Gulick RM, et al. – A scrutiny was performed of the safety and tolerability of Maraviroc (MVC)–containing preexposure prophylaxis (PrEP) over 48 weeks, in U.S. women at risk for HIV infection. The MVC–containing PrEP regimens were discovered to be safe and well–tolerated compared with tenofovir disoproxil fumarate (TDF)–FTC in U.S. women. No new occurrence of HIV infections were reported. Nevertheless, whether this was the result of study drugs or low risk in the population remained unknown. Hence, advanced studies were necessitated.

Methods

• The scheme of this research was a Phase 2 randomized, controlled, double-blinded study of 4 antiretroviral regimens used as PrEP.
• Its setting involved 12 clinical research sites of the HIV Prevention Trials Network and AIDS Clinical Trials Group.
• The enrollees included HIV-uninfected women reporting condomless vaginal or anal intercourse with at least 1 man with HIV infection or unknown serostatus within 90 days.
• MVC only, MVC–emtricitabine (FTC), MVC-tenofovir disoproxil fumarate (TDF), and TDF-FTC (control), served as the intervention.
• At each visit, clinical and laboratory (including HIV) analyses were performed.
• Primary outcomes were grade 3 and 4 adverse events and time to permanent discontinuation of the study regimen.
• The enrollees were examined based on their original assignment.

Results

• Among 188 participants, 85% completed follow-up, 11% withdrew early, and 4% were lost to follow-up; 19% discontinued their regimen prematurely.
• There was no variation in the number discontinuing and the time to discontinuation, among regimens.
• Grade 3 or 4 adverse events occurred in 5 (MVC), 13 (MVC-FTC), 9 (MVC-TDF), and 8 (TDF-FTC) participants.
• The rates did not vary among regimens.
• The MVC-TDF group reported 1 death (by suicide) but was judged not to be associated with study drugs.
• 60% exhibited detectable drug concentrations, among the available plasma samples at week 48 (n = 126).
• There was no new occurrence of HIV infections.