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

• Published in: The New England journal of medicine Vol. 375; no. 22; pp. 2133 - 2143
• Main Authors: Nel, Annalene, van Niekerk, Neliëtte, Kapiga, Saidi, Bekker, Linda-Gail, Gama, Cynthia, Gill, Katherine, Kamali, Anatoli, Kotze, Philip, Louw, Cheryl, Mabude, Zonke, Miti, Nokuthula, Kusemererwa, Sylvia, Tempelman, Hugo, Carstens, Hannelie, Devlin, Brid, Isaacs, Michelle, Malherbe, Mariëtte, Mans, Winel, Nuttall, Jeremy, Russell, Marisa, Ntshele, Smangaliso, Smit, Marlie, Solai, Leonard, Spence, Patrick, Steytler, John, Windle, Kathleen, Borremans, Maarten, Resseler, Sophie, Van Roey, Jens, Parys, Wim, Vangeneugden, Tony, Van Baelen, Ben, Rosenberg, Zeda
• Format: Journal Article
• Language: English
• Published: United States Massachusetts Medical Society 01.12.2016
• Subjects: Adolescent; Adult; Age; Antiretroviral drugs; Disease prevention; Double-Blind Method; Drug Resistance, Viral; Female; HIV; HIV Infections - epidemiology; HIV Infections - prevention & control; HIV Seropositivity; HIV-1 - isolation & purification; Human immunodeficiency virus; Humans; Incidence; Microbicides; Middle Aged; Patient safety; Pregnancy; Pyrimidines - administration & dosage; Pyrimidines - adverse effects; Reverse Transcriptase Inhibitors - administration & dosage; Reverse Transcriptase Inhibitors - adverse effects; RNA, Viral - blood; Safety; Seroconversion; South Africa - epidemiology; Uganda - epidemiology; Vagina; Viral infections; Women; Young Adult
• ISSN: 0028-4793; 1533-4406
• DOI: 10.1056/NEJMoa1602046

Preventing HIV-1 infection, especially with female-controlled approaches, is a high priority. In this trial in South Africa and Uganda, a dapivirine vaginal ring was associated with a rate of acquisition of HIV-1 infection that was approximately 30% lower than that with placebo. In 2014, approximately 36.9 million people worldwide were living with human immunodeficiency virus (HIV) infection. 1 Rates of new HIV infection among adolescent girls and young women remain high in Eastern and Southern Africa, 2 which underscores the need for the development of safe and effective tools against HIV infection that women initiate themselves. 3 – 5 Self-inserted vaginal rings, which provide a sustained release of antiretroviral drugs over time, have the potential to offer women a prevention option that does not require daily or pericoital use. 6 The International Partnership for Microbicides (IPM) developed a monthly self-administered vaginal ring that contains the nonnucleoside reverse-transcriptase . . .