Safety and Tolerability of Maraviroc-Containing Regimens to Prevent HIV Infection in Women: A Phase 2 Randomized Trial

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Abstract

Background:

Maraviroc (MVC) is a candidate drug for HIV preexposure prophylaxis (PrEP).

Objective:

To assess the safety and tolerability of MVC-containing PrEP over 48 weeks in U.S. women at risk for HIV infection.

Design:

Phase 2 randomized, controlled, double-blinded study of 4 antiretroviral regimens used as PrEP. (ClinicalTrials.gov: NCT01505114)

Setting:

12 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 at least 1 man with HIV infection or unknown serostatus within 90 days.

Intervention:

MVC only, MVC–emtricitabine (FTC), MVC–tenofovir disoproxil fumarate (TDF), and TDF–FTC (control).

Measurements:

At each visit, clinical and laboratory (including HIV) assessments were done. Primary outcomes were grade 3 and 4 adverse events and time to permanent discontinuation of the study regimen. All randomly assigned participants were analyzed according to 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. The number discontinuing and the time to discontinuation did not differ among regimens. Grade 3 or 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 (by suicide) occurred in the MVC–TDF group but was judged not to be related to study drugs. Of available plasma samples at week 48 (n = 126), 60% showed detectable drug concentrations. No new HIV infections occurred.

Limitations:

Participants were not necessarily at high risk for HIV infection. The regimen comprised 3 pills taken daily. The study was not powered for efficacy.

Conclusion:

Maraviroc-containing PrEP regimens were safe and well-tolerated compared with TDF–FTC in U.S. women. No new HIV infections occurred, although whether this was due to study drugs or low risk in the population is uncertain. Maraviroc-containing PrEP for women may warrant further study.

Primary Funding Source:

National Institutes of Health.

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