June 11, 2021 • By Liz Highleyman hep magazine
On June 10, the Food and Drug Administration (FDA) extended its approval of Epclusa (sofosbuvir/velpatasvir) and Mavyret (glecaprevir/pibrentasvir) for the treatment of hepatitis C in children ages 3 and older. Both combination pills are effective against all genotypes of hepatitis C virus (HCV).
Hepatitis C is uncommon among children, affecting an estimated 50,000 kids in the United States and some 3 to 5 million children worldwide, but it is a growing concern due to rising hep C rates among women of childbearing age. Pregnant women can transmit HCV to their infants during gestation or delivery, and experts recommend that they should be tested for the virus during each pregnancy. Most children born with HCV will develop chronic infection, which can lead to serious liver disease.
The FDA first approved Gilead Sciences’ Epclusa for adults in 2016 and extended the indication to children ages 6 and older in 2020. Now, the 12-week treatment is approved for pediatric patients ages 3 and up without cirrhosis or with compensated cirrhosis; those with decompensated cirrhosis can take Epclusa in combination with ribavirin. The latest approval covers two strengths of an oral pellet formulation of Epclusa developed for young children who can’t swallow tablets; the recommended dosage is based on body weight.
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