Candidate drug to prevent HIV infection in women safe and well-tolerated in phase 2 trial

1. Maraviroc pre-exposure prophylaxis regimens were observed to be safe and well tolerated in patients.

2. No new HIV infections occurred during the course of the 48-week study.

Evidence Rating Level: 1 (Excellent)

Study Rundown: HIV prevention is an important area of public health, as over 2 million new HIV infections occur annually worldwide. One method of HIV prevention is pre-exposure prophylaxis (PrEP). To date, PrEP in women has shown conflicting results. The authors of this study aimed to evaluate the safety and tolerability of a new candidate drug for HIV PrEP, Maraviroc (MVC). In general, the drug was found to be safe and well tolerated in this phase 2 trial. The study has several limitations. First, the study population was considered “at risk” but was not necessarily “high risk” based on self-reported behaviour. Changes in risk may have had an impact on patient’s medication compliance. Additionally, the study was not powered to detect differences in specific adverse effects and the study follow-up was at 48 weeks, meaning that long-term effects of the drug were not determined. Overall, the results of the study suggest that MVC may be a potential candidate for PrEP regimens in women.

Click to read the study, published today in the Annals of Internal Medicine

Relevant Reading: Preexposure Prophylaxis for HIV Infection among African Women

In-Depth [randomized controlled trial]: This study was a phase 2, randomized, controlled, double-blinded study. Participants included 188 HIV-uninfected women that had reported vaginal or anal intercourse, without condom use, with at least 1 man with HIV infection or unknown serostatus within the past 90 days. 4 different antiretroviral regimens as PrEP were tested: MVC only, MVC-emtricitabine (FTC), MVC-tenofovir disoproxil fumarate (TDF), and TDF-FTC (control). 85% of participants completed follow-up for this study. The authors found that Grade 3 or Grade 4 adverse events occurred, but the events did not differ significantly between regimens. 60% detectable drug concentrations at follow-up (n = 126). Additionally, no new HIV infections occurred during the course of the study.

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