The ACTG A5303 study at CROI 2015 was a double-blind, randomized trial that compared maraviroc (Selzentry, Celsentri), at 150 mg once daily, to tenofovir (TDF, Viread) in 259 treatment-naive patients, both arms with ritonavir (Norvir)-boosted darunavir (Prezista) plus emtricitabine (FTC, Emtriva). The main endpoint was toxicity, and not surprisingly the TDF-sparing maraviroc arm showed statistically-significant lower bone loss in bone DXA at 48 weeks.
Despite the promising results, the main jewel of the study remained unnoticed to most CROI attendants. In a secondary endpoint in the study, maraviroc had a 48-week efficacy (viral load < 50 copies/mL) of 86% versus 81% in the TDF arm. Despite not being a non-inferiority trial, this difference would meet non-inferiority with the commonly used statistical margin of 10 to 12%. Therefore, the once-daily regimen of maraviroc, emtricitabine and darunavir/ritonavir could become a new alternative for individuals who are not candidates for TDF.
View the full study poster.
Which other studies presented at CROI 2015 will have lasting impact? Read more of Llibre and Young's top picks.
Josep M. Llibre, M.D., is in the HIV Unit of the "Lluita contra la SIDA" Foundation at University Hospital Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Spain. Llibre has received funding for research or payment for conferences or participation on advisory boards from Abbott, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Janssen-Cilag, Merck Sharp & Dohme, and ViiV Healthcare.
Benjamin Young, M.D., Ph.D., is senior vice president and chief medical officer of the International Association of Providers of AIDS Care based in Washington, D.C., and an adjunct professor at the Josef Korbel School of International Studies at the University of Denver. Young has received consulting or speaking fees from Bristol-Myers Squibb, Gilead Sciences, Merck & Co., and ViiV Healthcare. He has received research funding from Bristol-Myers Squibb Company, Gilead Sciences, Merck & Co., and ViiV Healthcare.