West Virginia Clinical and Translational Science Institute
BACKGROUND—Maraviroc (MVC) is a candidate drug for HIV PrEP. OBJECTIVE—To assess the safety/tolerability of MVC-containing PrEP in U.S. women at-risk for HIV over 48 weeks. DESIGN—Phase 2 randomized, controlled, double-blinded study of four PrEP regimens (#NCT01505114). SETTING—Twelve clinical research sites of the HIV Prevention Trials Network and AIDS Clinical Trials Group. PARTICIPANTS—HIV-uninfected women reporting condomless vaginal or anal intercourse with ≥1 HIV-infected or unknown-serostatus man within 90 days. INTERVENTIONS—MVC alone, MVC+emtricitabine (FTC), MVC+tenofovir disoproxil fumarate (TDF), and TDF+FTC (control). MEASUREMENTS—At each visit, clinical and laboratory (including HIV) assessments were conducted. Primary outcomes were grade 3–4 adverse events and time to permanent regimen discontinuation. Analyses were conducted on all randomized participants, according to original regimen assignment. RESULTS—Among 188 participants, 85% completed follow-up, 11% withdrew early, and 4% were lost-to-follow-up; 19% discontinued their regimen prematurely. Number discontinuing and time-to-discontinuation did not differ among regimens. Grade 3/4 adverse events occurred in 5 (MVC), 13 (MVC+FTC), 9 (MVC+TDF) and 8 (TDF+FTC) participants; rates did not differ among regimens. One death occurred (suicide; MVC+FTC), judged not regimen-related. Of available samples at week 48 (n=126), 60% demonstrated detectable drug concentrations. No new HIV infections occurred. LIMITATIONS—Participants were not necessarily high-risk for HIV. Regimen was 3 pills daily. Study was not powered for efficacy. CONCLUSIONS—MVC-containing PrEP regimens were safe and well-tolerated compared to the control regimen of TDF+FTC in U.S. women. No new HIV infections occurred, although whether this was due to low risk of the population or to protection from the study regimens is not certain. MVC-containing PrEP for women may warrant further study. FUNDING SOURCE—U.S. National Institutes of Health
Digital Commons Citation
Gulick, Roy M.; Wilkin, Timothy J.; Chen, Ying Q.; Landovitz, Raphael J.; Amico, K. Rivet; Young, Alicia M.; Richardson, Paul; Marzinke, Mark A.; Hendrix, Craig W.; Eshleman, Susan H.; McGowan, Ian; Cottle, Leslie M.; Andrade, Adriana; Marcus, Cheryl; Klingman, Karin L.; Chege, Wairimu; Rinehart, Alex R.; Rooney, James F.; Andrew, Philip; Salata, Robert A.; Siegel, Marc; Manabe, Yukari C.; Frank, Ian; Ho, Ken; Santana, Jorge; Stekler, Joanne D.; Swaminathan, Shobha; McCauley, Marybeth; Hodder, Sally; and Mayer, Kenneth H., "Safety and Tolerability of Maraviroc-Containing Regimens to Prevent HIV Infection in Women: A Phase 2 Randomized Trial" (2017). Clinical and Translational Science Institute. 704.
Gulick RM, Wilkin TJ, Chen YQ, et al. Safety and Tolerability of Maraviroc-Containing Regimens to Prevent HIV Infection in Women. Annals of Internal Medicine. 2017;167(6):384. doi:10.7326/m17-0520