Maraviroc-Containing PrEP Regimens Found to be Safe in Women
HIV infections continue to occur at a rate of >2 million globally each year with women accounting for a little over 50% of infections. Antiretroviral therapy has been highly successful in reducing AIDS outcomes and death in HIV-infected patients worldwide; however, transmission of HIV remains a major global health problem.
The approval of oral TDF-FTC for HIV pre-exposure prophylaxis (PrEP) represents an approved intervention to help control this epidemic; however, the tolerability of this regime and the subsequent discontinuation of therapy pose a threat to the efficacy, and therefore, the main purpose of this management approach, Contagion reports.
However, the participants in these studies were male and transgender women. Indeed, most clinical trials of antiretroviral agents tend to have limited female enrollment, and therefore, results from these predominantly male studies are extrapolated to the female population. Furthermore, many of these studies do not report gender subgroup analyses, and those that do are underpowered to detect differences between men and women, limiting the ability to assess if the results are equally applicable to both sexes. Women may have differential responses to and adverse events from HIV therapy, but to what extent remains unknown.
To this end, Gulick et al, from Weill Cornell Medical College, New York City compared 4 MVC-containing regimens as HIV PrEP in a US population of women. This study was not powered to determine efficacy but was a double-blind randomized controlled study conducted over 48-weeks. The 4 interventions were MVC, MVC plus emtricitabine (FTC), MVC plus tenofovir-disproxil fumarate (TDF), and a control of TDF-FTC.
When speaking on the study to Contagion®, lead author Roy M. Gulick, MD, Chief, Division of Infectious Diseases at Weill Cornell Medicine said, “HIV PrEP is a strategy where at-risk HIV negative people take medications to prevent them from acquiring HIV infection. Currently, there’s only 1 approved drug combination [for PrEP] in women—our study explored other unique drug combinations for HIV PrEP. It would be useful for people to have a range of options for HIV PrEP.”
This Phase 2 study showed that MVC-containing anti-retroviral regimens were generally safe and well-tolerated in a female population, compared with a TDF-FTC regimen. These results are similar to those reported earlier by the same group of cohorts in men and provide evidence that women tolerate MVC-containing PrEP regimens for the management of HIV disease and that further studies are warranted.