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HEPATITIS C NEWS

Treatment Response in Cirrhotic Hepatitis C Patients with Portal Hypertension

Patients with cirrhosis due to chronic hepatitis C virus (HCV) infection may develop portal hypertension, a condition in which scarring in the liver causes impaired blood flow and elevated intrahepatic blood pressure.

Due to the risk of complications, interferon-based therapy has traditionally been considered contraindicated in cirrhotic patients, but some may benefit from treatment.

At the 57th annual meeting of the American Association for Liver Diseases (AASLD) last month in Boston, researchers from the University of Palermo in Italy reported on a study to assess outcomes in a prospective cohort of HCV positive patients with cirrhosis after antiviral therapy.

The study included 174 consecutive patients with Child-Pugh A5-A6 cirrhosis. The mean age was 57 years, 62.1% were men, and 56.3% had esophageal varices. Most (88.5%) had genotype 1 HCV. About two-thirds (67.2%) were treatment-naive and 32.8% were previously treated with conventional interferon monotherapy.

Participants were treated with pegylated interferon alone (27%) or pegylated interferon plus ribavirin (73%), and were followed for at least 6 months after therapy (median 24 months, range 6-53 months).

Results

  • 59 patients (34%) discontinued therapy due to side effects, and 115 received the full scheduled treatment.
  • 32 out of 174 patients (18.3%) achieved sustained virological response (SVR) in an intent-to-treat analysis, and 32 out of 115 (27.8%) in an as-treated analysis.
  • There were no significant differences in treatment response among patients with and without esophageal varices (15.5 vs 21.1%; P = 0.3).
  • Patients with SVR:

- were younger (53.7 vs 57.8 years; P < 0.01);
- were more likely to have genotype 2 or 3 HCV (65% vs 11.8%; P < 0.001);
- had higher baseline ALT levels (4.7 vs 3.6 x upper limit of normal [ULN]; P < 0.05);
- had lower baseline gamma-glutamyl transferase (GGT) levels (1.7 vs 2.7 x ULN; P < 0.05).

  • Logistic regression revealed that the following were independent predictors of SVR:

- age 62 years or younger (RR 5.8; 95% CI 1.1-30.2);
- genotype 2 or 3 HCV (RR 18.1; 95% CI 5.1-64);
- baseline ALT > 3 ULN (RR 4.1; 95% CI 1.5-11.5);
- baseline GGT ? 1 ULN (RR 4.3;, 95% CI 1.6-11.6).

  • During follow-up, 34 patients (19.5%) developed at least 1 liver complication.
  • 2 patients died due to liver-related causes, and 1 died due to extrahepatic cancer.
  • All 34 patients with complications had genotype 1 HCV and 25 had esophageal varices.
  • 31 liver-related events occurred in non-responders, compared with 2 events in patients achieving SVR (22.5% vs 6.3%; P < 0.05).
  • By Cox regression analysis, esophageal varices (RR 3.3; 95% CI 1.5-7.1) and SVR (RR 4.9; 95% CI 1.2-20.4) were significantly associated with liver disease progression.

Conclusion

Pegylated interferon and ribavirin obtains a sustained virological response in 1/5 of patients with compensated cirrhosis," the researchers wrote in conclusion. "The sustained response was more common for genotypes 2 or 3, in patients with age less than 60 years, with elevated values of ALT, and low levels of GGT."

Treatment withdrawal due to intolerance and hematological toxicity was common, without life-threatening events," they continued. "Patients with sustained virological response had a minor incidence of disease complications during a short-term follow-up."

V Di Marco, P Almasio, S De Lisi, and others. The effect of antiviral therapy on clinical outcome of HCV cirrhosis with portal hypertension: a prospective cohort study. 57th AASLD. Boston, MA. October 27-31, 2006. Abstract 719.


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