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On August 10, 2011, the FDA approved the fixed-dose combination of tenofovir/FTC/rilpivirine (Complera) for the treatment of HIV infection in antiretroviral-naive adults. The recommended dose is one tablet once daily, taken orally with a meal.
The approval is based on pooled 48-week safety and efficacy data from the ECHO and THRIVE trials, which compared rilpivirine to efavirenz, each in combination with two nucleoside reverse transcriptase inhibitors (NRTIs; see JW AIDS Clin Care Aug 1 2011). Eighty percent of the patients in those trials received tenofovir/FTC as their nucleoside backbone. Among these patients:
The proportion achieving viral loads <50 copies/mL was similar between the treatment arms (83% for rilpivirine and 81% for efaviren…