The safety and efficacy of the glecaprevir and pibrentasvir in pediatric patients was evaluated during clinical trials of 47 patients with genotype 1, 2, 3 or 4 HCV infection without cirrhosis or with mild cirrhosis.
The FDA today approved AbbVie’s glecaprevir and pibrentasvir (Mavyret) tablet to treat all 6 genotypes of hepatitis C virus (HCV) in children ages 12 to 17 years.
This drug was previously approved, in 2017, to treat HCV in adults. It is now indicated for children and adults age 12 years and older or weighing at least 99 pounds, who are infected with any of 6 identified HCV genotypes, either without cirrhosis or with compensated cirrhosis.
“Direct-acting antiviral drugs reduce the amount of HCV in the body by preventing the virus from multiplying, and in most cases, they cure HCV infection,” said Jeffrey Murray, MD, MPH, deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, in a prepared statement. “Today’s approval represents another treatment option for children and adolescents with HCV infection, but for the first time, in all genotypes of HCV.”
The safety and efficacy of the glecaprevir and pibrentasvir in pediatric 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% of patients who received the combination tablet for 8 or 16 weeks had no virus detected in the blood 12 weeks after finishing treatment, suggesting that patients’ infection had been cured.
In pediatric patients with cirrhosis, history of a kidney and/or 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. The adverse reactions observed were consistent with those observed in clinical studies of this combination therapy in adults.
Treatment duration with glecaprevir and pibrentasvir differs depending on treatment history, viral genotype and cirrhosis status. The most common adverse reactions in patients taking this therapy were headache and fatigue. The drug is not recommended in patients with moderate cirrhosis and contraindicated in patients with severe cirrhosis. It is also contraindicated in patients taking the drugs atazanavir and rifampin.
According to the CDC, an estimated 2.7 to 3.9 million people in the U.S. have chronic HCV, and children born to HCV-positive mothers are at risk for HCV infection. It is estimated that there are 23,000 to 46,000 children in the U.S. with HCV infection.
FDA approves first treatment for all genotypes of hepatitis C in pediatric patients [news release]. Silver Spring, MD; April 30, 2019: FDA website. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-all-genotypes-hepatitis-c-pediatric-patients?utm_campaign=04302019_PR_FDA%20approves%20first%20treatment%20for%20all%20genotypes%20of%20hepatitis%20C%20in%20children&utm_medium=email&utm_source=Eloqua. Accessed April 30, 2019.