Who Is More Likely to Respond to Dual Treatment With Pegylated-Interferon and Ribavirin for Chronic Hepatitis C?

A Gender-Oriented Analysis

V. Di Marco; L. Covolo; V. Calvaruso; M. Levrero; M. Puoti; F. Suter; G. B. Gaeta; C. Ferrari; G. Raimondo; G. Fattovich; T. Santantonio; A. Alberti; R. Bruno; C. Mussini; M. Mondelli; F. Donato; A. Craxì


J Viral Hepat. 2013;20(11):790-800. 

In This Article

Patients and Methods

Study Design

Patients were included in a prospective cohort study aimed at evaluating adherence to antiviral therapy, as well as viral and host factors that influence response to combined PEG-IFN and RBV therapy. The protocol was approved and supported by a grant from the Agenzia Italiana del Farmaco (AIFA).

Eligibility criteria for entering the study included Caucasian ancestry, age over 18 years, HCV-RNA in serum detectable by polymerase chain reaction (PCR) and alanine aminotransferase (ALT) above the upper limit of normal for at least 6 months before the treatment. Patients underwent liver biopsy according to current guidelines[29] and clinical practice protocols used in each centre. The study was approved by local ethics committees, and each patient signed an informed consent for the collection of clinical data and the storage of biological samples for virologic genetic and metabolic tests.

Therapy was based on the combination of Peg-IFN apha2a (180 μg/week) or Peg-IFN alpha2b (1.5 μg/kg/week) plus RBV (800–1200 mg/day) for 48 weeks in HCV genotype 1 or 4 patients, and for 24 weeks in HCV genotype 2 or 3 patients. Genotype 1 and genotype 4 patients who had less than a 2 log10 drop in viral load at week 12 with respect to baseline, and patients with HCV-RNA still detectable at week 24, were defined 'nonresponders' and stopped the therapy.[29] All patients abstained completely from alcohol during treatment.