Open AccessShortened 8‐Week Course of Sofosbuvir/Ledipasvir Therapy in Adolescents With Chronic Hepatitis C Infection
Author(s) -
Serranti Daniele,
Dodi Icilio,
Nicastro Emanuele,
Cangelosi Antonina M.,
Riva Silvia,
Ricci Silvia,
Bartolini Elisa,
Trapani Sandra,
Mastrangelo Greta,
Vajro Pietro,
D'Antiga Lorenzo,
Resti Massimo,
Indolfi Giuseppe
Publication year - 2019
Publication title -
journal of pediatric gastroenterology and nutrition
Language(s) - English
Resource type - Journals
eISSN - 1536-4801
pISSN - 0277-2116
DOI - 10.1097/mpg.0000000000002449
Subject(s) - medicine , adverse effect , ledipasvir , sofosbuvir , viremia , hepatitis c virus , clinical endpoint , hepatitis c , clinical trial , gastroenterology , ribavirin , virus , immunology
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.