Biomedical Prevention Update Thomas C. Quinn, M.D.
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1 Biomedical Prevention Update Thomas C. Quinn, M.D. Associate Director of International Research National Institute of Allergy and Infectious Diseases Director, Johns Hopkins Center for Global Health
2 Global Prevalence of HIV infection: 36.7 Million Incidence 2.1 Million; 1.1 Million Deaths
3 New HIV infections among men and women (aged years), global, Women aged years Men aged years
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10 HIV Prevention Strategies Advances in 4 key areas are of critical focus for the next 5 years: Widespread testing and linkage to care, enabling people living with HIV to access treatment early. Broad support for people living with HIV to remain engaged in comprehensive care, including support for treatment adherence. Universal viral suppression among people living with HIV. Full access to comprehensive PrEP services for those for whom it is appropriate and desired, with support for medication adherence for those using PrEP.
11 Four Prevention Opportunities Cohen et al., JCI, 2008 Cohen et al., JIAS,2008 UNEXPOSED EXPOSED (precoital/coital) EXPOSED (postcoital) INFECTED Behavioral, Structural Vaccines ART PrEP Microbicides Antibodies Vaccines ART PEP Treatment Of HIV to Reduce Infectivity STDS Circumcision Condoms YEARS HOURS 72h YEARS
12 ART for Prevention of HIV Transmission in Serodiscordant Couples HPTN 052: HIV-infected partner in healthy serodiscordant couples randomized to early or delayed ART (N = 1,763 couples) Overall 93% reduction in risk of transmission with early therapy No linked HIV transmissions where index partner suppressed on ART PARTNER: observational study in serodiscordant couples where HIV-infected partner on suppressive ART and condoms not used (N = 888 couples) [2] No linked transmissions recorded in any couple Median follow-up: 1.3 yrs; ~ 58,000 sex acts 1. Cohen MS, et al. N Engl J Med. 2016;375: Rodger A, et al. JAMA. 2016;316:
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14 Four Prevention Opportunities Cohen et al., JCI, 2008 Cohen et al., JIAS,2008 UNEXPOSED EXPOSED (precoital/coital) EXPOSED (postcoital) INFECTED Behavioral, Structural Vaccines ART PrEP Microbicides Antibodies Vaccines Treatment Of HIV ART PEP ttto Reduce Infectivity STDS Circumcision Condoms YEARS HOURS 72h YEARS
15 Clinical Trial Evidence for HIV Prevention Options (Feb. 2016) Prevention of sexual transmission PROUD daily oral TDF/FTC (MSM United Kingdom) IPERGAY event-driven TDF/FTC (MSM Canada, France) Partners PrEP daily oral TDF/FTC (Serodiscordant couples Kenya, Uganda) Partners PrEP daily oral TDF (Serodiscordant couples Kenya, Uganda) TDF2 daily TDF/FTC (Heterosexual men and women Botswana) iprex daily oral TDF/FTC (MSM North and South America, South Africa, Thailand) CAPRISA 004 BAT-24 dosing vaginal tenofovir gel (Women South Africa) RV 144 six injectable ALVAC/AIDSVAX (Heterosexual men and women Thailand) Effect size (CI) 86% (58; 97) 86% (44; 99) 75% (55; 87) 67% (44; 81) 62% (22; 84) 44% (15; 63) 39% (6; 60) 31% (1; 51) The Ring Study monthly vaginal ring containing dapivirine (Women South Africa, Uganda) ASPIRE monthly vaginal ring containing dapivirine (Women Malawi, South Africa, Uganda, Zimbabwe) MTN 003/VOICE daily dosing vaginal tenofovir gel (Women South Africa, Uganda, Zimbabwe) FEM-PrEP daily oral TDF/FTC (Women Kenya, South Africa, Tanzania) FACTS 001 event-driven vaginal tenofovir gel (Women South Africa) MTN 003/VOICE daily oral TDF/FTC (Women South Africa, Uganda, Zimbabwe) MTN 003/VOICE daily oral TDF (Women South Africa, Uganda, Zimbabwe) 31% (1; 51) 27% (1; 46) 15% (-21; 40) 6% (-21; 40) 0% (-40; 30) -4% (-49; 27) -49% (-129; 3) Prevention in people who inject drugs Bangkok Tenofovir Study daily oral TDF (PWID Thailand) % (10; 72) Effectiveness (%)
16 TDF/FTC Was FDA Approved for use for Prevention on July 16, 2012 Success depends entirely on adherence Alternatives to daily dosing are possible Tenofovir/emtricitabine PrEP uptake has been limited to date Perhaps longer-acting agents will prove more attractive?
17 WHO Guidelines 2015
18 Association between Adherence and Effectiveness Relative Risk (RR) - Placebo vs PrEP Intervention
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20 IPERGAY: Sex-Driven iprep 2 tablets 2-24 hours before sex 1 tablet 24 hours later 1 tablet 48 hours after first intake Friday Saturday Sunday Monday Tuesday Wednesday Thursday Friday Saturday Sunday 4 pills of TDF/FTC taken over 3 days to cover 1sexual intercourse
21 IPERGAY: Sex-Driven iprep 2 tablets 2-24 hours before sex 1 tablet every day during sexual activity 2 tablets after the last sexual intercourse Friday Saturday Sunday Monday Tuesday Wednesday Thursday Friday Saturday Sunday On demand PrEP tells you How to Start and How to Stop PrEP
22 HIV Incidence (mitt Analysis) Treatment Follow-Up Pt-years HIV Incidence per 100 Pt-years (95% CI) Placebo (double-blind) ( ) TDF/FTC (double-blind) ( ) TDF/FTC (open-label) ( ) Median Follow-up in Open-Label Phase: 18.4 months (IQR: ) 97% relative reduction vs placebo
23 STI During 12 Mos PrEP Use (%) STIs Will Occur for Persons Using PrEP Analysis of HIV/STI incidence in PrEP users in large healthcare system (Kaiser Permanente San Francisco) from 2012 to 2015 STIs in PrEP Initiators (N = 657) zero Any STI Chlamydia Gonorrhea Syphilis HIV PROUD: similar rates of any STI in 12 mos before starting PrEP (63%) vs during 12 months of PrEP (57%) [2] 1. Volk JE, et al. Clin Infect Dis. 2015;61: McCormack S, et al. Lancet. 2016;387:
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25 Efficacy Approximately 30% reduction in HIV-1 infection among women ages overall 31% reduction The Ring Study ASPIRE
26 Efficacy Women older than 21 years tended to be more adherent with a greater protection from HIV-1 The Ring Study ASPIRE
27 ASPIRE Dapivirine Ring Study Baeten JM et al. N Engl J Med 2016.
28 Long-Acting Injectable Nano-Suspensions TMC278LA (rilpivirine; PATH) Cabotegravir (GSK 744; ViiV) NNRTI (rilpivirine) Oral coformulation as rilpivirine/tdf/ftc Long-acting: up to 3 months? Multiple trials: Dose-ranging PK; PK/PD Phase-2: HPTN 076 Integrase inhibitor Similar to dolutegravir Safe in humans with oral run-in Activity up to 3 months NHP model efficacy Phase 2: Éclair and HPTN 077
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31 Neutralizing Antibody Epitopes on Native Trimer (since 2009) gp41 MPER: 2F5, 4E10 10e8 CD4 binding site: VRC01, PG04, CH31 3BNC117, 12A12 CH103, VRC07 Trimer (gp120/41) 8ANC195 PGT V1V2 Glycan: PG6, PG16, CH01-04 PGT CAP256-VRC26 Cryo-EM of viral spike by Subramaniam group. Fit with atomic-level structures from Kwong and Wilson groups N332 glycan supersite: PGT121, PGT Highly selected donors
32 Enrolled participants 2400 MSM and TG women 18 to 50 yo Study duration 92 weeks (infusions given through Week 72) HVTN 703 / HPTN 081 A phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection Regimen Total Note VRC01 10 mg/kg ,600 Infusions every 8 VRC01 30 mg/kg weeks through Week 72 (10 Control* ,300 total infusions per participant) Total 2,400 1,500 3,900 MSM and transgender persons Sub-Saharan African women Primary objective: HIV incidence, safety and tolerability
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35 Probability of HIV Infection (%) Thai Trial (RV144) Primary Results Placebo Vaccine Modified Intention-to-Treat Analysis* Years Perks-Ngarm et al: NEJM 2009
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