标签更改摘要
- Pharmacokinetics, safety, and effectiveness for treatment of HCV genotype 1, 2, 3, 4, or 6 infection in treatment-naïve and treatment-experienced pediatric patients 3 years of age and older without cirrhosis or with compensated cirrhosis have been established in an open-label, multicenter clinical trial.
- Safety and effectiveness in pediatric patients were comparable to those observed in adults. However, among the 41 pediatric patients less than 6 years of age, vomiting and product use issue (spitting up the drug) were reported more frequently compared to patients 6 years and older. Five patients discontinued treatment after vomiting or spitting up the drug.
- Safety and effectiveness of EPCLUSA for treatment of HCV genotype 5 in pediatric patients 3 years and older without cirrhosis or with compensated cirrhosis are supported by sofosbuvir, GS-331007, and velpatasvir exposures in adults and pediatric patients. Similar rationale was used to support dosing recommendations for pediatric patients with HCV genotype 1, 2, 3, 4, 5, or 6 infection who have decompensated cirrhosis (Child-Pugh B or C).
- Safety and effectiveness have not been established in pediatric patients less than 3 years of age.
- Information on dosing, adverse reactions, PK parameters, and clinical trial.
- Postmarketing study.
学习类型
Efficacy,Safety,Pharmacokinetic,Activity
国家
United States,Belgium,Italy,United Kingdom