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: R P Perrillo, T Wright, J Rakela, G Levy, E Schiff, R Gish, P Martin, J Dienstag, P Adams, R Dickson, G Anschuetz, S Bell, L Condreay, N Brown, Lamivudine North American Transplant Group
• Journal: Hepatology (Baltimore, Md.) (Hepatology) Vol. 33 Issue 2 Pg. 424-32 (Feb 2001) ISSN: 0270-9139 [Print] United States
• PMID: 11172345 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)

Chemical References

• Reverse Transcriptase Inhibitors
• Lamivudine
• DNA-Directed DNA Polymerase

Topics

• Adult
• Aged
• DNA-Directed DNA Polymerase (genetics)
• Female
• Hepatitis B virus (genetics)
• Hepatitis B, Chronic (therapy)
• Humans
• Lamivudine (adverse effects, therapeutic use)
• Liver Transplantation
• Male
• Middle Aged
• Mutation
• Postoperative Care
• Preoperative Care
• Reverse Transcriptase Inhibitors (adverse effects, therapeutic use)
• Safety
• Secondary Prevention
• Survival Analysis