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Enhancing Benefits of  Early Antiretroviral Enhancing Benefits of  Early Antiretroviral

Enhancing Benefits of Early Antiretroviral - PowerPoint Presentation

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Enhancing Benefits of Early Antiretroviral - PPT Presentation

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

cd4 art early hiv art cd4 hiv early nam viral viet suppression 350 count baseline aids benefits high pwid

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Slide1

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

Slide2

Early 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)

Slide3

Early 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

Slide4

WHO - 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

Slide5

Viet 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

Slide6

Implication 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

Slide7

Viet 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

Slide8

Translating 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

Slide9

Implementation 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

Slide10

MethodsStudy 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.

Slide11

Participant 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)

Slide12

Retention on ART (by baseline CD4 count)Retention high in the first 6 month of ART, especially those starting ART at CD4>350Baseline CD4 count

Slide13

Viral 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

Slide14

Self-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

Slide15

SummaryStrong 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

Slide16

AcknowledgementViet 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