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FDA approves once-daily rilpivirine for HIV
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The FDA has approved once-daily rilpivirine combined with other antiretroviral drugs for the treatment of HIV-1 infection in adults who are HIV treatment-naive.
Rilpivirine (Edurant, Tibotec Therapeutics) blocks HIV viral replication and is to be used as part of a highly active antiretroviral therapy regimen designed to suppress HIV viral load.
“Patients may respond differently to various HIV drugs or experience varied side effects. FDA’s approval of Edurant provides an additional treatment option for patients who are starting HIV therapy,” Edward Cox, MD, MPH, director, Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.
FDA approval was based upon data from two 48-week phase 3 clinical trials that included 1,368 adults with HIV and from one 96-week trial. Patients were treatment-naive and were selected to receive treatment with rilpivirine or efavirenz (Sustiva, Bristol-Myers Squibb) combined with other ART.
Rilpivirine was comparable to efavirenz in lowering viral load at 48 weeks (83% vs. 80%). Compared with patients assigned to rilpivirine with a lower viral load at the start of therapy, those with a higher viral load were more likely to not respond to the drug. Moreover, those who failed with rilpivirine developed more drug resistance vs. patients who failed efavirenz.
Common adverse events in patients assigned to rilpivirine included depression, insomnia, headache and rash. Fewer patients stopped taking the drug because of adverse events vs. patients taking efavirenz, according to the release.
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