Pharmacoeconomic Study Assessing the Cost of Chronic Hepatitis C Treatment With PegIntron (Peginterferon α-2b) and Rebetol (Ribavirin) in the Czech Republic (Study P04588)
Summary
The objective of the study is to evaluate the costs associated with PegIntron plus Rebetol treatment for chronic hepatitis C in the Czech Republic. Only costs associated with rescue medication, concomitant therapy, disease monitoring, and medical intervention costs recognized by the treating institution as treatment-related expenses will be included in the analysis. The study will also evaluate the correlation between HCV therapy-related costs with ribavirin dosing and patient history.
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Conditions
Hepatitis C, Chronic
Intervention
PegIntron (peginterferon alfa-2b; peginterferon α-2b; SCH 54031), Rebetol (ribavirin; SCH 18908)
Location
Coordinating Location
Prague
Czech Republic
Status
Recruiting
Source
Schering-Plough
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00723632
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Interferon Alfa-2c
A recombinant alfa interferon consisting of 165 amino acids with arginine at positions 23 and 34. It is used extensively as an antiviral and antineoplastic agent.
Interferon Alfa-2a
A recombinant alfa interferon consisting of 165 amino acids with lysine at position 23 and histidine at position 34. It is used extensively as an antiviral and antineoplastic agent.
Interferon Alfa-2b
A recombinant alfa interferon consisting of 165 amino acid residues with arginine in position 23 and histidine in position 34. It is used extensively as an antiviral and antineoplastic agent.
Epoetin Alfa
This recombinant erythropoietin, a 165-amino acid glycoprotein (about 62% protein and 38% carbohydrate), regulates red blood cell production. Epoetin alfa is produced by Chinese hamster ovary cells into which the human erythropoietin gene has been inserted. (USP Dictionary of USAN and International Drug Names, 1996).
Ribavirin
A nucleoside antimetabolite antiviral agent that blocks nucleic acid synthesis and is used against both RNA and DNA viruses.
Clinical Trials
The objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1)...
The objective of the study is to evaluate the rates of HCV eradication and relapse in subjects treated with PegIntron and Rebetol in clinical practice in Greece. Patients will not be trea...
The objective of this study is to evaluate patient satisfaction in hepatitis C patients receiving PegIntron pen plus Rebetol. The rationale is that the effectiveness of treatment is corre...
The objective of the study is to evaluate, in each group (treatment-naïve, retreatment, and co-infected patients), the number of patients who achieve rapid virological response (RVR) afte...
Study P02538 Part 2 is a 5-year follow-up study in pediatric subjects who were treated with at least one dose of peginterferon alfa-2b and ribavirin and who completed the follow-up in the...
PubMed Articles
BACKGROUND & AIMS:: Patients infected with hepatitis C virus (HCV) genotype 1, body weights >/=85 kg and high baseline viral loads respond poorly to standard doses of peginterferon and ribavirin. We e...
BACKGROUND: Peginterferon plus ribavirin achieves sustained virological response (SVR) in fewer than half of patients with genotype 1 chronic hepatitis C virus infection treated for 48 weeks. We teste...
BACKGROUND & AIMS: Peginterferon plus ribavirin has been the standard of care for chronic hepatitis C for a decade and an essential component of combination regimens for this disease. This large multi...
Objective: This analysis examines the safety profile of standard- versus high-dose peginterferon alfa-2a. Methods: Data were pooled from five trials including HCV genotype 1- or 4-infected naive and t...
Peginterferon alfa-2a results in a sustained response (SR) in a minority of patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB). This study investigated the role of early on...
