FDA approves Dovato for teens living with HIV

The U.S. Food and Drug Administration has approved Dovato (dolutegravir/lamivudine) for adolescents living with HIV.

The approval is for the treatment of HIV-1 infection in adolescents aged 12 years and older (weighing ≥25 kg) with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <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.

The approval is based on data from the DANCE study, which evaluated Dovato in treatment-naive adolescents, as well as evidence from well-controlled trials in adults living with HIV, GEMINI-1 and GEMINI-2 (treatment-naive adults), and TANGO (treatment-experienced adults).

The DANCE study demonstrated that 26 of 30 participants achieved and maintained viral suppression at week 48, with safety and efficacy in adolescents comparable to that seen in adults.

"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," Lynn Baxter, head of North America at ViiV Healthcare, said in a statement.

Approval of Dovato was granted to ViiV Healthcare.