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.
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