Safety and Efficacy of a Dapivirine Vaginal Ring for HIV Prevention in Women

作者：Annaléne Nel, Neliëtte van Niekerk, Saidi Kapiga, Linda‐Gail Bekker, Cynthia Gama, Katherine Gill, Anatoli Kamali, Philip Kotze, Cheryl Louw, Zonke Mabude, Nokuthula Miti, Sylvia Kusemererwa, Hugo Tempelman, Hannelie Carstens, Bríd Devlin, Michelle Isaacs, Mariëtte Malherbe, Winél Mans, Jeremy Nuttall, Marisa Russell, Smangaliso Ntshele, Marlie Smit, Leonard Nichiren Solai, Patrick Spence, John Steytler, Kathleen Marie Windle, Maarten Borremans, Sophie Resseler, Jens Van Roey, Wim Parys, Tony Vangeneugden, Ben Van Baelen, Zeda Rosenberg · 发表于：New England Journal of Medicine · 年份：2016 · DOI：10.1056/nejmoa1602046 · 被引用次数：472 · 研究领域：HIV Research and Treatment、HIV/AIDS Research and Interventions、Reproductive tract infections research

BACKGROUND: The incidence of human immunodeficiency virus (HIV) infection remains high among women in sub-Saharan Africa. We evaluated the safety and efficacy of extended use of a vaginal ring containing dapivirine for the prevention of HIV infection in 1959 healthy, sexually active women, 18 to 45 years of age, from seven communities in South Africa and Uganda. METHODS: In this randomized, double-blind, placebo-controlled, phase 3 trial, we randomly assigned participants in a 2:1 ratio to receive vaginal rings containing either 25 mg of dapivirine or placebo. Participants inserted the rings themselves every 4 weeks for up to 24 months. The primary efficacy end point was the rate of HIV type 1 (HIV-1) seroconversion. RESULTS: A total of 77 participants in the dapivirine group underwent HIV-1 seroconversion during 1888 person-years of follow-up (4.1 seroconversions per 100 person-years), as compared with 56 in the placebo group who underwent HIV-1 seroconversion during 917 person-years of follow-up (6.1 seroconversions per 100 person-years). The incidence of HIV-1 infection was 31% lower in the dapivirine group than in the placebo group (hazard ratio, 0.69; 95% confidence interval [CI], 0.49 to 0.99; P=0.04). There was no significant difference in efficacy of the dapivirine ring among women older than 21 years of age (hazard ratio for infection, 0.63; 95% CI, 0.41 to 0.97) and those 21 years of age or younger (hazard ratio, 0.85; 95% CI, 0.45 to 1.60; P=0.43 for treatment-by-a...