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

10 Citations (Scopus)

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

Fingerprint

Ribavirin
Chronic Hepatitis C
Placebos
Standard of Care
Hepatitis C
Therapeutics
Secondary Prevention
Infection
thymalfasin
peginterferon alfa-2a
Genotype
Incidence
Population

Keywords

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

ASJC Scopus subject areas

  • Hepatology
  • Infectious Diseases
  • Virology

Cite this

Thymosin alpha-1 with peginterferon alfa-2a/ribavirin for chronic hepatitis C not responsive to IFN/ribavirin : An adjuvant role? / Ciancio, A.; Andreone, P.; Kaiser, S.; Mangia, A.; Milella, M.; Solà, R.; Pol, S.; Tsianos, E.; De Rosa, A.; Camerini, R.; McBeath, R.; Rizzetto, M.

In: Journal of Viral Hepatitis, Vol. 19, No. SUPPL. 1, 01.2012, p. 52-59.

Research output: Contribution to journalArticle

Ciancio, A, Andreone, P, Kaiser, S, Mangia, A, Milella, M, Solà, R, Pol, S, Tsianos, E, De Rosa, A, Camerini, R, McBeath, R & Rizzetto, M 2012, 'Thymosin alpha-1 with peginterferon alfa-2a/ribavirin for chronic hepatitis C not responsive to IFN/ribavirin: An adjuvant role?', Journal of Viral Hepatitis, vol. 19, no. SUPPL. 1, pp. 52-59. https://doi.org/10.1111/j.1365-2893.2011.01524.x
Ciancio, A. ; Andreone, P. ; Kaiser, S. ; Mangia, A. ; Milella, M. ; Solà, R. ; Pol, S. ; Tsianos, E. ; De Rosa, A. ; Camerini, R. ; McBeath, R. ; Rizzetto, M. / Thymosin alpha-1 with peginterferon alfa-2a/ribavirin for chronic hepatitis C not responsive to IFN/ribavirin : An adjuvant role?. In: Journal of Viral Hepatitis. 2012 ; Vol. 19, No. SUPPL. 1. pp. 52-59.
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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.",
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