Lamivudine without HBIg for prevention of graft reinfection by hepatitis B: Long-term follow-up

Background. This open, multicenter study was conducted to evaluate the effi cacy and safety of lamivudine prophylaxis given to chronic hepatitis B viru s(HBV) infected patients before and after orthotopic liver transplantation (OLT), We now present long-term data that follow our previous short-term re port. Methods. Twenty-three patients were treated with lamivudine (100 mg orally, daily); 13 (57%), were serum HBV DNA positive (Abbott Genostics, Abbott La boratories, Chicago, IL) at study entry. Patients received lamivudine for a t least 4 weeks before OLT, and for up to 50 months (median 25 months) afte r OLT. Results. Of the 23 treated patients, 17 survived to undergo OLT, Eleven pat ients (65%) survived up to 4 years (median 36 months) after OLT. One of the survivors stopped lamivudine because of a possible adverse reaction 9 mont hs post-OLT, and prophylaxis with HBV immune globulin was then established. Ten survivors continue lamivudine, Eight long-term survivors have normal l iver function without evidence of HBV reinfection. Of the 17 transplanted p atients, 6 died. Four patients died (3 days to 5 months post-OLT) without e vidence of graft reinfection. Two further patients died at 19 and 23 months post-OLT from graft failure. Both patients had YMDD variant detected at 12 months post-OLT, Two other patients with YMDD-variant HBV remain alive on lamivudine, 9 and 15 months after development of the variant. Conclusions. Lamivudine, given before and after OLT, prevents significant g raft reinfection for the majority of treated patients. The study has also s hown that lamivudine is extremely well tolerated by liver failure patients and for a prolonged period after transplantation.