Source: Abstract #PS-101 Ledipasvir/sofosbuvir ± ribavirin for 12 or 24 weeks is safe and effective in children 6–11 years old with chronic hepatitis C infection—K.F. Murray, et al.
Study Aims and Results: The U.S. Food and Drug Administration (FDA recently expanded the use of Sovaldi (sofosbuvir) and Harvoni (sofosbuvir/ledipasvir) to adolescents 12 years and older who have hepatitis C virus (HCV). However, the only FDA-approved hep C treatment for children under age 12 is peginterferon plus ribavirin, a combination that has many side effects and poor response rates when compared to the new DAAs. This ledipasvir/sofosbuvir +/- ribavirin study enrolled 90 HCV+ children, ages 6–11 years old. The SVR4 rate among the 88 patients who completed the posttreatment Week 4 visit was 99%; one GT1a patient relapsed after 12 weeks.
Conclusion: This all-oral, interferon-free regimen was well tolerated, suggesting its potential as an important treatment option for children 6–11 years old. The study is continuing in children aged 3–5 years old.
Editorial Comments: This study is small and missing the final week 12 data. However, with few options for children, these results seem robust and point towards a hopeful future for children with hepatitis C. It also increases hope for parents; what parent would want to put their child through 24 to 48 weeks of peginterferon rather than 12 weeks of a DAA?
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