FDA Approves Dolutegravir/Lamivudine for Use in Virologically-Suppressed Adults With HIV-1

By Jeff Craven /alert Contributor

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The FDA has approved dolutegravir/lamivudine (Dovato), a combination HIV drug, for use in place of antiretroviral therapy (ART) in patients with HIV-1 who have already achieved virologic suppression, according to a press release from ViiV Healthcare, the drug’s developer.

“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,” Lynn Baxter, of ViiV Healthcare, said in the release. 

“At ViiV Healthcare, we’ve proven that with [dolutegravir/lamivudine], adults living with HIV can reduce the number of ARVs they take every day without compromising efficacy or barrier to resistance,” she said. “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.”

Dovato is a single tablet containing dolutegravir (50 mg) and lamivudine (300 mg) taken once daily that is available to adults with HIV-1. In April of 2019, FDA approved dolutegravir/lamivudine as a treatment for HIV-1 in patients who were naïve to ART and did not have known “resistance to the individual components of [dolutegravir/lamivudine].” 

The expanded approval for dolutegravir/lamivudine was in response to results from the phase 3 TANGO study, where patients with HIV-1 on a regimen with tenofovir alafenamide fumarate (TAF) achieved HIV-1 RNA<50c/mL for a minimum of 6 months without virologic failure, hepatitis B infection, historical nucleoside reverse transcriptase inhibitors (NRTI) or integrase strand transfer inhibitor (INSTI) major resistance mutation. These patients then continued on the TAF regimen or switched to dolutegravir/lamivudine, and viral load was measured at 48 weeks. 

The results showed patients in TANGO maintained virologic suppression regardless of whether they received dolutegravir/lamivudine or continued on the TAF regimen. No patients in the dolutegravir/lamivudine group reached virologic failure, compared with less than 1% of patients who continued the TAF regimen.

“This expanded approval for [dolutegravir/lamivudine] 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,” Charlotte-Paige Rolle, MD, MPH, Director of Research Operations at Orlando Immunology Center, said in the release. “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 [dolutegravir/lamivudine] while maintaining similar efficacy with zero cases of treatment-emergent resistance through 48 weeks.”


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