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

AUTHORS: Jared M. Baeten, Thesla Palanee-Phillips, Elizabeth R. Brown, Katie Schwartz, Lydia E. Soto-Torres, Vaneshree Govender, Nyaradzo M. Mgodi, Flavia Matovu Kiweewa, Gonasagrie Nair, Felix Mhlanga, Samantha Siva, Linda-Gail Bekker, Nitesha Jeenarain, Zakir Gaffoor, Francis Martinson, Bonus Makanani, Arendevi Pather, Logashvari Naidoo, Marla Husnik, Barbra A. Richardson, Urvi M. Parikh, John W. Mellors, Mark A. Marzinke, Craig W. Hendrix, Ariane van der Straten, Gita Ramjee, Zvavahera M. Chirenje, Clemensia Nakabiito, Taha E. Taha, Judith Jones, Ashley Mayo, Rachel Scheckter, Jennifer Berthiaume, Edward Livant, Cindy Jacobson, Patrick Ndase, Rhonda White, Karen Patterson, Donna Germuga, Beth Galaska, Katherine Bunge, Devika Singh, Daniel W. Szydlo, Elizabeth T. Montgomery, Barbara S. Mensch, Kristine Torjesen, Cynthia I. Grossman, Nahida Chakhtoura, Annalene Nel, Zeda Rosenberg, Ian McGowan and Sharon Hillier, for the MTN-020–ASPIRE Study Team

JOURNAL: N Engl J Med. 2016 Feb 22. [Epub ahead of print]

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=0.05) 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 ofHIV-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 ringcontaining 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 .).

For a link to the full article, click here: http://www.nejm.org/doi/full/10.1056/NEJMoa1506110

Link to abstract online: http://www.ncbi.nlm.nih.gov/pubmed/26900902

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