FDA approves first two-drug regimen for certain patients with HIV – APhA submits compounding comments to FDA. – (866) 348-2889
FDA on Tuesday approved dolutegravir + rilpivirine (Juluca—ViiV Healthcare), the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard HIV treatment. The regimen is a fixed-dose tablet containing two previously approved drugs (dolutegravir and rilpivirine) to treat adults with HIV-1 infections whose virus is currently suppressed on a stable regimen for at least 6 months, with no history of treatment failure and no known substitutions associated with resistance to the individual components of the regimen. “Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients,” said Debra Birnkrant, MD, director of the Division of Antiviral Products in FDA’s Center for Drug Evaluation and Research. The regiment’s safety and efficacy in adults were evaluated in two clinical trials of 1,024 participants whose virus was suppressed on their current anti-HIV drugs. Results showed the regimen was effective in keeping the virus suppressed and comparable to those who continued their current anti-HIV drugs. The most common adverse events in patients taking the regimen were diarrhea and headache. Serious adverse events include skin rash and allergic reactions, liver problems, and depression or mood changes.