300 mg QD or
150 mg BID
Body wt. < 50 kg:
2 mg/kg BID
Body wt. > 60 kg:
40 mg BID
Body wt.< 60 kg:
30 mg BID
Must take all ddI preparations on an
empty stomach, at least 30 minutes
before or 2 hours after eating.
With TDF, dose may be reduced to
250 mg/day and may be taken with a
light meal or snack.
Monitor for ddI toxicity.
Concomitant use with d4T is not
recommended.
It may be necessary to separate
administration of some medications
from ddI dose.
Must reduce dose if patient has renal
dysfunction.
Take with or without food.
dysfunction.
Serious: lactic acidosis/severe
hepatomegaly with steatosis
If signs/symptoms of
hypersensitivity reaction
occur: seek medical evaluation
immediately to determine need
to discontinue. DO NOT
restart: abacavir rechallenge
has been associated with fatal
hypersensitivity reactions.
nausea, vomiting, diarrhea,
peripheral neuropathy,
headaches, rash
Serious: pancreatitis,
hepatitis, lactic acidosis with
hepatic steatosis, body fat
changes†
headache, diarrhea, nausea,
rash, skin discoloration
Serious: lactic acidosis with
changes†
nausea
dysfunction.
Serious: lactic acidosis with
changes†
Dose reduction may be effective for
peripheral neuropathy and is necessary
if patient has renal dysfunction.
Concomitant use with ddI or AZT not
recommended.
peripheral neuropathy, nausea
Serious: pancreatitis, lactic
acidosis with hepatic steatosis
(higher incidence than with
other NRTIs), hyperlipidemia,
body fat changes†
40
tenofovir
(TDF)
Viread®
300 mg
tablet
1 tablet QD
dysfunction.
Concomitant use with d4T not
recommended.
zidovudine
(AZT)
Retrovir®
nausea, diarrhea
Serious: vomiting, flatulence,
asthenia, renal insufficiency,
lactic acidosis with hepatic
steatosis
nausea, vomiting, headaches,
insomnia
100 mg
300 mg BID or
capsules,
200 mg TID
300 mg
dysfunction.
tablets,
Concomitant use with d4T not
Serious: anemia, neutropenia,
10 mg/mL
recommended.
pancreatitis, lactic acidosis
IV solution,
with hepatic steatosis, body fat
10 mg/mL
changes†
oral solution
*Usual doses are provided. Doses may vary based on weight, the presence of renal or hepatic failure, or when using combinations
that have pharmacokinetic interactions. Dose reduction may be required.
†The association of NRTIs with body fat changes
Medications that
drug
interactions
with
Medications
that may
mayhave
haveclinically
clinicallysignificant
significant
drug
interactions
varies from agent to agent.
NRTIs
with
NRTIs
cimetidine,
cytotoxic
drugs,
d4T,d4T,
indomethacin,
methadone,
Metabolism of NRTIs AZT - hepatic via
AZT - aspirin,
AZT
aspirin,
cimetidine,
cytotoxic
drugs,
indomethacin,
probenecid,
ribavirin,
drugsribavirin,
that interfere
with
RBC,
WBC;with
glucuronidation; renal excretion of metabolites; ddI - methadone,
probenecid,
drugs
that
interfere
dapsone, indinavir (separate doses by at least 2 hours with
55% renal elimination as unchanged drug; d4T ddI - atazanavir,
RBC, WBC
indinavir
and
chewable
tabs), pentamidine,
drugs
cause2
renal excretion 50%; 3TC - renal elimination;
ddI
atazanavir,ddI
dapsone,
indinavir
(separate doses
bythat
at least
pancreatitis/peripheral
neuropathy,
tenofovir,
ribavirin;
abacavir - hepatic via alcohol dehydrogenase and
hours with indinavir and ddI chewable tabs), pentamidine,
cause peripheral neuropathy/
pancreatitis;
glucuronyl transferase; metabolites renal excretion
d4T - zidovudine,
drugs thatdrugs
causethat
pancreatitis/peripheral
neuropathy,
tenofovir,
ABC - ethanol; TDF - atazanavir, ddI, lopinavir/ritonavir, cidofovir,
85%; FTC -renal elimination; tenofovir - renal
ribavirin
valganciclovir
elimination
d4T
zidovudine, drugs that cause peripheral neuropathy/ pancreatitis
*This list is not all inclusive
ABCethanol
TDF atazanavir, ddI, lopinavir/ritonavir, cidofovir, valganciclovir
Generic Name
Abbreviation
Trade Name®
atazanavir
(ATV)
Reyataz®
Available
Dosage
Forms
100,150,
200, 300 mg
capsules
Protease Inhibitors (PIs)
Usual Dose*
Special Dosing
Considerations
Adverse Effects
RTV 100 mg + ATV 300
mg QD
Take with a meal or snack. Use
with caution with acid-reducing
agents: Contraindicated with
proton-pump inhibitors. Dose
atazanavir 10 hours apart from
H2 blocker dosing.
Use caution in patients on
medications that may cause PR
interval prolongation or if
underlying conduction defect.
Take with food. Use caution if
known sulfa allergy.
prolonged PR interval,
hyperglycemia, body fat
changes†, hyperbilirubinemia,
possible increased bleeding in pts
with hemophilia
400 mg QD
If taken with efavirenz,
etravirine, or tenofovir,
RTV boosting required
darunavir
(DRV)
Prezista®
400, 600 mg
tablets
600 mg BID + RTV 100
mg BID
- or 800 mg + RTV 100 mg
QD (ART-naïve patients
only)
skin rash, diarrhea, nausea,
headache, cold-like symptoms
Serious: elevated transaminases,
hyperlipidemia, body fat
changes†, hyperglycemia,
erythema multiforme, increased
bleeding in pts with hemophilia
41
fosamprenavir
(FPV)
Lexiva®
indinavir
(IDV)
Crixivan®
700 mg
tablet
Oral
suspension:
50 mg/mL
200, 333,
400 mg
capsules
ART-naïve patients:
1400 mg BID - or 1400 mg + RTV 200
mg QD - or 700 mg + RTV 100 mg
BID - or 1400 mg + RTV 100
mg QD
PI-experienced patients,
when QD regimen not
recommended: 700 mg +
RTV 100 mg BID.
With RTV: 800 mg +
RTV 100 or 200 mg
every 12 hours
Use with caution with any acidreducing agents.
Serious: hyperlipidemia, body fat
changes†, transaminase elevation,
hyperglycemia, possible increased
Take on empty stomach or with
a light meal or a low fat snack.
May be taken with food if
given with ritonavir.
Drink 1.5 liters of water each
day.
lopinavir +
ritonavir
(LPV/r)
Kaletra™
nelvinavir
(NFV)
Viracept®
ritonavir
(RTV)
Norvir®
LPV 200 mg
+ RTV 50
and
LPV 100 mg
+ RTV 25
mg tablets
LPV 80 mg
+ RTV 20
mg/1.0 mL
oral solution
250, 625 mg
tablets
50 mg/g oral
powder
2 tablets or 5 mL of oral
solution BID
- or 4 tablets QD
1,250 mg BID
- or 750 mg TID
Take with food.
100 mg
capsules
Used primarily as a
booster for other PIs –
see specific PI
Take with food.
100 mg.
tablets
600 mg/7.5
mL solution
saquinavir
(SQV)
Invirase®
200 mg hard
gel capsules,
500 mg
tablets
Unboosted use not
recommended
1000 mg + RTV 100 mg
BID
diarrhea, nausea, vomiting,
headache, rash
Does not need to be
refrigerated.
Capsules must be refrigerated
but may be stored at controlled
room temperature for 30 days.
Do not refrigerate oral solution.
Tablets do not require
refrigeration.
Take within 2 hours of a meal.
nausea, diarrhea, headaches,
blurred vision, dizziness, rash
Serious: hyperglycemia, body fat
changes†, increased indirect
bilirubin, hyperlipidemia,
nephrolithiasis, hemolytic
anemia, thrombocytopenia,
possible increased bleeding in pts
with hemophilia
nausea, diarrhea, taste perversion,
perioral and circumoral
paresthesia
Serious: elevated transaminases,
hyperglycemia, hyperlipidemia,
body fat changes†, possible
increased bleeding in pts with
hemophilia
diarrhea, flatulence, nausea, rash
Serious: hyperglycemia, body fat
changes†, hyperlipidemia,
elevated transaminases, possible
increased bleeding in pts with
hemophilia
nausea, vomiting, diarrhea, taste
perversion
Serious: extremity and
circumoral paresthesias, elevated
transaminases, hyperglycemia,
changes†, possible increased
nausea, diarrhea, headaches
Serious: hyperlipidemia, body fat
changes†, elevated transaminases,
hyperglycemia, possible increased
42
nausea, vomiting, diarrhea, rash,
Take with food. Use caution if
photosensitivity, increased risk of
known sulfa allergy.
rash with estrogen use
Administer 2 hours apart from
Risk-benefit not yet
ddI-EC and liquid antacids.
Serious: clinical hepatitis, hepatic
established in treatmentReview complex drug-drug
decompensation, elevated
naïve patients
interactions before using. Use
transaminases, symptoms of sulfa
with caution in the setting of
allergy, hyperglycemia,
hepatic impairment. Refrigerate
capsules, may be stored at
changes†, possible increased
controlled room temperature
(77° F or below) for 60 days.
Use caution in patients with
Black box warning: TPV has
increased risk for bleeding or
been associated with fatal and
taking medications known to
nonfatal intracranial hemorrhages
increase risk of bleeding.
† The association of PIs with changes in body fat varies from agent to agent.
*Usual doses are provided. Doses may vary based on weight, the presence of renal or hepatic failure, or when using
combinations that have pharmacokinetic interactions.
Metabolism of PIs. All of the
Medications that
Medications that have clinically significant drug interactions with
PIs are metabolized by the
should NOT be
PIs – Avoid Use or Modify Dosages*
atorvastatin, bupropion, carbamezapine, cerivastatin, clarithromycin,
cytochrome P450 enzyme,
administered with
clonazepam, cyclosporine, delavirdine, dexamethasone,
primarily by the isoenzyme
PIs: amiodarone,
dihydropyridine calcium channel blockers, diltiazem, disopyramide,
CYP3A4. All PIs inhibit the
astemizole, bepridil,
dronabinol, efavirenz, ethinyl estradiol, ethosuximide, fluticasone,
isoenzyme CYP3A4. The degree cisapride, ergotamine
of inhibition is dependent on the derivatives, flecainide, itraconazole, ketoconazole, lidocaine, meperidine, methadone,
lovastatin, midazolam, metoprolol, mexilitine, nefazadone, nevirapine, perphenazine,
particular PI being used with
pimzide, propafenone, phenobarbital, phenytoin, prednisone, propoxyphene, quinine,
ritonavir producing the greatest
rapamycin, rifabutin, risperidone, sedative/hypnotics, selective
quinidine, rifampin,
inhibition of the isoenzyme.
serotonin reuptake inhibitors, sildenafil, stimulants, tacrolimus,
Ritonavir induces the isoenzyme rifapentine,
simvastatin, St. John’s tadalafil, theophylline, thioridazine, timolol, tramadol, trazadone,
CYP1A2 and also inhibits
tricyclic antidepressants, verdenafil, verapamil, voriconazole,
CYP2A6, 2C9, 1A2, 2C19, 2D6, Wort, terfenadine,
warfarin
triazolam
and 2E1. Lopinavir/ritonavir
inhibits CYP2D6.
*This list is not all inclusive. The presence and the degree of
interaction are dependent on the particular PI used.
tipranavir
(TPV)
Aptivus®
250 mg
capsules
Generic Name
Abbreviation
Trade Name®
delavirdine
(DLV)
Rescriptor®
Available
Dosage
Forms
100, 200 mg
tablets
etravirine
(ETV)
Intelence™
100, 200 mg
tablets
500 mg + RTV 200 mg
BID
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)
Usual Dose*
Special Dosing
Considerations
Adverse Effects
400 mg 3 times a day;
four 100 mg tablets can
be dispersed in ≥ 3 oz. of
water
Space doses 1 hour apart from
antacids and ddI chewable
tablets, suspension, and oral
solution.
rash, elevated liver enzymes,
headaches, fatigue, GI upset,
neutropenia
200 mg BID
Take following a meal.
Serious: erythema multiforme
rash, headache, diarrhea, nausea
Serious: erythema multiforme
43
efavirenz
(EFV)
Sustiva®
50, 100, 200
mg capsules
or 600 mg
tablets
600 mg QD at or before
bedtime
Take on empty stomach as
rash, drowsiness, diarrhea,
high-fat/high caloric meals
dizziness, anxiety, depression,
increase peak plasma
trouble concentrating, unusual
concentrations.
dreams (effects usually transient
Should not be administered
lasting 2-4 weeks), elevated
during pregnancy or in women
liver enzymes
with pregnancy potential,
Serious: confusion,
unless negative pregnancy test
encephalopathy
prior to initiation and patient is
using 2 effective contraceptive
methods, including 1 barrier
method. Pregnancy category D.
nevirapine
200 mg
200 mg QD X 14 days
Baseline LFTs and monitor at 2
rash, GI upset, headaches,
(NVP)
tablets
(lead-in dosing), 200 mg weeks, 4 weeks, then frequently
elevated liver enzymes
Viramune®
BID thereafter
until 18 weeks of therapy.
50 mg/5 mL
Serious: erythema multiforme,
Continue to monitor LFTs
oral
Not recommended if
hepatotoxicity - lower risk if
frequently after initial 18-week
suspension
baseline CD4+ T cell
baseline CD4+ T cell count >
period.
Lead-in dosing should be
250 cells/mm³ (female) or > 400
count > 250 cells/mm³
(NVP XR is
repeated if drug is interrupted
cells/mm³ (male)
(female) or > 400
available –
for any reason for > 7 days.
cells/mm³ (male)
400 mg QD)
Rilpilverine
25 mg tablet
25 mg QD
Take with food. Space doses
depression, insomnia, headache,
(RPV)
several hours apart from
rash
Edurant®
antacids or H2-receptor
antagonists.
*Usual doses are provided. Doses may vary based on weight, the presence of renal or hepatic failure, or when using
combinations that have pharmacokinetic interactions.
NNRTI
Metabolism
Do NOT administer with
Medications with clinically significant
interactions – avoid use or modify dosages
nevirapine
Cytochrome P450
rifampin, rifapentine, St. John’s Wort
ketoconazole, methadone, clarithromycin,
metabolism primarily by
oral contraceptives, protease inhibitors,
CYP2B6 and CYP 3A
rifabutin, voriconazole
family; causes induction of
CYP3A isoenzymes
delavirdine
Cytochrome P450
alprazolam, amiodarone, astemizole,
amphetamines, amphotericin, antacids,
bepridil, carbamazepine, cisopride,
atorvastatin, bupropion, calcium channel
isoenzymes from the
ergotamine derivatives, flecainide,
blockers, erivastatin, clarithromycin,
CYP3A family although
fosamprenavir, H2 blockers,
clonazepam, dapsone, didanosine,
dihydropyridines, ethosuximide,
CYP2D6 may play a minor
lovastatin, midazolam, phenytoin,
ketoconazole, methadone, nefazadone,
role; causes inhibition of
phenobarbital, pimozide,
protease inhibitors, quinidine,
CYP3A and CYP2D6
propafenone, proton pump inhibitors,
sedative/hypnotics, selective serotonin
isoenzymes
rifabutin, rifampin, rifapentine, St.
reuptake inhibitors, sildenafil, tadalafil,
John’s Wort, simvastatin, terfenadine,
vardenafil, voriconazole, warfarin
triazolam
efavirenz
Cytochrome P450
asemizole, cisopride, ergotamine
carbamezapine, clarithromycin, oral
derivatives, midazolam, rifapentine,
contraceptives, methadone, phenobarbital,
isoenzymes CYP3A4 and
St. John’s Wort, terfenadine,
phenytoin, pimozide, protease inhibitors,
CYP 2B6; causes induction
triazolam, voriconazole
rifabutin, rifampin, voriconazole, warfarin
of CYP3A4 isoenzymes;
causes inhibition of CYP
2C9, 2 C19, and 3A4
isoenzymes
44
etravirine
Cytochrome P450
metabolism; causes
induction of CYP 3A4
isoenzyme; causes
inhibition of CYP2C9 and
CYP2C19
carbamazepine, phenobarbital,
phenytoin, rifampin, rifapentine,
rifabutin, St. John’s Wort, other
NNRTIs, ritonavir-boosted tipranavir,
ritonavir-boosted fosamprenavir,
ritonavir-boosted atazanavir, full dose
ritonavir, non-ritonavir-boosted PIs.
rilpivirine
Cytochrome P450 primarily
with induction of
isoenzyme CYP3A
other NNRTIs,
carbamazepine, oxcarbazepine,
phenobarbital, phenytoin, rifabutin,
rifampin, rifapentine, proton pump
inhibitors, dexamethasone, St. John’s
Wort
Generic Name
Abbreviation
Trade Name®
Fusion
Inhibitor:
enfuvirtide
(T20)
Fuzeon®
Available
Dosage
Forms
180 mg
vials –
reconstitute
with 1.1
mL sterile
water (90
mg/mL)
CCR5
Antagonist:
maraviroc
(MVC)
Selzentry®
150 and
300 mg
tablets
amiodarone, bepridil, clarithromycin,
cyclosporine, dexamethasone, diazepam,
disopyramide, flecainide, itraconazole,
ketoconazole, lidocaine (systemic),
lopinavir/ritonavir, maraviroc, mexiletine,
propafenone, quinidine, tacrolimus,
sirolimus, voriconazole, warfarin; coadministration of etravirine with substrates,
inhibitors, or inducers of CYP3A4, CYP2C9,
and/or CYP2C19 may alter the therapeutic
effect or adverse events profile of etravirine
or the co-administered drugs. Use caution
with these drugs in patients on etravirine
boosted and unboosted protease inhibitors,
antacids, azole fungal agents, H2-receptor
antagonists, macrolide antibiotics
Entry Inhibitors
Usual Dose
Adverse Effects
90 mg SQ every 12 hours
Patients must be willing and
able to prepare/administer
injections.
Requires thorough education
about storage, preparation, SQ
injection, and prevention of
injection site reactions.
Reconstituted drug may be
refrigerated up to 12 hours prior
to use.
local injection site
reactions,
diarrhea, nausea,
fatigue
150 mg BID when given with strong
CYP3A inhibitors (with or without
CYP3A inducers) including PIs
(except tipranavir/ritonavir)
300 mg BID when given with NRTIs,
enfuvirtide, tipranavir/ritonavir,
nevirapine, and other drugs that are
not strong CYP3A inhibitors
600 mg BID when given with CYP3A
inducers, including efavirenz,
etravirine, rifampin, etc. (without a
CYP3A inhibitor)
Must reduce dose if patient has
renal dysfunction.
Serious:
hypersensitivity
reaction, bacterial
pneumonia
abdominal pain,
cough, dizziness,
headache, rash,
fever, orthostatic
hypotension,
musculoskeletal
symptoms, upper
respiratory
infections,
hepatotoxicity
Metabolism of Entry Inhibitors
Enfuvirtide: catabolism to its constituent amino acids with recycling of amino acids in the body pool
Maraviroc: cytochrome P450 (CYP3A substrate). Care should be used with administering maraviroc with a CYP3A inducer, as
this could lower maraviroc concentrations.
Co-administration with a CYP3A inhibitor may raise maraviroc levels. In both cases dose adjustments may be necessary.
Medications that have clinically significant drug interactions with maraviroc*: clarithromycin, carbamazepine, delavirdine,
efavirenz, intraconazole, ketoconazole, rifampin, phenobarbital, phenytoin, protease inhibitors (except tipranavir/ritonavir), St.
John’s Wort
45
Integrase Inhibitor
Generic Name
Available
Usual Dose
Abbreviation
Dosage
Trade Name®
Forms
raltegravir (RAL)
400 mg
400 mg BID
Isentress®
tablets
Metabolism: UGT 1a1-mediated glucuronidation
Special Dosing
Considerations
Adverse Effects
Take with or without food
nausea, headache, diarrhea, fever,
CPK elevation
Fixed Dose Combinations
Trade Name®
Abbreviation
Atripla®
(FTC/TDF/EFV)
Available
Dosage Forms
FTC 200 mg +
TDF 300 mg +
EFV 600 mg at
or before
bedtime
Usual
Dose
1 tablet
QD
Combivir®
(AZT/3TC)
Complera™
(FTC/RPV/TDF)
AZT 300 mg +
3TC 150 mg
FTC 200 mg +
RPV 25 mg +
TDF 300 mg
ABC 600 mg +
3TC 300 mg
1 tablet
BID
1 tablet
QD
1 tablet
QD
ABC 300 mg +
AZT 300 mg +
3TC 150 mg
FTC 200 mg +
TDF 300 mg
1 tablet
BID
1 tablet
QD
Epzicom®
(ABC/3TC)
Trizivir®
(AZT/3TC/ABC)
Truvada®
(FTC/TDF)
Adverse Effects
Recommend taking on an empty stomach as highfat/high-calorie meals increase peak plasma
concentrations.
Pregnancy category D: Should not be
administered during pregnancy or in women with
pregnancy potential, unless negative pregnancy
test prior to initiation and patient using one
effective contraception method and one barrier
method.
See individual
components.
Take with food.
See individual
components.
See individual
components.
Risk of hypersensitivity
reaction; see individual
components.
Risk of hypersensitivity
reaction; see individual
components.
See individual
components.
46
Appendix C. List of Abbreviations
Ab
ADAP
Ag
AIDS
AETC
AFB
ALT
ART
AST
BID
BMD
BMI
BUN
CBC
CDC
CLIA
CMV
CNS
CPK
CSF
CT
CVD
DHHS
DNA
DOT
EIA/ELISA
FDA
HAV
HBV
HCV
HDL
HIV
HLA
HPV
HSV
IgG
IGRA
IFA
INH
IDU
antibody
AIDS Drug Assistance Program
antigen
acquired immunodeficiency syndrome
AIDS Education and Training Center
acid-fast bacillus
alanine aminotranferase
antiretroviral therapy
aspartate aminotransferase
2 times a day
bone mineral density
body mass index
blood urea nitrogen
complete blood count
Centers for Disease Control and Prevention
Clinical Laboratory Improvement Amendment
cytomegalovirus
central nervous system
creatinine phosphokinase
cerebrospinal fluid
computerized axial tomography
cardiovascular disease
Department of Health and Human Services
deoxyribonucleic acid
directly observed therapy
enzyme-linked immunoassay
Food and Drug Administration
hepatitis A virus
hepatitis B virus
hepatitis C virus
high density lipoprotein
human immunodeficiency virus
human leukocyte antigen
human papillomavirus
herpes simplex virus
immunoglobulin G
interferon gamma release assay
immunofluorescence assay
isoniazid
injection drug user/injection drug use
KS
LDL
LFT
MAC
MTCT
MMR
MRI
MSM
MTB
NNRTI
NSAIDS
NRTI
NtRTI
nPEP
OHL
OI
PCP
PCR
PEP
PI
PID
PGL
PLWH
PML
PPD
PTSD
QD
RNA
SMZ
SQ
STI
TB
TID
Td
Tdap
TMP
UNAIDS
VZIG
VZV
Kaposi sarcoma
low-density lipoprotein
liver function tests
Mycobacterium avium complex
mother-to-child transmission
measles, mumps, rubella
magnetic resonance imaging
men who have sex with men
Mycobacterium tuberculosis
non-nucleoside reverse transcriptase inhibitor
non-steroidal anti-inflammatory drugs
nucleoside reverse transcriptase inhibitor
nucleotide reverse transcriptase inhibitor
non-occupational post-exposure prophylaxis
oral hairy leukoplakia
opportunistic infection
Pneumocystis jiroveci pneumonia
polymerase chain reaction
post-exposure prophylaxis
protease inhibitor
pelvic inflammatory disease
persistent generalized lymphadenopathy
people living with HIV
progressive multifocal leukoencephalopathy
purified protein derivative skin test for TB; also
called Mantoux test
post-traumatic stress disorder
1 time a day
ribonucleic acid
sulfamethoxazole
subcutaneous
sexually transmitted infection
tuberculosis
3 times a day
tetanus, diphtheria vaccine
tetanus, diphtheria, acellular pertussis vaccine
trimethoprim
Joint United Nations Programme on HIV/AIDS
varicella zoster immune globulin
varicella zoster virus
Note. Abbreviations for antiretroviral medications can be found in Appendix B
47
Appendix D. National AIDS Services, Hotlines, and On-Line Resources
AETC National Resource Center
www.aidsetc.org
Provides listings of regional AETCs,
training materials, clinical resources, and
training opportunities.
AIDSinfo
www.aidsinfo.nih.gov
A service of U.S. DHHS; provides
information on HIV treatment, clinical
care, and current treatment guidelines.
1-800-HIV-0440 (1-800-448-0440)
AIDS InfoNet
www.aidsinfonet.org
Provides fact sheets on treatments,
prevention, social services, and web
resources; easy to print, appropriate for
patient and clinician education; updated
on a regular basis. Most fact sheets are
available in English and Spanish; also
other languages.
CDC National Prevention
Information Network (NPIN)
www.cdcnpin.org
National reference, referral, and
distribution service for HIV, STIs, and
TB; access to databases, materials,
guidelines, referrals, and training centers
for HIV, STIs, and TB.
1-800-458-5231
HIV Dent
www.hivdent.org
Information on oral manifestations of
HIV, infection control, PEP protocols,
pediatric/adolescent care, medications,
large picture gallery, other resources.
HIV InSite
www.hivinsite.org
Sponsored by UCSF. Provides search
capabilities in broad science, prevention,
and treatment spectrum.
American Academy of HIV
Medicine (AAHIVM)
www.aahivm.org
Infectious Diseases Society of
America (IDSA)
www.idsociety.org
Provides education resources and
credentialing services.
Information on practice guidelines,
journal publications, conferences,
advocacy, public policy, and other
resources related to infectious disease.
American Foundation for AIDS
Research (AmFAR)
www.amfar.org
International AIDS Society – USA
Provides information about basic science
and clinical research and public policy
programs.
Provides education and information to
clinicians who care for PLWH.
Association of Nurses in AIDS
Care (ANAC)
www.anacnet.org
Networking, information exchange,
social awareness, and advocacy.
www.iasusa.org
National Clinicians’ PostExposure Prophylaxis Hotline
(PEPline)
www.nccc.ucsf.edu
24-hour hotline with up-to-date
information on managing occupational
exposure to blood borne pathogens.
1-888-448-4911
National HIV/AIDS Telephone
Consultation Service (Warmline)
www.nccc.ucsf.edu
National HIV telephone consultation
service for providers offering clinical
information and individualized
consultations from clinicians
experienced in HIV care.
1-800-933-3413
National Minority AIDS Council
(NMAC)
www.nmac.org
Programs and services for communitybased organizations serving minorities
affected by HIV. Programs include
conferences, research, treatment
information, and technical assistance.
National Native American AIDS
Prevention Center (NNAAPC)
www.nnaapc.org
Information on HIV and related diseases
in American Indians, Alaska Natives,
and Native Hawaiians.
Women, Children, and HIV:
Resources for Prevention and
Treatment
www.womenchildrenhiv.org
Designed to provide current clinical
information and training resources on
maternal/child HIV infection.
48
Appendix E. National AIDS Services, Hotlines, and On-Line Resources
AIDS Drug Assistance Programs (ADAP) are authorized under Title II of the Ryan White Program and administered by HRSA,
an agency of the Department of Health and Human Services. States are required to use a portion of their funding to provide
medications to treat HIV and manage opportunistic conditions. Qualifications and amount of access varies from state to state;
state-specific information can be obtained from the following telephone numbers:
Colorado………………………………….…... (303) 692-2716
Kansas………………………………………... (785) 368-8218
Nebraska……………………………………... (402) 559-4673
New Mexico………………………………….. (505) 827-2435
North Dakota………………………………...… (701) 328-2378
South Dakota………………………..…………. (605) 773-3737
Utah……………………………….…………… (801) 538-6197
Wyoming………………………………….…… (307) 777-5800
Pharmaceutical companies with medication assistance programs for HIV-infected patients who are unable to afford the cost of their
medications are listed below. Eligibility requirements vary from program to program, some assess need on a case-by-case basis and
many require the applications for assistance be initiated by a physician. For more information, contact the companies directly.
Drug Name
Brand Name
Manufacturer
Telephone
ABC + 3TC
lamivudine (3TC)
zidovudine (AZT, ZDV)
abacavir (ABC)
AZT + 3 TC
AZT + 3TC + ABC
Fosamprenavir
delavirdine (DLV)
nelfinavir (NFV)
maraviroc (MVC)
didanosine (ddI)
atazanavir (ATV)
efavirenz (EFV)
stavudine (d4T)
TDF + FTC + EFV
saquinavir (SQV)
enfuvirtide (T20)
nevirapine (NVP)
tipranavir (TPV)
lopinavir/ritonavir (LPV/r)
ritonavir (RTV)
darunavir (DRV)
etravirine (ETV)
rilpivirine (RPV)
indinavir (IDV)
raltegravir (RAL)
tenofovir (TDF)
emtricitabine (FTC)
TDF + FTC
TDF + FTC + EFV
FTC + RPV + TDF
Epzicom™
Epivir®
Retrovir®
Ziagen™
Combivir®
Trizivir™
Lexiva®
Rescriptor®
Viracept®
Selzentry®
Videx EC®
Reyataz®
Sustiva™
Zerit®
Atripla™
Invirase®
Fuzeon®
Viramune®
Aptivus®
Kaletra™
Norvir®
Prezista™
Intelence™
Edurant ™
Crixivan®
Isentress®
Viread®
Emtriva™
Truvada™
Atripla®
Complera™
ViiV Healthcare
Bridges to Access:
888-825-5249
Bristol-Myers Squibb
Company
877-758-7877
Roche
800-282-7780
Boehringer Ingelheim
800-556-8317
Abbott Laboratories
800-222-6885
Janssen Pharmaceuticals
866-836-0114
Merck & Co., Inc.
800-727-5400
Gilead
800-226-2056
49
Appendix F. Regional and National AETC Programs
REGIONAL CENTERS
Delta Region AETC
Serving Arkansas, Louisiana,
Mississippi
New Orleans, Louisiana
504-903-1530
www.deltaaetc.org
Florida/Caribbean AETC
Serving Florida, Puerto Rico, and the
Virgin Islands
Tampa, Florida
813-974-4430
www.FAETC.org
Midwest ATEC
Serving Illinois, Indiana, Iowa,
Michigan, Minnesota, Missouri,
Wisconsin
Chicago, Illinois
312-996-1373
www.MATEC.info
Mountain Plains AETC
Serving Colorado, Kansas, Nebraska,
New Mexico, North Dakota, South
Dakota, Utah, Wyoming
Denver, Colorado
303-724-0867
www.mpaetc.org
New England AETC
Serving Connecticut, Maine,
Massachusetts, New Hampshire,
Vermont, Rhode Island
Boston, Massachusetts
617-262-5657
www.neaetc.org
New York/New Jersey AETC
Serving New Jersey, New York
New York, New York
212-304-5530
www.nynjaetc.org
Northwest AETC
Serving Alaska, Idaho, Montana,
Oregon, Washington
Seattle, Washington
206-685-6844
www.northwestaetc.org
Pacific AETC
Serving Arizona, California, Hawaii,
Nevada, and the 6 U.S.-affiliated
Pacific jurisdictions
San Francisco, California
415-597-8198
www.ucsf.edu/paetc
Pennsylvania/Mid-Atlantic AETC
Serving Delaware, Maryland, Ohio,
Pennsylvania, Virginia, Washington
D.C., West Virginia
Pittsburgh, Pennsylvania
412-624-1895
www.pamaaetc.org
Southeast ATEC
Serving Alabama, Georgia, Kentucky,
North Carolina, South Carolina,
Tennessee
Atlanta, Georgia
404-727-9709
www.seaetc.emory.edu
Texas/Oklahoma AETC
Serving Texas, Oklahoma
Dallas, Texas
214-590-5633
www.aidseducation.org
NATIONAL AND
INTERNATIONAL CENTERS
National Evaluation Center
San Francisco, CA
415-597-9213
www.aetcnec.ucsf.edu
National Resource Center
Newark, N.J.
973-972-6578
www.aidsetc.org
National Center for HIV Care in
Minority Communities
Washington, DC, 20009
202-232-6749
www.NCHCMC.org
National HIV/AIDS Clinicians’
Consultation Center
San Francisco, CA
HIV Medical Consultation:
800-933-3413
Perinatal Consultation:
888-448-8765
Post-exposure Consultation:
888-448-4911
For administrative issues:
415-206-8586
www.nccc.ucsf.edu
National Multicultural Center
Washington, D.C.
202-865-8146
www.aetcnmc.org
International Training and
Education Center for Health
Seattle, WA
206-221-4944
www.go2itech.org
50
Appendix G. Mountain Plains AETC Regional Office
and Local Performance Sites
REGIONAL OFFICE
Mountain Plains AETC
Anschutz Medical Campus
12631 E. 17th Avenue
Aurora, CO 80045
(p) (303) 724-0867
(f) (303) 724-0875
Lucy Bradley-Springer, PhD, RN,
ACRN, FAAN
Principal Investigator and Director,
MPAETC
Associate Professor, Division of
Infectious Diseases, School of Medicine
[email protected]
(303) 724-0811
Paul Cook, PhD
Project Evaluator, MPAETC
Assistant Professor, College of Nursing
[email protected]
(303) 724-8537
Emma de Anda Sosa
Program Assistant, MPAETC
[email protected]
(303) 724-0853
LOCAL PERFORMANCE
SITES
Anna Kinder, MS, OTR/L
Regional Program Manager
[email protected]
(307) 262-6322
Colorado AETC
12361 E. 17th Avenue, AO1
Aurora, CO 80045
(p) (303) 724-0646
(f) (303) 724-0875
www.coloradoaetc.org
Steven Johnson, MD
Medical Director, MPAETC
Professor of Medicine, Division of
Monica Carten, MD
Medical Director, Colorado AETC
Assistant Professor, Division of
Marla Corwin, LCSW, CACIII
Clinical Education Coordinator,
MPAETC
Instructor, Division of Infectious
Diseases, School of Medicine
[email protected]
(303) 724-0817
MeriLou Johnson, MSW, MPA
Program Director, Colorado AETC
Associate Professor, Division of
[email protected]
Whitney Starr, MS, FNP
Clinical Education Coordinator,
MPAETC
Instructor, Division of Infectious
[email protected]
(303) 724-0819
Dakota AETC
1400 W. 22nd Street
Sioux Falls, SD 57105
(p) (888) 325-2437
(f) (605) 357-1568
www.usd.edu/med/dakaids
Veronica Soler, MD
Principal Investigator, Dakota AETC
Medical Director, South Dakota
Department of Internal Medicine
USD School of Medicine
Gus Alonto, MD
Medical Director, North Dakota
Char Lowman, BA
Program Coordinator, Dakota AETC
USD School of Medicine
[email protected]
(605) 357-1354
Anne Grande, BS
Education Coordinator, North Dakota,
Dakota AETC
[email protected]
(p) (701) 234-4852
Lisa Lawrence, MSW
Program Coordinator, Colorado AETC
[email protected]
51
Kansas AETC
University of Kansas, School of
Medicine – Wichita
1010 North Kansas, #2027
Wichita, KS 67214
[email protected]
(f) (316) 293-1801
www.kaetc.org
Donna Sweet, MD
Principal Investigator and Director,
Kansas AETC
Professor of Internal Medicine
Susan Tusher, LMSW
Senior Coordinator, Kansas AETC
[email protected]
(316) 293-2682
Nebraska AETC
University of Nebraska Medical Center
998106 Nebraska Medical Center
Omaha, NE 68198-8106
(p) (866) 632-2437
(f) (402) 553-5527
www.unmc.edu/hiv
Susan Swindells, MBBS
Director, Nebraska AETC
Terry K. Wantanbe
Professor
Medical Director, HIV Clinic
Ann Fitzgerald, APRN
Coordinator, Nebraska AETC
[email protected]
(402) 559-6681
Deborah Justesen
Project Assistant, Nebraska AETC
[email protected]
(402) 559-8621
New Mexico AETC
University of New Mexico School of
Medicine
Truman Street Clinic
625 Truman Street NE
Albuquerque, NM 87110
http://hsc.unm.edu/som/Medicine/aids
Michelle Iandiorio, MD
Principal Investigator
[email protected]
(505) 925-4096
Tracy Tessman
Education and Outreach Coordinator
New Mexico AETC
[email protected]
(505) 272-8536
Mark Clark
Administrative Assistant
NMAETC
[email protected]
Utah AETC
Division of Infectious Diseases
University of Utah
30 N 1900 E Room 4B319
Salt Lake City, UT 84132
(p) (801) 581-5310
(f) (801) 585-5481
Harry Rosado Santos, MD
Principal Investigator, Utah AETC
Professor of Internal Medicine
[email protected]
(Mary) Jann DeWitt, PhD
Co-Director, Utah AETC
Assistant Professor, Department of
Family and Preventive Medicine
[email protected]
(801) 587-3396
Tiffani Pestotnik, MPH
Grant Coordinator, Utah AETC
[email protected]
(801) 581-5310
Sara Simonsen, BSN, MSPH
Education Coordinator, Utah AETC
Research Associate, Department of
Family and Preventive Medicine
[email protected]
(801) 587-3323
Wyoming AETC
Casper Natrona County Health
Department
851 Werner Court, Suite 292
Casper, WY 82601
www.wyaetc.org
Mark Dowell, MD, FACP
Medical Director, Wyoming AETC
Rocky Mountain Infectious Diseases,
Casper
Anna Kinder, MS, OTR/L
Program Director, Wyoming AETC
[email protected]
(307) 262-6322
C. Maggie Snyder, PA-C
Director, Utah AETC
[email protected]
(801) 581-6396
52
53
54
55
Mountain Plains AIDS Education and Training Center (MPAETC)
(303)724-0867
www.mpaetc.org
56

2012 HIV Sourcebook for the Primary Care Provider

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