Different PEG-interferon and Ribavirin Schedules for Chronic Hepatitis C in the Real Clinical Practice.
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| ClinicalTrials.gov Identifier: NCT01195181 |
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Recruitment Status
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Completed
First Posted
: September 6, 2010
Last Update Posted
: September 6, 2010
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatitis C Virus Chronic Liver Disease Viral Hepatitis Therapeutic Uses Antiviral Agents | Drug: peginterferon plus ribavirin | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 506 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Improvement of the Surveillance and Control of Liver Disease and Complication Due to Chronic Hepatitis C: Project A) Antiviral Drugs Use, Efficacy, Safety and Costs; Project B) Kinetics of Virological Response. |
| Study Start Date : | September 2005 |
| Actual Primary Completion Date : | December 2009 |
| Actual Study Completion Date : | August 2010 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: peginterferon alfa-2a plus ribavirin
patients will receive a fixed dose of 180ug/week of peginterferon alfa-2a plus ribavirin at 15mg/kg/daily.
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Drug: peginterferon plus ribavirin
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 Names:
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Active Comparator: peginterferon alfa-2b plus ribavirin
patients will receive a weight adjusted dose (1,5ug/kg) from 50 to 150ug/week of peginterferon alfa-2b (standard dose) or a lower dose (1,0ug/kg) at physician discretion (randomization list available only for 100 cases) plus ribavirin at 15mg/kg/daily.
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Drug: peginterferon plus ribavirin
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 Names:
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- Evaluation of real dose drugs intake in relation to sustained virological response (SVR). [ Time Frame: Measurement of HCV-RNA at 24° week after therapy withdrawal. ]Project A) The analysis will describe the efficacy (SVR) and costs of the 3 different antiviral schedules proposed.
- Description of the profile of the virus decay during antiviral therapy in relation to virological response. [ Time Frame: Measurement of HCV-RNA during therapy in relation to negativity at 24° week after therapy withdrawal. ]Project B) The analysis will evaluate the kinetics of virological response obtained with the two peginterferons plus ribavirin by HCV-RNA quantification (Cobas,TaqMan, Roche) at basal time and at 1°,4°,12°,24°,36°,48° week during therapy and at 24° week after therapy withdrawal.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01195181
| Italy | |
| Department of Clinical and Experimental Medicine, Out-patients Hepatologic Unit, Azienda Ospedaliera di Padova. | |
| Padua, Italy, 35100 | |
| Study Chair: | liliana chemello, M.D., Ph.D. | University of Padua | |
| Principal Investigator: | luisa cavalletto, M.D., Ph.D. | Azienda Ospedaliera di Padova |
Publications:
| Responsible Party: | Liliana Chemello, M.D, Ph.D., Scientific Director, Department of Clinical and Experimental Medicine, University of Padua. Italy |
| ClinicalTrials.gov Identifier: | NCT01195181 History of Changes |
| Other Study ID Numbers: |
HEPCOVE protocol DRG N.2920/2002 ( Other Grant/Funding Number: Regione Veneto ) |
| First Posted: | September 6, 2010 Key Record Dates |
| Last Update Posted: | September 6, 2010 |
| Last Verified: | September 2010 |
Keywords provided by Azienda Ospedaliera di Padova:
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peginterferon alfa 2a and 2b type ribavirin chronic hepatitis C antiviral therapy cost/efficacy viral kinetics |
Additional relevant MeSH terms:
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Hepatitis Hepatitis A Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections |
Flaviviridae Infections Ribavirin Peginterferon alfa-2a Interferon-alpha Peginterferon alfa-2b Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs |