Gottfried Hirnschall MD, MPH Department of HIV/AIDS, World Health Organization July 26, 2012

1. Expanding HIV testing and the use of ARVs for treatment and preventionGetting to 15 million by 2015… and thinking beyond Gottfried Hirnschall MD, MPH Department of HIV/AIDS, World Health Organization July 26, 2012

2. Questions for today • Can we reach 15 million by 2015? • Is 15 million enough to achieve optimal impact on treatment and prevention? • What strategic choices can be made? What are the opportunities to enhance ART program effectiveness and reach?

3. 8 million on ART by end 2011 …15 million is achievable ! 15.0 15 million 12.5 10.0 8 million 7.5 5.0 2.5 0.0 2002

4. ART scale-up: three success stories • High-level commitment and resources • Proactive approaches to HIV testing • Innovation in service delivery • Integration • Task-shifting • Community-based services ART coverage

5. Disparities in ART coverage between regions and populations ART coverage * 2010 HIV case reporting (18 countries)

6. Scale-up of ART, number of AIDS deaths and new HIV infections in LMIC*, 2001–2011 * LMIC = Low- and middle-income countries

7. Effect of ART coverage on rate of new HIV infections in a rural South African population 1.2 1.0 0.8 0.6 For every 10% increase in coverage there is a 17% decrease in individual risk 0.4 0.2 0.0 Source: Tanser F et al. CROI 2012

8. Balance of evidence favours earlier initiation of ART Delayed ART Earlier ART ↓Drug toxicity ↓Resistance ↓Upfront costs Preservation of Txoptions ↑Clinical benefits (AIDS- and non-AIDS related) ↓HIV and TBtransmission ↑Potency, durability, tolerability ↑Treatment sequencing options ↑ Medium/long-term cost savings

9. Relationship between transmitted resistance to NNRTI drugs and ART coverage in LMIC Source: HIV drug resistance report, WHO, 2012

10. ART eligibility: 5 policy scenarios Estimated millions of people eligible for ART in LMIC in 2011 1115232532 Recommended Since 2003 Recommended since 2010 “Test and treat” Incremental approach 2012 Ongoing systematic review of evidence (GRADE review) CD4 ≤ 200 CD4 ≤ 350 CD4 ≤ 350 + TasP CD4 ≤ 500 All HIV+ 5 3 4 1 2 ART regardless of CD4 count for: - Serodiscordant couples - Pregnant women - Key populations (SW, IDU, MSM)

11. ART eligibility: 5 policy scenarios Estimated millions of people eligible for ART in LMIC in 2011 1115232532 Recommended Since 2003 Recommended since 2010 “Test and treat” Incremental approach 2012 Ongoing systematic review of evidence (GRADE review) CD4 ≤ 200 CD4 ≤ 350 CD4 ≤ 350 + TasP CD4 ≤ 500 All HIV+ 5 3 4 1 2 ART regardless of CD4 count for: - Serodiscordant couples - Pregnant women - Key populations (SW, IDU, MSM)

12. WHO’s ARV-related guidance in 2012 Treatment as Prevention (TasP) • Recommendation for TasP in sero-discordant couples • Consider lifelong ART for pregnant women (“B/B+”) • Explore use of TasP in key populations (SW, IDU, MSM) Pre-Exposure Prophylaxis (PrEP) • Recommendation for demonstration projects in sero-discordant couples and MSM

13. WHO’s consolidated ARV guidelines in 2013(children, adolescents, adults, pregnant women, key populations) WHAT TO DO? (when to start or switch, how to monitor, which regimen to use, co-morbidities) Clinical HOW TO DECIDE? (scale-up, equity and ethics, M&E) Programmatic Operational HOW TO DO IT? (diagnostics, service delivery)

14. Significant variation in ART eligibility thresholds among countries Results of a WHO survey (2011, n= 61 countries)

15. Mean CD4 count at ART initiation is below 200 in LMIC Low-income Lower middle-income Upper middle-income High-income Mean CD count (cells/µL) 2002 2009 2002 2009 2002 2009 2002 2009 Year of starting ART Estimates from random-effects model adjusted for age, sex and year of starting ART, 2002-2009 Source: Egger M. CROI 2012

16. HIVDR Early Warning Indicators, 2011 Proportion of clinics achieving WHO-recommended standards % Source: Bennett DE et al. CID 2012 Supp 4 pp 280-9

17. The test-treat-retain cascade Create demand for testing and treatment ART eligible Pre-ART care and support ART Testing + HIV+ Adherence and viral suppression

18. Patient enrolment into HIV care and treatment, six studies in sub-Saharan Africa % N = 58,779 persons • Source: Mugglin C et al.IeDEASouthern Africa ( in press)

19. Key areas for optimization in the cascade • Expand, simplify and diversify HIV testing • Offer concrete interventions in the pre-ART window • Use simple and better drugs for first- and second-line • Provide diagnostic tests and monitoring tools at point-of-care • Innovate service delivery to enhance adherence and retention

20. Provider-initiated testing and counselling(PITC) in Africa Adoption of a policy on PITC 2003-2010 • 42/53 countries in Africa have PITC policies1 • High PITC acceptance by ANC2 & TB patients3,4 • Most clinical settings in generalized epidemics not routinely offering HIV testing5 2003 - 2004 2005 - 2006 2007 - 2008 2009 - 2010 Date not identified Not adopted Data not available 1Baggaley (2012) Bulletin WHO, 2Etirbet (2004) AIDS Care; Byamugisha (2010) J IntAIDS,3WHO, Global TB control(2011),4 Corneli (2008) IJTBLD,5MacPherson (2012) Trop Med.

21. Scaling up HIV testing in the community • Home-based (door-to-door) • Community • Index-case • Campaigns plus • HTC-plus –malaria, safe water • Non-communicable diseases • Mobile outreach • General populations • Key populations • Workplaces, schools

22. A potential new approach: self-testing Today • Practiced 'informally' by many health workers1 • Included in Kenyan National Guidelines • Readily available over the internet and in pharmacies in some countries • Approved by FDA in USA this month Future potential • General population? • Marginalized groups? • PrEP? 1Napierala S, (2011). HIV self-testing among health workers

23. ART optimization approaches SHORT TERM Next 1-2 years Improve currently available drugs and formulations LONG TERM Next 5-10 years Use new strategies MEDIUM TERM Next 2-5 years Add new drugs/better sequencing • New therapeutic approaches (e.g., induction/maintenance, co-therapies, anti-latency drugs) • Once daily FDC for 1st line (e.g., TDF/3TC/EFV) • Heat stable once-daily boosted PI options for 2nd line (e.g., ATV/r) • Solid pediatric formulations (sprinkles, dispersible tablets) • Replacement of regimen components by new drugs/classes (e.g., integrase inhibitors, NRTI pro-drugs, entry blockers)

24. Potential cost benefits of optimizing ARVs Adapted from Crawford et al, 2012

25. Breakthroughs in diagnostic testing and patient monitoring at point-of-care Number of POC technology releases expected (cumulative numbers) • Point-of-care CD4 is just emerging • 3 products available and 1 prequalified • Point-of-care testing • for VL and EID isimminent • Affordability is key

26. Retention rates for ART at 12, 24 and 60 months in selected countries, 2011 84% 78% 72%

27. Conclusions (1) • Global progress on scale-up of ART has been extraordinary. Countries show the way! 15 million can be reached • Further scale-up must address disparities and inequities (countries, key populations) • With new evidence and new policies, the number of persons eligible for ART will increase • Countries face strategic choices and are already taking advantage of new opportunities (early ART, TasP, PrEP)

28. Conclusions (2) • Now is the moment to think and plan beyond the 15 million target • This will require forward-looking policies,more effective and innovative approaches, together with further investments • ARVs for treatment and prevention are a powerful tool towards ending the HIV epidemic

29. Acknowledgements