FDA approves dispersible tablet formulation of Tivicay for HIV in infants, children
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The FDA has approved dolutegravir tablets and dolutegravir tablets for oral suspension to treat HIV infection, in combination with other antiretroviral agents, among pediatric patients at least 4 weeks old and weighing 3 kg or more, according to 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,” Debra Birnkrant, MD, director of the division of antivirals in the FDA’s Center for Drug Evaluation and Research, said in the 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.”
The approval of the dolutegravir tablets (Tivicay; ViiV Healthcare) and dolutegravir tablets for oral suspension (Tivicay PD; ViiV Healthcare) is supported by data from a trial of 75 infants, children and adolescents aged 4 weeks to less than 18 years old with HIV, according to the release. At 24 weeks, 62% of pediatric patients treated with either tablet formulation had an undetectable viral load, and 69% had an undetectable viral load at 48 weeks, the FDA reported. The safety profile in pediatric patients was similar to that of adult patients.
“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.” Birnkrant said.
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