ViiV Healthcare Receives FDA Approval for Drug to Treat Adults with HIV-1

August 8, 2020

Dovato lets adults with HIV reduce the number of antiretroviral therapies they take, while maintaining efficacy and a high barrier to resistance comparable to tenofovir-based regimens.

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, recently announced the US Food and Drug Administration (FDA) approved Dovato (dolutegravir/lamivudine) as a complete regimen for the treatment of HIV-1 infection to replace the current antiretroviral (ARV) regimen in adults who are virologically suppressed on a stable ARV regimen with no history of treatment failure and no known resistance to the individual components of Dovato.

According to a release, Dovato, a complete, once-daily, single-tablet, two-drug regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg, allows adults living with HIV the option to manage their virus without a third ARV. It's free of tenofovir alafenamide fumarate (TAF), tenofovir disoproxil fumarate (TDF) and abacavir (ABC). The drug was first approved by the FDA in April 2019 as a complete regimen for the treatment of HIV-1 infection in adults with no ARV treatment history and with no known resistance to the individual components of Dovato.

“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, head of North America, ViiV Healthcare, said. "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, the release said.

No participants on Dovato and one participant 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.

“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," Charlotte-Paige Rolle, director of Research Operations, Orlando Immunology Center, said. "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 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.