HCV Epidemiology in the United States - Core

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HCV Epidemiology in the United States
Module 1:
Lesson 1:
Contents:
Screening and Diagnosis of Hepatitis C Infection
HCV Epidemiology in the United States
HCV Incidence and Prevalence
Risk Factors for Acquiring HCV
CDC Case Definitions and Reporting
HCV Disease Burden
Summary Points
References
Figures
HCV Incidence and Prevalence
Definitions of HCV Incidence
The incidence of hepatitis C is defined as number of new infections in a specific region in a specific
time period. The CDC typically defines the incidence of hepatitis C in the United States (or in each
state) as the number of new hepatitis C virus infections that occur per year. The incidence rate is
the number of cases per total population (typically defined as number of cases per 100,000 persons).
Incidence Data
The CDC generates estimates for the total number of new cases that occur each year based on
reporting data. For each new symptomatic acute HCV case that is reported, an estimated 3.3 cases
of symptomatic acute HCV actually occur. In addition, for each new HCV case that is symptomatic
and reported, the actual number of acute cases is approximately 13 times the number of new HCV
infections reported. The CDC estimates that 30,500 persons were newly infected with hepatitis C in
2014. The number of new annual HCV infections has increased significantly from 2011 (16,500) to
2014 (30,500), but the number of annual new infections in recent years is markedly lower than
during the 1980’s, when an estimated 230,000 persons were newly infected with HCV each year
(Figure 1).
Importance of Incidence Data
The United States hepatitis C incidence data provide important information for monitoring trends in
transmission patterns, developing hepatitis C prevention strategies, monitoring the effectiveness of
any implemented plans, and identifying focal outbreaks or regional patterns of infection. In addition,
valuable information emerges when data is categorized by age group, gender, race/ethnicity, and
risk factor for acquiring hepatitis C virus.
Method of Estimating Incidence
Most patients with acute hepatitis C do not have an acute illness and most do not seek medical
care. In addition, many cases of diagnosed acute hepatitis C are not reported. Thus, determining the
incidence of new infections per year requires sophisticated epidemiologic modeling techniques that
use surveillance data to generate estimates for the number of new infections per year. The CDC
provides several numbers related to the incidence of hepatitis C in the United States, including (a)
number of reported acute cases, estimated number of acute clinical cases, estimated number of new
infections, and the national rates per 100,000 persons.
Definition of HCV Prevalence
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The HCV prevalence is defined as the number (or percent) of persons in the total population
observed infected with hepatitis C. Most often, the HCV prevalence specifically refers to persons
living with active (chronic) hepatitis C infection. Less frequently, the HCV prevalence data is given for
all individuals with anti-HCV (number of persons living who have been infected with hepatitis C),
which includes those with active HCV, persons who spontaneously resolved HCV, and those with HCVtreatment related cure. The prevalence rate of chronic hepatitis C is the number of persons living
with HCV per population (typically defined as number of persons per 100,000 population).
HCV Prevalence Data Based on NHANES Data
In the United States, hepatitis C virus infection is the most common bloodborne infection. The best
estimates of HCV prevalence derive from analysis of serum specimens taken from participants in
the National Health and Nutrition Examination Survey (NHANES) (Figure 2). The first estimate of HCV
prevalence in the United States was generated from NHANES conducted between 1988 and 1994
and it estimated 2.7 million persons had chronic HCV in the United States. In a similar subsequent
NHANES analysis, which involved a survey conducted between 1999 and 2002, investigators
estimated 3.2 million persons had chronic HCV, which corresponded to approximately 1.3% of the
population. A recent follow-up NHANES study that involved survey data from 2003 to 2010 estimated
prevalence of 2.7 million persons chronically infected with HCV, corresponding to a population
prevalence of chronic hepatitis C of 1.0%. These NHANES surveys, however, did not sample
certain populations, including the incarcerated, homeless, nursing home residents, persons on active
military duty, and immigrants.
CDC Current HCV Prevalence Estimate
Other investigators have estimated a higher HCV prevalence in the United States, based on the
knowledge that the NHANES surveys did not include certain populations in the survey, including
incarcerated, homeless, nursing home residents, hospitalized individuals, and persons on active
military duty. The CDC, after adjusting for populations not included in the NHANES surveys,
estimates that 3.5 million persons are living with HCV infection in the United States.
HCV Prevalence by Year of Birth
The HCV prevalence is highest among persons born during 1945 to 1965 (Figure 3). Indeed, the CDC
estimates that approximately three-fourths of all persons living with HCV infection in the United
States were born during 1945 to 1965. The relatively high prevalence of HCV infection among
persons born during 1945 to 1965 corresponds with the high HCV incidence (new infections) that
occurred among young adults in the 1970s and 1980s.
Awareness of HCV Infection Status
An estimated 40 to 85% of persons infected with HCV are unaware of their HCV infection status. One
study reported that among HCV-infected injection drug users who were 15 to 30 years old, 72% were
unaware of their HCV infection status. A more recent NHANES study conducted from 2001 through
2008 found that 50.3% of persons infected with HCV were unaware of their status. In a study
involving persons with access to medical care in four private health care organizations during the
years 2006 to 2008, an estimated 43% were unaware of their HCV infection.
HCV Genotype
In the United States, approximately 70% of chronic HCV infections are caused by hepatitis C
genotype 1, 15 to 20% by genotype 2, 10 to 12% genotype 3, 1% genotype 4, and less than 1%
genotype 5 or 6. Among the genotype 1 infections, approximately 55% are genotype 1a and 35%
1b.
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Risk Factors for Acquiring HCV
Overview of Risk Factors for HCV Acquisition
Investigators have identified multiple risk factors for acquiring HCV in the United States: injection
drug use, history of receiving a blood product transfusion prior to July 1992, receipt of a solid organ
transplantation, hemophilia with receipt of factor concentrates made before 1987, male to male sex,
body tattoos, and intranasal cocaine use. Among these, injection drug use is the most common and
important risk factor for acquiring HCV in the United States. Several studies have indicated that
approximately 45% of persons with HCV infection do not report an exposure. Many of these
patients, after undergoing careful questioning, eventually identified injection drug use as a risk
factor. In the 1970’s and 1980’s, receipt of HCV-infected blood products or organs accounted for
nearly 50% of new cases of HCV, but after the discovery of HCV as the cause of non-A, non-B
hepatitis in 1989 and introduction of blood screening tests in the early 1990’s, the proportion of new
HCV cases caused by contaminated blood or organs dramatically declined. Persons in different
ethnic groups may have relatively different routes of acquiring HCV.
Hemodialysis
The incidence of HCV infection in dialysis patients decreased from 1.7 to 0.2% during 1982 to 1997.
The overall prevalence of HCV among persons receiving dialysis is approximately 8% (nearly 5-fold
higher than the general population). Several risk factors have been identified for dialysis patients
acquiring HCV, including number of blood transfusion received, number of years on dialysis, mode of
dialysis (hemodialysis poses greater risk than peritoneal dialysis), and the prevalence of HCV in the
dialysis unit. In the United States, recent dialysis-associated outbreaks have occurred and HCV
transmission most likely resulted from inadequate infection control practices, particularly in
situations when patients received dialysis immediately after an HCV-infected patient received
dialysis. The CDC does not recommend using dedicated dialysis machines for patients with HCV, but
recommends universal precautions and strict sterilization procedures for all dialysis machines.
Hemophilia
Clotting factor concentrates used to treat patients with hemophilia (Factor VIII and Factor IX) are
plasma-based products. In the late 1970s through the mid 1980s, an estimated 6,000 to 10,000
persons with hemophilia acquired HCV infection via the receipt of contaminated clotting factor
concentrates. In 1985, several companies introduced virus inactivation procedures for hemophilia
blood products and by 1987 these procedures were uniformly used, virtually eliminating the risk of
transmission of HCV via clotting factor concentrates.
Household Contact
The number of persons acquiring HCV via household contact with a person infected with HCV is
extremely low. These cases would most likely involve sharing a razor or toothbrush, since this
process could involve transmission via a blood-tainted device.
Injection Drug Use
Injection drug use remains the most common risk factor for acquiring HCV in the United States,
accounting for more than 50% of all cases of HCV. A recent study identified injection drug use as the
risk factor for 84% of individuals diagnosed with acute HCV. Approximately 20 to 30% of persons
who inject drugs are infected with HCV within the first 2 years of starting to inject drugs and 75 to
90% of persons who inject drugs are anti-HCV positive. Transmission risk is greatest with “direct
sharing” of needles and syringes, but may also occur indirectly via sharing of injection paraphernalia,
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such as syringes, cookers, and cotton filters. The incidence of HCV in persons who inject drugs has
markedly declined in the past 20 years, likely secondary to use of needle exchange programs that
arose in response to the HIV epidemic and saturation of HCV infection in the population of persons
who inject drugs. Recent reports have identified a new cohort of HCV-infected injection-drug users
with the following characteristics: age 24 or younger, white race, residence in non-urban areas, and
use of oral prescription opiates prior to using heroin. The prototypical new heroin user initiates some
type of substance abuse, such as alcohol or marijuana at about age 13, transitions to using oral
opiates, most often oxycodone, around age 17, then eventually starts using cheaper and widely
available heroin by about age 18.
Immune Globulin
In 1993 and 1994, a major outbreak of HCV transmission in the United States occurred following
patient receipt of HCV-contaminated lots of intravenous immune globulin. This outbreak involved
more than 100 persons. Other reports involving a smaller number of patients have documented HCV
transmission with receipt of intravenous immune globulin. Advances in virus inactivation procedures
have nearly eliminated any risk of HCV transmission with immune globulin and manufacturers of
intravenous immune globulin use vigorous viral inactivation and removal procedures. No cases of
HCV transmission have been documented with administration of intramuscular immune globulin. All
immune globulin products undergo solvent detergent.
Noninjection Drug Use
The role of noninjection drug use, such as snorting crack cocaine, powder cocaine,
methamphetamines, or heroin, as a risk factor for acquiring hepatitis C remains controversial. The
risk of acquiring HCV is plausible with use of pipes that may cause burns in the oral mucosa (with
possible open mouth sores) or use of straws or tubing that causes erosion of nasal membranes (with
bleeding in the nasal passage). Sharing these blood-contaminated devices could then lead to HCV
transmission. The prevalence of HCV in noninjection drug users ranges from 2.3 to 35.3%. It is
possible that use of noninjection drugs is a surrogate for other risk behaviors associated with HCV
acquisition.
Organ and Tissue Transplantation
Rare cases of inadvertent HCV transmission via organ or tissue transplantation continue to occur in
the United States. Most cases of transmission have involved HCV-antibody negative, HCV RNA
positive donors. Among transplant recipients who receive HCV-infected organs or tissues, the risk of
developing chronic HCV infection is high. With the advent of more accurate testing methods for
donors, the risk of HCV transmission in this setting has markedly declined. In 2011, the U.S. Public
Health Service drafted guidelines that recommended HCV RNA testing of all organ and tissue donors.
Perinatal
Among pregnant women with chronic HCV infection, approximately 5% (range 4 to 10%) will
transmit HCV to their child. Nearly all cases of perinatal HCV transmission have involved mothers
who had detectable HCV RNA in plasma during pregnancy, but rare cases of perinatal HCV
transmission have occurred in HCV antibody positive, HCV RNA negative women. The major risk of
transmission occurs at the time of birth and the HCV RNA levels at the time of delivery correlate with
the relative risk of transmission. Women coinfected with HIV and HCV have an approximately twofold
higher risk of perinatal HCV transmission when compared with women who have HCV monoinfection.
The risk of HCV transmission via breastfeeding appears to be negligible.
Receipt of Infected Blood Transfusion
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In the 1960’s, the risk of acquiring HCV from a blood transfusion was about 33%. The universal
screening of blood and organ donors with routine use of second-generation HCV antibody tests in
1992 nearly eliminated the risk of transfusion-associated HCV. In the mid 1990’s the risk of
acquiring HCV from a blood transfusion had declined to less than 0.3%. The estimated risk of
acquiring HCV from a blood transfusion decreased further following the introduction, in 1999, of the
HCV nucleic acid testing (NAT) as a supplement to HCV antibody testing of blood products. Blood
banks in the United States now use a combination of the 3rd generation enzyme-linked
immunosorbent assay (ELISA) and NAT screening of minipool testing (16 samples). The current
estimated risk of acquiring HCV from a transfusion in the United States is approximately 1 in 2
million.
Sexual Exposure
The risk of acquiring HCV through sexual contact with another HCV-infected person remains highly
controversial. Overall, sexual transmission has accounted for up to 15% of cases of HCV in the
United States, but with very close interrogation most of these cases of sexual transmission also
involved injection drug use as a risk factor. Indeed, four large prospective studies involving
monogamous heterosexual couples have shown extremely low risk of HCV transition in this setting.
In a recent study involving 500 anti-HCV positive, HIV-negative subjects and their long-term
monogamous heterosexual partners, investigators reported transmission of HCV by sex at a rate of
0.07% per year among the couples, which translates to approximately 1 per 190,000 sexual
contacts. Among the bona fide cases of sexual transmission of HCV, most have involved either men
who have sex with men or heterosexuals with high numbers of sexual contacts. For heterosexual
HCV transmission, the number of sexual partners, not the number of sexual acts, appears to have
the greatest impact. Recently, researchers have investigated a significant number of new HCV cases
among HIV-infected men who have sex with men and have identified unprotected receptive anal
intercourse with ejaculation and having sex while high on methamphetamine as important risk
factors for acquiring HCV.
Tattoos and Piercings
In the United States, the risk of acquiring HCV from a licensed, regulated professional tattoo or
piercing center is extremely low. The risk in unregulated and unlicensed tattoo centers may be
significant, such as with tattoos applied by friends or in prison.
CDC Case Definitions and Reporting
CDC Hepatitis C Case Definitions
The CDC has established case definitions and reporting criteria for acute and for past (resolved) or
present (chronic) hepatitis C infection.
Acute Hepatitis C—2016 Case Definition
The CDC 2016 Case Definition for Acute Hepatitis C infection includes clinical and laboratory criteria
(Figure 4), along with a case classification as probable or confirmed (Figure 5). Of note, a patient can
have a confirmed case of acute hepatitis C based on laboratory data alone (a hepatitis test
conversion documented by a negative HCV antibody, HCV antigen or NAT laboratory test result
followed within 12 months by a positive result of any of these tests). Symptomatic cases often go
unreported and for multiple reasons, including many symptomatic patients do not seek medical care,
the diagnosis may be missed, and medical providers may fail to report diagnosed cases. It is
important not to report cases that have already been reported.
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Chronic Hepatitis C Virus Infection—2016 Case Definition
The CDC Case Definition for Chronic Hepatitis C is based entirely on laboratory criteria (Figure 6).
includes clinical description, laboratory criteria, and case classification (Figure 7). These cases
pertain to persons with current (active) hepatitis C infection and do not represent persons who
spontaneous cleared hepatitis C infection. Also, it is important not to report cases that have have
already been reported.
Reporting Criteria
Persons identified with acute hepatitis C should undergo an interview to determine an identifiable
risk factor in the 2-week to 6-month time frame that preceded the onset of their illness. Similarly, the
individual with past (resolved) or present (chronic) hepatitis C infection should be interviewed to
determine lifetime risk factors for hepatitis C. The Viral Hepatitis Case Report form should be filled
out for persons identified with either acute hepatitis C infection or past/present hepatitis C. Cases of
hepatitis C should be reported to a health department, which in turn submits reporting data to the
CDC via the Nationally Notifiable Diseases Surveillance System (NNDSS).
HCV Disease Burden
Deaths Related to Hepatitis C
Persons with HCV infection have all-cause mortality greater than twice that of HCV-negative persons.
In the United States, hepatitis C is the cause of death or contributing cause of death in
approximately 15,000 people per year. From 1997 to 2007, the number of annual deaths related to
hepatitis C increased substantially and in 2007, the number of deaths related to hepatitis C had
exceeded those related to HIV (Figure 8). A more recent study that analyzed HCV-related deaths in
the United States from 2003 to 2013 concluded the annual HCV-related deaths have continued to
increase since 2007, with an estimated 19,369 HCV-related deaths in 2013. Persons with chronic
hepatitis C infection have an estimated mortality rate 12 times higher than the general population.
In addition, the number of hepatitis C-related deaths are at least 8-fold greater than those related to
hepatitis B. Investigators have identified factors associated with an increased risk of death in
persons with chronic hepatitis C infection: chronic liver disease, coinfection with hepatitis B virus,
alcohol-related conditions, minority status, and coinfection with HIV. Among the HCV-related deaths
in recent years, more than 70% have involved persons 45 to 64 years of age.
Morbidity Related to Hepatitis C
Overall, approximately 20% of persons infected with hepatitis C, if not treated, will develop cirrhosis
after 20 years of infection and this number increases as the duration of infection increases. Hepatitis
C-associated liver disease is the number one indication for liver transplantation and approximately
one-third of all persons on liver transplantation waiting lists have hepatitis C-associated liver disease.
In addition, Hepatitis C-associated liver disease is the number one cause of hepatocellular
carcinoma, accounting for approximately 50% of cases of hepatocellular carcinoma.
Health Care Related Costs
In an analysis in a managed care setting, HCV-infected persons infected (when compared with
controls) had markedly higher total health care utilization costs, hospitalization costs, and
prescription costs. Persons infected with HCV have increased likelihood of requiring short-term or
long-term disability.
Projected HCV-Related Deaths
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Modeling studies have projected a dismal future in the next 40 to 50 years related to HCV-related
disease burden. In general, these models make forecasts based on current conditions of low rates of
screening and treatment and thus do not include a widespread program of identifying and treating
the large proportion of undiagnosed HCV-infected individuals. When excluding the potential impact
of treatment on future mortality, the projected HCV-related deaths will peak in 2030 to 2035, with
approximately 36,000 deaths per year (Figure 9). Factoring in treatment gives lower estimates of
death.
Projected End Stage Liver Disease Related to Hepatitis C
Investigators predict that 1.76 million persons with chronic HCV infection (if not treated) will develop
cirrhosis during the next 40 to 50 years, with a peak prevalence of about 1 million in the mid-2020’s.
The projected incidence peak (new cases) of end-stage liver disease will occur in 2030, with about
38,600 cases per year. The prevalence (number of people living) with end-stage liver disease also is
predicted to peak in 2030, with an estimated 131,300 persons living with end-stage liver disease.
Transplants would be expected to peak in 2032 to 2033 at level of 3200 HCV-related transplants per
year.
Summary Points
In the United States:
The number of estimated new HCV infections increased from 2011 (16,500) to 2014 (30,500).
Based on CDC estimates, 3.5 million persons are living with HCV infection in the United
States.
An estimated three-fourths of persons living with HCV were born during 1945 to 1965.
Approximately 50% of persons with HCV infection are unaware of their HCV status.
Injection drug use is the most common risk factor for HCV acquisition.
Sexual transmission of HCV can occur, but this most often involves men who have sex with
men.
The number of annual HCV-related deaths is approximately 19,000 persons and this now
exceeds the number of annual HIV-related deaths.
The CDC has established a clear definition of acute and chronic HCV infection for reporting
purposes as well as reporting guidelines.
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Figures
Figure 1 Hepatitis C Incidence in United States, 1982-2014.
This graphic represents the estimated number of new hepatitis C infections per year.
Source: Division of Viral Hepatitis. Statistics and Surveillance
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Figure 2 Estimated Number of Persons Infected with HCV in the United States.
This graphic shows data representing seroprevalence (anti-HCV) and chronic infection (HCV RNA)
from three distinct NHANES studies. The numbers on the bar graph represent millions of persons.
Source: Denniston MM, Jiles RB, Drobeniuc J, Klevens RM, Ward JW, McQuillan GM, Holmberg SD.
Chronic hepatitis C virus infection in the United States, National Health and Nutrition Examination
Survey 2003 to 2010. Ann Intern Med. 2014;160:293-300.
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Figure 3 Prevalence of HCV Antibody, by Year of Birth.
The HCV prevalence is highest among persons born from 1945 to 1965. This graphic shows
prevalence studies performed during two separate time periods: 1988-1994 (blue line) and
1999-2002 (purple line).
Source: Armstrong GL, Wasley A, Simard EP, McQuillan GM, Kuhnert WL, Alter MJ. The prevalence of
hepatitis C virus infection in the United States, 1999 through 2002. Ann Intern Med.
2006;144:705-14.
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Figure 4 Acute Hepatitis C: 2016 Case Definition—Clinical and Laboratory Criteria
Source: Centers for Disease Control and Prevention (CDC)
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Figure 5 Acute Hepatitis C: 2016 Case Definition—Case Classification as Probable or
Confirmed
Source: Centers for Disease Control and Prevention (CDC)
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Figure 6 Chronic Hepatitis C: 2016 Case Definition—Clinical and Laboratory Criteria
Source: Centers for Disease Control and Prevention (CDC)
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Figure 7 Chronic Hepatitis C: 2016 Case Definition—Case Classification as Probable or
Confirmed
Source: Centers for Disease Control and Prevention (CDC)
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Figure 8 Mortality Rates from HBV, HCV, and HIV in United States, 1999-2007.
This graphic shows that when determining age-adjusted mortality rates, hepatitis C-related deaths
surpassed HIV-related deaths in 2006. Abbreviations: PY = person years
Source: Ly KN, Xing J, Klevens RM, Jiles RB, Ward JW, Holmberg SD. The increasing burden of
mortality from viral hepatitis in the United States between 1999 and 2007. Ann Intern Med.
2012;156:271-8.
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Figure 9 Forecasted Annual Deaths Associated with Chronic Hepatitis C Infection.
Among persons with chronic hepatitis C infection and no liver cirrhosis, the hepatitis-C related
deaths peak in 2030 to 2035.
Source: Rein DB, Wittenborn JS, Weinbaum CM, Sabin M, Smith BD, Lesesne SB. Forecasting the
morbidity and mortality associated with prevalent cases of pre-cirrhotic chronic hepatitis C in the
United States. Dig Liver Dis. 2011;43:66-72.
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