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Approval of two Hepatitis C treatments for children aged 3 years or older

11 June 2021
By: Liz Highleyman

On June 10, 2021, the US Food and Drug Administration (FDA) extended its approval for Epclusa (sofosbuvir/velpatasvir) and Mavyret (glecaprevir/pibrentasvir) for the treatment of hepatitis C in children 3 years of age and older. Both combinations are effective against all genotypes of hepatitis C virus (HCV).
Hepatitis C is rare in children, affecting approximately 50,000 children in the United States and approximately 3 to 5 million children worldwide, but the increase in hepatitis C infection among women of childbearing age raises concerns about the increasing number of hepatitis C infections in children. Pregnant women can pass HCV to their babies during pregnancy or childbirth, and experts recommend that pregnant women be tested at every pregnancy. Most children born with HCV will develop a chronic infection, which can lead to serious liver disease.
The FDA first approved Gilead Sciences’ Epclusa (sofosbuvir/velpatasvir) for adults in 2016 and expanded the indication to children 6 years of age and older in 2020. Now, 12 weeks of treatment is approved for pediatric patients 3 years of age and older, without cirrhosis or with compensatory cirrhosis; those with decompensated cirrhosis can take Epclusa (sofosbuvir/velpatasvir) in combination with ribavirin. Recent approval uses an oral pellet formulation of Epclusa (sofosbuvir/velpatasvir) developed for young children who is unable to swallow tablets; The recommended dosage is based on body weight.
The approval was based on findings from a Phase II clinical trial that included 41 children aged 3 to 6 years treated with Epclusa for 12 weeks. Overall, 83% achieved a sustained virological response (SVR), or remained undetectable with HCV after treatment was completed. SVR rates were 100% for three children with HCV genotype 3 or 4, 88% (28 of 32 children) for children with genotype 1 and 50% (three out of six children) for those with genotype 2. who do not recover discontinue treatment early.
The FDA first approved AbbVie’s Mavyret (glecaprevir/pibrentasvir) for adults in 2017 and expanded the indications to children 12 years of age and older in 2019. The new approval is for pediatric patients 3 years of age and older without cirrhosis or with compensated cirrhosis. . Mavyret (glecaprevir/pibrentasvir) is also now available in an oral pellet formulation.
This approval is supported by the results of the Phase II/III DORA 2 trial, in which 62 children aged 3 to 12 years without cirrhosis were treated with Mavyret (glecaprevir/pibrentasvir) for 8, 12 or 16 weeks, depending on HCV genotype and previous treatment history. The overall cure rate was 98%; one child who did not achieve an SVR discontinued treatment early. The approved duration is eight weeks for children taking the treatment for the first time.
Both Epclusa (sofosbuvir/velpatasvir) and Mavyret (glecaprevir/pibrentasvir) were safe and well tolerated in pediatric trials, and side effects were generally similar to those seen in adults. In the Epclusa study, 15% of participants had vomiting, and 10% vomited the drug. In Mavyret’s trial, 8% experienced a side effect of vomiting, 4% had upper abdominal pain and 4% had rashes and rashes were more common in children than adults.

Source: FDA Approves Two Hepatitis C Treatments for Younger Children https://www.poz.com/article/fda-approves-two-hepatitis-treatments-younger-children

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