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APRIL 8, 2024

FDA Grants New Indication for Dovato to Treat Adolescents 12 and Older


Originally published by our sister publication Infectious Disease Special Edition

The FDA granted a new indication for dolutegravir-lamivudine (DTG-3TC; Dovato, ViiV Healthcare) to treat HIV-1 infection in adolescents 12 years of age and older and weighing at least 25 kg.

DTG-3TC can be given to adolescents 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