The impact of sofosbuvir/ledipasvir on chronic hepatitis C-infected paediatric patients: a Middle East single-centre experience.

Introduction: Direct-acting antiviral (DAA) regimens were approved in 2013 with a response rate exceeding 95% and minimal side effects. The response rate of sofosbuvir and ledipasvir exceeds 95% with minimal side effects.

Aim: To identify the effects of this regimen in the eradication of viruses from the patients.Material and methods: A prospective observational, open-label study took place between July 2018 and September 2020. The study included 37 patients, about two-thirds of them were male 23 (62.16%), while females comprised 14 (37.84%). All patients received a combination of sofosbuvir 400 mg and ledipasvir 90 mg in a single oral daily dose according to their weight.

Results: The most common HCV genotype was HCV-4, followed by HCV-1 and HCV-2. And by comparing parameters at baseline, end of the treatment, and 12 weeks after completing the treatment, the laboratory data revealed dramatic drops of all liver function tests, the mean of alanine aminotransferase (ALT) (31.1 ±1.42 IU/l vs. 95.5 ±23.16, < 0.05), aspartate aminotransferase (AST) (29.86 ±1.75 IU/l vs. 89.19 ±24.83, < 0.05), total serum bilirubin (TSB) (0.57 ±0.07 mg/dl vs. 1.73 ±0.38 mg/dl, < 0.05), mean HCV PCR (1605168 ±368223.72), after finishing the treatment course, and 12 weeks after that it was non-detectable ( < 0.05).

Conclusions: Treatment with dose-adjusted oral DAAs (SOF/LED) for 12 weeks was well tolerated in Iraqi children and adolescents infected with chronic HCV infections, with a high success rate and trivial adverse effects.