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As part of an FDA-approved expansion of the pediatric indication, children 3 years and older can now receive Epclusa for the treatment of chronic hepatitis C virus regardless of HCV genotype or severity.
The FDA originally approved Epclusa (Sofosbuvir / Velpatasvir, Gilead Sciences) in 2016 for adults and in March 2020 for children aged 6 and over.
Source: Shuuterstock.com.
Gilead said the FDA has approved two strengths of an oral pellet – sofosbuvir 200 mg / velpatasvir 50 mg and sofosbuvir 150 mg / velpatasvir 37.5 mg – that are designed for younger children who cannot swallow tablets. The recommended dose in the younger age group is based on the child’s weight, the drug maker said.
A 12-week treatment course is approved for children without cirrhosis or with compensated cirrhosis (Child-Pugh Class A) and in combination with ribavirin for patients with decompensated cirrhosis (Child-Pugh Class B or C), Gilead said. According to Gilead, it is the only protease inhibitor-free, pangenotypic HCV regimen approved for use in patients 3 years and older.
The decision “marks an important step forward towards this goal by expanding more curative options for children with HCV,” said Gilead Chief Medical Officer Merdad Parsey, MD, PhDsaid in a press release. “This approval complements the solid clinical evidence supporting the safety and efficacy of Epclusa in a wide range of patients, including end-stage patients.”
Up to 60,500 children were living with HCV in the United States by 2018, and the incidence rates are rising, according to Gilead. Mother-to-child transmission, which is the leading cause of HCV in children, increased 161% from 2009 to 2017, the company said. Intravenous drug use is the leading cause of HCV in women of childbearing age.
The expanded approval is based on data from an open-label phase 2 clinical study in 41 children aged 3 to under 6 years treated with sofosbuvir / velpatasvir for 12 weeks
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Philip Rosenthal, MD
Philipp Rosenthal
This is wonderful news for those young children affected by HCV who can take Epclusa Therapy as early as 3 years of age. The two pellet formulations enable the appropriate weight-based dose to be achieved for the child.
Philip Rosenthal, MD
Professor of Pediatrics and Surgery
Director of Pediatric Hepatology
University of California, San Francisco
Disclosure: Rosenthal does not disclose any relevant financial information.
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