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Interferon-based Therapy Less Effective for Hepatitis C Patients with Advanced Liver Fibrosis or Cirrhosis

SUMMARY: People with chronic genotype 1 hepatitis C virus (HCV) infection who have developed advanced liver fibrosis or cirrhosis are not as likely as those with less severe disease to achieve sustained virological response to pegylated interferon plus ribavirin, according to a report in the February 2010 issue of Hepatology. Sustained response rates were similar, however, for people with good early viral suppression.

By Liz Highleyman

Over years or decades, chronic hepatitis C can progress to severe liver disease including advanced fibrosis affecting large areas of the liver, cirrhosis, and hepatocellular carcinoma (liver cancer).

Savino Bruno and colleagues from Italy conducted a study to assess the safety and efficacy of pegylated interferon alfa-2a (Pegasys) plus ribavirin in people with advanced fibrosis enrolled in 3 international randomized clinical trials.

The analysis included data from 341 chronic hepatitis C patients with hard-to-treat HCV genotypes 1 or 4 patients (99 of whom had bridging fibrosis or cirrhosis) and 1547 patients with genotype 2 or 3 (380 of whom had advanced fibrosis or cirrhosis). Genotype 1 or 4 patients were treated 48 weeks, while those with genotypes 2 or 3 were treated for either 16 or 24 weeks.

The researchers looked at early virological response after starting treatment and sustained virological response (SVR), defined as continued undetectable HCV RNA viral load 24 weeks after completion of therapy.


SVR rates progressively decreased as degree of liver damage increased:
Genotype 1 or 4 patients:
60% SVR without advanced fibrosis;
51% SVR with bridging fibrosis;
33% SVR with cirrhosis (P = 0.0028 for trend).
Genotype 2 or 3 treated for 24 weeks:
76% SVR without advanced fibrosis;
61% SVR with bridging fibrosis;
57% SVR with cirrhosis (P < 0.0001 for trend).
Regardless of genotype, participants without advanced fibrosis were more likely to experience early response to treatment.
Earlier treatment response was associated with higher SVR rates and lower relapse rates during post-treatment follow-up.
Patients with similar responses during the first 12 weeks of treatment had similar SVR and relapse rates, regardless of degree of fibrosis/cirrhosis.

Based on these findings, the study authors concluded, "Compared with patients with less severe disease, SVR rates are significantly lower in patients with advanced fibrosis."

However, they added, "irrespective of genotype and degree of fibrosis, the time to become hepatitis C virus (HCV) RNA undetectable was the strongest predictor of SVR."

AO Fatebenefratelli e Oftalmico, Milan, Italy; Virginia Commonwealth University Medical Center, Blacksburg, VA; The Alfred Hospital, Melbourne, Australia; Auckland Clinical Studies, Auckland, New Zealand; IST, Mannheim, Germany; Henry Dunant Hospital, Athens, Greece; Service d'Hepatologie and Centre de Recherches Biologiques Bichat Beaujon (Inserm CRB3), Hôpital Beaujon, Clichy, France.


S Bruno, ML Shiffman, SK Roberts, and others. Efficacy and safety of peginterferon alfa-2a (40KD) plus ribavirin in hepatitis C patients with advanced fibrosis and cirrhosis. Hepatology 51(2): 388-397 (Abstract). February 2010.






















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