Ishigami M, Hayashi K, Honda T et al.
Department of Gastroenterology and Hepatology, Nagoya University School of Medicine.
Journal of gastroenterology and hepatology. Mar 2017.
In this study, we investigated the real-world data of the first approved interferon free regimen in Japan; daclatasvir as asunaprevir in chronic hepatitis C patients with severe fibrosis.Among 924 patients registered in our multicenter study, 535 patients were defined as having severe fibrosis with Fib-4 index≧3.25, and were included in this study. We investigated anti-viral effect and factors associated with SVR12, and the additional effects on serum AFP and albumin levels by eradicating virus in patients who attained SVR were investigated. In statistical analysis, P<0.05 was considered as significant levels.Anti-viral effect was lower in patients with severe fibrosis at 8 and 12 weeks after start of the treatment (96.3%, 97.1% with severe fibrosis vs 99.5%, 99.2% without severe fibrosis, P=0.002 and P=0.036, respectively), and more early relapse (SVR4; 90.4% with severe fibrosis vs 95.4% without fibrosis, P=0.008) were seen in patients with severe fibrosis, however, there were no differences in SVR12 and SVR24. In the safety profiles, discontinuation rate due to liver injury (2.8% with severe fibrosis vs 3.3% without severe fibrosis) or other causes of discontinuation was not different between two groups. Serum AFP significantly decreased and serum albumin levels significantly increased as early as 4 weeks after the start of treatment.Though the anti-viral effect was slightly lower in patients with severe fibrosis compared with those without, treatment with daclatasvir and asunaprevir is basically an effective, and well-tolerable treatment in these populations. Pubmed