Reviewer's report
Title:Hyperimmune Anti-HBs Plasma as Alternative to Commercial
Immunoglobulins for Prevention of HBV Recurrence After Liver Transplantation
Version: 1Date:9 November 2009
Reviewer: James Fung
Reviewer's report:
I enjoyed reading the study on the use of HIP in the prevention of HBV
recurrence after LT. The use of HBIG is still recommended in most centers in
combination with NA. Some studies have shown efficacy with combination NAs
only - however re-emergence of HBsAg (even with negative HBV DNA) in a small
proportion is likely a result of recurrent HBV and the negative HBV DNA is merely
secondary to the virus being suppressed by NAs.
Minor Comments:
1. The demographics (age/sex/ethnicity) of the 21 patients should be provided
2. The statistical tests used throughout the study should be described under the
section of data analysis
Major Comments"
1. Of the 21 patients, 19 (90%) had undetectable HBV DNA at the time of
transplantation. Were these patients already on oral NA treatment? The patients
underwent liver transplantation between 1989-2007, but NA was only available
from 1996.
2. 3 patients had fulminant HBV - how was hepatitis B diagnosed in these
patients (at least 1 patient would have had negative HBV DNA given that 19
patients had negative HBV DNA at the time of transplantation). Could these
patients have had acute infection with HBV rather than acute on chronic flare
leading to fulminant hepatitis. The authors should state the mode of diagnosis for
their 3 groups of patients (HBV, fulminant HBV, HBVHDV) - eg: HBsAg positive
for at least 6 months etc etc
3. One third of the patients developed hypersensitivity reactions - do the authors
recommend premeds to be given to all patients as 1/3 of these patients would
have had their HIP transfusions stopped initially and having to switch to HBIG.
4. Given the decline of anti-HBs levels in HIP with storage - do the authors
recommend testing before the administration of HIP to ensure the levels are
adequate or to perform a post-dose level routinely
5. Long term IV transfusion may be tedious. Initial treatment with HIP
(intra-operatively and for the first week as inpatient) and followed by lower dose
IM HBIG after the patient is discharged may be a logical/alternative option - can
the authors comment on potential different approaches
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests
Reviewer's report
Title:Hyperimmune Anti-HBs Plasma as Alternative to Commercial
Immunoglobulins for Prevention of HBV Recurrence After Liver Transplantation
Version: 1Date:9 November 2009
Reviewer: James Fung
Reviewer's report:
I enjoyed reading the study on the use of HIP in the prevention of HBV
recurrence after LT. The use of HBIG is still recommended in most centers in
combination with NA. Some studies have shown efficacy with combination NAs
only - however re-emergence of HBsAg (even with negative HBV DNA) in a small
proportion is likely a result of recurrent HBV and the negative HBV DNA is merely
secondary to the virus being suppressed by NAs.
Minor Comments:
1. The demographics (age/sex/ethnicity) of the 21 patients should be provided
2. The statistical tests used throughout the study should be described under the
section of data analysis
Major Comments"
1. Of the 21 patients, 19 (90%) had undetectable HBV DNA at the time of
transplantation. Were these patients already on oral NA treatment? The patients
underwent liver transplantation between 1989-2007, but NA was only available
from 1996.
2. 3 patients had fulminant HBV - how was hepatitis B diagnosed in these
patients (at least 1 patient would have had negative HBV DNA given that 19
patients had negative HBV DNA at the time of transplantation). Could these
patients have had acute infection with HBV rather than acute on chronic flare
leading to fulminant hepatitis. The authors should state the mode of diagnosis for
their 3 groups of patients (HBV, fulminant HBV, HBVHDV) - eg: HBsAg positive
for at least 6 months etc etc
3. One third of the patients developed hypersensitivity reactions - do the authors
recommend premeds to be given to all patients as 1/3 of these patients would
have had their HIP transfusions stopped initially and having to switch to HBIG.
4. Given the decline of anti-HBs levels in HIP with storage - do the authors
recommend testing before the administration of HIP to ensure the levels are
adequate or to perform a post-dose level routinely
5. Long term IV transfusion may be tedious. Initial treatment with HIP
(intra-operatively and for the first week as inpatient) and followed by lower dose
IM HBIG after the patient is discharged may be a logical/alternative option - can
the authors comment on potential different approaches
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests
Please review this paper.
user
Reviewer's report
Title:Hyperimmune Anti-HBs Plasma as Alternative to Commercial
Immunoglobulins for Prevention of HBV Recurrence After Liver Transplantation
Version: 1Date:9 November 2009
Reviewer: James Fung
Reviewer's report:
I enjoyed reading the study on the use of HIP in the prevention of HBV
recurrence after LT. The use of HBIG is still recommended in most centers in
combination with NA. Some studies have shown efficacy with combination NAs
only - however re-emergence of HBsAg (even with negative HBV DNA) in a small
proportion is likely a result of recurrent HBV and the negative HBV DNA is merely
secondary to the virus being suppressed by NAs.
Minor Comments:
1. The demographics (age/sex/ethnicity) of the 21 patients should be provided
2. The statistical tests used throughout the study should be described under the
section of data analysis
Major Comments"
1. Of the 21 patients, 19 (90%) had undetectable HBV DNA at the time of
transplantation. Were these patients already on oral NA treatment? The patients
underwent liver transplantation between 1989-2007, but NA was only available
from 1996.
2. 3 patients had fulminant HBV - how was hepatitis B diagnosed in these
patients (at least 1 patient would have had negative HBV DNA given that 19
patients had negative HBV DNA at the time of transplantation). Could these
patients have had acute infection with HBV rather than acute on chronic flare
leading to fulminant hepatitis. The authors should state the mode of diagnosis for
their 3 groups of patients (HBV, fulminant HBV, HBVHDV) - eg: HBsAg positive
for at least 6 months etc etc
3. One third of the patients developed hypersensitivity reactions - do the authors
recommend premeds to be given to all patients as 1/3 of these patients would
have had their HIP transfusions stopped initially and having to switch to HBIG.
4. Given the decline of anti-HBs levels in HIP with storage - do the authors
recommend testing before the administration of HIP to ensure the levels are
adequate or to perform a post-dose level routinely
5. Long term IV transfusion may be tedious. Initial treatment with HIP
(intra-operatively and for the first week as inpatient) and followed by lower dose
IM HBIG after the patient is discharged may be a logical/alternative option - can
the authors comment on potential different approaches
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests
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