title: A multicenter United States-Canadian trial to assess lamivudine monotherapy before and after liver transplantation for chronic hepatitis B.
abstract: Seventy-seven liver transplant candidates were enrolled in a multicenter study in which patients were treated with lamivudine (100 mg daily) without the adjunctive use of hepatitis B immune globulin. Treatment was begun while patients awaited liver transplantation and continued after transplantation. All were hepatitis B surface antigen (HBsAg) positive, and 61% had detectable hepatitis B e antigen (HBeAg) and HBV DNA when treatment was begun. Forty-seven underwent liver transplantation and 30 did not. Median study participation was 38 months (range, 2.7-48.5) in the transplanted patients and 26 months (range, 0.1-37) in the nontransplanted group. Twenty-five of 42 (60%) transplanted patients with 12 or more weeks of posttransplantation follow-up were HBsAg negative at the last study visit. At treatment week 156, 13 of 22 (59%) remained HBsAg negative, and all 9 reinfected patients were HBV-DNA positive before treatment. In the nontransplanted patients, HBeAg was initially detectable in 20 of 27 (74%) but this decreased to 3 of 17 (18%) after 104 weeks of treatment, and significant improvement in biochemical parameters was observed. HBV-DNA polymerase mutants were detected in 15 (21%) and 6 (20%) of the transplanted and nontransplanted patients, respectively. When compared with historical cohorts, lamivudine-treated patients appeared to have improved survival, and transplanted patients had a decrease in the rate of recurrent HBV infection. Lamivudine therapy was partially effective in preventing recurrent HBV infection when given before and after transplantation. Thus, future trials using a combination of HBIg and lamivudine are needed to assess the optimal prophylactic therapy.
authors.affiliation: Section of Gastroenterology and Hepatology, Ochsner Clinic, New Orleans, LA 70121, USA.
authors.forename: R P
authors.initials: RP
authors.lastname: Perrillo
authors.forename: T
authors.initials: T
authors.lastname: Wright
authors.forename: J
authors.initials: J
authors.lastname: Rakela
authors.forename: G
authors.initials: G
authors.lastname: Levy
authors.forename: E
authors.initials: E
authors.lastname: Schiff
authors.forename: R
authors.initials: R
authors.lastname: Gish
authors.forename: P
authors.initials: P
authors.lastname: Martin
authors.forename: J
authors.initials: J
authors.lastname: Dienstag
authors.forename: P
authors.initials: P
authors.lastname: Adams
authors.forename: R
authors.initials: R
authors.lastname: Dickson
authors.forename: G
authors.initials: G
authors.lastname: Anschuetz
authors.forename: S
authors.initials: S
authors.lastname: Bell
authors.forename: L
authors.initials: L
authors.lastname: Condreay
authors.forename: N
authors.initials: N
authors.lastname: Brown
mesh_terms: D000328:Adult; D000368:Aged; D004259:DNA-Directed DNA Polymerase / Q000235:genetics; D005260:Female; D006515:Hepatitis B virus / Q000235:genetics; D019694:Hepatitis B, Chronic / Q000628:therapy*; D006801:Humans; D019259:Lamivudine / Q000009:adverse effects / Q000627:therapeutic use*; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D009154:Mutation; D011182:Postoperative Care; D011300:Preoperative Care; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D012449:Safety; D055502:Secondary Prevention; D016019:Survival Analysis
chemical_list: D018894:Reverse Transcriptase Inhibitors; D019259:Lamivudine; D004259:DNA-Directed DNA Polymerase