Thymosin alpha-1 with peginterferon alfa-2a/ribavirin for chronic hepatitis C not responsive to IFN/ribavirin: An adjuvant role?

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

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)52-59
Number of pages8
JournalJournal of Viral Hepatitis
Volume19
Issue numberSUPPL. 1
DOIs
Publication statusPublished - Jan 2012

Keywords

  • chronic hepatitis C
  • clinical trial
  • nonresponder HCV patients
  • re-treatment
  • thymosin alpha 1

ASJC Scopus subject areas

  • Hepatology
  • Infectious Diseases
  • Virology

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