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On May 20, 2011, the FDA approved rilpivirine (Edurant), a second-generation nonnucleoside reverse transcriptase inhibitor dosed as a single pill daily, for use in treatment-naive HIV-infected adults. The drug's approval is based on its performance in two phase III trials, each of which evaluated rilpivirine — in combination with two nucleoside reverse transcriptase inhibitors (NRTIs) — against similar efavirenz-based combinations (see JW AIDS Clin Care Aug 9 2010).
Rilpivirine- and efavirenz-based regimens performed similarly overall, but differences were seen in subanalyses. Among patients with high pre-treatment viral loads, rilpivirine-based combinations were less effective: At viral loads between 100,000 and 500,000 copies/mL, virologic…