Ledipasvir‐sofosbuvir in Adolescents With Chronic Hepatitis C and Hematological Malignancies Undergoing Chemotherapy

ABSTRACT Objectives: In children with hematological malignancies, chronic hepatitis C virus (HCV) infection has been associated with more rapid liver disease progression and higher risk of malignancy relapse due to chemotherapy interruption. We evaluated the safety and efficacy of ledipasvir‐sofosbuvir for 12weeks in these patients. Methods: In a phase 2, open‐label study, at one site in Egypt, patients ages 12‐3‐fold increase from Day 1 and HCV RNA elevation >1 × log10 from Day 1. Results: Of the 19 adolescents enrolled and treated, median age was 14 years (range 12–17), 84% (16/19) were male, and all had HCV genotype 4 and were HCV treatment naive. All patients completed treatment and achieved SVR12 (19/19, 100%, 95% confidence interval, 82–100). Common adverse events were pyrexia (5/19, 26%), diarrhea (4/19, 21%), and headache (4/19, 21%). Three patients experienced serious adverse events of pneumonia (two patients), and osteoarthritis and diarrhea (one patient); none were considered related to study drug. No patient experienced HCV flares. Conclusions: Ledipasvir‐sofosbuvir was well‐tolerated and efficacious in adolescents with chronic HCV genotype 4 and leukemia undergoing maintenance chemotherapy. These data support the use of this interferon and ribavirin‐free regimen in adolescents with hematological malignancies.