Efficacy of Sofosbuvir/Ledipasvir in Adolescents With Chronic Hepatitis C Genotypes 1, 3, and 4: A Real-world Study

Daniele Serranti, Gabriella Nebbia, Mara Cananzi, Emanuele Nicastro, Fabiola Di Dato, Federica Nuti, Silvia Garazzino, Erika Silvestro, Vania Giacomet, Federica Forlanini, Michele Pinon, Pier Luigi Calvo, Silvia Riva, Icilio Dodi, Antonina Marta Cangelosi, Roberto Antonucci, Silvia Ricci, Elisa Bartolini, Greta Mastrangelo, Sandra TrapaniMatteo Lenge, Paola Gaio, Pietro Vajro, Raffaele Iorio, Lorenzo D'Antiga, Giuseppe Indolfi

Research output: Contribution to journalArticlepeer-review


OBJECTIVES: Sofosbuvir/Ledipasvir (SOF/LDV) has been approved by the European Medicine Agency (EMA) for the treatment of children and adolescents (at least 3 years of age) with chronic hepatitis C (CHC) genotype 1, 3, and 4 infection. The aim of this study was to evaluate the efficacy and safety of SOF/LDV in adolescents (12 to <18 years old) with CHC in the real-world setting. METHODS: Prospective, open-label, multicentre study involving 12 Italian centres. Patients received the fixed-dose combination of SOF/LDV (400/90 mg) once daily ± ribavirin as per EMA approval and recommendations. The key efficacy endpoint was sustained virological response 12 weeks after the end of treatment (SVR12) as per intention-to-treat analysis. Safety was assessed by adverse events and clinical/laboratory data. RESULTS: Seventy-eight consecutive adolescents (median age 15.2 years, range 12-17.9; girls 53.8%) were enrolled and treated between June 2018 and December 2019. Genotype distribution was as follows: genotype 1 (82.1%), 3 (2.5%), and 4 (15.4%). Seventy-six (97.4%) patients completed treatment and follow-up. Overall, SVR12 was 98.7%. One patient was lost to follow-up after 4 weeks of treatment; 1 patient completed treatment and missed the follow-up visit. No virological breakthrough or relapse were observed. No patient experienced grade 3 to 4 adverse event or serious adverse event. CONCLUSIONS: The results of this real-world study confirmed the high efficacy and the optimal safety profile of SOF/LDV for treatment of CHC in adolescents.

Original languageEnglish
Pages (from-to)95-100
Number of pages6
JournalJournal of Pediatric Gastroenterology and Nutrition
Issue number1
Publication statusPublished - Jan 1 2021

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Gastroenterology


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