FDA Approves Dolutegravir Tablets for Oral Suspension for Children With HIV

Officials with the FDA have approved dolutegravir (Tivicay PD, ViiV Healthcare) dispersible tablets for oral suspension for children who are at least 4 weeks of age and weigh at least 3 kg, according to a press release.

This approval marks the first ever dispersible tablet formulation of dolutegravir, which are used in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients. Additionally, the approval also expands dolutegravir’s indication for the existing 50-mg film-coated tablets (Tivicay) for use in children weighing 20 kg and above.

The treatment is administered by dispersing the tablet in water and addresses both dosing and administration needs ensuring children have access to essential HIV treatments.

Previously, dolutegravir was indicated for use in pediatric patients from 6 years of age and weighing more than 30 kg.

The new approval is based on data from the ongoing P1093 and ODYSSEY (PENTA20) studies. P1093 is a safety, tolerability, and dose-finding registrational study in pediatric patients ages 4 weeks to 18 years being conducted by the IMPAACT network in the United States, Brazil, Thailand, South Africa, Zimbabwe, Kenya, and Tanzania. The ODYSSEY trial is a randomized control efficacy study in first- and second-line treatment in pediatric patients ages 4 weeks to 18 years being conducted by the PENTA network in Europe, South America, Thailand, Uganda, Zimbabwe, and South Africa. The study will now also provide data to support revised dosing and continue to 96 weeks, according to ViiV.

“Children are often forgotten in the global fight to end HIV/AIDS and face a unique set of challenges, particularly when HIV medication and treatments are often hard to swallow or tolerate,” Chip Lyons, president and CEO of the Elizabeth Glaser Pediatric AIDS Foundation, said in a statement. “Barriers like these have resulted in only half of the 1.7 million children living with HIV accessing the lifesaving treatment they need–and even fewer still reaching viral suppression. Families affected by HIV will benefit from ViiV Healthcare’s development of child-friendly formulations that aim to close the gap between treatment options available for adults and children. This tailored approach to pediatric treatment of HIV will help meet the urgent needs of this vulnerable population.”

References:

1. ViiV Healthcare announces US FDA approval of the first-ever dispersible tablet formulation of dolutegravir, Tivicay PD, a once-daily treatment for children living with HIV. ViiV Healthcare. News Release; June 12, 2020. Accessed June 12, 2020. https://viivhealthcare.com/en-us/us-news/us-articles/2020/viiv-healthcare-announces-us-fda-approval-of-the-first-ever-disp/.