Pegylated interferon-α2b plus ribavirin : an efficacious and well-tolerated treatment regimen for patients with hepatitis C virus related histologically proven cirrhosis

• Published in: Antiviral therapy Vol. 13; no. 5; pp. 663 - 673
• Main Authors: ROFFI, Luigi, COLLOREDO, Guido, RAMELLA, Giuliano, CORRADI, Chiara, ROSSINI, Angelo, BRUNO, Savino, PIOLTELLI, Pietro, BELLATI, Giorgio, POZZI, Massimo, PARRAVICINI, Pierpaolo, BELLIA, Valentina, DEL POGGIO, Paolo, FORNACIARI, Giovanni, CERIANI, Roberto
• Format: Journal Article
• Language: English
• Published: London International Medical Press 01.07.2008
• Subjects: Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiviral agents; Biological and medical sciences; Gastroenterology. Liver. Pancreas. Abdomen; Human viral diseases; Infectious diseases; Liver. Biliary tract. Portal circulation. Exocrine pancreas; Medical sciences; Other diseases. Semiology; Pharmacology. Drug treatments; Viral diseases; Viral hepatitis; Antineoplastic agent; Human; Drug combination; Cytokine; Hepatic disease; Ribavirin; Infection; Virus; Cirrhosis; Treatment; Interferon alpha 2b; Viral disease; Nucleoside analog; Digestive diseases; Antiviral; Flaviviridae; Pegylated form; Hepatitis C virus; Hepacivirus; Viral hepatitis C
• ISSN: 1359-6535; 2040-2058
• DOI: 10.1177/135965350801300506

Background Little is known about the efficacy, safety and tolerability of pegylated interferon plus ribavirin treatment in patients with chronic hepatitis C virus (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-α2b (PEG-IFN-α2b; 1.0 μg/kg/week, n=56; group A) or recombinant interferon-α2b (IFN-α2b; 3 million IU three times/week, n=36; group B), 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<0.0001). Platelet count at baseline, rapid virological response, and early virological response were predictors of SVR. Twelve patients discontinued treatment because of an adverse event and 20 patients required ribavirin dose reduction for the management of anaemia. Conclusions PEG-IFN-α2b plus ribavirin for 48 weeks is an efficacious and well-tolerated treatment regimen for patients with HCV-induced cirrhosis. Although SVR rates were more satisfactory in genotype 2/3 than in genotype 1 patients, our study identified additional predictors of response that could allow physicians to better manage treatment in this ‘difficult-to-cure’ subset of patients.