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Sofosbuvir and Ribavirin Therapy for Children Aged 3 to <12 Years With Hepatitis C Virus Genotype 2 or 3 Infection
Author(s) -
Rosenthal Philip,
Schwarz Kathleen B.,
GonzalezPeralta Regino P.,
Lin ChuanHao,
Kelly Deidre A.,
Nightingale Scott,
Balistreri William F.,
Bansal Sanjay,
Jonas Maureen M.,
Massetto Benedetta,
Brainard Diana M.,
Hsueh ChiaHsiang,
Shao Jiang,
Parhy Bandita,
Davison Suzanne,
FeiternaSperling Cornelia,
Gillis Lynette A.,
Indolfi Giuseppe,
Sokal Etienne M.,
Murray Karen F.,
Wirth Stefan
Publication year - 2020
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.30821
Subject(s) - medicine , ribavirin , sofosbuvir , vomiting , adverse effect , gastroenterology , dosing , hepatitis c , hepatitis c virus , immunology , virus
Currently, the only approved hepatitis C virus (HCV) treatment for children aged <12 years is pegylated interferon plus ribavirin. In an open‐label study, we evaluated the safety and efficacy of sofosbuvir plus ribavirin for 12 weeks in children aged 3 to <12 years chronically infected with genotype 2 or for 24 weeks in patients with genotype 3. Patients aged 3 to <6 years weighing <17 kg received sofosbuvir 150 mg, and patients aged 3 to <6 years weighing ≥17 kg and all patients aged 6 to <12 years received sofosbuvir 200 mg once daily. Intensive pharmacokinetic sampling conducted in each age group confirmed the appropriateness of sofosbuvir doses. For all patients, ribavirin dosing was determined by baseline weight (up to 1,400 mg/day, two divided doses). The primary efficacy endpoint was sustained virologic response 12 weeks after therapy (SVR12). Fifty‐four patients were enrolled (41 aged 6 to <12 years and 13 aged 3 to <6 years). Most were treatment naïve (98%) and infected perinatally (94%). All but one patient achieved SVR12 (53/54, 98%; 95% confidence interval, 90%‐100%). The patient who did not achieve SVR12 was a 4‐year‐old who discontinued treatment after 3 days because of “abnormal drug taste.” The most commonly reported adverse events in patients aged 6 to <12 years were vomiting (32%) and headache (29%), and those in patients aged 3 to <6 years were vomiting (46%) and diarrhea (39%). One 3‐year‐old patient had a serious adverse event of accidental ribavirin overdose requiring hospitalization for monitoring; this patient completed treatment and achieved SVR12. Conclusion: Sofosbuvir plus ribavirin was well tolerated and highly effective in children aged 3 to <12 years with chronic HCV genotype 2 or 3 infection.