FDA Approves HIV Drug for Use in Infants and Children

The US Food and Drug Administration (FDA) approved Tivicay (dolutegravir) tablets and Tivicay PD (dolutegravir) tablets for suspension for the treatment of HIV-1 infection in conjunction with other antiretroviral therapies among children aged at least 4 weeks who weigh at least 3 kg.

Tivicay and Tivicay PD are intended for patients who are treatment-naïve or who have received treatment previously, but not with a drug belonging to the integrase strand transferase inhibitor class.

“For babies and young children with HIV, getting treatment early is very important. HIV can progress more quickly in children than adults,” said Debra Birnkrant, MD, director of the Division of Antivirals in FDA’s Center for Drug Evaluation and Research, in a press release.

“While the incidence of pediatric HIV infections continues to decline, the availability and early initiation of effective treatment are critical for infants and children living with HIV,” Dr Birnkrant added.

Insomnia, fatigue, and headache were the most common adverse reactions observed in adults who received Tivicay.

—Christina Vogt

FDA approves drug to treat infants and children with HIV. US Food and Drug Administration. News release. June 12, 2020.