The FDA on Monday announced the approval of ViiV Healthcare's Dovato (dolutegravir/lamivudine) for use in adults with HIV-1 infection with no prior history of antiretroviral therapy and no known resistance to the individual components of the drug, becoming the first two-drug regimen cleared in the US for HIV-infected adults with no prior history of treatment. Debra Birnkrant, director of the agency's Division of Antiviral Products, stated "having a drug-sparing treatment available that uses fewer drugs is beneficial to patients who may have issues taking multiple medications over a long period of time."
The approval was backed by safety and efficacy results from the GEMINI 1 and GEMINI 2 studies involving 1433 HIV-infected adults. In the Phase III trials, the results of which were unveiled in July 2018, Dovato had similar efficacy as the three-drug combination of ViiV's Tivicay (dolutegravir) and Gilead Sciences' Truvada (tenofovir disoproxil fumarate/emtricitabine) in treatment-naïve adults with HIV-1.
ViiV submitted Dovato for approval in Europe for the same indication last September. The drugmaker, which is majorly owned by GlaxoSmithKline with Pfizer and Shionogi as shareholders, said the treatment is also under review in Australia, Canada and South Africa, with several submissions additionally planned for this year.
According to the FDA, the therapy labeling includes a boxed warning, which says that "patients infected with both HIV and hepatitis B should add additional treatment for their hepatitis B or consider a different drug regimen."
Meanwhile, Tivicay has also been approved as part of a two-drug combination in the US and EU with Johnson & Johnson's non-nucleoside reverse transcriptase inhibitor Edurant (rilpivirine) under the name Juluca.
For related analysis, ViewPoints: ViiV's approval kicks off the latest battle in Gilead's HIV war.
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