Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis

Ann Intern Med. 2007 Nov 20;147(10):677-84. doi: 10.7326/0003-4819-147-10-200711200-00003.


Background: Clinical outcomes of chronic hepatitis C infection in patients with advanced fibrosis include liver failure, hepatocellular carcinoma, and death.

Objective: To investigate whether sustained virologic response to treatment for hepatitis C is associated with improved clinical outcomes.

Design: Retrospective cohort study.

Setting: 5 hepatology units of tertiary care centers in Europe and Canada caring for patients with chronic hepatitis C treated between 1990 and 2003.

Patients: Consecutively treated patients with chronic hepatitis C who had biopsy-proven advanced fibrosis or cirrhosis (Ishak score, 4 to 6).

Measurements: Sustained virologic response, defined as absence of detectable hepatitis C virus RNA at 24 weeks after the end of treatment, and clinical outcomes, defined as death (liver-related or non-liver-related), liver failure, and hepatocellular carcinoma.

Results: Of 479 patients, 29.6% had sustained virologic response and 70.3% did not. Median follow-up was 2.1 years (interquartile range, 0.8 to 4.9 years). Four patients with and 83 without sustained virologic response had at least 1 outcome event. Sustained virologic response was associated with a statistically significant reduction in the hazard of events (adjusted hazard ratio, 0.21 [95% CI, 0.07 to 0.58]; P = 0.003). The effect was largely attributable to a reduction in liver failure, which developed in no patients with and 42 patients without sustained virologic response (5-year occurrence, 0% vs. 13.3% [CI, 8.4% to 18.2%]; unadjusted hazard ratio, 0.03 [CI, 0.00 to 0.91]).

Limitations: Because few events occurred in the sustained virologic response group, the study had limited ability to detect differences between groups in individual outcomes. In addition, the study was retrospective; selection and survival biases may therefore influence estimates of effect.

Conclusion: Sustained virologic response to treatment is associated with improved clinical outcomes, mainly prevention of liver failure, in patients with chronic hepatitis C and advanced fibrosis.

Publication types

  • Multicenter Study

MeSH terms

  • Adult
  • Antiviral Agents / therapeutic use*
  • Carcinoma, Hepatocellular / etiology
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Hepatitis C, Chronic / complications
  • Hepatitis C, Chronic / drug therapy*
  • Hepatitis C, Chronic / virology*
  • Humans
  • Interferon alpha-2
  • Interferon-alpha / therapeutic use*
  • Liver Cirrhosis / etiology
  • Liver Failure / etiology
  • Liver Failure / mortality
  • Liver Neoplasms / etiology
  • Liver Transplantation / mortality
  • Male
  • Middle Aged
  • RNA, Viral / blood
  • Recombinant Proteins
  • Retrospective Studies
  • Ribavirin / therapeutic use*
  • Treatment Outcome


  • Antiviral Agents
  • Interferon alpha-2
  • Interferon-alpha
  • RNA, Viral
  • Recombinant Proteins
  • Ribavirin