Efficacy and safety of anti-Hepatitis C virus regimens containing daclatasvir: a systematic review and meta-analysis from Egypt

Abstract Background Daclatasvir-containing combinations are a central component of Egypt’s national response to hepatitis C virus (HCV). We aimed to explore the effectiveness and safety of these regimens in Egyptian populations. We searched PubMed, Scopus, and Web of Science from inception to 16 November 2024 for Egyptian studies evaluating sofosbuvir plus daclatasvir with or without ribavirin or other agents. Eligible designs were observational cohorts and clinical trials that reported sustained virological response and adverse events. Main body Two reviewers independently screened records and extracted data. Random-effects meta-analyses generated pooled sustained virological response with 95% confidence intervals and examined prespecified subgroups (cirrhosis, prior direct-acting antiviral failure, children, older adults, and human immunodeficiency virus [HIV] coinfection). Thirty-three studies enrolling 25,098 participants were included. The pooled SVR across all regimens was 96% (95–97) with substantial heterogeneity (I 2 = 80.5%). Subgroup results were consistently high and are reported with study counts and heterogeneity: children (3 studies), SVR 99.19% (96.35–99.99), I 2 = 0%; HIV coinfection (3 studies), SVR 92.78% (86.95–96.99), I 2 = 0%; prior treatment failure (2 studies), SVR 96.61% (93.03–98.93), I 2 = 11.37%. Among patients with cirrhosis, pooled SVR was 93% (88–98) overall; in compensated cirrhosis (2 studies), SVR 97.33% (86.65–99.79), I 2 = 92.99%; in decompensated cirrhosis (3 studies), SVR 92.21% (70.20–99.99), I 2 = 94.72%. By regimen, sofosbuvir + daclatasvir (without ribavirin) showed pooled SVR 96.17% (94.95–97.23) with moderate heterogeneity (I 2 = 53.79%); results for ribavirin-containing combinations were similar but with more AEs. AEs were generally infrequent and mild (headache, fatigue, anemia, dizziness), occurring mainly with ribavirin- or simeprevir-containing regimens. Conclusions Daclatasvir-based therapy delivers high and reliable cure rates with a favorable safety profile in Egyptian patients with HCV, including those with cirrhosis and those living with HIV. These findings support the continued, wide-scale use of sofosbuvir plus daclatasvir (with or without ribavirin) in real-world programs and reinforce Egypt’s progress toward HCV elimination.