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Science and Sex: HPTN 052 and Treatment as Prevention 

Monica Gandhi MD, MPH Associate Professor and Women’s HIV Clinic provider, HIV/AIDS Division San Francisco General Hospital/ UCSF Safe Poz Love, U.S. Positive Women’s Network February 14, 2012. Science and Sex: HPTN 052 and Treatment as Prevention . 70. 60. 50. Percent female (%). 40.

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Science and Sex: HPTN 052 and Treatment as Prevention 

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  1. Monica Gandhi MD, MPHAssociate Professor and Women’s HIV Clinic provider, HIV/AIDS DivisionSan Francisco General Hospital/ UCSFSafe Poz Love, U.S. Positive Women’s NetworkFebruary 14, 2012 Science and Sex: HPTN 052 and Treatment as Prevention 

  2. 70 60 50 Percent female (%) 40 30 20 10 0 1990 ‘91 ‘92 ‘93 ‘94 ‘95 ‘96 ‘97 ‘98 ‘99 ‘00 ‘01 ‘02 ‘03 ‘04 ‘05 ‘06 2009 Year Percent of adults (15+) living with HIV who are female, 1990–2009 Sub-Saharan Africa GLOBAL Caribbean Asia E Europe & C Asia Latin America www.unaids.org

  3. Proportion of all AIDS cases in women: 7% in 1985 to 26% today

  4. We already thought HIV-positive people on antiretrovirals cannot pass on the virus readily • The lower your HIV viral load in plasma, the lower the viral load in semen and vaginal secretions • Concentration of HIV in the genital area correlates with sexual transmission • Observational studies had shown very low rates of transmission to sexual partners if HIV-infected person is on treatment • But in MEDICINE, “evidence” means a randomized controlled trial

  5. Cohen MS et al. Prevention of HIV-1 infection with early antiretroviral therapy. NEJM August 2011 (HPTN-052)

  6. HPTN 052 Study Design Stable, healthy, serodiscordant couples, sexually active CD4 count: 350 to 550 cells/mm3 Randomization Immediate ART CD4 350-550 Delayed ART CD4 <250 Primary Transmission Endpoint Transmission events that were linked to that primary partnership Primary Clinical Endpoint WHO stage 4 clinical events, pulmonary tuberculosis, severe bacterial infection and/or death

  7. HPTN 052 Enrollment 10,838 Individuals Screened Major reasons for exclusion: 3058 HIV+ but CD4 count out of range 2565 HIV- but HIV+ partner ineligible 308 Seroconcordant couples 155 Ineligible due to sexual history 1763 Couples (3526 Individuals) Randomized Immediate Arm 886 Couples Delayed Arm 877 Couples

  8. HPTN 052 Enrollment (Total Enrollment: 1763 couples) U.S. Thailand India Americas 278 Kenya Malawi Asia 531 Brazil Zimbabwe Botswana South Africa Africa 954

  9. HPTN 052: Baseline Characteristics

  10. The Data safety and monitoring board announced April 28, 2011 “The Board recommends that the results of the trial be announced as soon as possible” (was supposed to go until 2014) HPTN 052 continues to follow couples, but all HIV-infected participants are being offered ART

  11. HPTN 052: HIV-1 Transmission Total HIV-1 Transmission Events: 39 Immediate Arm 4 Delayed Arm 35 p < 0.0001

  12. HPTN 052: HIV-1 Transmission Total HIV-1 Transmission Events: 39 Linked Transmissions: 28 Unlinked or TBD Transmissions: 11 People have sex outside of their partnerships. . Wait, REALLY????!!! Immediate Arm: 1 Delayed Arm: 27 • 23/28 (82%) transmissions in sub-Saharan Africa • 18/28 (64%) transmissions from female to male partners • 238 pregnancies p < 0.001 People have unprotected sex . Wait, REALLY????!!!

  13. HPTN 052: HIV-1 Transmission *Person-years specific for transmission events 0.1/1.7 = 96% reduction

  14. HPTN 052: Effect of ART Proportion of participants with VL<400 at each visit 100 Immediate Arm Delayed Arm (not on ART) Delayed Arm (on ART) 80 60 40 20 0 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 Months

  15. One Transmission Event on ART Index begins ART AZT/3TC/EFV Index VL<400 Partner HIV+ (WB) Enrollment Screening -14 Days 0 1 28 85 Partner VL < 400 Index CD4 = 482 Index VL = 87,202 • Single Genome Analysis: 1-2 viruses transmitted • Analysis of Transmission: >50 days earlier (84 – 190 days)

  16. HPTN 052 Prevention Conclusion Early ART that suppresses viral replication led to 96% reduction of sexual transmission of HIV-1 in serodiscordant couples

  17. Sex and sexuality for HIV-positive women With such strong evidence for protection and prevention, let’s think about sexual rights in women living with HIV infection!

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