Adefovir Dipivoxil Therapy for Lamivudine–Resistant Hepatitis B in Pre- and Post-Liver Transplantation Patients

• DOI: 10.1016/j.hep.2003.09.040
• Publication Date: 2003-11-25T20:29:01Z
• Authors: Eugene R. Schiff; Ching-Lung Lai; Stefanos Hadziyannis; Peter Neuhaus; Norah Terrault; Massimo Colombo; Hans L. Tillmann; Didier Samuel; Stefan Zeuzem; Leslie Lilly; Maria Rendina; Jean-Pierre Ville...; Nicole Lama; Craig James; Michael S. Wulfsohn; Hamid Namini; Christopher Westland; Shelly Xiong; Gavin S. Choy; Sally Van Doren; John Fry; Carol L. Brosgart
• Keywords: Adefovir; Hepatitis B

Three–hundred and twenty–four patients were enrolled in an open–label, multicenter, international study which pre– post–liver transplantation (LT) with recurrent chronic hepatitis B (CHB) evidence of lamivudine–resistant HBV treated adefovir dipivoxil 10 mg once daily. In the post–LT cohorts, 128 196 for a median duration 18.7 56.1 weeks, respectively. who received 48 weeks treatment, 81% pre–LT 34% cohort achieved undetectable serum virus (HBV) DNA (Roche Amplicor Monitor TM polymerase chain reaction [PCR] assay lower limit quantification [LLQ] < 400 copies/mL) change from baseline -4.1 log -4.3 copies/mL, Serum alanine aminotransferase (ALT), albumin, bilirubin, prothrombin time normalized 76%, 81%, 50%, 83% 49%, 75%, 20% patients. The Child–Pugh–Turcotte (CPT) score improved over 90% both cohorts. Genotypic analysis 122 samples revealed that 98% these had mutant HBV. No resistance mutations identified after therapy. One–year survival was 84% 93% (Kaplan–Meier analysis). Treatment–related adverse effects associated this setting primarily mild to moderate severity. conclusion, resulted significant improvements virologic, biochemical, clinical parameters CHB