The FDA approved an expanded indication of ViiV Healthcare’s Dovato (dolutegravir/lamivudine), a complete two-drug regimen for virologically suppressed adults with HIV-1 with no history of treatment failure or resistance to Dovato’s components. 

Originally approved for treatment-naïve adults living with HIV, Dovato is now available for appropriate virologically suppressed adults living with HIV who may be looking to switch treatments to reduce the number of ARV therapies they take without compromising efficacy or barrier to resistance.

Lynn Baxter, Head of North America, ViiV Healthcare, said: “As HIV treatment and care progress, people living with HIV will be on medication for decades and need solutions to challenges that may arise from prolonged use of ARV therapy. At ViiV Healthcare, we’ve proven that with Dovato, adults living with HIV can reduce the number of ARVs they take every day without compromising efficacy or barrier to resistance. This remarkable, innovative approach challenges the notion that three or more drugs are needed to maintain virologic suppression, and today’s FDA approval brings this switch treatment option to virologically suppressed adults living with HIV.”

The approval of Dovato in adults who are virologically suppressed is based on the Week 48 results from the phase III TANGO study. This study demonstrated adults living with HIV-1, who had maintained virologic suppression for at least six months on a TAF-containing regimen of at least three drugs, were able to maintain similar rates of virologic suppression after switching to Dovato, compared with those who continued the original regimen. No participants on Dovato and one participant (<1%) on the TAF-containing regimen met confirmed virologic failure criteria, with no resistance mutations observed at failure. The safety results for those who switched to Dovato were consistent with the product labeling for dolutegravir and lamivudine.

Dr. Charlotte-Paige Rolle, Director of Research Operations, Orlando Immunology Center, said: “This expanded approval for Dovato is particularly important for my virologically suppressed patients living with HIV who are seeking a new option that can reduce the number of drugs they are exposed to each day. The data supporting the approval demonstrates how virologically suppressed adults with no known resistance to dolutegravir or lamivudine were able to switch from a TAF-containing regimen of at least three drugs to Dovato while maintaining similar efficacy with zero cases of treatment-emergent resistance through 48 weeks.”

Dovato is approved for the treatment of HIV-1 in treatment-naïve and virologically suppressed adults by the European Medicines Agency and additional regulatory authorities around the world. In 2019, the Adult and Adolescent Antiretroviral Treatment Guidelines from the Department of Health and Human Services (DHHS) included Dovato in the list of Recommend Initial Regimens for Most People with HIV, the first time a complete two-drug regimen has been recommended by the DHHS in the first-line setting (except in individuals with HIV RNA >500,000 copies/ml, HBV co-infection, or in whom ART is to be started before the results of the HIV genotypic resistance testing for RT or HBV testing are available).

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