A randomized study comparing lamivudine monotherapy after a short course of hepatitis B immune globulin (HBIg) and lamivudine with long-term lamivudine plus HBIg in the prevention of hepatitis B virus recurrence after liver transplantation.
OBJECTIVE
To compare the efficacy in preventing hepatitis B virus (HBV) recurrence of lamivudine vs. lamivudine plus hepatitis B immune globulin (HBIg) after a short course of HBIg and lamivudine in liver transplanted chronic hepatitis B patients.


METHODS
Forty-six patients with HBV cirrhosis received lamivudine before liver transplantation and were then randomized to receive lamivudine plus HBIg for 1 month followed by lamivudine or both drugs for 17 months.


RESULTS
Thirty-two patients were transplanted and 29 were randomized to receive combination therapy (15 cases) or lamivudine monotherapy (14 cases). HBV DNA was undetectable in all cases (17 induced by lamivudine therapy) at the time of liver transplantation. After 18 months of follow-up, all patients survived without HBV recurrence: hepatitis Bs antigen and HBV DNA were negative; however, HBV DNA was detected by polymerase chain reaction in four cases (three with HBIg plus lamivudine and one with lamivudine). Alanine aminotransferase levels were normal except in six cases (one HCV and two HDV coinfections). There were no drug-related adverse events.


CONCLUSIONS
Lamivudine monotherapy after a short course of lamivudine and HBIg is equally as efficacious in preventing HBV recurrence as HBIg plus lamivudine during the first 18 months after liver transplantation. This strategy is more economic and convenient to administer than long-term HBIg plus lamivudine.
Buti
María
M
Servicio de Hepatologi;a, Hospital General Universitario Valle de Hebrón, Paseo Valle de Hebron 119, 08035, Barcelona, Spain. mbuti@hg.vhebron.es
Mas
Antoni
A
Prieto
Martín
M
Casafont
Fernando
F
González
Antonio
A
Miras
Manuel
M
Herrero
Jose Ignacio
JI
Jardí
Rossendo
R
Cruz de Castro
Eva
E
García-Rey
César
C
D000293:Adolescent; D000328:Adult; D000368:Aged; D004334:Drug Administration Schedule; D016527:Drug Costs; D004359:Drug Therapy, Combination; D006509:Hepatitis B / Q000188:drug therapy* / Q000517:prevention & control*; D006515:Hepatitis B virus / Q000502:physiology; D006801:Humans; D007136:Immunoglobulins / Q000008:administration & dosage* / Q000191:economics; D019259:Lamivudine / Q000008:administration & dosage* / Q000191:economics; D016031:Liver Transplantation; D008875:Middle Aged; D011182:Postoperative Care / Q000191:economics; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage* / Q000191:economics; D055502:Secondary Prevention; D016896:Treatment Outcome; D014779:Virus Replication / Q000187:drug effects
D007136:Immunoglobulins; D018894:Reverse Transcriptase Inhibitors; D019259:Lamivudine; C045213:hepatitis B hyperimmune globulin