New FDA-Approved Anti-HIV Drug Edurant

On May 20, 2011, the U.S. Food and Drug Administration (FDA) approved a new antiretroviral drug Edurant (rilpivirine). It is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It is approved for treatment naïve patients who have not previously been treated with ART.

Clinical trial results show that Edurant shares similar safety and efficacy to Sustiva (efavirez). 83% of study participants on Edurant achieved undetectable viral load after 48 weeks of treatment compared to 80% of participants on Sustiva.  However, data shows that participants who failed Edurant were more likely to experience drug resistance than those who failed Sustiva.  Resistance was seen in other antiretrovirals they were taking and other NNRTIs. In addition, participants who started Edurant with viral loads greater than 100,000 copies per millimeter were less likely to achieve viral suppression than those who had lower baseline viral load. 13% of participants on Edurant experienced virologic failure, whereas 9% in Sustiva participants.

Edurant shares similar side effects to those of Sustiva. Common side effects seen in study participants were depression, insomnia, headache, and rash. However, only 2% of Edurant participants stopped taking the medication due to side effects versus 7% seen in Sustiva participants.

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