Different PEG-interferon and Ribavirin Schedules for Chronic Hepatitis C in the Real Clinical Practice.
Different PEG-interferon and Ribavirin Schedules for Chronic Hepatitis C in the Real Clinical Practice.
Hepatitis C virus (HCV) infection provokes thousands of deaths every year all over the world,
 being the major cause of progressive liver disease, primary hepatic cancer and liver
 transplantation. Today, a "curative" therapy is available, that can eradicate the viral
 infection and determine the regression of liver fibrosis, also in cirrhotic subjects.

 The current standard-of-care for HCV chronic infection is combination therapy with
 peginterferon (P-IFN) and ribavirin (RBV). However, this treatment is not only expensive but
 determines several side effects, that can reduce drug tolerance and hence, patient adherence
 to therapy. There are two types of available P-IFN on the market: P-IFN alfa-2a (Pegasys®,
 F.Hoffmann-La Roche) administered at a flat-dose of 180 mcg/week and P-IFN alfa-2b
 (PegIntron®, Schering-Plough) given at a weight-based dose of 50 to 150 mcg/week. Since only
 a single amino acid differentiates these types of IFN, administration strategies depend on
 their pegilation with molecules of 40 or 12kDa, respectively, that accounts for differences
 in the pharmacokinetic and pharmacodynamic drug-profile and influences probably also
 bioactivity. No comparative data are available on the benefits and costs of the licensed
 Peg-IFN plus RBV for the treatment of HCV infection in the real clinical practice, even if,
 the benefit and favourable cost-efficacy of this antiviral therapy is well established and of
 large consensus. Recently, the first randomized controlled mega-trial to compare antiviral
 therapeutic efficacy in naïve patients with HCV-genotype 1 infection during different
 regimens of P-IFN alfa-2b (at low and standard-dose) and P-IFN alfa-2a plus RBV, has been
 published, confirming a similar efficacy, of around 40%, obtained with the three schedules
 evaluated.

 In Italy, a regional program on the Surveillance and Control of HCV Infection, set up by the
 Regional Health Councillorship, has led to the development of a clinical and epidemiological
 observatory, constituted by a network of liver tertiary centres (Hepatological Cooperative
 Network of Veneto, HepCoVe). This collaborative group is connected on-line by a common
 database that, since 2003, has prospectively collected data on a cohort of more than 3000
 patients with chronic HCV infection and, among them, of 506 naïve subjects that consecutively
 underwent combination therapy with P-IFN alfa-2a or alfa-2b plus RBV.

 The aim of this study was to rationalize and improve the social regional health program on
 antiviral treatment of chronic hepatitis C by assessing the different schedules utilization
 of P-IFN plus RBV as well as the respective therapeutic effectiveness, safety and costs in
 the real clinical practice (Project A).
(Project B) To evaluate the viral kinetic decay during antiviral combination therapy with
 P-IFN alfa-2a and 2b type plus ribavirin.
Inclusion Criteria:

 -  Naive adult subject

 -  active HCV infection (HCV-RNA positive)

 -  histological/biochemical signs of chronic hepatitis or compensated cirrhosis

 -  willingness of treatment

 Exclusion Criteria:

 -  autoimmune disorders

 -  severe depression or psychiatric disease

 -  previous decompensation of cirrhosis

 -  gastroesophageal bleeding

 -  hepatocellular carcinoma

 -  major disease with a life expectancy of less than 5 years

 -  pregnancy or nursing