Use of a vaginal ring containing dapivirine for HIV-1 prevention in women.
Open accessAbstract
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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Vaginal rings containing dapivirine have provided some reduction in HIV infection.
“Vaginal rings containing dapivirine have provided some reduction in HIV infection (50,51).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [50]
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- Authors
- Baeten, J. M., Palanee-Phillips, T., Brown, E. R., Schwartz, K., Soto-Torres, L. E., Govender, V., Mgodi, N. M., Matovu Kiweewa, F., Nair, G., Mhlanga, F., Siva, S., Bekker, L.-G., Jeenarain, N., Gaffoor, Z., Martinson, F., Makanani, B., Pather, A., Naidoo, L., Husnik, M., Richardson, B. A., Parikh, U. M., Mellors, J. W., Marzinke, M. A., Hendrix, C. W., van der Straten, A., Ramjee, G., Chirenje, Z. M., Nakabiito, C., Taha, T. E., Jones, J., Mayo, A., Scheckter, R., Berthiaume, J., Livant, E., Jacobson, C., Ndase, P., White, R., Patterson, K., Germuga, D., Galaska, B., Bunge, K., Singh, D., Szydlo, D. W., Montgomery, E. T., Mensch, B. S., Torjesen, K., Grossman, C. I., Chakhtoura, N., Nel, A., Rosenberg, Z., McGowan, I., & Hillier, S.
- Affiliations
- University of Cape Town (ZA)
- Family Health International 360 (US)
- Johns Hopkins University (US)
- South African Medical Research Council (ZA)
- National Institutes of Health (US)
- International Partnership for Microbicides (US)
- ORCID
- Baeten, Jared M.
- Brown, Elizabeth R.
- Schwartz, Katie
- Govender, Vaneshree
- Mgodi, Nyaradzo M.
- Nair, Gonasagrie
- Mhlanga, Felix
- Bekker, Linda-Gail
- Gaffoor, Zakir
- Naidoo, Logashvari
- Husnik, Marla
- Richardson, Barbra A.
- Parikh, Urvi M.
- Marzinke, Mark A.
- Hendrix, Craig W.
- Chirenje, Zvavahera M.
- Nakabiito, Clemensia
- Taha, Taha E.
- Mayo, Ashley
- Livant, Edward
- Jacobson, Cindy
- White, Rhonda
- Bunge, Katherine
- Singh, Devika
- Szydlo, Daniel W.
- Montgomery, Elizabeth T.
- Mensch, Barbara S.
- Torjesen, Kristine
- McGowan, Ian
- Hillier, Sharon
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2016-12
- Volume
- 375
- Issue
- 22
- Pages
- 2121-2132
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC4993693
- OpenAlex
- W2290010664
- Cited by
- 772
- References
- 29
- Citations by year
- 2026: 26 · 2025: 48 · 2024: 47 · 2023: 55 · 2022: 72 · 2021: 107 · 2020: 77 · 2019: 111 · 2018: 80 · 2017: 94 · 2016: 52
- FWCI
- 103.75
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- eScholarship (California Digital Library) (submittedVersion, cc-by)
- eScholarship (California Digital Library) (submittedVersion)
- Funders
- National Institute of Mental Health (P30MH062246)
- National Institute of Allergy and Infectious Diseases (U01AI068633, UM1AI068615, UM1AI068633, UM1AI069422, UM1AI106707, UM1AI069436, P30AI094189, UM1AI069518, UM1AI069423, UM1AI069530, UM1AI069463, UM1AI069469, UM1AI069519)
- Topics
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
- Life Sciences › Immunology and Microbiology › Virology › HIV Research and Treatment
- Keywords
- HIV-1 prevention, dapivirine, vaginal ring, HIV-1 infection, women, antiretroviral prophylaxis, non-nucleoside reverse transcriptase inhibitors, medication adherence, age subgroup differences, antiretroviral resistance, African women, PrEP, long-acting drug delivery, retention in care, adverse events
- MeSH terms
- Adolescent, Adult, Africa, Southern, Age Factors, Double-Blind Method, Female, Humans, Middle Aged, Patient Compliance, Pyrimidines, Vagina, HIV-1, HIV Infections, Incidence, Reverse Transcriptase Inhibitors, Drug Resistance, Viral, Young Adult
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