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Ann Intern Med. 2017 Sep 19;167(6):384-393. doi: 10.7326/M17-0520. Epub 2017 Aug 22.

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

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1
From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.

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.

PMID:
28828489
PMCID:
PMC5667908
DOI:
10.7326/M17-0520
[Indexed for MEDLINE]
Free PMC Article

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