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Safety and efficacy of a dapivirine vaginal ring for HIV prevention in women.

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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·2016·New England Journal of Medicine

DOI 10.1056/nejmoa1602046

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Abstract

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-age interaction). Among participants with HIV-1 infection, nonnucleoside reverse-transcriptase inhibitor resistance mutations were detected in 14 of 77 participants in the dapivirine group (18.2%) and in 9 of 56 (16.1%) in the placebo group. Serious adverse events occurred more often in the dapivirine group (in 38 participants [2.9%]) than in the placebo group (in 6 [0.9%]). However, no clear pattern was identified. CONCLUSIONS: Among women in sub-Saharan Africa, the dapivirine ring was not associated with any safety concerns and was associated with a rate of acquisition of HIV-1 infection that was lower than the rate with placebo. (Funded by the International Partnership for Microbicides; ClinicalTrials.gov number, NCT01539226 .).

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Authors: Nel, A., van Niekerk, N., Kapiga, S., Bekker, L.-G., Gama, C., Gill, K., Kamali, A., Kotze, P., Louw, C., Mabude, Z., Miti, N., Kusemererwa, S., Tempelman, H., Carstens, H., Devlin, B., Isaacs, M., Malherbe, M., Mans, W., Nuttall, J., Russell, M., Ntshele, S., Smit, M., Solai, L., Spence, P., Steytler, J., Windle, K., Borremans, M., Resseler, S., Van Roey, J., Parys, W., Vangeneugden, T., Van Baelen, B., & Rosenberg, Z.
Affiliations: International Partnership for Microbicides (US)
ORCID: Kapiga, Saidi
Bekker, Linda-Gail
Gill, Katherine
Kotze, Philip
Kusemererwa, Sylvia
Isaacs, Michelle
Nuttall, Jeremy
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2016-12
Volume: 375
Issue: 22
Pages: 2133-2143
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1602046
OpenAlex: W2558446330
Cited by: 479
References: 16
Citations by year: 2026: 31 · 2025: 39 · 2024: 34 · 2023: 43 · 2022: 50 · 2021: 72 · 2020: 40 · 2019: 78 · 2018: 57 · 2017: 32 · 2016: 3
FWCI: 52.34
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
UpSpace Institutional Repository (University of Pretoria) (submittedVersion)
Topics: Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
Keywords: dapivirine, vaginal ring, HIV prevention, HIV-1 seroconversion, women, drug safety
MeSH terms: Adolescent, Adult, Double-Blind Method, Female, HIV Seropositivity, Humans, Middle Aged, Pregnancy, Pyrimidines, RNA, Viral, South Africa, Uganda, Vagina, HIV-1, HIV Infections, Incidence, Reverse Transcriptase Inhibitors, Drug Resistance, Viral, Young Adult

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Safety and efficacy of a dapivirine vaginal ring for HIV prevention in women.

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