FDA Approves New HIV Drug Edurant

May 20, 2011 -- The FDA has approved Edurant (rilpivirine) for use in anti-HIV drug cocktails.

In a head-to-head clinical trial, Edurant was as effective as the popular drug Sustiva (efavirenz). Edurant and Sustiva are in the class of anti-HIV drugs known as non-nucleoside reverse transcriptase inhibitors (NNRTIs).

"FDA’s approval of Edurant provides an additional treatment option for patients who are starting HIV therapy,” Edward Cox, MD, MPH, director of the FDA's office of antimicrobial products, says in a news release.

The most commonly reported side effects in patients taking Edurant included depression, difficulty sleeping, headache, and rash. However, in the study, fewer patients stopped taking Edurant because of side effects compared to patients taking Sustiva.

Patients with a large amount of virus in the bloodstream at the start of treatment were most likely not to respond to Edurant. And when Edurant failed, it left patients with more resistant virus than seen in patients for whom Sustiva failed.

Neither Edurant nor any other drug can cure HIV infection. Edurant is intended for use only as part of combination therapy with other highly active anti-HIV drugs.

Edurant is made by Tibotec Therapeutics, a division of Centocor Ortho Biotech Inc.