By Henry Chang Clinical Research Coordinator, Hospital Sungai

By Henry Chang
BSc. (Hons) Nutrition, MMedSc Public Health (UM)
Clinical Research Coordinator, Hospital Sungai Buloh
[email protected]
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Clinical Research Activities in Malaysia
*Definition from Keck School of Medicine, University of Southern California
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mechanisms of human disease
therapeutic interventions
clinical trials
development of new technologies
These studies seek to identify the most effective and most efficient
interventions, treatments, and services.

Major hospitals or centers that involved in clinical research of infectious
diseases (HIV/AIDS) as a site.

Hospital Sungai Buloh

UMMC / PPUM / CERIA

Hospital Pulau Pinang

Hospital attached University (HUKM, USM, UPM, UKM-HKL etc) - Minor
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GLOBAL RESPONSE target
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Source: http://www.avert.org/professionals/hiv-around-world/global-response/targets
PDF source: http://www.unaids.org (resources page)
amfAR and Treat Asia
TREAT Asia (Therapeutics Research, Education, and AIDS Training in Asia)
Collaborative network of
1) Clinics
2) Hospitals,
3) Research institutions,
4) Civil society
to ensure the safe and effective delivery of HIV treatments to adults
and children across the Asia-Pacific through research, education, and
advocacy of evidence-based HIV-related policies. TREAT Asia’s unique
capacity to bring together researchers, doctors, activists, advocates,
and policymakers plays an important role in the region’s response to
HIV, and it has become a model for regional collaboration on HIV/AIDS.
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** The publication are not organized in any
order or sequences and each research is stand
alone information.
All research topics are based on the
presentation in the TAHOD Annual meeting.
Therefore, credits is given to all the
investigators named in each presentation and
their team members.
Result presented are partial from the original
publication. Please refer to sources or
references for more details.
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Research Update

Study Publication and updates

START Study (interim result)

HIV and Aging

CD4 Monitoring frequency and virological outcome of long-term ARV

Community and policy updates

Integrated technology-based interventions in community-based clinic

Thailand’s Test and treat program

ARV for all and how?
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Credits to:
Abdel Babiker, PhD, Co-chair, MRC CTU, UCL, London
Fred M. Gordin, MD, Co-chair, DC VAMC and GWU
Jens D. Lundgren, MD, Co-chair, Univ. of Copenhagen
James D. Neaton, PhD, INSIGHT PI, University of Minnesota
and the INSIGHT START Study Group
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
Evidence for initiating antiretroviral therapy (ART) at
CD4+ counts >350 cells/mm3 primarily comes from large
cohort studies for which the findings have not been
consistent.

There is uncertainty about the effects of early ART on
serious non-AIDS conditions.

Most of the morbidity at high CD4+ counts is due to nonAIDS conditions.

The absolute risk of AIDS is low at higher CD4+ counts,
thus the adverse effects of early ART could easily
outweigh the benefits of reducing the risk of AIDS.
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Total N= 4685, Primary composite endpoint, target = 213
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 Number of death by any causes is lower in
Imm. ART arm (12) compared to Def. ART arm
(21)
 Event of all type of cancer is lower in Imm.
ART arm (14) compared to Def. ART arm (39)
 Bacterial infectious disorder is lower in imm.
ART arm (HR=0.38, p = 0.002)
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
Combination antiretroviral therapy (ART) should
be recommended for all HIV-positive persons
regardless of CD4+ count.

The START Study results align the benefits of ART
to the HIV-positive individual to the benefits of
ART to reducing the risk of viral transmission from
HIV-positive persons to non-HIV-infected
individuals.
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Reference: The INSIGHT START STUDY Group, Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection. New England Journal of
Medicine. 2015;373:795-807
Research Update

Study Publication and updates

START Study (interim result)

HIV and Aging

CD4 Monitoring frequency and virological outcome of long-term ARV

Community and policy updates

Integrated technology-based interventions in community-based clinic

Thailand’s Test and treat program

ARV for all and how?
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A total of 1,198 medications
prescribed to 89 participants
Average 13.46
medication per
participants
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
HAND (HIV Associated Neurocognitive Disorders)

Brain Integrity

Parkinsonism

Risk for Alzheimer's Disease
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HIV & Aging is a Critical Need to Re-engage
 Optimal models of Care for HIV elders
 Manage the syndromes associated with aging in HIV
elders
 Understanding social networks, safety nets, support
networks
 Improving the quality of life for patients unlikely to be
eligible for cure strategies in the next decade
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Reference: Han N, Wright S, O'Connor C, Hoy J, Ponnampalavanar S, Grotowski M, et al. HIV and aging: insights from the Asia Pacific
26 HIV Observational
Database (APHOD). HIV Medicine. 2015;16(3):152-60.

Study Publication and updates

START Study (interim result)

HIV and Aging

CD4 Monitoring frequency and virological outcome of long-term ARV

Community and policy updates

Integrated technology-based interventions in community-based clinic

Thailand’s Test and treat program

ARV for all and how?
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CD4 monitoring frequency on clinical end
point.
TAHOD and TAHOD-LITE analyses
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Reference: Ahn JY, Boettiger D, Law M, Kumarasamy N, Yunihastuti E, Chaiwarith R, et al. Effects of CD4 Monitoring Frequency on Clinical End Points in Clinically
Stable HIV-Infected Patients With Viral Suppression. Journal of Acquired Immune Deficiency Syndrome. 2015;69(3):e85.
Long term virological outcome of first line ARV
Systematic Review and Meta-analysis
Reference: Boender TS, Sigaloff KCE, McMahon JH, Kiertiburanakul S, Jordan MR, Barcarolo J, et al. Long-term virological outcomes of first-line
antiretroviral therapy for HIV-1 in low- and middle-income countries: a systematic review and meta-analysis Clinical Infectious Diseases.
2015;61(11):1749-58.
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On-Treatment Patients (active follow up) : Virological
Suppression rate is >80% up to 5 years after ART
initiation.
Intention-to-treat Patients (included died, stopped
ART and LTFU) : Virological Suppression rate
declined from 75% (6mths)
to 62% after 4 years.
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1) High rates of OT virolocigal suppression probably due to
• Analysis limited on individuals on ART retained in care
• Spontaneous viral suppression
• Impact of adherence
2) ITT analysis:
Numbers of patients died, LTFU or stopped therapy
Virological failure did not observed probably because of
dropped out from care before can be identified or very little
switched to secondline regime.
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Research Update

Study Publication and updates

START Study (interim result)

HIV and Aging

CD4 Monitoring frequency and virological outcome of long-term ARV

Community and policy updates

Integrated technology-based interventions in community-based clinic

Thailand’s Test and treat program

ARV for all and how?
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
Outline

Hepatitis C treatment access
-Developments on viral hepatitis policy
-Direct-acting antivirals (DAAs) in the region
-Emerging generic DAAs
-Pricing and availability

Trade agreements and Intellectual property

Youth ACATA
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Hepatitis policy

HCV Medicines in Model
 Sofosbuvir
 Simeprevir
 Ledipasvir+Sofosbuvir
 Daclatasvir
 Ombitasvir/Paritaprevir/Ribavirin/Ritonavir

± Dasabuvir
Guildelines for HCV treatment and HBV/HCV screening
in development and plan to launch in early next year.
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Direct-acting antivirals (DAAs) in the region
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Emerging of Generic DAAs
Generic $161 (Lowest)
Price listed in per month basis.
Reference treatment duration:
24 weeks (Sofosbuvir + RBV)
Total: USD 1854 (Generic)
Gilead $31937 (Highest)
Source and report in hard copy form, Hepatitis C.
Intellectual property and accessTrans Pacific Partnership (TPP)
 Involved
12 countries included Malaysia,
Vietnam, Singapore, others)
 Affecting
the access to medicines especially
generics.

Related to patent-ship
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Youth ACATA

Youth ACATA
 Youth

Leadership program among Young people
Youth living with HIV from 18 to 24 years of age
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young people from Thailand, Vietnam, Cambodia and
Indonesia

English skills support classes

Share experiences, HIV and treatment literacy, gender
identity, young people and human rights, advocacy
landscape
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Research Update

Study Publication and updates

START Study (interim result)

HIV and Aging

CD4 Monitoring frequency and virological outcome of long-term ARV

Community and policy updates

Integrated technology-based interventions in community-based clinic

Thailand’s Test and treat program

ARV for all and how?
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Integrated technology-based interventions
By Purple Haze (Red Thai Cross), Tarandeep Anand
 Adam’s Love and TemanTeman.org Program
 Thailand, Indonesia, Malaysia and Taiwan
 “Online Test & Test Study for MSM and TG Individuals”, the
amfAR Implementation Science Research
 Asia’s First Electronic Health Record (EHR) System for MSM
and TG individuals
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Integrated technology-based interventions
ADAM’S LOVE
for men who love men
Thailand and Taiwan
“Only 7% of MSM reached
through conventional offline
outreach activities received
HIV testing.”
Source: Thailand Global Fund Round 8 Program, 2012
http://www.adamslove.org/
http://www.adamslove.org/tw/
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Integrated technology-based interventions
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Integrated technology-based interventions
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Integrated technology-based interventions
TEMANTEMAN
Indonesia and Malaysia
http://www.temanteman.org/myen.php
http://www.temanteman.org/indo/
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Integrated technology-based interventions
Future plan
“Just like checking your
bank account balance,
credit card reports or
making reservation of
your flight tickets and
accommodation…”
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Integrated technology-based interventions
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Integrated technology-based interventions
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Integrated technology-based interventions
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Research Update

Study Publication and updates

START Study (interim result)

HIV and Aging

CD4 Monitoring frequency and virological outcome of long-term ARV

Community and policy updates

Integrated technology-based interventions in community-based clinic

Thailand’s Test and treat program

ARV for all and how?
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Thailand’s Test and treat program
by Nittaya Phanuphak
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Thailand’s Test and Treat Program
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Thailand’s Test and Treat Program
Hard-to-reach
population and bring
them into HIV
prevention and care
High CD4 do not want to
start HAART. Probably poor
adherence and causing the
spread of resistance
Only professional can
provides HIV testing and
giving counselling about
ARVs.
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Thailand’s Test and Treat Program
Hard-to-reach population and bring
them into HIV prevention and care
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Thailand’s Test and Treat Program
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Thailand’s Test and Treat Program
Only professional can provides HIV testing
and giving counselling about ARVs.
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Thailand’s Test and Treat Program
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Thailand’s Test and Treat Program
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Thailand’s Test and Treat Program
Promoting barebacking, cause
widespread resistance, side
effect and burdening doctors?
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Thailand’s Test and Treat Program
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Thailand’s Test and Treat Program
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Research Update

Study Publication and updates

START Study (interim result)

HIV and Aging

CD4 Monitoring frequency and virological outcome of long-term ARV

Community and policy updates

Integrated technology-based interventions in community-based clinic

Thailand’s Test and treat program

ARV for all and how?
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ART for all and how?
By Kiat Ruxrungtham
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Reference: Hospital Sungai Buloh, maybe slight differ with actual case or others hospital.
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Special Updates
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Reference: ENCORE1 Study Group . Efficacy and safety of efavirenz 400 mg daily versus 600 mg daily: 96-week data from the randomised, doubleblind, placebo-controlled, non-inferiority ENCORE1 study. Lancet, Infectious Diseases. 2015;15:S1473-3099.
Viral load
CD4 cells count
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1) 400mg EFV remains virologically non-inferior to the standard 600mg.
 Rates of viral suppression is similar in both arms.
2) Overall frequency and severity of adverse events do not reduced.
 Most events mild to moderate
 Significantly EFV-related adverse events (included CNS AE) is higher in 600mg
dose.
 Fewer people discontinue treatment in 400mg dose arm.
 However, does not effecting DASS-21 score (Depression and Anxiety).
3) Applicable to healthy adult, further investigation needed for adolescents and
malnourished patients.
4) Wide practices of reduced-dose EFV would reduce the drug costs especially middle
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and low-income country.
 MUST AQUIRED Consent form
 Registry number (NMRR)
 Objectives of the study and duration
 Investigators’ Institute, name, person to contact and
phone numbers
 What is the procedures involved or What you going to
eat (eg: Supplements and medications)************
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