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

Research output: Contribution to journalArticle

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 (1 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.

Original languageEnglish
Pages (from-to)690-696
Number of pages7
JournalDigestive Diseases and Sciences
Volume45
Issue number4
DOIs
Publication statusPublished - 2000

Keywords

  • Chronic hepatitis B
  • Therapy
  • Thymosin-α

ASJC Scopus subject areas

  • Gastroenterology

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