ART for Prevention From Evidence to Action

1. ART for Prevention From Evidence to Action Wafaa El-Sadr, MD, MPH ICAP-Columbia University

2. The Evidence is Here! • Ecological data • Observational studies in discordant couples • Randomized clinical trial (HPTN 052)

3. Number of PLWH receiving ART in low- and middle-income countries, by region, 2002–2009 UNAIDS, 2010

4. HIV Treatment Coverage in Low & Middle Income Countries WHO Towards Universal Access 2010

5. ART for Prevention Test HIV Positive Adopt safer behaviors Enroll in Care Treat Maintain viral suppression Initiation of ART Testing Adherence to ART Positive Prevention Linkage to care Decrease in HIV Transmission

6. ART for Treatment & Prevention Test HIV Positive Adopt safer behaviors Enroll in Care Treat Maintain viral suppression Initiation of ART Testing Adherence to ART Positive Prevention Linkage to care • Decrease in HIV Transmission • Optimal Treatment Outcomes

7. HIV Care Continuum ART eligible ART Pre-ART HIV Diagnosis Monitoring and Retention in Care Monitoring, Retention and Adherence Support

8. HIV Testing and Knowledge of HIV Status--Kenya 16% knew they were positive 56% never tested for HIV 28% reported last HIV-test negative 84% of HIV-infected adults did not know their status. KAIS, 2008

9. Awareness of HIV Status Among Persons with HIV and Estimates of Transmission-- US ~21% Unaware of Infection ~54 - 70% of New Infections ~75% Aware of Infection ~30 - 46% of New Infections People Living with HIV/AIDS 1,106,400 New HIV Infections Each Year: ~56,000 Marks, et al AIDS 2006

10. Point of Entry into HIV care ICAP-Supported Programs VCT PMTCT PICT TB/HIV Other clinic referral/unknown January 2010-March 2011

11. Advances in HIV Testing • Home-based testing: • Randomization of household members of HIV-infected patients to home-based or clinic based VCT • Household testing versus clinic VCT: • 55.8% versus 10.9% OR: 10.4 (95% CI: 7.89-13.73; P<0.001) • Community-based testing: Project Accept (HPTN 043) • Community-randomized study (32 communities) • Community-based plus clinic-based C&T versus clinic-based C&T • Community-based plus clinic-based: • Mean difference in proportion tested: 40.2% (95% CI: 15.8-64.7%, P=).019 • Detected four fold more HIV cases than clinic based (952 vs 265 (P=0.003)) • Self testing: • Feasibility study in Malawi • Of 260 who opted for self-test, 99.2% accurate test • 100% indicated would recommend to friends and family Lugada et al. JAIDS, 2010 Sweat et al, Lancet 2011 Choko et al, CROI 2011

12. Expansion of Provider Initiated Testing (PIHCT)--Ethiopia 80 health facilities HIV Counseled 2,077,592 HIV Tested 1,762,636 HIV +ve: 44,835 (2.5%) ICAP-supported sites--Ethiopia

13. HIV Concordance/Discordance in Couples (DHS) Eyawo et al. Lancet 2010

14. Couples Versus Individual Counseling and Testing-- Tanzania • 1521 women attending three ANC randomized to Couples C&T versus Individual C&T Becker et al, AIDS Beh 2010

15. Cumulative enrollment in HIV care and treatment 768 clinics 1,113,543 in care 561,722 on ART Number of patients Number of clinics ICAP-Supported Programs

16. Woman (Mother), Age: ______ 0 1 2 3 4 5 _____6______ UAN: Man (Father), Age: _______ 0 1 2 3 4 5 _ 6______ UAN: 1st child, Age: _______ 0 1 2 3 4 5 6 7__ UAN: 2nd child, Age: ______ 0 1 2 3 5 4 _6 7_ _ UAN: 3rd child, Age: ______ 0 1 2 3 4 5 6__ 7_____ UAN: 4th child, Age: ______ 0 1 2 3 4 5 6_ 7______ UAN: 5th child, Age: ______ 0 1 2 3 4 5 6 _7______ UAN: 6th child, Age: ______ 0 1 2 3 4 5 6 7______ UAN: 7th child, Age: ______ 0 1 2 3 4 5 6_ 7_____ UAN: Family Enrollment Form Date: ____/____/____ ART Client -Unique ART No. of the Index Client: __________________________________ Pre ART Client -Pre ART Serial No (Facility card number): ___________________________ Family Code Number: _________________________________________________________ 0= Not counseled 4 = HIV Positive 1 = Counseled not Tested 5 = Pre-ART 2 = HIV-exposed infant 6 = ART 3 = HIV Negative 7 = Died

17. HIV Care Continuum ART eligible ART Pre-ART HIV Diagnosis Monitoring and Retention in Care Monitoring, Retention and Adherence Support

18. From HIV Testing to HIV Care to ART Initiation-- Mozambique 23,430 Tested for HIV 7,005 Tested HIV positive (30%) 3,049 (43%) not enrolled in HIV care 3,956 Enrolled HIV care < 30 days after HIV test (57%) 910 (23%) No CD4 test drawn 3,046 CD4 test <30 days after enrollment (77%) 1,506 Eligible for ART Initiation (49%) 1,035 (69%) did not initiate ART 471 Initiated ART < 90 days after CD4 test (31%) 65 (14%) LTFU after ART 317 Adherent to ART for 6 months (83%) Micek et al JAIDS 2009

19. HIV Care Cascadeby Testing Site • 62.6% newly diagnosed patients linked to care • Highest % linkage in STI tested (84.1%) • Lowest % linkage in VCT (53.5%) KranzerPlos Med 2010

20. Eggers et al, CROI 2007

21. Median CD4 Count at Enrollment into Care, by Point of Referral ICAP-Supported Programs

22. Median CD4 count at enrollment into care, by enrollment year 306 cells/uL 242 cells/ul ICAP-Supported Programs

23. HIV Care Continuum ART eligible ART Pre-ART HIV Diagnosis Monitoring and Retention in Care Monitoring, Retention and Adherence Support

24. Retention in ART ProgramsMeta-analysis SSA • 36 cohorts • 226,307 patients • All losses except transfers • Retention: • 6 months: 86.1% • 12 months: 80.2% • 24 months: 76.8% • 36 months: 72.3% Fox and Rosen, Trop Med Int Health 2010

25. Interventions Emenyonu CROI 2010 Kohler et al CROI 2011 Ivers et al. AIDS Res Therapy 2010 Chang et al, Plos One June 2010 Faal et al IAS 2010 Jani et al IAS 2010 Gardner et al JAMA 2005 Etienne et al. Trop Med Int Health 2010

26. ART for Prevention: A Multi-Component Strategy • Expanded testing • Linkage to care • Initiation of ART • Adherence support • Positive prevention Positive Prevention Testing Antiretroviral Treatment Linkage Adherence Plus • Community Mobilization • Policies and Guidelines • Buy-in by PLWH

27. Time for Action PIVOTAL STUDY FINDS THAT HIV MEDICATIONS ARE HIGHLY EFFECTIVE AS PROPHYLAXIS AGAINST HIV INFECTION IN MEN AND WOMEN IN AFRICA HIV Prevention Trial (HPTN 052) Releases New Findings Early initiation of ART leads to 96% reduction in HIV transmission according to study conducted by HIV Prevention Trials Network

28. ART for Prevention • Annual testing by all >15 year old individuals • All HIV+ individuals started on ART immediately • 99% decrease in infectiousness • High adherence with ART • Low failure with first line ART • 95% reduction in new HIV cases in 10 years • HIV Incidence reduced from • 15-20,000 to 1000 per million • Prevalence decreases to less than 1% by 2050 Granich et al Lancet 2009; 373:48-57 Granich et al, Lancet 2009

29. Populations Demographics and Couple Serostatus El-Sadr, Coburn, Blower

30. Change in HIV Incidence with Increasing ART Coverage in Discordant Couples

31. Treatment Coverage and Infections Prevented El-Sadr, Coburn, Blower

32. Conclusions-1 • Evidence accumulating on the value of ART for prevention of HIV transmission • Several challenges and opportunities impede/enable the potential of ART for prevention (and for treatment) • Expansion of HIV testing • Identification of individuals earlier in HIV disease • Optimization of HIV care cascade (from testing to linkage to ART initiation to retention and adherence) Seek, Link, Treat, Retain and Support

33. Conclusions-2 • Implementation and scale-up need to be guided by evidence, prioritization, adaptation, innovation, monitoring and evaluation • Need for continued research to: • Determine the feasibility and effectiveness of ART as prevention at a population level • Examine the effect(s) of combined interventions • Identify interventions to enable/maximizing every step of the HIV care cascade • Conduct modeling to guide prioritization and action at country levels

34. Thank you