Different PEG-interferon and Ribavirin Schedules for Chronic Hepatitis C in the Real Clinical Practice.
Status:
Completed
Trial end date:
2010-08-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 4
Details
Lead Sponsor:
Azienda Ospedaliera di Padova
Collaborators:
Regione Veneto University of Padova University of Padua