FDA Approves First Pan-Genotypic Hepatitis C Therapy for Pediatric Patients with 100% Cure Rate

Recently, the FDA approved AbbVie’s Mavyret (glecaprevir and pibrentasvir) for an expanded indication to treat hepatitis C virus (HCV) infection across all six genotypes in pediatric patients aged 12 to 17 years. Mavyret was initially approved in 2017 for the treatment of HCV infection in adult patients.

Hepatitis C is a viral infection that causes inflammation of the liver and impaired liver function, potentially progressing to liver failure. In the United States, approximately 2.7 to 3.9 million people are affected by chronic hepatitis C. Mothers who are HCV-positive may transmit the virus to their newborns. Statistics indicate that between 23,000 and 46,000 children in the United States are infected with HCV.

Mavyret consists of two direct-acting antiviral agents: glecaprevir, which inhibits HCV NS3/4A protease activity and plays a critical role in the cleavage of the HCV-encoded polyprotein and viral replication; and pibrentasvir, which inhibits HCV NS5A activity and is essential for viral RNA replication and virion assembly.

This approval is based on the performance of Mavyret in a clinical trial involving 47 pediatric patients infected with hepatitis C virus (HCV) genotype 1, 2, 3, or 4, who had no cirrhosis or only mild cirrhosis. The trial results demonstrated that 100% of treated patients achieved undetectable viral levels in their blood 12 weeks after completion of therapy, indicating cure of the infection. The side effects observed in pediatric patients were comparable to those observed in adult clinical trials.

“Direct-acting antivirals prevent viral replication, thereby reducing the amount of HCV in the body and, in most cases, achieving a cure for HCV infection,” said Dr. Jeffrey Murray, Deputy Director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval provides a new treatment option for adolescents infected with HCV. This treatment is the first to target all genotypes of HCV.”

References:

[1] FDA approves first treatment for all genotypes of hepatitis C in pediatric patients. Retrieved April 30, 2019, from https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-all-genotypes-hepatitis-c-pediatric-patients

Source: WuXi AppTec