Shortened 8-Week Course of Sofosbuvir/Ledipasvir Therapy in Adolescents With Chronic Hepatitis C Infection
The authors did not receive any financial support for this article. The authors did not receive any financial support by the National Institutes of Health (NIH), the Wellcome Trust, and the Howard Hughes Medical Institute (HHMI).
D.S., G.I., E.N., and L.D. are investigators in clinical trials sponsored by Gilead. The sponsors did not play any role in the design, methods, data collection, and analyses, or in the preparation of the present article.
The remaining authors report no conflicts of interest.
ABSTRACT
Treatment-naïve, noncirrhotic adults with chronic hepatitis C virus genotype 1 infection and with viremia levels <6 million IU/mL could be effectively treated with sofosbuvir/ledipasvir for 8 weeks. The aim of this pilot, prospective, open-label, multicenter study was to evaluate the efficacy and safety of this shortened treatment course in adolescents (≥12 years). The efficacy endpoint was sustained virological response 12 weeks after the end of treatment. Safety was assessed by adverse events and clinical/laboratory data. Fourteen consecutive adolescents (median age 16.5 years, Q1 14.1–Q3 17.4; female 57.1%), vertically infected, were enrolled and treated (June 2018–January 2019). Overall, the end of treatment response and sustained virological response 12 weeks after the end of treatment were 100%. No grade 3 to 4 adverse event or a serious adverse event was observed. Further studies are needed to confirm the optimal efficacy of the shortened 8-week treatment with sofosbuvir/ledipasvir for treatment-naïve, noncirrhotic adolescents with chronic hepatitis C virus genotype 1 infection and pretreatment viremia level < 6 million IU/mL.