Исследование: Получены результаты КИ вагинального кольца для профилактики ВИЧ-инфекции
More than half of the 35 million persons currently living with human immunodeficiency virus type 1 (HIV-1) infection are women. A majority of these women reside in sub-Saharan Africa,1 a region that has some of the highest incidences of HIV-1 infection in any population worldwide.
The use of antiretroviral medications as pre-exposure prophylaxis is a promising approach to the prevention of HIV-1 acquisition. Several clinical trials of the antiretroviral tenofovir showed such protection against HIV-1. However, in three trials involving African women, adherence to tenofovir-containing pills and vaginal gels was low, and HIV-1 protection was not shown.
Across trials of tenofovir-based prophylaxis, a sizable proportion of participants were not adherent, a finding that emphasizes the need for additional options, particularly ones that women can control and longer-acting approaches that do not require daily or coitally dependent use.
Vaginal rings can provide sustained and controlled release of medications. For example, rings containing exogenous hormones are licensed for contraception and estrogen replacement.
For HIV-1 prevention, an antiretroviral-containing vaginal ring could provide long-acting HIV-1 protection while reducing systemic exposure to the active pharmaceutical ingredient and delivering the anti–HIV-1 agent at the site of viral transmission.
Dapivirine is a non-nucleoside HIV-1 reverse-transcriptase inhibitor that has activity against a broad range of HIV-1 subtypes. In two phase 1 trials, genital biopsy tissue samples obtained from women using dapivirine vaginally in the form of a ring, films, and gels were substantially less susceptible to HIV-1 when challenged ex vivo than were tissue samples obtained from placebo-treated women.
A monthly vaginal ring containing dapivirine was found to be safe and acceptable in phase 1 and 2 studies, with typical plasma levels of the drug that were lower by a factor of 1000 than levels in women receiving oral dapivirine.
We conducted a phase 3, randomized, double-blind, placebo-controlled trial of the dapivirine vaginal ring among African women.