Two-drug regimen for certain HIV patients approved by FDA

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

Juluca is a fixed-dose tablet containing two previously approved drugs (dolutegravir, ViiV Healthcare, and rilpivirine, Janssen), representing the first complete treatment regimen for certain patients with HIV-1. Currently, a standard HIV treatment consists of three or more drugs.

Specifically, this treatment is for patients with HIV-1 infections whose virus is currently suppressed on a stable regimen for at least six months, with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.

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

The safety and efficacy of Juluca were evaluated in two clinical trials, which included 1,024 patients whose virus was suppressed on their current anti-HIV drugs. All participants of the trial were randomised to received either Juluca or to remain on their usual anti-HIV drugs. The results demonstrated that Juluca was effective in keeping the virus suppressed and offered comparable results to patients who remained on the normal treatment schedule.

FDA approval of Juluca was awarded to ViiV Healthcare.