FDA Approves Dolutegravir/Lamivudine For Adolescents With HIV-1 Infection

Pharmacy Times (4/8, McGovern) reports, “The FDA has approved dolutegravir/lamivudine (Dovato; ViiV Healthcare) for the treatment of HIV-1 infection in adolescents.” The new indication is for teens “who are 12 years of age or older that weigh at least 25 kg who have no previous treatment history of antiretroviral (ARV), or for patients who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) with no history of treatment failure and who are on a stable ARV regimen looking to replace the current regimen.” In a late-stage trial in this population, “26 of the 30 participants who completed the study achieved and maintained viral suppression at week 48.”