Background/purpose: The effect of sofosbuvir and daclatasvir in treatment of genotype 4 Hepatitis C Virus (HCV) is not well documented. This study investigated the safety and efficacy of sofosbuvir plus daclatasvir with or without ribavirin in treatment of HCV genotype 4 patients. The impact of therapy on liver fibrosis as well as the role of IL18 polymorphism in therapeutic outcome was assessed.
Methods: One hundred HCV genotype 4 patients were categorized into 2 groups. The group 1 comprised treatment naïve patients, with total serum bilirubin ≤ 1.2 mg/10-1 L, serum albumin ≥ 3.5 g/10-1 L, INR ≤ 1.2, and platelet count ≥ 150 × 109/L. This group was treated with sofosbuvir plus daclatasvir for 12 weeks. The group 2 included Peg-IFN-α-or sofosbuvir treatment experienced, or patients with at least 2 of the following findings: total serum bilirubin > 1.2 mg/10-1 L, serum albumin < 3.5 g/10-1 L, INR > 1.2, and platelet count < 150 × 109 L-1. Group 2 was treated with sofosbuvir-daclatasvir + ribavirin for 12 weeks, with the exception of sofosbuvir treatment experienced patients, who were treated with sofosbuvir/daclatasvir + ribavirin for 24 weeks.
Results: Sustained Virological Response (SVR12) (undetectable viremia12 weeks post-treatment), was 93.3% in group 1 and 87.5% in group 2 (total = 91%). Such high efficacy was accompanied with tolerable adverse effects as well as with significant improvement in liver fibrosis. No significant association was observed between IL18 polymorphism (rs1946518) at position -607 and achievement of SVR12 in HCV patients after treatment.
Conclusion: Sofosbuvir plus daclatasvir, with or without ribavirin achieved high efficacy and safety in HCV genotype 4 patients. Their effects were accompanied with attenuation of liver fibrosis. Further wider-scale studies are needed to evaluate the actual role of IL18 polymorphisms in treatment response with sofosbuvir/daclatasvir.
Keywords: DAA, Direct Acting Anti-viral; FIB 4, Fibrosis Score 4; HCV; HCV, Hepatitis C Virus; IL-18 polymorphism; IL-18, Interleukin 18; INF, Interferon; NS, Non-Structural; PCR, Polymerase Chain Reaction; RFLP, Restriction Fragment Length Polymorphism; RNA, Ribonucleic Acid; SNPs, Single-Nucleotide Polymorphisms; SVR12, Sustained Virologic Response 12 Week Post Treatment; daclatasvir; sofosbuvir.