ABSTRACT An affordable, effective, safe, pan-genotypic, all-oral, direct-acting antiviral (DAA) drug combination, approved for treatment of chronic hepatitis C virus (HCV) infection in pediatric age group is still needed. We aimed to test the effectiveness and safety of a 12-week course of combined Sofosbuvir plus Daclatasvir (SOF/DCV) treatment for chronic HCV genotype-4-infected adolescent patients. A total of 94 eligible chronic HCV genotype-4-infected adolescent patients (mean age 14 ± 2 years; 78% males) were included in this study. All patients received dual Sofosbuvir 400 mg and Daclatasvir 60 mg orally once daily, for 12 weeks. Laboratory and virological indices were assessed at baseline, weeks 4, 8 and 12 (EOT), and 12 weeks after end of treatment. Patients were sub-classified according to the status of liver fibrosis into no-to-mild fibrosis (F0/F1) and significant-to-advanced fibrosis (F2/F3). The overall intent-to-treat (ITT) SVR12 was 88/94 (93.6%; 95% confidence interval (CI): 86.7 – 97%). Four patients dropped out before the last visit and 2 patients relapsed (one from each fibrosis subclass). So the Per-Protocol (PP) SVR12 rate was 88/90 (97.8%; CI: 92-99.4%). Not achieving early virologic response at week 4 (-ve-EVR4) was the only significant predictor for virologic failure in our study population (p = 0.004). No serious or severe adverse events were reported. The 12-week Daclatasvir plus Sofosbuvir regimen is effective in chronic hepatitis C genotype-4-infected adolescent patients, with an excellent safety and tolerability.
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