Different PEG-interferon and Ribavirin Schedules for Chronic Hepatitis C in the Real Clinical Practice.
Condition: Hepatitis C Virus; Chronic Liver Disease; Viral Hepatitis; Therapeutic Uses; Antiviral Agents
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Liver Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      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).
    

Detailed description: 
      (Project B) To evaluate the viral kinetic decay during antiviral combination therapy with
      P-IFN alfa-2a and 2b type plus ribavirin.
    

Intervention name(s): peginterferon plus ribavirin
Intervention type(s): Drug
Intervention description(s): peginterferon alfa-2a at 180ug/week (preempt syringe, sc) or peginterferon alfa-2b at 1,5 ug/kg/week (standard dose) or at 1,0 ug/kg/week (lower dose)(preempt pen, sc) for 24 or 48 week in relation to HCV genotype plus ribavirin (capsules, po) at 15mg/kg/daily combination therapy.
Other intervention name(s): Pegasys; PegIntron; Copegus; Rebetol
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: peginterferon alfa 2a and 2b type; ribavirin; chronic hepatitis C; antiviral therapy cost/efficacy; viral kinetics