Shortened 8-Week Course of Sofosbuvir/Ledipasvir Therapy in Adolescents with Chronic Hepatitis C Infection.

Abstract

Treatment-naïve, non-cirrhotic adults with chronic hepatitis C virus (HCV) 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, multicentre 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 (SVR12). 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 SVR12 were 100%. No grade 3-4 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, non-cirrhotic adolescents with chronic HCV genotype 1 infection and pre-treatment viremia level < 6 million IU/mL.