The Food and Drug Administration (FDA) has expanded Dovato’s approval to include virologically suppressed adults with HIV.
The medication is a complete, once-daily, single-tablet, two-drug treatment consisting of 50 mg of dolutegravir and 300 mg of lamivudine. It does not contain tenofovir alafenamide fumarate (TAF), tenofovir disoproxil fumarate (TDF) or abacavir.
Lynn Baxter, head of ViiV Healthcare North America, said “with Dovato, adults living with HIV can reduce the number of ARVs they take every day without compromising efficacy or barrier to resistance.”
Baxter said Dovato’s approval was based on week 48 results from a phase III study. The study found that adults living with HIV-1 who maintained virologic suppression for at least six months while taking TAF and at least two other antivirals maintained similar virologic suppression rates after switching to a Dovato regimen, compared with people who kept taking their original regimen. Those who switched to Dovato saw safety results consistent with dolutegravir and lamivudine’s product labeling.
The HIV-1 infected study participants were on a regimen containing TAF with HIV-1 RNA<50c/mL for at least six months. They had no prior virologic failure, no historical integrase strand transfer inhibitor or nucleoside reverse transcriptase inhibitor major resistance mutation and no evidence of infection with hepatitis B. They were randomized to stay on their original regimen or switch to Dovato and the primary endpoint was the proportion of participants with a >50 c/mL viral load at week 48.
“The approval of Dovato as a treatment option for virologically suppressed patients living with HIV provides clinicians with the ability to offer a switch to a single-tablet regimen containing fewer antiretrovirals – allowing these patients the opportunity to reduce the number of medications they take every day while still maintaining durable viral suppression,” said Dr. Charlotte-Paige Rolle, director of research operations.at Orlando Immunology Center. “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.”
Treatment of existing HIV infection with TDF was linked by a 2010 study to decreased bone density and osteoporosis. A 2018 study linked treatment of existing HIV infection with TDF with kidney damage and renal failure.