A randomized controlled trial of thymopentin therapy in patients with chronic hepatitis B

• Published in: Journal of hepatology Vol. 21; no. 3; p. 361
• Main Authors: Fattovich, G, Giustina, G, Alberti, A, Guido, M, Pontisso, P, Favarato, S, Benvegnù, L, Ruol, A
• Format: Journal Article
• Language: English
• Published: Netherlands 01-09-1994
• Subjects: Adult; Alanine Transaminase - blood; Chronic Disease; DNA, Viral - blood; DNA, Viral - genetics; Dose-Response Relationship, Drug; Female; Follow-Up Studies; Hepatitis B - drug therapy; Hepatitis B - epidemiology; Hepatitis B Surface Antigens - blood; Hepatitis B virus - genetics; Humans; Male; Middle Aged; Thymopentin - adverse effects; Thymopentin - standards; Thymopentin - therapeutic use
• ISSN: 0168-8278
• DOI: 10.1016/S0168-8278(05)80314-9

Strategies of treatment of chronic hepatitis type B are currently based on the use of either antiviral or immunomodulatory agents. A randomized, controlled trial was performed to assess the safety and efficacy of 6-month thymopentin therapy in 30 patients with chronic hepatitis B. Inclusion criteria were biopsy-proven chronic hepatitis, elevated alanine aminotransferase and serum HBsAg and HBV-DNA positivity for at least 12 months. At the conclusion of the study (1 year), HBV-DNA was negative and alanine aminotransferase had normalized in 13% and 20% of treated cases and in 20% and 27% of controls. None of the ten treated and one of the nine control patients who were initially HBeAg positive subsequently cleared HBeAg. None became HBsAg negative. A histologic improvement was noted in 27% of the treated patients compared with 18% of controls. These results indicate that this regimen of thymopentin therapy is not effective in treating chronic hepatitis B.