The Italian compassionate use of sofosbuvir observational cohort study for the treatment of recurrent hepatitis C: clinical and virological outcomes

Transpl Int. 2017 Dec;30(12):1253-1265. doi: 10.1111/tri.13018. Epub 2017 Sep 7.

Abstract

Direct antivirals are available for treating recurrent hepatitis C (RHC). This study reported outcomes of 424 patients with METAVIR F3-F4 RHC who were treated for 24 weeks with sofosbuvir/ribavirin and followed for 12 weeks within the Italian sofosbuvir compassionate use program. In 55 patients, daclatasvir or simeprevir were added. Child-Pugh class and model of end stage liver disease (MELD) scores were evaluated at baseline and 36 weeks after the start of therapy. The sustained viral response (SVR) was 86.7% (316/365) in patients who received sofosbuvir/ribavirin and 98.3% (58/59) in patients who received a second antiviral (P < 0.01). In patients treated with sofosbuvir/ribavirin, a significant difference in SVR was observed between patients diagnosed with METAVIR F4 (211/250; 84.4%), METAVIR F3 (95/105; 90.5%) and fibrosing cholestatic hepatitis (10/10; 100%) (P = 0.049). A significant association was found between patients who worsened from Child-Pugh class A and who experienced viral relapse (4/26 vs. 8/189, P = 0.02). In patients with a baseline MELD score <15, a significant association was found between maintaining a final MELD score <15 and the achievement of SVR (187/219 vs. 6/10, P = 0.031). This real-world study indicates that sofosbuvir/ribavirin treatment for 24 weeks was effective, and the achievement of SVR was associated with a reduced probability of developing worsening liver function.

Keywords: cholestatic hepatitis; hepatitis C; liver transplantation; sofosbuvir.

Publication types

  • Comparative Study
  • Observational Study

MeSH terms

  • Analysis of Variance
  • Antiviral Agents / therapeutic use*
  • Cohort Studies
  • Compassionate Use Trials*
  • Confidence Intervals
  • Disease Progression
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • Hepatitis C, Chronic / diagnosis
  • Hepatitis C, Chronic / drug therapy*
  • Hepatitis C, Chronic / epidemiology
  • Humans
  • Italy
  • Liver Cirrhosis / prevention & control*
  • Liver Cirrhosis / virology
  • Liver Function Tests
  • Logistic Models
  • Male
  • Multivariate Analysis
  • Prognosis
  • Recurrence
  • Ribavirin / therapeutic use*
  • Risk Assessment
  • Severity of Illness Index
  • Sofosbuvir / therapeutic use*
  • Treatment Outcome

Substances

  • Antiviral Agents
  • Ribavirin
  • Sofosbuvir