A multicenter United States-Canadian trial to assess lamivudine monotherapy before and after liver transplantation for chronic hepatitis B

February 27, 2001

1: Hepatology 2001 Feb;33(2):424-432

A multicenter United States-Canadian trial to assess lamivudine monotherapy

before and after liver transplantation for chronic hepatitis B.

Perrillo RP, T, Rakela J, Levy G, Schiff E, Gish R, P,

Dienstag J, P, Dickson R, Anschuetz G, Bell S, Condreay L, Brown N

Section of Gastroenterology and Hepatology, Ochsner Clinic, New Orleans, LA.

[Record supplied by publisher]

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.

PMID: 11172345

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