Safety and Efficacy of Ledipasvir–Sofosbuvir With or Without Ribavirin for Chronic Hepatitis C in Children Ages 6‐11

• DOI: 10.1002/hep.30123
• Publication Date: 2018-08-06T22:16:04Z
• Authors: Karen F. Murray; William F. Balist...; Sanjay Bansal; Suzanne Whitworth; Helen M. Evans; Regino P. Gonzale...; Jessica Wen; Benedetta Massetto; Kathryn Kersey; Jiang Shao; Kimberly L. Garrison; Bandita Parhy; Diana M. Brainard; Ronen Arnon; Lynette A. Gillis; Maureen M. Jonas; Chuan‐Hao Lin; Michael R. Narkewicz; Kathleen Schwarz; Philip Rosenthal
• Keywords: Sofosbuvir; Hepatitis C; Ledipasvir

Currently, there are no interferon-free treatments available for hepatitis C virus (HCV)-infected patients younger than 12 years. We evaluated the safety and effectiveness of all-oral regimen ledipasvir-sofosbuvir ± ribavirin in HCV-infected children aged 6 to <12 In an open-label study, years received ledipasvir 45 mg-sofosbuvir 200 mg as two fixed-dose combination tablets 22.5/100 once daily, with or without ribavirin, 24 weeks, depending on HCV genotype cirrhosis status. The primary efficacy endpoint was sustained virologic response weeks after therapy (SVR12). Twelve underwent intensive pharmacokinetic sampling confirm appropriateness sofosbuvir dosages. Ninety-two were enrolled (88 1, 2 3, 4), a median age 9 (range, 6-11). Most perinatally infected (97%) treatment-naive (78%). Two confirmed have cirrhosis, while degree fibrosis unknown 55 patients. overall SVR12 rate 99% (91/92; 95% confidence interval, 94%-100%). single patient not reaching SVR relapsed 4 completing treatment. most common adverse events headache pyrexia. One had three serious events, which considered be related study treatment: tooth abscess, abdominal pain, gastroenteritis. area under concentration-time curve maximum concentration values sofosbuvir, its metabolite GS-331007, within predefined equivalence boundaries (50%-200%) compared adults phase 2/3 studies. Conclusion: Ledipasvir-sofosbuvir well tolerated highly effective old chronic HCV.