Long-term changes in hepatic reserve and prognosis after direct-acting antiviral treatment in patients with hepatitis C virus-related decompensated cirrhosis: a five-year follow-up study of a Japanese phase 3 trial.

BACKGROUND

Long-term effects of direct-acting antiviral (DAA) on hepatic reserve and prognosis in hepatitis C virus (HCV)-related decompensated cirrhosis remain unclear.

METHODS

Ninety-four patients from a follow-up study of the Japanese phase 3 trial of DAA treatment for decompensated cirrhosis were included.

RESULTS

Twelve, seventy-seven, and ten percent of patients had Child-Pugh class A/B/C, respectively. The sustained virologic response (SVR) rate was 93.6%. The proportion of Child-Pugh A patients was 21% at end of treatment (EOT), and 40%, 42%, 49%, 40% at 24 weeks, 1 year, 3 years, and 5 years after EOT, respectively. A significant breakpoint for Child-Pugh class improvement to A was observed between 24 weeks and 1 year after EOT. The proportions of patients with albumin levels > 3.5 g/dl increased from 11% (baseline) to 39% (5 years after EOT), and significant breakpoint for this improvement was observed between 12 and 24 weeks after EOT. During the 4.8 years from EOT, 19 patients died, and 1 underwent liver transplantation (LT). The five-year LT-free survival rate was 74.7%. Multivariate analysis identified virologic response and Child-Pugh class at 12 weeks after EOT as significant LT-free survival predictors. The four-year LT-free survival rates were 91.5% for SVR patients and 33.3% for virologic failure patients.

CONCLUSIONS

In HCV-related decompensated cirrhosis, 5 year LT-free survival rate after DAA was 74.7%, and viral clearance and post-treatment Child-Pugh class were associated with long-term prognosis. Child-Pugh class improved until 24 weeks after EOT, but little change was observed thereafter, which was closely associated with albumin levels.