Lamivudine or adefovir dipivoxil alone or combined with immunoglobulin for
preventing hepatitis B recurrence after liver transplantation.
Author(s): Katz LH, Tur-Kaspa R, Guy DG, Paul M.
Affiliation(s): Gastroenterology Department, Sheba Medical Center, Tel-Hashomer, Ramat-Gan,
Israel, 52621.
Publication date & source: 2010, Cochrane Database Syst Rev. , (7):CD006005
BACKGROUND: Recurrence of hepatitis B virus (HBV) infection in the liver graft is
a grave complication following liver transplantation for HBV cirrhosis. Hepatitis
B immunoglobulin (HBIg) seems effective in increasing survival after liver
transplantation. HBIg and anti-viral drugs are given alone or in combination for
its prevention.
OBJECTIVES: To assess the benefits and harms of different regimens for preventing
HBV reactivation following liver transplantation.
SEARCH STRATEGY: We searched The Cochrane Hepato-Biliary Group Controlled Trials
Register, The Cochrane Central Register of Controlled Trials (CENTRAL) in The
Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until
February 2010. We attempted to identify further trials by reviewing the reference
lists and contacting the principal authors of identified trials.
SELECTION CRITERIA: Randomised clinical trials addressing benefits and harms of
lamivudine or adefovir dipivoxil alone or in combination with hepatitis B
immunoglobulins (HBIg) for preventing recurrent HBV infection in patients who are
liver transplanted due to HBV infection with or without hepatocellular carcinoma.
DATA COLLECTION AND ANALYSIS: Two authors independently assessed the trials for
risk of bias and extracted data. We contacted study authors whenever information
was lacking. We collected information on adverse events. The primary outcomes
were all-cause mortality and reappearance of hepatitis B surface antigen in serum
after liver transplantation. Relative risks were calculated from individual
trials.
MAIN RESULTS: Four trials, recruiting 136 participants, were included. Two trials
compared lamivudine alone versus HBIg alone. Randomisation was performed one week
after transplantation in one of the trials and after six months after
transplantation in another; from transplantation until randomisation, HBIg alone
was given to all patients in the two trials. A third trial compared combination
treatment with lamivudine and HBIg versus lamivudine alone after one month of
combination treatment, and a fourth trial compared the combination of lamivudine
and HBIg versus a combination of lamivudine and adefovir dipivoxil after at least
12-month of lamivudine and HBIg combination treatment. Statistically significant
differences were not detected in any of the comparisons and outcomes. All trials
were open-labelled, and none of the trials were adequately powered to show a
difference in HBV recurrence. No meta-analyses were performed since the
identified trials assessed different comparisons.
AUTHORS' CONCLUSIONS: This review could not derive clear evidence from randomised
clinical trials for the treatment of patients with chronic HBV following liver
transplantation for preventing recurrence of HBV infection. Large randomised
clinical trials comparing long-term combination treatment to each of the
monotherapy alone, including the newer antiviral drugs, are needed.
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