Five-Year Safety Evaluation of Maraviroc in HIV-1â

Five-Year Safety Evaluation of Maraviroc in HIV-1–Infected Treatment-Experienced Patients

https://journals.lww.com/jaids/fulltext/2014/...in.11.aspx

Given the unique mechanism of action of CCR5 antagonists, and the potential for longer-term safety issues, the US Food and Drug Administration requested extended 5-year follow-up for all study subjects receiving these compounds. In this study, we report the pooled safety findings from the MOTIVATE 1 and MOTIVATE 2 phase 3 studies for >5 years, the longest-term safety data available with a CCR5 antagonist.

In summary, in a population of HIV-infected treatment-experienced patients with >5 years of exposure to maraviroc, the incidence of death and other selected clinical events, including hepatic failure, malignancies, and myocardial infarctions, was low, and no new safety signals were reported. Maraviroc appears generally safe and well tolerated for at least 5 years in treatment-experienced patients.

Ultimately, a total of 938 study subjects (including 98 study subjects originally randomized to placebo) received maraviroc and contributed to a total maraviroc exposure of 2639 patient-years with a median exposure of 908 days (range, 1–2220 days).