FDA Approves Dolutegravir Tablets for Pediatric HIV

The US Food and Drug Administration (FDA) has approved dolutegravir tablets (Tivicay) and tablets for suspension (Tivicay PD) for the treatment of HIV-1 infection in pediatric patients.

The indication, granted to ViiV Healthcare, allows for the administration of dolutegravir to patients as young as 4 weeks old, and as light as 3 kg (6.61 lbs) in combination with other antiretroviral therapy.

There was more than 2200 children younger than 13 years old in the US living with HIV at the end of 2016, according to the US Centers for Disease Control and Prevention (CDC). Another 99 new HIV-1 infections were diagnosed in this age group in the next year.

Patients eligible for the therapy have not been treated for their HIV—or at least not with an integrase strand transferase inhibitor (INSTI) class drug.

The efficacy and safety of dolutegravir in pediatric patients was evidenced by a trial including 75 infected infants, children, and adolescents aged 4 weeks to 18 years old. Mean patient age was 27 months. Both patients and investigators were informed of which therapy they were being administered in the trial.

At 24 weeks, 62% of pediatric patients taking dolutegravir had an undetectable viral load; by 48 weeks, the rate reached 69% of treated patients. Patients also reported an increased mean CD4 cell count.

Commonly observed adverse reactions among adult patients treated with dolutegravir—of whom pediatrics report similar safety and tolerability outcomes—include insomnia, fatigue, and headaches.

Debra Birnkrant, MD, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, advocated for early, effective treatment options for pediatric HIV—an infection which can progress more quickly than in adult cases.

"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,” Birnkrant explained. “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."

The pediatric application was previously granted Priority Review by the FDA, indicating its value in significantly improving the safety or effectiveness or treating a serious condition.