The Food and Drug Administration (FDA) has expanded the approval of Zepatier (elbasvir and grazoprevir) to include patients 12 years of age and older or weighing at least 30kg with chronic hepatitis C virus (HCV) genotype 1 or 4 infection. Previously, the treatment was approved only for adults.
Zepatier is a fixed-dose combination product containing elbasvir, an HCV NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor.
The approval was based on data from an open-label phase 2b clinical study (ClinicalTrials.gov Identifier: NCT03379506), which evaluated the efficacy, safety, and pharmacokinetics of Zepatier 50mg/100mg in 22 patients aged 12 to less than 18 years with chronic HCV genotype 1 (n=21) or 4 (n=1) infection without cirrhosis. The median age of study participants was 13.5 years; 64% were treatment-naïve and 46% had baseline HCV RNA levels greater than 800,000 IU/mL.
Results showed that all patients met the primary endpoint achieving sustained virologic response, defined as HCV RNA less than the lower limit of quantification at 12 weeks after cessation of treatment.
The safety profile of Zepatier was consistent with that observed in adults. The most common adverse reactions were headache and nausea.
Zepatier is supplied as 50mg/100mg strength tablets.
Zepatier. Package insert. Merck Sharp & Dohme Corp.; 2021. Accessed December 13, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208261s007lbl.pdf.