title: Thymosin alpha-1 with peginterferon alfa-2a/ribavirin for chronic hepatitis C not responsive to IFN/ribavirin: an adjuvant role?
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.
authors.affiliation: Division of Gastroenterology, University of Torino, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Ciancio
authors.forename: P
authors.initials: P
authors.lastname: Andreone
authors.forename: S
authors.initials: S
authors.lastname: Kaiser
authors.forename: A
authors.initials: A
authors.lastname: Mangia
authors.forename: M
authors.initials: M
authors.lastname: Milella
authors.forename: R
authors.initials: R
authors.lastname: Solà
authors.forename: S
authors.initials: S
authors.lastname: Pol
authors.forename: E
authors.initials: E
authors.lastname: Tsianos
authors.forename: A
authors.initials: A
authors.lastname: De Rosa
authors.forename: R
authors.initials: R
authors.lastname: Camerini
authors.forename: R
authors.initials: R
authors.lastname: McBeath
authors.forename: M
authors.initials: M
authors.lastname: Rizzetto
mesh_terms: D000276:Adjuvants, Immunologic; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics / Q000502:physiology; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D012254:Ribavirin / Q000008:administration & dosage / Q000627:therapeutic use; D000077596:Thymalfasin; D013947:Thymosin / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000627:therapeutic use; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; D013947:Thymosin; C100416:peginterferon alfa-2a; D000077596:Thymalfasin