Details

Autor(en) / Beteiligte

• Stalter, Randy M
• Dong, Tracy Q
• Hendrix, Craig W
• Palanee-Phillips, Thesla
• van der Straten, Ariane
• Hillier, Sharon L
• Kiweewa, Flavia M
• Mgodi, Nyaradzo M
• Marzinke, Mark A
• Bekker, Linda-Gail
• Soto-Torres, Lydia
• Baeten, Jared M
• Brown, Elizabeth R

Titel

Assessing Per-Sex-Act HIV-1 Risk Reduction Among Women Using the Dapivirine Vaginal Ring

Ist Teil von

• The Journal of infectious diseases, 2024-04, Vol.229 (4), p.1158-1165

Ort / Verlag

US: Oxford University Press

Erscheinungsjahr

2024

Link zum Volltext

Quelle

Oxford Journals 2020 Medicine

Beschreibungen/Notizen

• Abstract Background Confounding introduced by individuals’ sexual risk behavior is potentially a significant source of bias in HIV-1 prevention intervention studies. To more completely account for sexual behaviors when assessing the efficacy of the monthly dapivirine ring, a new longer-acting HIV-1 prevention option for women, we estimated per-sex-act risk reduction associated with product use. Methods We conducted a secondary analysis of data from MTN-020/ASPIRE, a phase 3, randomized, placebo-controlled efficacy trial of the dapivirine ring that recruited HIV-uninfected, African women aged 18–45 years. With cumulative sex acts as the time scale, we used multivariable Cox regression with inverse probability of censoring weights to estimate HIV-1 risk reduction associated with a rate of dapivirine release indicative of consistent product use. Results Women in the dapivirine ring group (n = 1187) had an estimated incidence rate of 2.3 (95% confidence interval [CI], 1.8–3.1) HIV-1 acquisition events per 10 000 sex acts versus 3.6 (95% CI, 2.9–4.4) per 10 000 acts in the placebo group (n = 1187). Dapivirine release indicative of consistent ring use was associated with a 63% (95% CI, 33%–80%) per-sex-act HIV-1 risk reduction. Conclusions These results support the efficacy of the dapivirine vaginal ring for HIV-1 prevention and help to inform decision-making for women, providers, and policymakers regarding product use. Clinical Trials Registration NCT01617096. Among cisgender African women using the dapivirine vaginal ring for HIV-1 prevention, drug release rates consistent with continuous product use were associated with a 63% (95% CI, 33%–80%) per-sex-act HIV-1 risk reduction, further supporting the product's efficacy.