FDA approves drug to treat HIV-1 infection in pediatric patients

June 15, 2020

The U.S. Food and Drug Administration 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 6.61 pounds in combination with other antiretroviral treatments, the agency said in a press release.

“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.

Effective treatment is important in reducing the amount of virus in the blood. 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, according to the U.S. Centers for Disease Control and Prevention CDC).

Tivicay and Tivicay PD are intended to treat pediatric patients at least 4 weeks old and 3 kg (6.61 pounds) who have never been treated for HIV or who have been treated, but not with an integrase strand transferase inhibitor (INSTI) class drug.

A trial of Tivicay and Tivicay PD included 75 HIV-1-infected infants, children and adolescents between 4 weeks and less than 18 years old. The average age was 27 months old. This trial, where both the researchers and subjects knew which treatment was being administered, along with another trial, showed that the safety, effectiveness and pharmacokinetics of Tivicay and Tivicay PD in pediatric patients was comparable to adults taking dolutegravir. At 24 weeks, 62 percent of pediatric patients taking Tivicay or Tivicay PD had an undetectable viral load (the presence of virus in the blood) and at 48 weeks, 69 percent had an undetectable viral load. Also, on average, study subjects had higher levels of certain cells (CD4 cells) that help the body fight off infection.

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