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news.Tibotec Therapeutics, a division of Centocor Ortho Biotech, has received the US Food and Drug Administration (FDA) approval for its Edurant (rilpivirine) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy.
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Edurant, a non-nucleoside reverse transcriptase inhibitor (NNRTI), is used as part of a highly active antiretroviral therapy (HAART) regimen that is designed to suppress the amount of HIV (viral load) in the blood.
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 who had not received prior HIV therapy were selected to receive treatment with Edurant or efavirenz (another FDA-approved NNRTI for the treatment of HIV infection).
Both drugs were given in combination with other antiretroviral drugs.
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.
FDA concluded that Edurant does not cure HIV infection and patients must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses.