FDA expands approval for ViiV's Dovato to teens with HIV

2024-04-08

临床3期上市批准临床结果

ViiV Healthcare announced on Monday that the FDA approved Dovato (dolutegravir/lamivudine) for the treatment of certain adolescents with HIV-1 infection, making it the first oral, two-drug, single-tablet HIV regimen available for people as young as 12 years old.

Specifically, Dovato is now indicated for adolescents weighing at least 25kg with no prior antiretroviral (ARV) treatment or to replace the current ARV regimen in individuals who are virologically suppressed on an ARV regimen.

The broader indication provides "a complete HIV therapy with fewer ARV medicines – an important consideration for young people who will require lifelong treatment," said Lynn Baxter, who heads ViiV's North America operations.

The label expansion was supported by data from the DANCE study, which evaluated Dovato in treatment-naïve adolescents as well as three Phase III trials in adults with HIV, GEMINI-1, GEMINI-2 and TANGO. Results from the DANCE study showed that 26 of 30 participants achieved and maintained viral suppression at week 48, with safety and efficacy data comparable to those seen in adults.

Dovato was initially approved in the US in 2019 for adults with treatment-naïve HIV. The drug also gained FDA approval the following year for use in virologcally suppressed adults with HIV.

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