Real‐World Effectiveness and Safety of Sofosbuvir‐Based Therapy in Chinese Children and Adolescents With Chronic HCV Infection: A Retrospective Multicentre Study

ABSTRACT

Few direct‐acting antiviral regimens are approved in China for children and adolescents with chronic hepatitis C virus (HCV) infection and data are limited on their efficacy and safety in this population. This retrospective, multi‐centre study aimed to assess the real‐world effectiveness and safety of ledipasvir/sofosbuvir (LDV/SOF) and sofosbuvir/velpatasvir (SOF/VEL) in Chinese paediatric patients. The study included patients aged 3–17 years from five hospitals across China who received either LDV/SOF or SOF/VEL for chronic HCV infection. The outcomes included the proportion of patients who achieved sustained virologic response at 12 weeks post‐treatment (SVR12), normalisation rates of ALT and AST levels, and incidence of adverse events (AEs). A total of 129 patients from five sites were included and 128 completed 12 weeks of post‐treatment follow‐up. Mean age was 9.9 years (standard deviation, 3.9), with 30 (23.3%), 55 (42.6%), and 44 (34.1%) patients aged 3–6, 7–11, and 12–17 years, respectively, 84 (65.1%) were male, 62 (48.1%) were infected with genotype 3, and baseline ALT and AST levels were elevated in 64 (49.6%) and 75 (58.1%) patients, respectively. The SVR12 rate was 98.4% (126/128) in the overall population, remaining consistent across subgroups by sex, age, HCV genotype, or regimen. ALT and AST levels were normalised in all patients with available data. AEs were reported by 16.4% (21/128) of patients and none were serious. Collectively, this study demonstrated that LDV/SOF and SOF/VEL were highly effective and well tolerated in Chinese paediatric patients with chronic HCV infection.