The Food and Drug Administration (FDA) has approved Dovato (dolutegravir and lamivudine; Viiv Healthcare) as a complete regimen for the treatment of HIV-1 infection in treatment-naïve adults with no known or suspected substitutions associated with resistance to the individual components of Dovato.

Dovato combines dolutegravir, an HIV-1 integrase strand transfer inhibitor, and lamivudine, a nucleoside reverse transcriptase inhibitor, into a single tablet. “Currently, the standard of care for patients who have never been treated is a 3-drug regimen,” said Debra Birnkrant, MD, Director of the Division of Antiviral Products. “With this approval, patients who have never been treated have the option of taking a 2-drug regimen in a single tablet while eliminating additional toxicity and potential drug interactions from a third drug.”

The approval was based on data from the GEMINI 1 and 2 phase 3 studies (N=1433) in which treatment with Dovato was compared with another drug regimen (dolutegravir, emtricitabine, and tenofovir). Results showed that viral suppression rates (HIV-1 RNA <50 copies/mL) were found to be similar between the 2 treatment arms at Week 48. With regard to safety, the most common adverse reactions associated with Dovato treatment were headache, diarrhea, nausea, insomnia, and fatigue; in patients who experienced virologic failure, treatment-emergent resistance was not observed in either treatment arm.

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Dovato carries a Boxed Warning regarding patients co-infected with hepatitis B virus (HBV) and HIV-1. Prior to initiating treatment, patients should be tested for HBV infection. The emergence of HBV variants associated with resistance to lamivudine has been reported in HIV-1-infected patients who have received lamivudine-containing antiretroviral regimens in the presence of concurrent infection with HBV. In addition, severe exacerbations of HBV have been reported in patients co-infected with HIV-1 and HBV who have discontinued lamivudine.

Dovato is supplied in 50mg/300mg strength tablets.

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