FDA Approves HIV Drug in Combination Treatment

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The U.S. Food and Drug Administration approved today the drug Edurant (rilpivirine) as a treatment for HIV infection in adults, when used in combination with other antiretroviral drugs. Edurant is manufactured by Tibotec Therapeutics, a subsidiary of Johnson & Johnson, in Raritan, New Jersey.

FDA approved the drug for the treatment of HIV-1 — the more virulent type of HIV and cause of the majority of HIV infections — in adults who have never taken an HIV therapy. Edurant is a pill taken once a day with food. It belongs to a class of HIV drugs called non-nucleoside reverse transcriptase inhibitors that work by by blocking HIV viral replication. The agency conditioned the drug’s approval on its use with a highly active antiretroviral therapy regimen designed to suppress the amount of HIV (viral load) in the blood.

The safety and effectiveness of Edurant are based on data from two 48-week Phase 3 clinical trials with 1,368 adult subjects with HIV infection, and from a 96-week — extended to 192 weeks — trial. Patients had not received prior HIV therapy and were selected to receive treatment with Edurant or efavirenz, a similar FDA-approved treatment of HIV infection. Both drugs were given in combination with other antiretroviral drugs.

FDA cautions that Edurant does not cure HIV infection. Patients must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses. The most commonly reported side effects in patients taking Edurant included depression, difficulty sleeping, headache, and rash. Fewer patients stopped taking the drug due to side effects as compared to patients taking efavirenz.

Read more: Study Shows Drug Combo Effective as HIV Prevention

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