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Good Hepatitis B Treatment Outcomes in Patients with Advanced Liver Fibrosis or Cirrhosis

People with chronic hepatitis B who have advanced liver fibrosis are often not considered for treatment with pegylated interferon, because interferon may lead to immunological 'flares' of liver inflammation that could potentially cause hepatic decompensation.

As reported in the August 2007 issue of Hepatology, researchers assessed the efficacy and safety of treating advanced chronic hepatitis B patients with pegylated interferon alone or in combination with lamivudine (Epivir-HBV).

The study included 239 hepatitis B "e" antigen (HBeAg) positive patients, of whom 70 had advanced fibrosis (Ishak fibrosis score 4-6). All had compensated liver disease at study entry. Patients were treated with 100 mcg/week pegylated interferon alpha-2b (PegIntron) with or without 100 mg daily lamivudine (Epivir-HBV) for 52 weeks.

Results

Virological response (defined as HBeAg seroconversion and HBV DNA < 10,000 copies/mL at week 78) occurred significantly more often in patients with advanced fibrosis than in those without (25% vs 12%, respectively; P = 0.02).

Patients with cirrhosis (n = 24) exhibited a virological response more frequently than those without cirrhosis (30% vs 14%, respectively; P = 0.02).

Improvement in liver fibrosis occurred more frequently in patients with advanced fibrosis at baseline (66% vs 26%; P < 0.001).

HBV genotype A was more prevalent among patients with advanced fibrosis than among those without (57% vs 24%; P < 0.001).

Most adverse events, including serious adverse events, were observed with equal frequency in patients with and without advanced fibrosis.

Fatigue, anorexia, and thrombocytopenia occurred more often in patients with advanced fibrosis than in those without (P < 0.01).

The frequency of necessary dose reduction or discontinuation of therapy was comparable for both groups (P = 0.92 and P = 0.47, respectively).

Conclusion

"Pegylated interferon is effective and safe for HBeAg-positive patients with advanced fibrosis," the authors concluded. "Because pegylated interferon therapy results in a high rate of sustained off-therapy response, patients with advanced fibrosis or cirrhosis but compensated liver disease should not be excluded from pegylated interferon treatment."

09/14/07

Reference
E H Buster, B E Hansen, M Buti, and others (HBV 99-01 Study Group). Peginterferon alpha-2b is safe and effective in HBeAg-positive chronic hepatitis B patients with advanced fibrosis. Hepatology 46(2): 388-394. August 2007.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FDA-approved
Monotherapies for HBV

Baraclude
  (entecavir)
 Epivir-HBV
  (lamivudine; 3TC)
Intron A
  (interferon alfa-2b)
Hepsera
  (adefovir dipivoxil)
Pegasys
  (peginterferon alfa-2a)
Tyzeka
  (telbivudine)

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