ViiV Healthcare Submits Supplemental New Drug Application to US FDA for Use of Dovato in Virologically Suppressed Adults with HIV-1

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced the submission of a supplemental New Drug Application to the US Food and Drug Administration (FDA) for Dovato (dolutegravir and lamivudine) as a switch treatment for HIV-1 infection in virologically suppressed adults on a stable antiretroviral regimen with no treatment failure. In the US, Dovato is currently approved as a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for the treatment of HIV-1 infection in adults with no antiretroviral treatment history and with no known resistance to either DTG or 3TC.

The filing is based on the results from the phase III TANGO study, which demonstrated adults living with HIV-1, who had maintained virologic suppression for at least six months on a tenofovir alafenamide fumarate (TAF)-containing regimen of at least three drugs, were able to maintain similar rates of virologic suppression after switching to the two-drug regimen (2DR) Dovato, compared to those who continued the TAF-containing regimen. The safety results for those who switched to Dovato were consistent with the product labeling for DTG and 3TC.1

Kimberly Smith, M.D., Head of Research & Development at ViiV Healthcare, said: “The TANGO study shows virologically suppressed adults with HIV-1 looking to switch their treatment can get the efficacy of a three-drug TAF-containing regimen with Dovato, a two-drug regimen. Today’s submission takes us a step closer toward offering this option for virologically suppressed adults living with HIV who are looking to treat HIV with fewer drugs.”