FDA Approves Drug to Treat Infants and Children with HIV

On June 12, 2020, the U.S. Food and Drug Administration (FDA) approved Tivicay (dolutegravir) tablets and Tivicay PD (dolutegravir) tablets for suspension to treat HIV-1 infection in pediatric patients at least four weeks old and weighing at least 3 kg (6.61 pounds) in combination with other antiretroviral treatments.

“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, M.D., director of the Division of Antivirals in FDA’s Center for Drug Evaluation and Research. “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. Tivicay and Tivicay PD are taken once daily, which could help patients and caregivers better adhere to the regimen. Today’s approval gives our youngest HIV patients more options, helping them live longer, healthier lives.”

According to the U.S. Centers for Disease Control and Prevention, at the end of 2016, there were 2,238 children younger than 13 years old living with HIV in the U.S. and dependent areas, with 99 new HIV-1 infections diagnosed in this age group in 2017. Effective treatment is important in reducing the amount of virus in the blood.

Read the full FDA announcement.