A randomized controlled trial of thymopentin therapy in patients with chronic hepatitis B.
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.
Istituto di Semeiotica e Nefrologia Medica, University of Verona, Italy.
G
G
Fattovich
G
G
Giustina
A
A
Alberti
M
M
Guido
P
P
Pontisso
S
S
Favarato
L
L
Benvegnù
A
A
Ruol
D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D002908:Chronic Disease; D004279:DNA, Viral / Q000097:blood / Q000235:genetics; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006509:Hepatitis B / Q000188:drug therapy* / Q000453:epidemiology; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000235:genetics; D006801:Humans; D008297:Male; D008875:Middle Aged; D016305:Thymopentin / Q000009:adverse effects / Q000592:standards / Q000627:therapeutic use*
D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D000410:Alanine Transaminase; D016305:Thymopentin