6th IAS Conference On HIV Pathogenesis, Treatment and Prevention


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MOAX0102 - Oral Abstract Session

Antiretroviral treatment to prevent the sexual transmission of HIV-1: results from the HPTN 052 multinational randomized controlled trial

Presented by Myron Cohen (United States).

M. Cohen1, Y. Chen2, M. McCauley3, T. Gamble4, R. Bollinger5, Y. Bryson6, D. Burns7, D. Celentano8, S. Chariyalertsak9, F. Conradie10, L. Cottle2, G. de Bruyn10, V. Elharrar7, S. Eshelman5, M. Essex11, E.C.J. Filho12, S. Godbole13, B. Grinsztejn14, J.G. Hakim15, I.F. Hoffman1, M. Hosseinipour1, N. Kumarasamy16, J. Kumwenda17, J. Makhema18, A. Martinez7, K.H. Mayer19, S. Mehendale13, L.A. Mills20, K.A.-H. Nielsen6, J.H.d.S. Pilotto21, E. Piwowar-Manning5, I. Sanne10, B.R. Santos22, T. Taha5, L. Wang2, S. Safren23, T. Fleming2, HPTN052 Protocol Team

1University of North Carolina at Chapel Hill, Chapel Hill, United States, 2University of Washington, Seattle, United States, 3Family Health International, Arlington, United States, 4Family Health International, Durham, United States, 5Johns Hopkins University, Baltimore, United States, 6University of California at Los Angeles, Los Angeles, United States, 7National Institute of Allergy and Infectious Diseases, Bethesda, United States, 8Johns Hopkins Bloomberg School of Public Health, Baltimore, United States, 9Ciang Mai University, Chiang Mai, Thailand, 10University of the Witwatersrand, Johannesburg, South Africa, 11Harvard School of Public Health, Boston, United States, 12Hospital dos Servidores do Estado, Rio de Janeiro, Brazil, 13National AIDS Research Institute, Pune, India, 14Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro, Brazil, 15University of Zimbabwe, Harare, Zimbabwe, 16Y. R. Gaitonade Center for AIDS Research and Education, Chennai, India, 17College of Medicine, Blantyre, Malawi, 18Botswana Harvard School of Public Health AIDS Initiative Partnership, Gaborone, Botswana, 19Fenway Institute, Boston, United States, 20KEMRI-CDC Research and Public Health Collaboration, Atlanta, United States, 21Hospital Geral de Nova Iguaçu, Rio de Janeiro, Brazil, 22Hospital Nossa Senhora da Conceiçao/GHC, Porto Alegre, Brazil, 23Harvard University, Boston, United States

Background: HIV-1 transmission is driven by the concentration of virus in blood and genital secretions, levels that can be reduced by antiviral therapy (ART). We conducted a randomized controlled trial (HPTN 052) to determine the effect of ART on sexual transmission of HIV-1. We report the results of this study in response to the April 28, 2011, recommendation of the NIAID Multinational Data Safety and Monitoring Board.
Methods: We studied linked HIV transmission in 1,763 HIV-serodiscordant couples in sub-Saharan Africa (N=954), Asia (N=531), Latin America (N=276) and the United States (N=2). HIV-infected participants with 350≤ CD4 count ≤550 were randomized to either immediate ART (N=886) or delayed ART (two consecutive CD4 counts ≤250 or an AIDS-defining illness, N=877). Transmission linkage was assessed by comparing HIV sequences of-partner pairs.
Results: Thirteen sites in 9 countries (Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, US and Zimbabwe) enrolled 890 and 873 HIV-infected men and women, respectively. Median baseline CD4 count was 436 cells/mm3 and median baseline viral load (log10 scale) was 4.4. Twenty-eight linked transmission events were identified after median follow-up of 20 months. Seventeen (61%) of 28 HIV-1 infected participants had CD4 >350 at the visit prior to the transmission event. One linked transmission event occurred in the immediate ART arm (hazards ratio of immediate vs. delayed therapy, 0,037; 95% CI, 0.005-0.272; exact log-rank test statistic, 13, p< 0.001) which was documented shortly after ART was initiated. In addition, 11 other transmission events were detected, 8 in the delayed arm and 3 in the immediate arm, and the latter 3 were unlinked. Thirty-two (82%) of the transmission events occurred in sub-Saharan Africa.
Conclusion: Early ART prevented HIV transmission from infected participants to their sexual partners. All couples enrolled in the HPTN 052 will now be offered ART.

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