Document Detail

Efficacy, tolerability and predictive factors for early and sustained virologic response in patients treated with weight-based dosing regimen of PegIFN alpha-2b ribavirin in real-life healthcare setting.
MedLine Citation:
PMID:  17410285     Owner:  NLM     Status:  MEDLINE    
BACKGROUND AND AIM: Increasing evidence to date highlights that individualized treatment regimens with pegylated interferon (PegIFN) and ribavirin represent a better approach for patients nowadays showing negative predictive factors for sustained virological response. The aims of this study were to assess the rate of early (EVR) and sustained virological response (SVR), tolerability and baseline predictive factors associated with EVR and SVR in patients with chronic hepatitis C treated with individualized weight-based dosing regimen for both PegIFN alpha-2b and ribavirin. METHODS: The observational analysis included 234 consecutive patients with chronic hepatitis C genotype 1 treated with PegIFN alpha-2b and ribavirin on an out-patient basis between January 2003-March 2006. RESULTS: The mean age of the study group was 49.5 years, and 35% were male patients; the group was slightly overweight (mean BMI=26.5 kg/sq.m). EVR was achieved in 84.6% (198/234 patients). The end-of-treatment and sustained biochemical responses were 76.3% and 66.1%, respectively. At the end of follow-up, an overall intent-to-treat SVR was achieved by 71 of 127 patients (in 55.9%). Lower baseline (< 1,000 000 IU/mL) HCV viral load was the only predictive factor associated with EVR (p=0.04); absent or mild fibrosis (F0-1) and a low histological activity (HAI < 8) were independently associated with SVR. Side effects resulted in PegIFN and ribavirin dose reductions in 9.4% and, respectively, 18.1%, but definitive discontinuation of therapy was necessary only in 8.7% of patients. CONCLUSION: PegIFN alpha-2b and ribavirin can be safe and successful when using a weight-based dosing regimen, leading to high response rates even in overweight patients.
Liana Gheorghe; Speranta Iacob; Ioan Sporea; Mircea Grigorescu; Roxana Sirli; Dana Damian; Cristian Gheorghe; Razvan Iacob
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of gastrointestinal and liver diseases : JGLD     Volume:  16     ISSN:  1841-8724     ISO Abbreviation:  J Gastrointestin Liver Dis     Publication Date:  2007 Mar 
Date Detail:
Created Date:  2007-04-05     Completed Date:  2007-06-19     Revised Date:  2009-12-16    
Medline Journal Info:
Nlm Unique ID:  101272825     Medline TA:  J Gastrointestin Liver Dis     Country:  Romania    
Other Details:
Languages:  eng     Pagination:  23-9     Citation Subset:  IM    
Department of Hepatology, Center of Gastroenterology and Hepatology, Fundeni Clinical Institute, Str. Fundeni no. 258, 72437 Bucharest, Romania.
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MeSH Terms
Antiviral Agents / administration & dosage*
Body Weight
Cohort Studies
Dose-Response Relationship, Drug
Drug Therapy, Combination
Interferon Alfa-2b / administration & dosage*
Middle Aged
Polyethylene Glycols
Predictive Value of Tests
Ribavirin / administration & dosage*
Time Factors
Treatment Outcome
Viral Load
Reg. No./Substance:
0/Antiviral Agents; 0/Polyethylene Glycols; 0/peginterferon alfa-2b; 36791-04-5/Ribavirin; 99210-65-8/Interferon Alfa-2b
Comment In:
J Gastrointestin Liver Dis. 2007 Jun;16(2):171-2   [PMID:  17592565 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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