FDA Approves First Two-Drug Regimen for HIV
The U.S. Food and Drug Administration has approved the first two-drug treatment regimen to treat HIV-1 (human immunodeficiency virus type 1) in certain patients. Standard HIV treatment protocols contain three or more medications.
The drug, called Juluca, includes dolutegravir and rilpivirine, which are both already approved HIV medications. This new treatment is approved for use in adults with HIV-1 whose viral load has been suppressed on a stable regimen for at least six months, with no history of treatment failure, and no known drug substitutions associated with resistance to dolutegravir or rilpivirine. In two clinical trials involving 1,024 participants, Juluca proved effective and comparable to standard HIV regimens.
According to Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, limiting the number of drugs used to treat HIV can help reduce adverse effects.