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Thymosin alpha-1 with peginterferon alfa-2a/ribavirin for chronic hepatitis C not responsive to IFN/ribavirin: an adjuvant role?
MedLine Citation:
PMID:  22233415     Owner:  NLM     Status:  In-Process    
Abstract/OtherAbstract:
This study was conducted to determine whether the adding thymosin alpha-1 to standard of care for re-treatment of nonresponding hepatitis C infections can improve sustained viral response (SVR) rates. Patients (n = 552) with hepatitis C infections not responding to the combination of Peginterferon alfa-2a or 2b with ribavirin (RBV)were randomized to receive peginterferon alfa-2a 180 mg/week with RBV 800-1200 mg/daily plus either thymosin alpha-1 1.6 mg SC twice weekly (n = 275) or placebo (n = 277) for 48 weeks. Eighty-eight per cent of patients had HCV genotype 1, 6.6% type 4, 2.2% type 2 and 3.6% type 3. SVR rates in the intention to treat population were similar between thymosin alpha-1 and placebo (12.7%vs 10.5%; P = 0.407). Among patients who completed all 48 weeks of therapy, the SVR rate was significantly higher in the thymosin alpha-1 group at 41.0% (34/83) compared with 26.3% (26/99) in the placebo group (P = 0.048). No significant difference was observed between treatment groups in the incidence of adverse events. The addition of thymosin alpha-1 to the standard of care did not increase the on-treatment HCV viral response. Thymosin alpha-1 seems to play no role in the primary therapy of the disease. This study raises the hypothesis that thymosin alpha-1 may have a secondary therapeutic role as an adjuvant in the prevention of relapses in patients achieving a virologic response during therapy.
Authors:
A Ciancio; P Andreone; S Kaiser; A Mangia; M Milella; R Solà; S Pol; E Tsianos; A De Rosa; R Camerini; R McBeath; M Rizzetto
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of viral hepatitis     Volume:  19 Suppl 1     ISSN:  1365-2893     ISO Abbreviation:  J. Viral Hepat.     Publication Date:  2012 Jan 
Date Detail:
Created Date:  2012-01-11     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9435672     Medline TA:  J Viral Hepat     Country:  England    
Other Details:
Languages:  eng     Pagination:  52-9     Citation Subset:  IM    
Copyright Information:
© 2012 Blackwell Publishing Ltd.
Affiliation:
Division of Gastroenterology, University of Torino, Italy.
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