Therapy Evidence Implication and Preliminary Findings from an Implementation Research in Viet Nam Masaya Kato WHO Viet Nam National Scientific Conference on HIVAIDS 2425 November 2015 Hanoi Viet Nam ID: 788859
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Enhancing Benefits of Early Antiretroviral TherapyEvidence, Implication and Preliminary Findings from an Implementation Research in Viet NamMasaya Kato, WHO Viet NamNational Scientific Conference on HIV/AIDS24-25 November 2015, Hanoi, Viet Nam
Slide2Early ART – Evidence of Therapeutic Benefits- Two large randomized controlled trials -TEMPERANOSTARTSample size20564651CD4 inclusion criteriaImmediate ARTDeferred ARTCD4<800Immediate startCD4<250, 350, 500CD4>500Immediate startCD4<350Primary outcomesDeath or severe HIV-related illnessComposite end point: Serious AIDS & non-AIDS events, deaths, TB, etcHazard ratio of primary outcomes0.56 (0.41-0.76)0.43 (0.30-0.62)
Slide3Early ART – Evidence of Preventive Benefits- HPTN052 – RCT among serodiscordant partners -3Early ART (CD4 350-550) vs delayed ART (CD4<250) in index partners93% decrease in linked infections Only 8 cases of transmission when index partner was on ART4 diagnosed shortly after ART start → Likely before viral suppression 4 occurred while treatment failureNo transmissions when viral load undetectable93% reductionN = 1761
Slide4WHO - When to Start in Adults: Evidence summaryA systematic review comparing ART initiation at CD4 <500 CD4 vs ≥500 CD4 cells/µL1 RCT* (TEMPRANO) and 17 cohorts or meta-analyses of cohorts Less severe HIV morbidity, HIV disease progression and HIV transmission, without increase in grade III/IV lab adverse events.WHO 2015 Early Release GuidelinesART should be initiated among all adults with HIV regardless of WHO clinical stage and at any CD4 cell count As a priority, ART should be initiated among all adults with severe or advanced HIV clinical disease (WHO clinical stage 3 or 4) and adults with CD4 count ≤350 cells/mm3
Slide5Viet Nam: Findings from Modelling StudiesThree modelling studies on potential impact of early ART in Viet Nam:VAAC, WHO, CDC, Can Tho data (JAIDS, 2013. 63(5): e142-9)UNSW, PrevTool (Lancet Global Health, 2014. 2: e23-34)VAAC, Asian Epidemic Model (VAAC)Early diagnosis and immediate ART → significant reduction in HIV transmission and AIDS deathsHighly effective and cost-efficient if high coverage achieved in key populations Initial investment needed, but will leads to high returns
New HIV
infection 2013-30
Asian Epidemic Model
Baseline
80% CD4<350
80% CD4<350
+ immediate ART for key populations
Slide6Implication for ProgrammeNeed for Higher Coverage at Cascade StepsSources: Estimation by Asian Epidemic Model (PLHIV); Case reporting system (Diagnosed); Routine reporting system Decision 28 (Enrolled in OPC, On ART); Estimated from the results of acquired HIV drug resistance survey (viral suppression)Viral suppression needed for full benefits of ARTDiagnosisEnrolment
ART
Viral suppression
Viet Nam HIV Care Cascade 2014
Slide7Viet Nam: Care Cascade in Key PopulationsCascade among PWID using Viet Nam IBBS 2013 dataEarlier diagnosis and improved cascade in key populations critical to achieve benefits of early ART
Large gap
Slide8Translating Evidence into Programme- Operational Questions - Feasibility and acceptability in Viet Nam programmeEarlier diagnosis and immediate ART Especially among key populationsAdherence, retention and viral suppressionAmong those starting ART with higher CD4 countPossible behavioral disinhibition (risk compensation) after ART initiationARV toxicity especially among people with high CD4 countHence, an implementation research study to inform implementation of early ART in Vietnam
Slide9Implementation ResearchViet Nam HIV Testing and Early ART (V-HEART)By VAAC, HMU, NIHE, WHO ObjectiveTo assess the operational feasibility and acceptability of periodic voluntary HIV testing among PWID, and immediate ART irrespective of CD4 count among HIV+ PWID in Viet Nam’s programme.Outcome indicators (selected)Viral suppression at 6 and 12 months after ART startRetention across the care cascadeSelf-reported risk behavioursQualitative analysis of feasibility and acceptability (not shown in this presentation)Study ongoing: Interim results shown in this presentation
Slide10MethodsStudy setting and interventionsSince April 2014, in Thai Nguyen and Thanh Hoa provinces:HIV testing every 6 month recommended to PWID, andImmediate ART (irrespective of CD4 count) offered to PWID diagnosed HIV+ Counselling promoting concomitant use of other prevention methodsFollowing consent after informed on benefits and risks of immediate ARTParticipantsPWID defined as an individual:who self-reported injecting drugs within 30 days; orwho self-reported ever injecting drugs and had a visible injection site; or
on
MMT
Assessments & Procedures
HIV viral load (VL) assessed before ART start (baseline), at months 6 and 12
Behaviours
assessed at baseline, at months 3, 6, and 12.
Slide11Participant Baseline CharacteristicsInterim analysis based on 251 individuals who started ART by December 2014 CD4 ≤ 350CD4 > 350Overall N = 163N = 88N = 251Sex% Male
98.2%
98.9%
98.4%
Age (
Years)
Median (
IQR)
34 (30-39)
36 (30-39)
34 (30-39)
Education
% Secondary school and above
80.4%
86.4%
82.5%
CD4 baseline
Median (IQR)
97 (31-204)
478 (402-632)
208 (55-402)
Viral load baseline
(
copies/ml
)
Median
(
IQR)
112,201
(43,651 – 257,039)
16,595
(5,754 – 47,863)
63,095
(15,848-169,824)
Slide12Retention on ART (by baseline CD4 count)Retention high in the first 6 month of ART, especially those starting ART at CD4>350Baseline CD4 count
Slide13Viral suppression at Month 6At month 6, >85% achieved viral suppression (<1000 copies/ml) irrespective of CD4 countN (CD4 ≤ 350)
168
120
N (
CD4
>
350
)
88
72
Slide14Self-reported Risk BehaviorsNo increase in risk behaviours observed in the first 6 months % Clean needle use in the last injection among those reporting injection drug use in the past 1 month
% Consistent condom use in the past 3 months among those reporting ongoing sex partners
Slide15SummaryStrong evidence supporting benefits of early ARTPrevents morbidity, mortality and transmissionWHO recommends ART initiation at any CD4 cell count Programmatic Implications of early ART Earlier diagnosis and improved cascade in key populations critical Cost-effective, and investment likely leads to high returnImplementation research interim analysisIn early phase of ART, high retention and viral suppression achieved among PWID starting ART at the higher CD4 countComprehensive analysis to inform programming of early ART
Slide16AcknowledgementViet Nam Authority for HIV/AIDS ControlNguyen Hoang LongBui Duc Duong Nguyen Huu HaiDo Thi NhanHanoi Medical UniversityLe Minh GiangDinh Thi Thanh ThuyNguyễn Minh SangTruong Van HaiNational Institute of Hygien and EpidemiologyPham Hong ThangNguyen Le HaiTran Hong TramThai Nguyen Provincial AIDS Center
Le Ai Kim Anh
Ho Thi Quynh Trang
Thanh Hoa
Provincial AIDS Center
Nguyen Ba Can
Vu Dinh Nam
WHO Viet Nam
Masaya
Kato
Nguyen
Thi
Thuy
Van
Vu
Quoc
Dat
Amitabh Suthar
WHO WPRO Ying-Ru Lo
VAAC, MOH
V-HEART study
participants
Health care workers at study sites
Community collaborators, peer educators
Donors:
MAC AIDS Foundation,
Global Fund
United Nations in Viet
Nam
Nathan Ford, Naoko Ishikawa
V-HEART investigators