FDA Approves Expanded Indication for HIV Regimen Dolutegravir/Lamivudine

is a key issue for people living with HIV.

Now, the HIV medication Dovato, made up of antiretrovirals (ART) dolutegravir and lamivudine, has been approved by the US Food and Drug Administrtion (FDA) in an expanded indication.

Dovato can now be used as a complete regimen for treatment of HIV-1 infection to replace an existing ART regimen in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known resistance to the individual components of Dovato.

Dovato is 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 is free of tenofovir alafenamide fumarate (TAF), tenofovir disoproxil fumarate (TDF) and abacavir (ABC).

Dovato was initally 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.

The approval in adults who are virologically suppressed is based on Week 48 results from the phase 3 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.