Document Detail

Efficacy and tolerability of peginterferon alfa-2a or alfa-2b plus ribavirin in the daily routine treatment of patients with chronic hepatitis C in Germany: the PRACTICE study.
MedLine Citation:
PMID:  20158603     Owner:  NLM     Status:  MEDLINE    
In randomized clinical trials, treatment with peginterferon plus ribavirin (RBV) results in a sustained virological response (SVR) in around half of hepatitis C virus genotype 1-infected and 80% of genotype 2/3-infected individuals. This study aimed to evaluate efficacy and tolerability of peginterferon alfa-2a plus RBV compared with peginterferon alfa-2b plus RBV for the treatment of chronic hepatitis C in routine clinical practice. The intent-to-treat cohort consisted of 3414 patients treated with either peginterferon alfa-2a plus RBV (Group A) or peginterferon alfa-2b plus RBV (Group B) in 23 centres participating in the large, multicentre, observational PRACTICE study. Collected data included baseline characteristics, treatment regimen, RBV dose and outcome. Rates of early virological response, end of treatment response and SVR were 76.6%, 75.7% and 52.9% in Group A, and 70.2%, 65.6% and 50.5% in Group B, respectively. In patients matched by baseline parameters, 59.9% of patients in Group A and 55.9% in Group B achieved an SVR (P < or = 0.051). In genotype 1-infected patients matched by baseline parameters and cumulative RBV dose, SVR rates were 49.6% and 43.7% for Group A and Group B, respectively (P < or = 0.047); when matched by baseline parameters and RBV starting dose, SVR rates were 49.9% and 44.6%, respectively (P = 0.068). Overall, 21.8% of group A and 29.6% of group B patients discontinued treatment (P < or = 0.0001). The efficacy and tolerability of peginterferon plus RBV in this large cohort of patients treated in routine daily practice was similar to that in randomized clinical trials. In matched pairs analyses, more patients achieved an SVR with peginterferon alfa-2a compared with peginterferon alfa-2b.
T Witthoeft; D Hueppe; C John; J Goelz; R Heyne; B Moeller; G Teuber; S Wollschlaeger; A Baumgarten; K-G Simon; G Moog; N Dikopoulos; S Mauss
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study     Date:  2010-02-11
Journal Detail:
Title:  Journal of viral hepatitis     Volume:  17     ISSN:  1365-2893     ISO Abbreviation:  J. Viral Hepat.     Publication Date:  2010 Jul 
Date Detail:
Created Date:  2010-07-20     Completed Date:  2010-10-19     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9435672     Medline TA:  J Viral Hepat     Country:  England    
Other Details:
Languages:  eng     Pagination:  459-68     Citation Subset:  IM    
Private Gastroenterological Practice, Stade, Germany.
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MeSH Terms
Antiviral Agents / administration & dosage,  therapeutic use
Cohort Studies
Hepacivirus / drug effects
Hepatitis C, Chronic / drug therapy*
Interferon Alfa-2a / adverse effects*,  therapeutic use*
Interferon Alfa-2b / adverse effects*,  therapeutic use*
Middle Aged
Polyethylene Glycols / adverse effects*,  therapeutic use*
Ribavirin / adverse effects*,  therapeutic use*
Treatment Outcome
Viral Load
Reg. No./Substance:
0/Antiviral Agents; 0/Polyethylene Glycols; 0/peginterferon alfa-2a; 0/peginterferon alfa-2b; 36791-04-5/Ribavirin; 76543-88-9/Interferon Alfa-2a; 99210-65-8/Interferon Alfa-2b

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

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