Daclatasvir Plus Sofosbuvir With and Without Ribavirin for Previously Treated or Untreated Chronic HCV Infection Genotype 1, 2 and 4 in Togo

Abstract

Background: Daclatasvir (DCV) is a potent, pangenotypic nonstructural protein 5A inhibitor with demonstrated antiviral efficacy when combined with sofosbuvir (SOF) with or without ribavirin (RBV) in patients with chronic hepatitis C virus (HCV) infection. We are using SOF-DCV combination for large scale treatment. Objectives: The aim of the current study was designed to investigate the efficacy and safety of sofosbuvir/daclatasvir, with or without ribavirin for previously treated or untreated in treatment of HCV genotype 1, 2 and 4, as well as their effect on the liver fibrosis. Methods: One hundred twenty-seven patients with chronic HCV infection were categorized into 2 groups. The group 1 comprised treatment naïve patients, with total serum bilirubin ≤ 1.2mg/10-1L, serum albumin ≥ 3,5g/10-1L, ALAT ≥ 3N, ASAT≤ 2N and platelets count 150 x 109 /L. The group 2 included Peg-INF-alpha or sofosbuvir treatment-experienced patients or patients having at least 2 of the following characteristics: total bilirubin ≤ 1.2mg/10-1L, serum albumin ≥ 3,5g/10-1L, ALAT ≥ 3N, ASAT ≤ 2N and platelets count 150 x 109 /L. The first group was treated with sofosbuvir/daclatasvir for 12 weeks except sofosbuvir treatment experienced patients, who were treated with sofosbuvir/daclatasvir + ribavirin for 24 weeks, with generic medications: DCV 60 mg plus SOF 400 mg ± ribavirin (RBV) within the treatment of hepatitis C virus infection. Efficacy and safety were assessed, and baseline factors associated with sustained virological response at post-treatment week 12 (SVR12) were explored. Results: Sustained virological response (SVR12), was 95,8% in group 1 and 93,8% in group 2. Such high efficacy was accompanied with tolerable adverse effects as well as with significant improvement in liver fibrosis. Conclusion: SOF plus DCV with or without ribavirin achieved high efficacy and safety in HCV genotypes 1,2 and 4 patients. Their effect was accompanied with attenuation of liver fibrosis. Further wider-scale studies are needed to evaluate the actual role of IL 18 polymorphism in treatment response with Sofosbuvir/Daclatasvir.