TY - JOUR
T1 - A multicenter United States-Canadian trial to assess lamivudine monotherapy before and after liver transplantation for chronic hepatitis B
AU - Perrillo, Robert P.
AU - Wright, Teresa
AU - Rakela, Jorge
AU - Levy, Gary
AU - Schiff, Eugene
AU - Gish, Robert
AU - Martin, Paul
AU - Dienstag, Jules
AU - Adams, Paul
AU - Dickson, Rolland
AU - Anschuetz, Gaya
AU - Bell, Steve
AU - Condreay, Lynn
AU - Brown, Nathaniel
N1 - Funding Information:
Abbreviations: HBV, hepatitis B virus; HBIg, hepatitis B immune globulin; HBeAg, hepatitis B e antigen; HBsAg, hepatitis B surface antigen; ALT, alanine transaminase. From the 1Section of Gastroenterology and Hepatology, Ochsner Clinic, New Orleans, LA; 2Gastroenterology Division, Veterans Affairs Medical Center, San Francisco, CA; 3Division of Gastroenterology, University of Pittsburgh Medical Center, Pittsburgh, PA; 4Toronto General Hospital, Toronto, Canada; 5Center for Liver Diseases, University of Miami Medical Center, Miami, FL; 6California Pacific Medical Center, San Francisco, CA; 7Division of Gastroenterology, UCLA Medical Center, Los Angeles, CA; 8Gastrointestinal Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA; 9London Health Sciences Center, London/Ontario, Canada; 10University of Florida, Gainesville, FL; and 11Glaxo Wellcome, Research Triangle Park, NC. Received May 15, 2000; accepted November 9, 2000. The investigators who were members of the Lamivudine Transplant Group are listed in the Appendix. Address reprint requests to: Robert P. Perrillo, M.D., Ochsner Clinic, 1514 Jefferson Highway, New Orleans, LA 70121. E-mail: rperrillo@ochsner.org; fax: 504-842-7466. Copyright © 2001 by the American Association for the Study of Liver Diseases. 0270-9139/01/3302-0015$35.00/0 doi:10.1053/jhep.2001.21554
PY - 2001
Y1 - 2001
N2 - 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 (HBesAg) 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.
AB - 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 (HBesAg) 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.
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U2 - 10.1053/jhep.2001.21554
DO - 10.1053/jhep.2001.21554
M3 - Article
C2 - 11172345
AN - SCOPUS:2942559300
SN - 0270-9139
VL - 33
SP - 424
EP - 432
JO - Hepatology
JF - Hepatology
IS - 2
ER -