Press Announcements > FDA approves new HIV treatment

The U.S. Food and Drug Administration today approved Edurant (rilpivirine) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy (treatment-naïve).

The safety and effectiveness of Edurant is based on 48-week data from two Phase 3 clinical trials with 1,368 adult subjects with HIV infection, and from a 96-week (with extension to 192 weeks) trial. Patients had not received prior HIV therapy and were selected to receive treatment with Edurant or efavirenz (another FDA-approved non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV infection). Both drugs were given in combination with other antiretroviral drugs.

Edurant was as effective as efavirenz in lowering viral load. In the Edurant and efavirenz groups, 83 percent and 80 percent of subjects, respectively, had undetectable amounts of HIV in their blood after 48 weeks of treatment. Patients receiving Edurant who had a higher viral load at the start of therapy were more likely not to respond to the drug than were patients with a lower viral load at the start of therapy. In addition, persons who failed therapy with Edurant developed more drug resistance than patients who failed efavirenz.

The most commonly reported side effects in patients taking Edurant included depression, difficulty sleeping (insomnia), headache and rash. Fewer patients stopped taking the drug due to side effects as compared to patients taking efavirenz.

For more information, please visit: Edurant
Press Announcements > FDA approves new HIV treatment