Glecaprevir and pibrentasvir combo pill for HCV in childrenJuly 5, 2019
Glecaprevir and pibrentasvir tablets (Mavyret) has been granted USFDA approval to treat all six genotypes of hepatitis C virus (HCV) in children ages 12 to 17.
The drug combo was approved to treat HCV in adults in 2017.
The safety and efficacy of the pill in paediatric patients was evaluated during clinical trials of 47 patients with genotype 1, 2, 3 or 4 HCV infection without cirrhosis or with mild cirrhosis. Results of the trials demonstrated that 100 percent of patients who received the drug for eight or 16 weeks had no virus detected in the blood 12 weeks after finishing treatment, suggesting that patients’ infection had been cured.
In paediatric patients with cirrhosis, history of a kidney and liver transplant, or genotype 5 or 6 HCV infection, the safety and efficacy of the drug are supported by previous studies observed in glecaprevir and pibrentasvir in adults.
Treatment duration differs depending on treatment history, viral genotype and cirrhosis status, AbbVie said.