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

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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.

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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