Treatment with Pegasys Plus Ribavirin in Genotype 2/3 Chronic Hepatitis C Patients with Liver Cirrhosis

Chronic hepatitis C patients with advanced liver fibrosis or cirrhosis have a higher risk of developing severe complications, and therefore are in particular need of treatment.

In the ACCELERATE trial of pegylated interferon alfa-2a (Pegasys) plus ribavirin in patients with genotype 2 or 3 HCV infection, cirrhosis was a significant negative prognostic factor for sustained virological response (SVR).

As reported at the Digestive Disease Week 2007 meeting this week in Washington, DC, researchers further analyzed information from the ACCELERATE database to compare the efficacy of treatment in patients with and without cirrhosis. They also assessed whether on-treatment virological response would assist treatment optimization.

The analysis included 1309 genotype 2/3 chronic hepatitis C patients who received 180 mcg/week Pegasys plus 800 mg/day ribavirin for either 16 or 24 weeks; 24 weeks is the standard duration of therapy for these genotypes, but some research suggests that 16 weeks may be adequate for some patients.

Results

• 56% of patients with cirrhosis and 71% of non-cirrhotic patients achieved rapid virological response (RVR), defined as undetectable HCV RNA at week 4 of treatment.
  
  
• Patients with cirrhosis had a lower sustained virological response (SVR) rate than non-cirrhotic patients.
  
  
• For both cirrhotic and non-cirrhotic groups, the SVR rate was higher with 24 versus 16 weeks of therapy.
  
  
• Non-cirrhotic patients with RVR had SVR rates of 85% and 91% with 16 and 24 weeks of therapy, respectively.
  
  
• Among cirrhotic patients with RVR, the corresponding SVR rates were 71% and 87%.
  
  
• 24-week treatment also produced higher SVR rates in both cirrhotic and non-cirrhotic patents without RVR.
  

Conclusion

“Higher SVR rates with peginterferon alfa-2a plus ribavirin therapy are achieved in genotype 2/3 pts without cirrhosis, supporting early treatment before progression to advanced liver disease,” the researchers concluded. “In patients with RVR, 24 weeks’ treatment resulted in SVR rates > 87% in both cirrhotic and non-cirrhotic patients.”

“Cirrhotic patients without RVR have a chance of SVR of only 30% with the currently recommended 24-wk regimen,” they continued. “[I]n these patients, longer treatment durations might be beneficial.”

They added that, “Assessing on-treatment virologic response at week 4 thereby allows treatment optimization in both cirrhotic and non-cirrhotic pts with HCV genotype 2/3 infection.”

Virginia Commonwealth University Medical Center, Richmond, VA; Ospedali Riuniti, Bergamo, Italy; St Louis University, St Louis, MO; University of Florida, Gainsville, FL; Royal Adelaide Hospital, Adelaide, SA, Australia; Minas Gerais Faderal University School of Medicine, Barcelona, Spain; University of Alberta Hospital, Edmonton, AB, Canada; Hopital Purpan, Toulouse, France; Saarland University Hospital, Homburg/Saar, Germany; Roche, Nutley, NJ and Welwyn, UK.

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