FDA Approves Dolutegravir for Infants, Children with HIV

The FDA has approved dolutegravir tablets (Tivicay and Tivicay PD, ViiV Healthcare) for suspension to treat HIV-1 infection in pediatric patients at least 4 weeks old and weighing at least 6.61 pounds in combination with other antiretroviral treatments.

Dolutegravir tablets are intended to treat pediatric patients at least 4 weeks old and at least 6 pounds who have never been treated for HIV or who have been treated, but not with an integrase strand transferase inhibitor class drug, according to the press release.

The approval is supported from a dolutegravir trial that included 75 HIV-1-infected infants, children, and adolescents 4 weeks to less than 18 years of age, with an average age of 27 months old. The safety and efficacy of dolutegravir was comparable to adults taking dolutegravir.

At 24 weeks, 62% of pediatric patients taking dolutegravir had an undetectable viral load, while at 48 weeks, 69% had an undetectable viral load. On average, study subjects had higher levels of CD4 cells that help the body fight off infection, according to the press release.

The most common adverse reactions observed in adult patients treated with dolutegravir are insomnia, fatigue, and headache. Patients with a hypersensitivity to dolutegravir should not take dolutegravir tablets, and the tablets should not be administered with dofetilide.

REFERENCE

FDA approves drug to treat infants and children with HIV. FDA. https://www.fda.gov/news-events/press-announcements/fda-approves-drug-treat-infants-and-children-hiv?utm_campaign=FDA%20Approves%20Drug%20to%20Treat%20Infants%20and%20Children%20with%20HIV&utm_medium=email&utm_source=Eloqua. Published June 12, 2020. Accessed June 15, 2020.