Update on global guidelines. and emerging issues on perinatal HIV prevention. WHO 2013 Consolidated ARV Guidelines

Transcription

1 WHO 2013 Consolidated ARV Guidelines Update on global guidelines H I V / A I D S DEPARTMENT and emerging issues on perinatal HIV prevention Children & HIV, St. Petersburg, Russia Sept 25-26, 2014 Dr. Nathan Shaffer, PMTCT Lead, WHO, Geneva

2 Objectives of Presentation obackground: MTCT-> PMTCT-> EMTCT ooverview of WHO 2013 Recommendations oemerging Issues / Future directions okey questions for Russia and Euro Region

3 Global summary of HIV epidemic in mothers and children, 2013 ~1.4 million pregnant women living with HIV 3.2 million children < 15 years of age living with HIV infection 240,000 new infections in children ~ 660 new infections in children per day 190,000 pediatric deaths attributed to HIV >90% of new pediatric infections attributed to mother-to-child transmission

4 Risk period for MTCT Relative proportion of risk Risk extends across ANC, L&D, and BF (from 9-36 months) Transmission risk changes with different interventions and duration of exposure With no ART interventions, transmission risk 30-40% During pregnancy and L&D ~ 20-25% During breastfeeding ~ 15-20% Progressive move over 15 years to increase drug coverage

5 MTCT of HIV What we can achieve with ARV interventions MTCT transmission < 2 % demonstrated in non-bf settings when appropriate interventions received MTCT of transmission <5% estimated to be feasible in BF settings. BF transmission probability depends on ARV coverage and CD4/VL level Without treatment ~1/3 of children living with HIV die by their first birthday ~1/2 die by their second birthday ART can reduce morbidity and mortality among children with HIV Estimated ART coverage among children with HIV: 23% 5

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7 New HIV infections among children in low- and middle-income countries declining:

8 PMTCT ART Evolution of WHO PMTCT ARV Recommendations Launch July weeks AZT; AZT+ 3TC, or SD NVP No recommendation AZT from 28 wks + SD NVP AZT from 28wks + sdnvp +AZT/3TC 7days Option A (AZT +infant NVP) Option B (triple ARVs) Option B or B+ Moving to ART for all PW/BF CD4 <200 CD4 <200 CD4 <350 CD4 <500 Move towards: more effective ARV drugs, extending coverage throughout MTCT risk period, and ART for the mother s health

9 Summary of Changes in Recommendations: When to Start in Adults TARGET POPULATION (ARV-NAIVE) HIV+ ASYMPTOMATIC HIV+ SYMPTOMATIC PREGNANT AND BREASTFEEDING WOMEN WITH HIV HIV/TB CO-INFECTION 2010 ART GUIDELINES 2013 ART GUIDELINES CD4 350 cells/mm 3 WHO clinical stage 3 or 4 regardless of CD4 cell count CD4 350 cells/mm 3 or WHO clinical stage 3 or 4 Presence of active TB disease, regardless of CD4 cell count CD4 500 cells/mm 3 (CD4 350 cells/mm 3 as a priority) No change Regardless of CD4 cell count or WHO clinical stage No change STRENGTH OF RECOMMENDATION & QUALITY OF EVIDENCE Strong, moderate-quality evidence Strong, moderate-quality evidence Strong, moderate-quality evidence Strong, low-quality evidence HIV/HBV CO- INFECTION Evidence of chronic active HBV disease, regardless of CD4 cell count Evidence of severe chronic HBV liver disease, regardless of CD4 cell count Strong, low-quality evidence HIV+ PARTNERS IN SERODISCORDANT COUPLE RELATIONSHIP(S) No recommendation established Regardless of CD4 cell count or WHO clinical stage Strong, high-quality evidence

10 Recommendations Option B+ Option B All pregnant and breastfeeding women infected with HIV should initiate triple ARVs (ART), which should be maintained at least for the duration of mother-to-child transmission risk. Women meeting treatment eligibility criteria should continue lifelong ART. (strong recommendation, moderate-quality evidence) For programmatic and operational reasons, particularly in generalized epidemics, all pregnant and breastfeeding women infected with HIV should initiate ART as lifelong treatment. (conditional recommendation, lowquality evidence) In some countries, for women who are not eligible for ART for their own health, consideration can be given to stopping the ARV regimen after the period of mother-to-child transmission risk has ceased. (conditional recommendation, lowquality evidence)

11 Rationale: Benefits of Option B+ (triple ART) BENEFITS FOR MOTHER AND CHILD Ensures all ART eligible women initiate treatment Prevents MTCT in future pregnancies Potential health benefits of early ART for non-eligible women Reduces potential risks from treatment interruption Improves adherence with once daily, single pill regimen Reduces sexual transmission of HIV BENEFITS FOR PROGRAM DELIVERY & PUBLIC HEALTH Reduction in number of steps along PMTCT cascade Same regimen for all adults (including pregnant women) Simplification of services for all adults Simplification of messaging Protects against transmission in discordant couples Cost effective Major issue now is not when to start or what to start but whether to stop

12 Summary of Changes in Recommendations: What to Start in Adults FIRST-LINE REGIMENS (PREFERRED ARV REGIMENS) TARGET POPULATION 2010 ART GUIDELINES 2013 ART GUIDELINES STRENGTH & QUALITY OF EVIDENCE HIV+ ARV-NAIVE ADULTS AZT or TDF + 3TC (or FTC) + EFV or NVP HIV+ ARV-NAIVE PREGNANT WOMEN HIV/TB CO-INFECTION AZT + 3TC + NVP or EFV AZT or TDF + 3TC (or FTC) + EFV TDF + 3TC (or FTC) + EFV (as fixed-dose combination) Strong, moderate-quality evidence HIV/HBV CO-INFECTION TDF + 3TC (or FTC) + EFV

13 What to start: First-line regimen Preferred: once daily FDC: TDF/3TC(FTC)/EFV Increasing evidence of safety in pregnancy EFV advantages over NVP Harmonized with 1 st line adult regimen Decreasing cost Once daily fixed-dose combination regimen Alternative regimens: AZT/3TC/EFV; TDF/3TC/NVP, boosted PI regimens

14 Emerging Issues/ Future Directions General issues for new guidelines Optimal use of Viral Load, including for pregnant women Quality of Care / Package of Services Data quality From Coverage to Impact Specific issues for PMTCT Option B vs. B+ Triple infant prophylaxis New strategies for EID (eg. Birth testing) and final diagnosis Validation of Elimination

15 Emerging Issues/ Future Directions Single infant prophylaxis or triple infant prophylaxis? - Should WHO continue to recommend 4-6 weeks of AZT or NVP for the infant or recommend triple infant prophylaxis? Concern that «high risk» infants are not fully covered with maternal ARVs and single infant prophylaxis High risk: mothers not receiving ARVs, mothers starting ARVs late and not fully suppressed, mothers identified as HIV+ at L&D Rationale: despite interventions, some of these high risk infants will still be infected; triple prophylaxis could provide more effective protection (PEP) and could be provided for a longer period of time

16 Emerging Issues/ Future Directions Optimal timing of infant testing for EID and final diagnosis Should WHO recommend birth testing in addition to 6 week EID testing and final testing at months?

17 Context: When HIV transmission occurs How services are delivered Optimal timing for Virological testing 10/3/

18 Testing at birth Better retention in the cascade Earlier ART initiation Low sensitivity of virological testing at birth Increased cost 10/3/2014 Birth 19 PCR

19 Emerging Issues/ Future Directions Validation of «Elimination» of MTCT How can we validate that countries have achieved elimination targets? - New global guidance on Validation of Elimination - Regions developing their own regional strategies and frameworks to achieve elimination and validate results

20 Global Initiatives for EMTCT of HIV/AIDS and Syphilis 21

21 GP AND GP

22 Implementation Issues EURO region Updating national policies and harmonizing ARV recommendations for adults and pregnant women Identifying HIV+ pregnant women in ANC or at delivery Providing services to high risk, hard to reach populations (eg. sex workers, injecting drug users) Providing access for later presenters (HIV+ women identified at delivery); preventing HIV in very high risk infants ART access in MCH settings or specialized ART clinics (models of service delivery Adherence with ART regimen, follow up and retention Linkages with chronic ART care and treatment

23 Summary Major paradigm shift; convergence of PMTCT and ART Simplified, harmonized approach for adults and pregnant women All HIV+ pregnant and breastfeeding (BF) women should start first-line ART (same regimen for Option B and B+) With Option B, women not «eligible» for lifelong treatment stop ART at delivery (if no BF) or end of BF With Option B+, all pregnant women with HIV «eligible» for lifelong ART 1.4 million pregnant women with HIV annually Benefit for mother s health, prevention of infant infections, prevention of partner infections

24 25 Thank You!