FDA approval of Dovato (dolutegravir/lamivudine) for adolescents living with HIV – ViiV Healthcare

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, announced the FDA approved Dovato (dolutegravir/lamivudine) for the treatment of HIV-1 infection in adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Dovato.

In the U.S., 20 percent of new HIV diagnoses in 2020 were among young people aged 13-24.2 This expanded indication marks the first time an oral, two-drug, single-tablet regimen is available for adolescents between 12- and 18-years old living with HIV and underscores ViiV Healthcare’s ongoing commitment to bringing more therapeutic options to young people.

Lynn Baxter, Head of North America at ViiV Healthcare, said: “This expanded indication for Dovato brings an oral, two-drug, single-tablet regimen to adolescents living with HIV, providing a complete HIV therapy with fewer ARV medicines – an important consideration for young people who will require lifelong treatment. As a leader in HIV, ViiV Healthcare is proud of our focused efforts to improve and expand care for children and adolescents and we remain committed to addressing the existing treatment gaps in these communities.”

The US approval is supported by data from the DANCE study which evaluated Dovato in treatment-naïve adolescents as well as evidence from well-controlled trials in adults living with HIV, GEMINI-1 and GEMINI-2 (treatment-naïve adults) and TANGO (treatment-experienced adults). Results from the DANCE study, which included adolescents between 12- and 18-years old weighing at least 25 kg with HIV-1 RNA 1000 to less than 500,000 c/mL, showed that 26/30 participants achieved and maintained viral suppression at Week 48. The safety and efficacy data in adolescents from the DANCE study were comparable to those observed in adults. Exposures for components of Dovato were higher but were not clinically significant.