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FDA approves first two-drug HIV regimen for ART-naive adults, Dovato

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The FDA has approved the first complete two-drug HIV regimen for ART-naive adults.

Dovato (ViiV Healthcare) is a once-daily, single-tablet regimen containing dolutegravir 50 mg and lamivudine 300 mg that is intended to treat patients with no history of ART and no known resistance to either drug.

The approval came 6 months after ViiV submitted a new drug application for the regimen based on results from two phase 3 trials, GEMINI 1 and GEMINI 2, which showed it was noninferior to a standard three-drug regimen in treatment-naive patients.

In a news release announcing the FDA approval, ViiV CEO Deborah Waterhouse said the regimen gives patients the ability to treat their HIV infection “with as few drugs as possible.”

“People are now living longer with HIV and will spend a lifetime taking drugs to suppress their virus. The approval of the fixed-dose combination of dolutegravir and lamivudine, a complete, single-tablet, two-drug regimen, marks a pivotal moment in the treatment of HIV-1,” Pedro Cahn, MD, PhD, the principal investigator for the GEMINI trials, said in the release. “Treatment-naive people living with the virus have a powerful option that delivers noninferior efficacy to a dolutegravir-based three-drug regimen, allowing them to take fewer [antiretrovirals] and get and remain suppressed.”

The regimen is also under review in Europe, Canada, Australia and South Africa, ViiV said.

Disclosures: Waterhouse is employed by ViiV. Infectious Disease News was unable to confirm Cahn’s relevant financial disclosures at the time of publication.