The unique formulation is a dispersible tablet for children.
FDA cleared a unique pediatric HIV-1 medication in dispersible tablet formulation.
Dolutegravir (Tivicay PD, ViiV Healthcare) tablets for oral suspension are used in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in pediatric patients.
“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, in a press 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.”
Patients taking the drug must be treatment-naïve (or -experienced but INSTI- naïve), at least 4 weeks old, and weigh at least 3 kg. Viiv also received an extended indication to expand the use of the already approved Tivicay 50 mg film-coated tablet in paediatric HIV patients weighing 20 kg and above.
Tivicay is the first integrase inhibitor available as a dispersible tablet for oral suspension for children as young as 4 weeks of age and weighing at least 3 kg, Viiv said in a press release. Prior to this, dolutegravir was indicated in the US for children from 6 years of age and weighing more than 30 kg.
“This step will expand the use of dolutegravir by providing an age-appropriate formulation to a younger population and will help to close the gap between HIV treatment options available for adults and children,” ViiV said.
“I am delighted that our innovative approach to science has enabled us to achieve FDA approval of the first-ever dispersible tablet formulation of dolutegravir, now making it easier for young children to take this medication by dispersing the tablet in water,” ViiV CEO Deborah Waterhouse said. "The development and availability of age-appropriate formulations is essential in ensuring children have access to life-saving HIV treatments from an early age and as they grow.”
There are 1.7 million children living with HIV1, and the majority of AIDS-related deaths among children still occur during the first 5 years of life, ViiV said. “Major obstacles persist for children, such as continued mother-to-child transmission, the availability of HIV testing, slow initiation of treatment and poor availability of optimised paediatric formulations of antiretrovirals,” the pharma maker said.
The safety and effectiveness of Tivicay and Tivicay PD were supported by a trial that included 75 HIV-1–infected infants, children and adolescents 4 weeks to less than 18 years old. At 24 weeks, 62% 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% had an undetectable viral load, FDA said.
Also, on average, study subjects had higher levels of certain cells (CD4 cells) that help the body fight off infection.