Document Detail

Safety and efficacy of combination therapy with peginterferon alfa-2a (40kD) and ribavirin in the outpatient setting: prospective analysis of 197 patients with chronic hepatitis C viral infection.
MedLine Citation:
PMID:  17646782     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: Combination therapy using peginterferon alfa-2a (40 kD) plus ribavirin achieves viral eradication in nearly 60% of patients with chronic hepatitis C viral infection. However, because of the numerous side effects, use of the combination regimen might be restricted for patients consulting private practitioners specialized in hepatogastroenterology. PATIENTS AND METHOD: Conducted in this specific context, this prospective clinical trial investigated the safety and efficacy of combination therapy in 197 patients. Therapy was given in compliance with the recommendations of the French consensus conference on hepatitis C treatment. RESULTS: Commonly reported adverse effects were noted in 90% of patients, most occurring during the first three months, with a stable prevalence thereafter and resolution after treatment end. The most frequent adverse events were asthenia (35 to 37.5% according to the treatment group pruritus (25 to 26.3%) and flu-like syndrome (19 to 21.7%). A depressive syndrome was reported in 20 to 21% of patients. Grade 4 neutropenia was exceptional and never led to severe infections. At intent-to-treat analysis, the rate of sustained virological response was 54.8% for the entire population. It was 71.1% for patients with genotypes 2 or 3 (mainly treated for 24 weeks) and 44.6% for patients with genotype 1 (all treated 48 weeks). CONCLUSION: The characteristic features of combination therapy observed in the context of private hepatogastroenterology consultations are similar to those observed in randomized clinical trials.
Thierry Fontanges; Sylvain Beorchia; Catherine Douvin; Patrick Delassalle; Jean-Marc Combis; Bertrand Hanslik; Jean-Paul Jacques; Bernard Filoche; Hervé Desmorat; Catherine Chandelier; Denis Ouzan
Publication Detail:
Type:  Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Gastroentérologie clinique et biologique     Volume:  31     ISSN:  0399-8320     ISO Abbreviation:  Gastroenterol. Clin. Biol.     Publication Date:    2007 Jun-Jul
Date Detail:
Created Date:  2007-07-24     Completed Date:  2007-12-27     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7704825     Medline TA:  Gastroenterol Clin Biol     Country:  France    
Other Details:
Languages:  eng     Pagination:  566-72     Citation Subset:  IM    
93, rue de la Libération, 38300 Bourgoin-Jallieu.
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MeSH Terms
Aged, 80 and over
Ambulatory Care
Antiviral Agents / adverse effects,  therapeutic use*
Drug Therapy, Combination
Hepatitis C, Chronic / drug therapy*
Interferon Alfa-2a / adverse effects,  therapeutic use*
Middle Aged
Polyethylene Glycols / adverse effects,  therapeutic use*
Prospective Studies
Ribavirin / therapeutic use*
Reg. No./Substance:
0/Antiviral Agents; 0/Polyethylene Glycols; 0/peginterferon alfa-2a; 36791-04-5/Ribavirin; 76543-88-9/Interferon Alfa-2a

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