Digestive Diseases and Sciences

, Volume 45, Issue 4, pp 690–696

A Randomized, Controlled Study of Thymosin-α1 Therapy in Patients with Anti-HBe, HBV-DNA-Positive Chronic Hepatitis B

  • Claudio Zavaglia
  • Remo Severini
  • Carmine Tinelli
  • Josè S. Franzone
  • Aldo Airoldi
  • Silvana Tempini
  • Giuseppina Bettale
  • Gaetano Ideo
Article

DOI: 10.1023/A:1005431323945

Cite this article as:
Zavaglia, C., Severini, R., Tinelli, C. et al. Dig Dis Sci (2000) 45: 690. doi:10.1023/A:1005431323945

Abstract

No consistently effective therapy is yet available for the treatment of chronic HBsAg, anti-HBe, HBV-DNA-positive hepatitis. A multicenter trial has shown that the response rates are not significantly different when patients with anti-HBe-positive hepatitis are treated with six-month course of thymosin-α1 or of interferon-α. However, since among these patients, interferon's real efficacy is still debated, with sustained biochemical response achieved in only a few of the treated patients, we conducted this controlled study to investigate the safety and efficacy of thymosin-α1 as compared with no treatment. Forty-four chronic hepatitis B virus (HBV) carriers, who were anti-HBe- and HBV-DNA-positive, were randomized, with stratification for the presence of cirrhosis at baseline liver biopsy, to receive either thymosin-α1 at a dose of 900 μg/m2 twice a week for six months or no treatment. At entry, both groups of patients were comparable for sex, age, liver histology, ALT, IgM anti-HBc, and HBV-DNA levels. Forty-two patients were followed-up for 20 months (median; range 12–32 months) after completion of therapy: one dropped out, and one developed hepatocellular carcinoma at six months. Thymosin-α1 treatment had no side effects. Six months after the end of the therapy, HBV-DNA was negative and ALT had normalized in 14% of treated cases and in 4.5% of control group, while IgM anti-HBc was negative (<0.200) in 14% of the treated patients and in 4.5% of the controls. Among the treated patients, the median ALT levels stayed significantly lower compared to the pretreatment values during the treatment period and six months of follow-up. During the first year, there were six flares of hepatitis in the control group and five among the treated patients (P = NS), yielding a per year average of 0.3 and 0.23 flares per patient, respectively. Among the treated patients, median IgM anti-HBc levels were low with respect to baseline values 4–10 months after treatment started. None became HBsAg negative. In conclusion, these results indicate that, in anti-HBe, HBV-DNA-positive chronic hepatitis B, thymosin-α1 therapy alone does not increase the response rate, but may contribute to reduce the immune-mediated liver cell necrosis as indirectly assessed by ALT and IgM anti-HBc levels.

thymosin-α1therapychronic hepatitis B

Copyright information

© Plenum Publishing Corporation 2000

Authors and Affiliations

  • Claudio Zavaglia
    • 1
    • 2
    • 3
  • Remo Severini
    • 1
    • 2
    • 3
  • Carmine Tinelli
    • 1
    • 2
    • 3
  • Josè S. Franzone
    • 1
    • 2
    • 3
  • Aldo Airoldi
    • 1
    • 2
    • 3
  • Silvana Tempini
    • 1
    • 2
    • 3
  • Giuseppina Bettale
    • 1
    • 2
    • 3
  • Gaetano Ideo
    • 1
    • 2
    • 3
  1. 1.Divisione di Medicina Generale e Servizio di EpatologiaOspedale NiguardaMilanItaly
  2. 2.Direzione MedicaSclavo, SienaItaly
  3. 3.Direzione Scientifica, IRCSS, Policlinico S. MatteoPaviaItaly