The US FDA approved the supplementary application of Gilead ’s third-generation hepatitis C drug Sofosbuvir / Vipatavir (Epclusa) for the treatment of age ≥6 years or weight ≥17 kg, without cirrhosis (liver disease) or only mild Children with chronic hepatitis C of genotype 1-6 with severe cirrhosis. At the same time, Bong Tong Sha combined with ribavirin is used to treat pediatric patients with severe liver cirrhosis aged ≥6 years or weighing ≥17 kg.
Dr. Debra Birnkrant, Director of the Antiviral Division of the FDA's Center for Drug Evaluation and Research, said: "This approval will provide new treatment options for children and adolescents with hepatitis C."
Hepatitis C is caused by Hepatitis C virus (HCV) infection, which can lead to decreased liver function or failure. According to statistics, about 130-150 million people worldwide have chronic hepatitis C. Among the infected people, about 11 million are children under 15 years of age, of which 5 million are in the period of viremia (referring to the virus in the blood).
Dr. Kathleen B Schwarz, Professor of Pediatrics at the Johns Hopkins University School of Medicine, said: "Although the treatment of hepatitis C has improved significantly in recent years, pediatricians still have to consider a variety of factors, including genotypes, when choosing treatment And the severity of liver disease. Expansion of the approval of Bongtongsa can help eligible children with hepatitis C fight this fatal liver disease. "
Epclusa is the world's first fully oral, pan-genotype, single tablet hepatitis C treatment plan. Approved in the United States in June 2016 for the treatment of adult patients with chronic HCV infection with / without cirrhosis of all genotypes (types 1-6) Patients with compensated cirrhosis). Currently, the drug has also been listed in China.
The approval was based on data from a phase II unblind, multi-center clinical trial (Study 1143). The trial enrolled 175 children who received 12 weeks of Epclusa treatment, of which 173 were included in the efficacy analysis. The pharmacokinetics, safety and effectiveness of Epclusa have been verified here.
The results show that:
· There is no significant difference in the pharmacokinetics of pediatric patients compared to adult patients.
· The safety and effectiveness of Bentongsha treatment for children 6 years old and above are basically consistent with the results of adults.
· Among 102 patients aged 7-12 years, 93% of patients with genotype 1 and 100% of patients with genotypes 2, 3, 4 and 6 did not detect virus in the blood after 12 weeks of completion of treatment, Shows that the hepatitis C infection has been cured.
· Of 71 patients aged 6-11 years old with genotypes 1-4, 93% had genotype 1 patients, 91% had genotype 3 patients, 100% had genotype 2 and genotype 4 patients. After 12 weeks, no virus was detected in the blood.
· The most common adverse reactions are fatigue and headache. The adverse reactions observed in pediatric patients are consistent with those in adult patients.
Epclusa contains a black box warning: suggesting that the drug may cause the risk of hepatitis B virus reactivation in patients with hepatitis C / HBV co-infection. For children younger than 6 years of age, the safety and effectiveness of Bentongsa is yet to be determined.