Thymosin alpha1 treatment of chronic hepatitis B: results of a phase III multicentre, randomized, double-blind and placebo-controlled study.

Abstract

Previous clinical trials have suggested that thymosin alpha1 (Talpha1), an immunomodulatory peptide, may be effective in the treatment of chronic hepatitis B (CHB). The aim of this study was to determine the efficacy of Talpha1 in a multicentre, placebo-controlled and double-blind study of 97 patients with serum hepatitis B virus (HBV) DNA- and hepatitis B e antigen (HBeAg)-positive CHB. Patients who had been hepatitis B surface antigen (HBsAg) positive for at least 12 months entered a 3-month screening period prior to randomization. Forty-nine patients received Talpha1 (1.6 mg) and 48 patients received placebo, twice weekly for 6 months, and were followed-up for an additional 6 months. At inclusion, both groups were comparable for age, gender, histological grading, and aminotransferase and HBV DNA levels. A complete response to treatment, defined as a sustained serum HBV DNA-negative status (two negative results at least 3 months apart) during the 12-month study, with negative HBV DNA and HBeAg values at month 12, was seen in seven (14%) patients given Talpha1 and in two (4%) patients treated with placebo (P = 0.084). Five (10%) patients given Talpha1 and four (8%) patients given placebo exhibited a delayed response (defined as sustained serum HBV DNA negativity achieved after the 12-month study period with negative HBV DNA and HBeAg values at the last assessment). A total of 12 (25%) patients given Talpha1 and six (13%) patients given placebo showed a sustained loss of HBV DNA with a negative HBeAg value during or following the 12-month study period (P < 0.11). These results do not confirm observations of treatment efficacy reported in other clinical studies.

• Authors: M G Mutchnick, K L Lindsay, E R Schiff, G D Cummings, H D Appelman, R R Peleman, M Silva, K C Roach, F Simmons, S Milstein, S C Gordon, M N Ehrinpreis
• Journal: Journal of viral hepatitis (J Viral Hepat) Vol. 6 Issue 5 Pg. 397-403 (Sep 1999) ISSN: 1352-0504 [Print] England
• PMID: 10607256 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Adjuvants, Immunologic
• Antiviral Agents
• DNA, Viral
• Hepatitis B e Antigens
• Thymosin
• Thymalfasin

Topics

• Adjuvants, Immunologic (therapeutic use)
• Adult
• Antiviral Agents (therapeutic use)
• DNA, Viral (blood)
• Double-Blind Method
• Female
• Hepatitis B e Antigens (blood)
• Hepatitis B virus (isolation & purification, physiology)
• Hepatitis B, Chronic (drug therapy, virology)
• Humans
• Male
• Middle Aged
• Thymalfasin
• Thymosin (analogs & derivatives, therapeutic use)
• Treatment Outcome