A double-blind evaluation of transfer factor therapy of HB_sAg-positive chronic aggressive hepatitis: Preliminary report of efficacy

A controlled, prospective, double-blind trial of transfer factor in chronic aggressive hepatitis was carried out. This report presents the results obtained from study of the nine HB_sAg-positive subjects who were included in the trial. Transfer factor was prepared from adults who had recovered from acute hepatitis B or from acute non-B viral hepatitis and was administered to five HB_sAg-positive subjects. Four HB_sAg-seropositive subjects received placebo. Percutaneous liver biopsy was performed at the beginning and at the conclusion of the 10-week study period; biochemical and clinical parameters were monitored throughout. Cell-mediated immunity was assessed at the beginning and at the end of the study period. Four of five transfer factor recipients showed moderate or marked improvement in hepatic histology, clinical status, and serum transaminase levels, while none of four placebo recipients demonstrated improvement. The difference in response between the two groups was significant (P = 0.048). No consistent changes in in vivo or in vitro correlates of cell-mediated immunity were demonstrated. No adverse effects were noted among transfer factor recipients. These data suggest that transfer factor may be of benefit in chronic aggressive hepatitis associated with HB_sAg. Additional studies appear to be indicated to delineate the mode of action of transfer factor as well as the role that such immunotherapy should play in the management of patients with this disorder.