2013 WHO Consolidated ARV Guidelines Summary of Major Recommendations and Estimated Impact GSG Briefing July 19, 2013 Gottfried Hirnschall, Director HIV Department, WHO

ART Scale up : Progress Towards Global Targets WHO Global ART report, 2013

Number of pregnant women living with HIV needing and receiving ARVs for PMTCT, % 56% 1,570,000 1,470,000 HIV+ pregnant women receiving ARVs for PMTCT HIV+ pregnant women needing ARVs for PMTCT (WHO, Global Report 2013)

Number of children acquiring HIV infection in low- and middle-income countries, No ARV prophylaxis for PMTCT Current ARV prophylaxis coverage for PMTCT 800,000 pediatric infections averted ~290,000 new pediatric infections 2012 (WHO, Global Report 2013) goal: 40,000 new pediatric infections

30 th June | Results: The gap between adult and child ART coverage in 20 high burden countries is widening Source: Global AIDS Response Progress Reporting (WHO/UNICEF/UNAIDS) and 2013 UNAIDS estimates.

Guidance for Programme Managers HOW TO DO IT? Service delivery Diagnostics Drug supply HOW TO DO IT? Service delivery Diagnostics Drug supply HOW TO DECIDE? Prioritization Equity and ethics Monitoring & Evaluation HOW TO DECIDE? Prioritization Equity and ethics Monitoring & Evaluation WHAT TO DO? When to start or switch Which regimen to use How to monitor Co-infections & co-morbidities WHAT TO DO? When to start or switch Which regimen to use How to monitor Co-infections & co-morbidities Operational WHO 2013 Consolidated ARV Guidelines Simplification and consolidation across: - Continuum of HIV care - Ages and populations - Clinical, operational and programmatic guidance - Existing and new recommendations

Treatment 2.0

Clinically relevant o Earlier initiation of ART (CD4 ≤ 500) o Immediate ART for children < 5 years o ART initiation for all pregnant and breastfeeding women (Option B/B+) and lifelong ART (Option B+) o Harmonization of ART across populations (e.g., adults and pregnant women) and age groups o Simplified, fewer, and less toxic 1 st -line regimens (TDF/XTC/EFV) Clinically relevant o Earlier initiation of ART (CD4 ≤ 500) o Immediate ART for children < 5 years o ART initiation for all pregnant and breastfeeding women (Option B/B+) and lifelong ART (Option B+) o Harmonization of ART across populations (e.g., adults and pregnant women) and age groups o Simplified, fewer, and less toxic 1 st -line regimens (TDF/XTC/EFV) Key New Recommendations in 2013 WHO Guidelines Operationally relevant o Use of Fixed Dose Combinations as a preferred approach o Improved patient monitoring to support better adherence and detect earlier treatment failure (increased use of VL) o Recommend task shifting, decentralization, and integration o Community based testing to complement broader HTC Operationally relevant o Use of Fixed Dose Combinations as a preferred approach o Improved patient monitoring to support better adherence and detect earlier treatment failure (increased use of VL) o Recommend task shifting, decentralization, and integration o Community based testing to complement broader HTC

Summary of Changes in Recommendations When to Start in Adults

Recommendations: CD4 Independent Conditions

Rationale: Shift from Option A to B+ or B Major issue now is not “when to start” or “what to start” but “whether to stop”

30 th June 2013 CD4 <350* on ART CD4 <500* <5y * incl. co-infected with TB or HBV ** ** only CD4>500, others included in adults = 16.7 = Number of people eligible for ART in low- and middle-income countries in million per WHO 2010 and 2013 ARV guidelines, based on end of 2012 epidemic situation Estimated impact on ART eligibility of implementing the new recommendations

Estimated impact on incidence and deaths of implementing the new recommendations WHO Global ART report, 2013

Estimated cost of implementing the new recommendations WHO Global ART report, % increase of the billion USD annually for full HIV response

30 th June 2013 Child – adult coverage gap is widening, other key populations lag behind Child – adult coverage gap is widening, other key populations lag behind Switching from 2010 to 2013 guidelines will enhance impact on lives & epidemic 15 by 15 is within reach Global Update on HIV Treatment 2013: Key Findings and Messages 9.7 million on ART, 1.6 more than in million on ART, 1.6 more than in children on ART, only more than in children on ART, only more than in 2011 Eligibility increase from 17 to 26 m Mortality/ incidence decline by 1/3 Eligibility increase from 17 to 26 m Mortality/ incidence decline by 1/3 HIV treatment scale-up is paying off ARVs saved 4.2 million lives and prevented child infections Many countries do well, but some need intensified support Many countries do well, but some need intensified support In high burden countries, ART coverage varies from 30% to 90%

Next Steps Global level – Launch of guidelines at IAS KL (30 June 2013) Full guidelines Short summaries in 6 UN languages + Portuguese Regional level – Regional dissemination workshops All regions planned for the next 3-6 months UN and implementing partners support Country level – Country adaptation Policy and national guidelines updates Implementation roll out 10/10/201516

30 th June 2013 Find the New 2013 WHO Consolidated ARV Guidelines on