FDA approves Gilead Epclusa for use in fullgenotype HCV children

On March 19, the FDA announced the approval of gilead Epcuvir (sofosbuvir/velpatasvir, sophobuvir,sophobuvir/vipatavir) for the treatment of six genotypes (GT-1,-2,-3, -4,-5,-6) of HCV-infected children (no liver or mild liver)Epclusa is the world's first all-oral, generic, single tablet of hepatitis C treatment, once a day, and can be used in 6 genotype hepatitis C patientsThe drug is made up of Gilead's listed hepatitis C star drug, sofosbuvir, and the antiviral drug velpatasvirPreviously, the FDA has approved Epclusa for the treatment of HCV adult patients, and Epclusa in combination with ribavirin for treatment of patients with severe cirrhosis aged 6 and over or at least 17 kgThis approval makes Epclusa the first FDA-approved treatment for generic, protease-free inhibitors available in adults and childrentreatment options are limited for HCV patients under 12 years of age, especially those with genotypes 2 and 3"This approval will provide more treatment options for children and adolescents with HCVDrDebra Birnkrant, head of the antiviral drug division at the FDA's Drug Assessment and Research Center, saidthis approval is based on data from a Phase II study, an open label study of children with HCV genotypes 1, 2, 3, 4, and 6, which recruited 173 untreated or treated pediatric patients 6 years of age and older without or mild liver cirrhosis for 12 weeksThe results showed that 12 weeks after completion of treatment, 93% of patients aged 12-17 and 100% of patients with genotype 2, 3, 4 and 6 had no detectable virus in the blood, indicating that the patient had been cured; The most common adverse reactions observed instudies were fatigue and headache, consistent with the results observed by Epclusa in adult clinical trialsis worth noting that Epclusa has a black-box warning that if you are infected with both hepatitis B and C, if you do not take HBV antiviral drugs, taking the drug may cause the activation of the hepatitis B virusREACTIVATION OF HBV CAN LEAD TO SUDDEN HEPATITIS, KIDNEY FAILURE AND EVEN DEATHHealth care providers are advised to test all patients before using Epclusa treatment to check for evidence of current or previous HBV infection, and to check for the activation of HBV during treatmentCurrently, applications for epclusa use in patients under 6 years of age are being reviewed by the European Medicines Agencyreference source: 1, FDA Approves New Treatment for Pediatrics Patient Spaediatrics Any Strain of Of Phyitis C 2, FDA Clears Gilead's S Hepatitis C drug Epclusa for use