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Sofosbuvir and Ribavirin Therapy for Children Aged 3 to < 12 Years With Hepatitis C Virus Genotype 2 or 3 Infection

dc.contributor.authorGillis, Lynette A.
dc.identifier.citationRosenthal, P., Schwarz, K. B., Gonzalez-Peralta, R. P., Lin, C. H., Kelly, D. A., Nightingale, S., Balistreri, W. F., Bansal, S., Jonas, M. M., Massetto, B., Brainard, D. M., Hsueh, C. H., Shao, J., Parhy, B., Davison, S., Feiterna-Sperling, C., Gillis, L. A., Indolfi, G., Sokal, E. M., Murray, K. F., … Wirth, S. (2020). Sofosbuvir and Ribavirin Therapy for Children Aged 3 to <12 Years With Hepatitis C Virus Genotype 2 or 3 Infection. Hepatology (Baltimore, Md.), 71(1), 31–43.
dc.descriptionOnly Vanderbilt University affiliated authors are listed on VUIR. For a full list of authors, access the version of record at
dc.description.abstractCurrently, 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 naive (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.en_US
dc.description.sponsorshipSupported by funding from Gilead Sciences, Inc.en_US
dc.rightsCopyright © 2019 The Authors. Hepatology published by Wiley Periodicals, Inc., on behalf of American Association for the Study of Liver Diseases. This is an open access article under the terms of the License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
dc.titleSofosbuvir and Ribavirin Therapy for Children Aged 3 to < 12 Years With Hepatitis C Virus Genotype 2 or 3 Infectionen_US

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