Lamivudine therapy for Hepatitis B (HBV) infection in post renal transplant patients: results after 12 months follow up

Abstract

INTRODUCTION: The prevalence of HBV infection is high among renal transplant patients. Interferon-alpha (standard therapy), is inappropriate in this situation, as it is associated with an unacceptable risk of graft rejection. OBJECTIVE: Assess the efficacy of lamivudine in HBV infection among post-renal transplant patients. METHODS: Post-renal transplant patients with chronic (>6 months) HBV infection were recruited from April 1999. They were given lamivudine lOOmg/day. Their liver function and HBV serology were assessed 3 monthly, and HBV-DNA annually. Post-transplant immunosuppressive therapy was not altered. RESULTS: 28 patients [M:F=16:12; median age 41yrs (range 28-76)] have completed 12 months follow-up. At recruitment, they were all HBsAg(+), HBV-DNA(+) [median DNA level 3235 MEq/ml serum (range 359.3->4400], and anti-HBe(-); 25 were HBeAg(+). Serum ALT levels ranged from 33-768 IU/L (median 106). 3 patients had hepatic decompensation; 2 of them died within one month of starting lamivudine. At the end of 12 months, 26 were still alive. All were HBsAg(+); 4 (15.4%) had developed resistance to lamivudine (YMDD mutants); 3 had seroconverted [HBeAg(-), anti-HBe(+)]; 4 became HBeAg(-) but were still anti-HBe(-). There was reduction of HBV-DNA [median <0.7 MEq/ml serum (range<0.7-2072)] (p<0.01, Mann-Whitney U test), levels being undetectable (<0.7 MEq/ml) in 19 (73.1%). 8 of these 19 patients discontinued treatment; 3 months later HBV-DNA levels had become elevated in all 8 and HBeAg had reappeared in 4 who had also become HBeAg(-). CONCLUSIONS: Lamivudine therapy given over 12 months significantly reduces HBV-DNA load in post-renal transplant patients on immunosuppressive therapy, although the effect seems to be reversed on discontinuation of therapy. Full seroconversion is not common, and resistance to lamivudine occurs in a significant proportion after 12 months of treatment.