Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women

Jared M. Baeten(University of Washington), Thesla Palanee‐Phillips(University of the Witwatersrand), Elizabeth R. Brown(Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa), Katie Schwartz(Family Health International 360), Lydia Soto‐Torres(Johns Hopkins University), Vaneshree Govender(South African Medical Research Council), Nyaradzo Mgodi(Fred Hutch Cancer Center), Flavia Matovu Kiweewa(Fred Hutch Cancer Center), Gonasagrie Nair(Centre for the AIDS Programme of Research in South Africa), Felix Mhlanga(Fred Hutch Cancer Center), Samantha Siva(South African Medical Research Council), Linda‐Gail Bekker(Desmond Tutu HIV Foundation), Nitesha Jeenarain(South African Medical Research Council), Zakir Gaffoor(South African Medical Research Council), Francis Martinson(Fred Hutch Cancer Center), Bonus Makanani(Johns Hopkins University), Arendevi Pather(South African Medical Research Council), Logashvari Naidoo(South African Medical Research Council), Marla Husnik(Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa), Barbra A. Richardson(Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa), Urvi M. Parikh(Fred Hutch Cancer Center), John W. Mellors(Fred Hutch Cancer Center), Mark A. Marzinke(National Institutes of Health), Craig W. Hendrix(National Institutes of Health), Ariane van der Straten(RTI International), Gita Ramjee(South African Medical Research Council), Zvavahera M. Chirenje(Fred Hutch Cancer Center), Clemensia Nakabiito(Fred Hutch Cancer Center), Taha E. Taha(Johns Hopkins University), Judith Jones(University of Pittsburgh), Ashley Mayo(Family Health International 360), Rachel Scheckter(Family Health International 360), Jennifer Berthiaume(Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa), Edward Livant(University of Pittsburgh), Cindy Jacobson(University of Pittsburgh), Patrick Ndase(University of Washington), Rhonda White(Family Health International 360), Karen Patterson(Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa), Donna Germuga(Johns Hopkins University), Beth Galaska(University of Pittsburgh), Katherine Bunge(Fred Hutch Cancer Center), Devika Singh(University of Pittsburgh), Daniel Szydlo(Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa), Elizabeth Montgomery(RTI International), Barbara Mensch(Fred Hutch Cancer Center), Kristine Torjesen(Family Health International 360), Cynthia I. Grossman(Johns Hopkins University), Nahida Chakhtoura(Johns Hopkins University), Annaléne Nel(International Partnership for Microbicides), Zeda Rosenberg(International Partnership for Microbicides), Ian McGowan(Fred Hutch Cancer Center), Sharon L. Hillier(Fred Hutch Cancer Center)
New England Journal of Medicine
February 22, 2016
10.1056/nejmoa1506110
Cited by 762Open Access
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Abstract

BACKGROUND: Antiretroviral medications that are used as prophylaxis can prevent acquisition of human immunodeficiency virus type 1 (HIV-1) infection. However, in clinical trials among African women, the incidence of HIV-1 infection was not reduced, probably because of low adherence. Longer-acting methods of drug delivery, such as vaginal rings, may simplify use of antiretroviral medications and provide HIV-1 protection. METHODS: We conducted a phase 3, randomized, double-blind, placebo-controlled trial of a monthly vaginal ring containing dapivirine, a non-nucleoside HIV-1 reverse-transcriptase inhibitor, involving women between the ages of 18 and 45 years in Malawi, South Africa, Uganda, and Zimbabwe. RESULTS: Among the 2629 women who were enrolled, 168 HIV-1 infections occurred: 71 in the dapivirine group and 97 in the placebo group (incidence, 3.3 and 4.5 per 100 person-years, respectively). The incidence of HIV-1 infection in the dapivirine group was lower by 27% (95% confidence interval [CI], 1 to 46; P=0.046) than that in the placebo group. In an analysis that excluded data from two sites that had reduced rates of retention and adherence, the incidence of HIV-1 infection in the dapivirine group was lower by 37% (95% CI, 12 to 56; P=0.007) than that in the placebo group. In a post hoc analysis, higher rates of HIV-1 protection were observed among women over the age of 21 years (56%; 95% CI, 31 to 71; P<0.001) but not among those 21 years of age or younger (-27%; 95% CI, -133 to 31; P=0.45), a difference that was correlated with reduced adherence. The rates of adverse medical events and antiretroviral resistance among women who acquired HIV-1 infection were similar in the two groups. CONCLUSIONS: A monthly vaginal ring containing dapivirine reduced the risk of HIV-1 infection among African women, with increased efficacy in subgroups with evidence of increased adherence. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01617096 .).

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