Daclatasvir and asunaprevir treatment in patients with severe liver fibrosis by hepatitis C virus genotype 1b infection: Real-world data.

Abstract

BACKGROUND AND AIM:

In this study, we investigated the real-world data of the first approved interferon-free regimen in Japan: daclatasvir and asunaprevir in chronic hepatitis C patients with severe fibrosis.

METHODS:

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 antiviral effect and factors associated with sustained viral response 12 (SVR12), and the additional effects on serum α-fetoprotein and albumin levels by eradicating virus in patients who attained SVR were investigated. In statistical analysis, P < 0.05 was considered as significant levels.

RESULTS:

Antiviral 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) was 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 α-fetoprotein significantly decreased, and serum albumin levels significantly increased as early as 4 weeks after the start of treatment.

CONCLUSION:

Although the antiviral 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.

• Authors: Masatoshi Ishigami, Kazuhiko Hayashi, Takashi Honda, Teiji Kuzuya, Yoji Ishizu, Tetsuya Ishikawa, Isao Nakano, Fumihiro Urano, Takashi Kumada, Kentaro Yoshioka, Hidemi Goto, Yoshiki Hirooka
• Journal: Journal of gastroenterology and hepatology (J Gastroenterol Hepatol) Vol. 32 Issue 11 Pg. 1879-1886 (Nov 2017) ISSN: 1440-1746 [Electronic] Australia
• PMID: 28258705 (Publication Type: Journal Article)
• Copyright: © 2017 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

Chemical References

• Antiviral Agents
• Carbamates
• Imidazoles
• Isoquinolines
• Pyrrolidines
• Sulfonamides
• Valine
• daclatasvir
• asunaprevir

Topics

• Aged
• Antiviral Agents (administration & dosage)
• Carbamates
• Drug Therapy, Combination
• Female
• Genotype
• Hepacivirus (classification, genetics)
• Hepatitis C, Chronic (complications, drug therapy, virology)
• Humans
• Imidazoles (administration & dosage)
• Isoquinolines (administration & dosage)
• Liver Cirrhosis (drug therapy, etiology)
• Male
• Middle Aged
• Pyrrolidines
• Severity of Illness Index
• Sulfonamides (administration & dosage)
• Treatment Outcome
• Valine (analogs & derivatives)