The approval will enable ViiV Healthcare to use the complete regimen as a replacement for 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.
Dovato, a complete, once-daily, single-tablet, two-drug regimen of dolutegravir (DTG) 50mg and lamivudine (3TC) 300mg, enables adults living with HIV to manage their virus without a third ARV.
Dolutegravir is an integrase strand transfer inhibitor (INSTI), which can be used in combination with other antiretroviral agents to treat HIV-1.
The current approval is based on the week 48 results from the phase III TANGO study, which shown adults living with HIV-1were able to maintain similar rates of virologic suppression after switching to Dovato, compared with those who continued the original regimen.
TANGO is a phase III, randomised, open-label, active-controlled and multicentre study to evaluate the antiviral efficacy and safety of switching to a two-drug regimen consisting of DTG/3TC in HIV-infected adults who are virologically suppressed and on a stable antiretroviral regimen with no treatment failure.
Free from tenofovir alafenamide fumarate (TAF), tenofovir disoproxil fumarate (TDF) and abacavir (ABC), Dovato secured first FDA approval in April 2019 as a complete regimen to treat HIV-1 infection in adults with no ARV treatment history and with no known resistance to the individual components of the drug.
Dovato already secured approval from the European Medicines Agency and additional regulatory authorities to treat HIV-1 in treatment-naïve and virologically suppressed adults. It is approved in over 100 countries across North America, Europe, Asia, Africa and Latin America.
ViiV Healthcare North America head Lynn Baxter said: “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.
“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.”
In July this year, ViiV Healthcare secured approval from the FDA for its Rukobia (fostemsavir) 600mg extended-release tablets to treat HIV in adult patients.