In the Journals Plus

PrEP regimens containing Selzentry safe, well-tolerated compared with Truvada

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November 8, 2016

Pre-exposure prophylaxis regimens containing Selzentry were generally safe and well-tolerated compared with Truvada, the standard-of-care PrEP drug, according to the results of a phase 2 trial.

Roy M. Gulick, MD, MPH, professor of medicine and chief of the division of infectious diseases at Weill Cornell Medicine, and colleagues studied four PrEP regimens in at-risk HIV-uninfected men and transgender women who have sex with men and concluded that regimens containing Selzentry (maraviroc, ViiV Heathcare; MVC) “may warrant further study for PrEP,” they wrote in The Journal of Infectious Diseases.

Gulick and colleagues enrolled 406 participants in a prospective, randomized, double blind, multicenter study of the safety and tolerability of MVC. They investigated four regimens — MVC by itself; MVC plus emtricitabine (FTC); MVC plus tenofovir disoproxil fumarate (TDF); and Truvada (FTC/TDF, Gilead Sciences) by itself.

The study was conducted between July 2012 and April 2014 at sites in the United States and included adults aged at least 18 years who were born male and who self-reported having condomless anal sex with at least one man who was either known to be HIV–infected or who did not know his infection status within 90 days prior to study entry. Patients were excluded if they had used any antiretroviral drug within 90 days, reported active IV drug use, or had a reactive HIV test or positive hepatitis B virus surface antigen.

Eligible participants were randomly assigned one of the four regimens for 48 weeks. They were assessed, tested and counseled at weeks 2, 4, 8 and then every 8 weeks until the study drugs were discontinued.

The median age of the participants was 40 years. Among them, 84% completed follow-up, 7% stopped the study early, 9% were lost to follow-up, and 9% discontinued the study regimen prior to week 48.

The primary outcome was the safety and tolerability of each regimen, not efficacy.

In assessing safety, Gulick and colleagues found no difference in the rate of grade 3 to 4 adverse events — defined as severe or life-threatening — among the study regimens. In assessing tolerability, they found no difference in the number of patients who permanently discontinued study drugs and the time to discontinuation through 48 weeks of follow-up among the study regimens.

“Combination [MVC]-containing oral PrEP regimens may warrant further investigation in fully powered efficacy studies as an alternative to TDF/FTC PrEP,” Gulick and colleagues concluded. – by Gerard Gallagher

Disclosures: Please see the full study for a list of all researchers’ relevant financial disclosures.

itj+ Perspective

Paul A. Volberding, MD

Paul A. Volberding

The field of HIV pre-exposure prophylaxis continues a rapid evolution. While the only approved regimen of FTC/TDF is nearly completely effective when used as prescribed, some concern remains about long-term safety, especially important in otherwise healthy persons who may be using PrEP for prolonged periods. TDF has well-known renal and bone side effects, so other approaches are of interest. Most hope lies in replacing TDF with tenofovir alafenamide (TAF, Gilead Sciences), a safer form of the parent drug. Those trials are in progress. Meanwhile, trials like this one using MVC, a very well-tolerated antiretroviral, are worth examining. That said, these results are unlikely to generate much enthusiasm. If used with TDF, the drug does not change the side effect concerns, and as this drug is unlikely to decrease transmission of HIV using the CXCR4 receptor (MVC is a CCR5 blocker), its use with only lamivudine or FTC may be a problem. Nevertheless, until we hopefully find that TAF with FTC is effective as PrEP in both men and women, research in this area is definitely worth continuing. Meanwhile, we need to encourage more use of FTC/TDF PrEP, one of the key HIV–prevention tools already in hand.

Paul A. Volberding, MD, Infectious Disease News Chief Medical Editor; Director, AIDS Research Institute, University of California, San Francisco

Disclosure: Volberding reports serving on a data and safety monitoring board for Merck.