Maraviroc HIV PrEP Regimens Assessed for Safety, Tolerability
HealthDay News — Maraviroc (MVC)-containing HIV pre-exposure prophylaxis (PrEP) regimens are well tolerated for preventing HIV infection in uninfected women, according to a study published online August 22 in the Annals of Internal Medicine.
Roy M. Gulick, MD, MPH, from Weill Cornell Medicine in New York City, and colleagues conducted a phase 2 study of 4 antiretroviral regimens used as PrEP in 12 clinical research sites among HIV-uninfected women reporting condom-less vaginal or anal intercourse with at least 1 man with HIV infection or unknown serostatus. Participants received MVC only, MVC-emtricitabine (FTC), MVC-tenofovir disoproxil fumarate (TDF), and TDF-FTC (control).
Eighty-five percent of the 188 participants completed follow-up; 19% discontinued their regimen prematurely. The researchers observed no difference among regimens in the number discontinuing and the time to discontinuation. Five MVC, 13 MVC-FTC, 3 MVC-TDF, and 8 TDF-FTC participants had grade 3 or 4 adverse events; the rates did not differ among regimens. The MVC-TDF group had 1 death by suicide, which was judged not to be related to study drugs. Sixty percent of the 126 available plasma samples at week 48 showed detectable drug concentrations. There were no new HIV infections.
"Maraviroc-containing PrEP regimens were safe and well tolerated compared with TDF-FTC in U.S. women," the authors write. "Maraviroc-containing PrEP for women may warrant further study."
Several authors disclosed financial ties to the pharmaceutical industry.