Real-world effectiveness and safety of sofosbuvir plus daclatasvir with or without ribavirin for genotype 2 chronic hepatitis C in Taiwan

J Formos Med Assoc. 2019 May;118(5):907-913. doi: 10.1016/j.jfma.2018.09.016. Epub 2018 Oct 11.

Abstract

Background and purpose: Sofosbuvir (SOF) and daclatasvir (DCV) treatment achieves excellent efficacy and safety in treating chronic hepatitis C (CHC) with various genotypes. Real world experience of SOF/DCV regimen to treat genotype 2 CHC was scanty in Asia. This study aimed to evaluate the effectiveness and safety of SOF/DCV with or without ribavirin to treat genotype 2 CHC patients in real world practice in Taiwan.

Methods: Patients with genotype 2 CHC treated with 12-week of SOF/DCV or SOF/DCV/ribavirin were enrolled prospectively. Effectiveness was evaluated by sustained virological response (SVR) which was defined as undetectable hepatitis C virus (HCV) RNA at post-treatment week 12. Adverse events were recorded for safety analysis.

Results: In total of 32 patients were enrolled from October 2016 to June 2017. All were infected with genotype 2 HCV. Sixteen patients (50%) exhibited cirrhosis including 6 patients with decompensation. Regimens of SOF/DCV and SOF/DCV/ribavirin were used to treat 14 and 18 patients, respectively. SVR was achieved in all 31 patients (100%) who completed follow-up. Significantly higher levels of cholesterol (p = 0.013) and higher low density lipoprotein-cholesterol (p = 0.015) were exhibited after successful viral clearance. SOF/DCV/ribavirin regimen resulted in more adverse events, significantly higher bilirubin levels, and decline of hemoglobin during treatment than SOF/DCV regimen. Four patients with chronic kidney disease maintained renal function during treatment. Overall, SOF/DCV or SOF/DCV/ribavirin treatment was well tolerated.

Conclusion: SOF/DCV with or without ribavirin is highly effective and safe for patients with genotype 2 HCV infection in real-world experience in Taiwan.

Keywords: Chronic hepatitis C; Genotype 2; Sofosbuvir/daclatasvir.

Publication types

  • Observational Study

MeSH terms

  • Aged
  • Antiviral Agents / administration & dosage*
  • Antiviral Agents / adverse effects
  • Carbamates
  • Drug Therapy, Combination
  • Female
  • Genotype
  • Hepacivirus / genetics
  • Hepatitis C, Chronic / drug therapy*
  • Humans
  • Imidazoles / administration & dosage*
  • Liver Cirrhosis / virology
  • Male
  • Middle Aged
  • Prospective Studies
  • Pyrrolidines
  • Ribavirin / administration & dosage*
  • Sofosbuvir / administration & dosage*
  • Sustained Virologic Response
  • Taiwan
  • Valine / analogs & derivatives

Substances

  • Antiviral Agents
  • Carbamates
  • Imidazoles
  • Pyrrolidines
  • Ribavirin
  • Valine
  • daclatasvir
  • Sofosbuvir