Lamivudine or adefovir dipivoxil alone or combined with immunoglobulin for preventing hepatitis B recurrence after liver transplantation

[Guest guest]

http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD006005.pub2/abstract;jsess\

ionid=3BD319EDA2324E6E2038DD0C45106DDD.d01t04

Intervention Review

Lamivudine or adefovir dipivoxil alone or combined with immunoglobulin for

preventing hepatitis B recurrence after liver transplantation

Lior H Katz1,*,

Ran Tur-Kaspa2,

G Guy3,

Mical 4

Editorial Group: Cochrane Hepato-Biliary Group

Published Online: 7 JUL 2010

Assessed as up-to-date: 11 APR 2009

DOI: 10.1002/14651858.CD006005.pub2

The Cochrane Collaboration. Published by Wiley & Sons,

Ltd.

Database Title

The Cochrane Library

Abstract

Plain language summary

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.

Jump to…Top of pageAbstractPlain language summary

Plain language summary

Abstract

Plain language summary

Drugs for preventing hepatitis B recurrence after liver transplantation

Chronic hepatitis B is a very common infectious disease leading to chronic liver

disease, affecting around 350 million people all over the world. Liver

transplantation is often the only viable treatment option. Recurrence of

hepatitis B virus (HBV) infection in the liver graft is one of the grave

complications of liver transplantation, and to prevent it, hepatitis B

immunoglobulin (HBIg) seem associated with improved survival. HBIg and/or

antiviral drugs are given alone or in combination after liver transplantation.

We attempted to identify the optimal preventive treatment option.

We found only four randomised clinical trials that compared different

prophylactic regimens in 136 participants. None of the trials compared the same

prophylaxis regimen. In each individual trial no significant differences were

detected with regard to patients' survival after transplantation, HBV

recurrence, or the recurrence of liver disease. All trials were too small to

detect a difference, if it existed.

Prevention of HBV recurrence following liver transplantation is currently

non-evidence based. Practice is to administer a combination of HBIg and an

antiviral drug. Randomised clinical trials are needed to examine this practice.

[Guest guest]

http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD006005.pub2/abstract;jsess\

ionid=3BD319EDA2324E6E2038DD0C45106DDD.d01t04

Intervention Review

Lamivudine or adefovir dipivoxil alone or combined with immunoglobulin for

preventing hepatitis B recurrence after liver transplantation

Lior H Katz1,*,

Ran Tur-Kaspa2,

G Guy3,

Mical 4

Editorial Group: Cochrane Hepato-Biliary Group

Published Online: 7 JUL 2010

Assessed as up-to-date: 11 APR 2009

DOI: 10.1002/14651858.CD006005.pub2

The Cochrane Collaboration. Published by Wiley & Sons,

Ltd.

Database Title

The Cochrane Library

Abstract

Plain language summary

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.

Jump to…Top of pageAbstractPlain language summary

Plain language summary

Abstract

Plain language summary

Drugs for preventing hepatitis B recurrence after liver transplantation

Chronic hepatitis B is a very common infectious disease leading to chronic liver

disease, affecting around 350 million people all over the world. Liver

transplantation is often the only viable treatment option. Recurrence of

hepatitis B virus (HBV) infection in the liver graft is one of the grave

complications of liver transplantation, and to prevent it, hepatitis B

immunoglobulin (HBIg) seem associated with improved survival. HBIg and/or

antiviral drugs are given alone or in combination after liver transplantation.

We attempted to identify the optimal preventive treatment option.

We found only four randomised clinical trials that compared different

prophylactic regimens in 136 participants. None of the trials compared the same

prophylaxis regimen. In each individual trial no significant differences were

detected with regard to patients' survival after transplantation, HBV

recurrence, or the recurrence of liver disease. All trials were too small to

detect a difference, if it existed.

Prevention of HBV recurrence following liver transplantation is currently

non-evidence based. Practice is to administer a combination of HBIg and an

antiviral drug. Randomised clinical trials are needed to examine this practice.