RECOMBINANT INTERFERON-ALPHA THERAPY FOR ACUTE HEPATITIS-B - A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

In spite of the availability of hepatitis B vaccine, acute hepatitis B continues to be a worldwide problem for which no specific therapy is available, We investigated the safety and the effectiveness of recombi nant interferon-alpha 2b (rIFN-alpha 2b) in the treatment of acute hep atitis B by determining overall severity and duration of symptoms, tim e required to clear viral antigens and hepatitis B virus (HBV) DNA, an d titre of antibodies to hepatitis B surface antigen (HBsAb), 24 weeks after the onset of therapy, One hundred patients were randomly assign ed to treatment with either 3 million units (MU) (n = 34) or 10MU (n = 33) rIFN-alpha 2b or to placebo (n=33), three times weekly for 3 week s, Follow-up was for 24 weeks, A significantly shorter duration of the symptoms and signs of acute hepatitis was observed in patients who re ceived 3 MU rIFN-alpha 2b compared with those who received 10 MU rIFN- alpha 2b or placebo, Twenty-one weeks post-therapy, patients treated w ith 10MU rIFN-alpha 2b showed a significantly higher geometric mean HB sAb titre than those treated with placebo (85.1 vs 35.5 IU l(-1), P < 0.05), rIFN-alpha 2b administration was well tolerated even in jaundic ed patients, No serious side-effects were observed necessitating reduc tion in dose or discontinuation of the drug. The effect of rIFN-alpha 2b on transition of HBV infection to chronicity could not be evaluated in this trial because such an unfavourable course was not seen in any of the treated or the control patients, In conclusion, rIFN-alpha 2b was safe in acute hepatitis B, and at low dose was found to ameliorate symptoms and to shorten significantly the duration of illness.