Late-breaking news: FDA approves rilpivirine for HIV-1 infection in treatment-naive adults

FDA has approved rilpivirine (Edurant, Tibotec Therapeutics, a division of Centocor Ortho Biotech) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy.

Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI); it works by blocking HIV viral replication. Rilpivirine is to be used as part of a highly active antiretroviral therapy (HAART) regimen that is designed to suppress the viral load in the blood. Rilpivirine is to be taken once daily with food.

The safety and effectiveness of rilpivirine is based on 48-week data from 2 phase 3 clinical trials with 1,368 adult subjects with HIV infection, and from a 96-week trial that extended to 192 weeks. Patients had not received prior HIV therapy and were selected to receive treatment with rilpivirine or efavirenz (another FDA-approved NNRTI for the treatment of HIV infection). Both drugs were given in combination with other antiretroviral drugs.

Rilpivirine was as effective as efavirenz in lowering viral load. In the rilpivirine and efavirenz groups, 83% and 80% of subjects, respectively, had undetectable amounts of HIV in their blood after 48 weeks of treatment. Patients receiving rilpivirine 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, patients who failed therapy with rilpivirine developed more drug resistance than those who failed efavirenz.

The most commonly reported side effects in patients taking rilpivirine included depression, insomnia, headache, and rash. Fewer patients stopped taking the drug because of side effects than did patients taking efavirenz.

Rilpivirine does not cure HIV infection. Patients must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses.