Premium
Thymosin treatment of chronic hepatitis B: A placebo‐controlled pilot trial
Author(s) -
Mutchnick Milton G.,
Appelman Henry D.,
Chung H. T.,
Aragona Emma,
Gupta Tej P.,
Cummings Glen D.,
Waggoner Jeanne G.,
Hoofnagle Jay H.,
Shafritz David A.
Publication year - 1991
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.1840140302
Subject(s) - thymosin , medicine , placebo , gastroenterology , hbsag , immunology , hepatitis , liver disease , hepatitis c , hepatitis b virus , virus , pathology , alternative medicine
Chronic hepatitis B is a severe and frequently progressive disease. We assessed the safety and efficacy of thymosin fraction 5 and thymosin‐α 1 in a prospective, placebo‐controlled trial in 12 patients with chronic hepatitis B. All patients had histological and biochemical evidence of active liver disease for at least 6 mo before treatment and were positive for serum hepatitis B virus DNA and HBsAg. Seven patients received thymosin fraction 5 or thymosin‐α 1 and five patients received placebo twice weekly for 6 mo. By the conclusion of the study (1 yr), serum aminotransferase levels had improved significantly in thymosin‐treated patients, but not in the placebo group. Six (86%) of the thymosin treated patients and one (20%) patient given placebo cleared hepatitis B virus DNA from serum (p < 0.04, Fisher's exact test). After treatment, replicative forms of hepatitis B virus DNA were present in the liver specimens of four of five placebo‐treated patients but in only one of seven thymosin‐treated patients (p < 0.04, Fisher's exact test). Response to thymosin therapy was associated with significant improvements in peripheral blood lymphocyte and CD3 and CD4 counts and in in vitro production of interferon‐γ over initial values. No significant side effects were observed in patients given thymosin or in placebo‐treated patients. Clinical, biochemical and serological improvement in patients responding to thymosin were sustained during 26 ± 3 mo of follow‐up. The results of this pilot trial suggest that thymosin therapy promotes disease remission and cessation of hepatitis B virus replication in patients with chronic viral infection.