Rilpivirine has been approved for the treatment of HIV-1 infection, in combination with other antiretroviral drugs, in treatment-naive adults, according to a statement by the Food and Drug Administration.
The May 20 decision adds an alternative option to the armamentarium of highly active antiretroviral therapies intended to suppress the viral load in the blood.
The approval is based in part on 48-week safety and effectiveness data from two phase III trials involving a total of 1,368 adult patients with HIV infection. In the two trials, rilpivirine was compared with efavirenz, which is also approved for the treatment of HIV infection. Both are non-nucleoside reverse transcriptase inhibitors, which block HIV viral replication. In the study, both agents were given in combination with other antiretroviral therapies, according to the statement.
Rilpivirine was as effective as efavirenz in lowering viral load. After 48 weeks of treatment, 83% and 80% of each group, respectively, had undetectable levels of HIV in their blood. However, fewer patients stopped taking rilpivirine due to side effects that included depression, insomnia, headache, and rash, according to the FDA statement.
Rilpivirine (Edurant) is manufactured by Tibotec Therapeutics, a division of Centocor Ortho Biotech Inc.