Adefovir dipivoxil for wait-listed and post-liver transplantation patients with lamivudine-resistant hepatitis B: final long-term results
Eugene Schiff, Ching-Lung Lai, Stephanos Hadziyannis, Peter Neuhaus, Norah Terrault, Massimo Colombo, Hans Tillmann, Didier Samuel, Stefan Zeuzem, Jean-Pierre Villeneuve, Sarah Arterburn, Katyna Borroto-Esoda, Carol Brosgart, Steven Chuck, Adefovir Dipivoxil Study 45 Intrnational Investigators Group, Eugene Schiff, Ching-Lung Lai, Stephanos Hadziyannis, Peter Neuhaus, Norah Terrault, Massimo Colombo, Hans Tillmann, Didier Samuel, Stefan Zeuzem, Jean-Pierre Villeneuve, Sarah Arterburn, Katyna Borroto-Esoda, Carol Brosgart, Steven Chuck, Adefovir Dipivoxil Study 45 Intrnational Investigators Group
Abstract
Wait-listed (n = 226) or post-liver transplantation (n = 241) chronic hepatitis B (CHB) patients with lamivudine-resistant hepatitis B virus (HBV) were treated with adefovir dipivoxil for a median of 39 and 99 weeks, respectively. Among wait-listed patients, serum HBV DNA levels became undetectable (<1,000 copies/mL) in 59% and 65% at weeks 48 and 96, respectively. After 48 weeks, alanine aminotransferase (ALT), albumin, bilirubin, and prothrombin time normalized in 77%, 76%, 60%, and 84% of wait-listed patients, respectively. Among posttransplantation patients, serum HBV DNA levels became undetectable in 40% and 65% at weeks 48 and 96, respectively. After 48 weeks, ALT, albumin, bilirubin, and prothrombin time normalized in 51%, 81%, 76%, and 56% of posttransplantation patients, respectively. Among wait-listed patients who underwent on-study liver transplantation, protection from graft reinfection over a median of 35 weeks was similar among patients who did (n = 34) or did not (n = 23) receive hepatitis B immunoglobulin (HBIg). Hepatitis B surface antigen was detected on the first measurement only in 6% and 9% of patients who did or did not receive HBIg, respectively. Serum HBV DNA was detected on consecutive visits in 6% and 0% of patients who did or did not receive HBIg, respectively. Treatment-related adverse events led to discontinuation of adefovir dipivoxil in 4% of patients. Cumulative probabilities of resistance were 0%, 2%, and 2% at weeks 48, 96, and 144, respectively. In conclusion, adefovir dipivoxil is effective and safe in wait-listed or posttransplantation CHB patients with lamivudine-resistant HBV and prevents graft reinfection with or without HBIg.
(c) 2007 AASLD.
Source: PubMed