First two-drug HIV treatment approved by FDA

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The US Food and Drug Administration (FDA) has approved the first two-drug treatment regimen for the treatment of human immunodeficiency virus type 1 (HIV-1).

Current standard HIV treatments comprise three or more drugs but the newly approved treatment, Juluca, is made up of just two — dolutegravir (ViiV Healthcare) and rilpivirine (Janssen). Both drugs have been previously approved to treat adults with HIV-1 infections whose virus is currently suppressed on a stable regimen for at least six months with no history of treatment failure.

“Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients,” said Debra Birnkrant, director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research.

The efficacy and safety of the two-drug treatment was evaluated in two clinical trials comprising 1,024 eligible participants. Participants were randomly assigned to remain on their current treatment or switch to Juluca.

The results from the Juluca group were comparable to the current treatment group and show that the two-drug treatment was as effective in keeping the HIV virus suppressed.

Diarrhoea and headache were the most common side effects recorded during the study and more serious side effects included liver problems and depression.

The FDA advised that Juluca should not be given with other anti-HIV drugs and may interact with other commonly used medications.

Last updated
The Pharmaceutical Journal, First two-drug HIV treatment approved by FDA;Online:DOI:10.1211/PJ.2017.20203989

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