Long term response to therapy of chronic anti-HBe-positive hepatitis B is poor independent of type and schedule of interferon

OBJECTIVE: The response rate to alpha interferon (IFN) of chronic anti-HBe- positive hepatitis B is variable, We studied whether type, dose, and schedu le of IFN, and type and frequency of posttreatment monitoring, influence th e response rate. METHODS: Seventy-two consecutive anti-HBe-positive chronic hepatitis B pati ents (59 male and 13 female, median age 41 yr) stratified by sex and histol ogy were randomly allocated to three treatment arms. Twenty-seven patients (A) received 10 million units alpha-N1 IFN i.m. t.w. for 24 wk (total dose: 720 million units); 21 (B) received 9 million units alpha-2a IFN i.m. t.w. for 4 wk, followed by 18 million units for 12 wk and 9 million units for 8 wk (972 million units); 24 (C) received 2 alpha-2a IFN courses (9 million units i.m. t.w. for 16 and 12 wk separated by a 6-month interval [756 milli on units]). Primary response was defined by normal ALT and serum HBV-DNA le vels below 10 pg/ml at the end of therapy and sustained response by normal ALT (tested monthly), undetectable HBV-DNA and IgM anti-HBc (<7 I.U. Paul E hrlich institute) (tested every 3 months) during the posttreatment follow-u p. RESULTS: At the end of treatment, 12, 8, and 13 patients from groups A, B, and C, respectively, were responders. At the 18-month follow-up, two patien ts in group A and only one in groups B and C maintained the response. Overa ll, after 34 months (median posttreatment follow-up), three patients were l ong term responders, whereas three showed a sustained remission after relap se. CONCLUSIONS: The rate of long term response to interferon of anti-HBe-posit ive chronic hepatitis B is poor, independent of IFN type, dose, or schedule ; the more stringent the monitoring, the higher the relapse rate. (C) 1999 by Am. Cell. of Gastroenterology.