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HIV and Hepatitis.com Coverage of
Digestive Disease Week 2006 (DDW 2006)
 May 20 - 25, 2006, Los Angeles, California
The Effect of Liver Fibrosis and Scirrhosis on Sustianed Virological Response in 4913 patients with hepatitis C: Results from the Win-R Trial

Fibrosis is a predictor of sustained virological response (SVR) in hepatitis C (HCV). The majority of prior studies do not involve enough patients with cirrhosis to truly define the contribution of advanced fibrosis to SVR and nearly all combine Stage 3 and Stage 4 in their analyses.

The primary objective of the study was to analyze the effect of fibrosis on SVR in the Win-R trial of 4913 patients receiving PEG-IFN alfa 2b and ribavirin (RBV: fixed-dose (FD) 800 mg or weight-based (WBD) 800 – 1400mg daily.

Fibrosis stage was obtained on biopsies within 3 years of randomization using the Metavir scoring system by local pathologists. SVR was determined by PCR negativity (<29 IU/ml) 24 weeks after treatment was stopped.

The effect of Metavir stage 0 – 2 versus 3 - 4 on SVR for each treatment group was determined as in prior studies. Only patients with weight > 65kg were included in this analysis (n = 4223). The effect of each individual fibrosis stage on SVR was determined by logistic regression for all patients (n = 4913) regardless of treatment group.

Results

  • The distribution of fibrosis score was as follows; Stage 0 = 654; stage 1 = 1460; Stage 2 = 1324; Stage 3 = 975; Stage 4 = 500.
  • SVR was no different between WBD (657/1464; 45%) and FD 611/1445; 42%) RBV in patients with stage 0 – 2 fibrosis.
  • However SVR in stage 3 to 4 was significantly increased in the WBD group ( 282 / 657; 43%) compared to the FD group ( 242 / 657; 37%); p = 0.02.
  • In the entire population of patients logistic regression showed no statistically significant difference in SVR rates between Stage 0 (44%), Stage 1 (46%), Stage 2 (44%) and Stage 3 (44%).
  • However all stages were significantly superior to Stage 4 which only had an SVR of 34% (p < 0.0001).

 

In conclusion, the authors write, “WBD of RBV is important to increase SVR in patients with more advanced stages of liver disease. However, overall only cirrhosis is a negative predictor of SVR when individual fibrosis stage and SVR is evaluated.”

“The cirrhotic patient represents a difficult to treat patient requiring optimal therapy, including weight-based RBV.”

The Win-R trial was supported by Schering-Plough.

05/23-06

Reference
N. Afdhal, I. Jacobsen, R. Brown, and others. The effect of liver fibrosis and cirrhosis on SVR in 4913 patients with hepatitis C; Results from the Win-R trial. Abstract 655 (Oral Presentation). Digestive Disease Week 2006 (DDW 2006). May 20-25, 2006. Los Angeles, CA.