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Low-Dose PegIFN Maintenance Therapy Successful
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Reported by Jules Levin
EASL, April 2007, Barcelona, Spain
"LONGTERM TREATMENT WITH PEG-IFN-ALFA2B REDUCES HEPATOCELLULAR INCIDENCE AND PREVENTS CLINICAL COMPLICATIONS IN HEPATITIS C CIRRHOSIS - AN INTERIM ANALYSIS OF A MULTICENTER TRIAL"
A. Erhardt 1, U. Heinzel-Pleines 1, W. Boecher 2, H. Wedemeyer 3, M.M. Dollinger 5, F.W. Albert 6, T. Witthoeft 4, D. Haeussinger 1
1 Universitaetsklinik Duesseldorf, Duesseldorf, Germany; 2 Universitaetsklinik Mainz, Mainz, Germany; 3 Medizininische Hochschule Hannover, Hannover, Germany; 4 Universitaetsklinik Schleswig-Holstein, Schleswig-Holstein, Germany; 5 Universitaetsklinik Halle, Halle, Germany; 6 Westpfalzklinik Kaiserslautern, Kaiserslautern, Germany
Background and aims: Interferons has been shown to inhibit fibrosis progression. This multicenter, randomized, prospective trial investigated the efficacy of low-dose pegylated interferon-alpha 2b (0,35-1µg/kg/wk) given for 3 years to prevent complications of liver cirrhosis.
Methods/patients: Patients (N=88) with chronic hepatitis C and histologically proven cirrhosis (Child Pugh Score 5-7) who were non-responsive to anti-viral therapy were randomised to treatment with low dose pegylated interferon-alpha 2b (0,35-1µg/kg/wk, group A) or observation only (group B). Gastroscopy and liver function tests were performed every 12 months, sonography, clinical and laboratory controls were carried out every 6 months.
Results:
Mean follow-up of the patients was 17±11 months.
--Kaplan-Meier analysis showed a decreased incidence of hepatocellular carcinoma in patients treated with low-dose pegylated interferon compared to untreated controls (p<0.01).
--There were 6 HCC in the control arm but none in the treatment arm.
--Other complications of liver cirrhosis like hepatic encephalopathy, ascites and esophageal variceal bleeding or progression of varices were significantly diminished (p<0.01) in the treated compared to the untreated patients.
--ALT and GGT levels at one year worsened in untreated patients but remained stable in IFN treated patients (p<0.005).
--HCV load dropped from 1.7 x106 IU/ml to 0.8 x 106 IU/ml in group A (p<0.004) but did not change in group B.
Conclusions: The interim analysis suggests that the incidence of HCC and other complications of liver cirrhosis can be reduced in HCV-associated liver cirrhosis by longterm application of pegylated interferon-alpha 2b. However complete follow-up of patients has still to be accomplished
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