Pegylated interferon-alpha2b plus ribavirin: an efficacious and well-tolerated treatment regimen for patients with hepatitis C virus related histologically proven cirrhosis

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Antivir Ther. 2008;13(5):663-73.

Pegylated interferon-alpha2b plus ribavirin: an efficacious and well-tolerated

treatment regimen for patients with hepatitis C virus related histologically

proven cirrhosis.

Roffi L, Colloredo G, Pioltelli P, Bellati G, Pozzpi M, Parravicini P, Bellia V,

Del Poggio P, Fornaciari G, Ceriani R, Ramella G, Corradi C, Rossini A, Bruno S;

Gruppo Epatologico Lombardo.

Department of Internal Medicine, Azienda Ospedaliera della Valtellina e della

Valchiavenna, Sondrio, Italy.

BACKGROUND: Little is known about the efficacy, safety and tolerability of

pegylated interferon plus ribavirin treatment in patients with chronic hepatitis

Cvirus (HCV) infection and histologically proven fully established cirrhosis. We

aimed here to evaluate the safety of this regimen in such patients and to

identify baseline and on-treatment predictors of a sustained virological

response (SVR). METHODS: Patients with histologically proven, HCV-induced

cirrhosis were randomized to receive pegylated interferon-alpha2b

(PEG-IFN-alpha2b; 1.0 microg/kg/week, n=56; group A) or recombinant

interferon-alpha2b (IFN-alpha2b; 3 million IU three times/week, n=36; group ,

each in combination with a weight-based dose of ribavirin (800-1,200 mg/day) for

up to 48 weeks. The primary endpoint of the study was the assessment of SVR,

defined as undetectable HCV RNA 24 weeks after treatment cessation. RESULTS:

Overall, 40% (37/93) of patients attained SVR: 44% (25/57) in group A and 33%

(12/36) in group B (P=0.31). SVR rates were significantly higher in genotype 2/3

patients than in genotype 1 patients (69% versus 25%; P