Reviewer ’s report  
 
Title: Sustained serological and complete responses in HBeAg -Positive Patients treated with  
Peginterferon alfa -2b: a 6 -Year Long -Term Follow -Up of a Multicenter, Randomized, 
Controlled  Trial in China  
 
Version: 1 Date: 11 Feb 2018  
 
Reviewer: Florian MAYER  
 
Reviewer's report:  
 
Major points:  
 
1) The "long -term follow up" should be explained in more detail. You are mixing the methods of 
the original study ("Peginterferon alfa -2b in the treatment of Chine se patients with HBeAg -
positive chronic hepatitis B: a randomized trial") with the methods of your follow up study. The 
authors need to clarify and outline which of the study investigations were solely carried out for 
the "long -term follow up" and those wh ich belong to the original study.  
 
2) Did you obtain an approval of your local ethics committee for your long -term follow study, 
and if so, did all patients give written and informed consent for both the original (48 weeks) as 
well as the 6 year follow up  study? Please clarify and state in the method section whether you 
obtained the above mentioned agreements.  
 
3) Most of your  presented data (including the tables and the figure) has been published in your 
previous publication: Cheng J, Wang Y, Hou J, Luo D, Xie Q, Ning Q, et al. Peginterferon alfa -
2b in the treatment of Chinese patients with HBeAg -positive chronic hepatitis B: a randomized 
trial. J Clin Virol. 2014;  
 
 
 
 
 
Minor points:  
 
1) This belongs to the method section: 3.3; Line 1 -10 : "We used univariat e and multivariate Cox 
regression analysis to analyze factors associated with SR and CR (Table 3). Factors with p<0.05 
in univariate analysis were included in the multivariate analysis" AND 3.1, Line 6.: and were 
requested to participate in long -term follo w-up by returning for an onsite visit.  
 
2) Your endpoint is the sustained combined response and the sustained serological response after 
6 years.  You do not provide any data regarding the median follow -up (I highly doubt that all 
patients were investigated   EXACTLY after 6 years).  
 
3) Table 2. What kind of statistical test did you use for the determination of the p -value?  
 
4) Table 3. This table doesnt make any sense. What are you trying to present here? Do you want 
to show which variables you included in your stepwise model ? If so, simply show which 
variables you included in the final model.  Or do you want to show the difference between the 
PEG -IFN dosing schemes after 6 years?  
 
 
 
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the authors.  
 
No 
 
Does the work include the necessary controls?  
If not, please specify which controls are required in your comments to the authors.  
 
No 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, p lease explain in your comments to the authors.  
 
Unable to assess  
 
Are you able to assess any statistics in the manuscript or would you recommend an  
additional statistical review?  
If an additional statistical review is recommended, please specify what aspects  require further  
assessment in your comments to the editors.  
 
I am able to assess the statistics  
 
Quality of written English  
Please indicate the quality of language in the manuscript:  
 
Needs some language corrections before being published  
 
 
 
 
 
Declaration of competing interests  
Please complete a declaration of competing interests, considering the following questions:  
 
1. Have you in the past five years received reimbursements, fees, funding, or salary from an  
organisation that may in any way gain  or lose financially from the publication of this  
manuscript, either now or in the future?  
 
2. Do you hold any stocks or shares in an organisation that may in any way gain or lose  
financially from the publication of this manuscript, either now or in the fut ure? 
 
3. Do you hold or are you currently applying for any patents relating to the content of the  
manuscript?  
 
4. Have you received reimbursements, fees, funding, or salary from an organization that 
holds  or has applied for patents relating to the content of  the manuscript?  
 
5. Do you have any other financial competing interests?  
 
6. Do you have any non -financial competing interests in relation to this paper?  
 
 
 
 
If you can answer no to all of the above, write 'I declare that I have no competing interests' 
below.  If your reply is yes to any, please give details below.  
 
I declare that I have no competing interests.  
 
I agree to the open peer review policy of the journal. I understand that my name will be included  
on my report to the aut hors and, if the manuscript is accepted for publication, my named report  
including any attachments I upload will be posted on the website along with the authors'  
responses. I agree for my report to be made available under an Open Access Creative Commons  
CC-BY license ( http://creativecommons.org/licenses/by/4.0/ ). I understand that any comments  
which I do not wish to be included in my named report can be included as confidential comments  
to the editors, which will not be published.  
 
I agree to the open peer re view policy of the journal  
Reviewer ’s report  
 
Title: Sustained serological and complete responses in HBeAg -Positive Patients treated with  
Peginterferon alfa -2b: a 6 -Year Long -Term Follow -Up of a Multicenter, Randomized, 
Controlled  Trial in China  
 
Version: 1 Date: 11 Feb 2018  
 
Reviewer: Florian MAYER  
 
Reviewer's report:  
 
Major points:  
 
1) The "long -term follow up" should be explained in more detail. You are mixing the methods of 
the original study ("Peginterferon alfa -2b in the treatment of Chine se patients with HBeAg -
positive chronic hepatitis B: a randomized trial") with the methods of your follow up study. The 
authors need to clarify and outline which of the study investigations were solely carried out for 
the "long -term follow up" and those wh ich belong to the original study.  
 
2) Did you obtain an approval of your local ethics committee for your long -term follow study, 
and if so, did all patients give written and informed consent for both the original (48 weeks) as 
well as the 6 year follow up  study? Please clarify and state in the method section whether you 
obtained the above mentioned agreements.  
 
3) Most of your  presented data (including the tables and the figure) has been published in your 
previous publication: Cheng J, Wang Y, Hou J, Luo D, Xie Q, Ning Q, et al. Peginterferon alfa -
2b in the treatment of Chinese patients with HBeAg -positive chronic hepatitis B: a randomized 
trial. J Clin Virol. 2014;  
 
 
 
 
 
Minor points:  
 
1) This belongs to the method section: 3.3; Line 1 -10 : "We used univariat e and multivariate Cox 
regression analysis to analyze factors associated with SR and CR (Table 3). Factors with p<0.05 
in univariate analysis were included in the multivariate analysis" AND 3.1, Line 6.: and were 
requested to participate in long -term follo w-up by returning for an onsite visit.  
 
2) Your endpoint is the sustained combined response and the sustained serological response after 
6 years.  You do not provide any data regarding the median follow -up (I highly doubt that all 
patients were investigated   EXACTLY after 6 years).  
 
3) Table 2. What kind of statistical test did you use for the determination of the p -value?  
 
4) Table 3. This table doesnt make any sense. What are you trying to present here? Do you want 
to show which variables you included in your stepwise model ? If so, simply show which 
variables you included in the final model.  Or do you want to show the difference between the 
PEG -IFN dosing schemes after 6 years?  
 
 
 
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the authors.  
 
No 
 
Does the work include the necessary controls?  
If not, please specify which controls are required in your comments to the authors.  
 
No 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, p lease explain in your comments to the authors.  
 
Unable to assess  
 
Are you able to assess any statistics in the manuscript or would you recommend an  
additional statistical review?  
If an additional statistical review is recommended, please specify what aspects  require further  
assessment in your comments to the editors.  
 
I am able to assess the statistics  
 
Quality of written English  
Please indicate the quality of language in the manuscript:  
 
Needs some language corrections before being published  
 
 
 
 
 
Declaration of competing interests  
Please complete a declaration of competing interests, considering the following questions:  
 
1. Have you in the past five years received reimbursements, fees, funding, or salary from an  
organisation that may in any way gain  or lose financially from the publication of this  
manuscript, either now or in the future?  
 
2. Do you hold any stocks or shares in an organisation that may in any way gain or lose  
financially from the publication of this manuscript, either now or in the fut ure? 
 
3. Do you hold or are you currently applying for any patents relating to the content of the  
manuscript?  
 
4. Have you received reimbursements, fees, funding, or salary from an organization that 
holds  or has applied for patents relating to the content of  the manuscript?  
 
5. Do you have any other financial competing interests?  
 
6. Do you have any non -financial competing interests in relation to this paper?  
 
 
 
 
If you can answer no to all of the above, write 'I declare that I have no competing interests' 
below.  If your reply is yes to any, please give details below.  
 
I declare that I have no competing interests.  
 
I agree to the open peer review policy of the journal. I understand that my name will be included  
on my report to the aut hors and, if the manuscript is accepted for publication, my named report  
including any attachments I upload will be posted on the website along with the authors'  
responses. I agree for my report to be made available under an Open Access Creative Commons  
CC-BY license ( http://creativecommons.org/licenses/by/4.0/ ). I understand that any comments  
which I do not wish to be included in my named report can be included as confidential comments  
to the editors, which will not be published.  
 
I agree to the open peer re view policy of the journal  
Please review this paper.
user
Reviewer ’s report  
 
Title: Sustained serological and complete responses in HBeAg -Positive Patients treated with  
Peginterferon alfa -2b: a 6 -Year Long -Term Follow -Up of a Multicenter, Randomized, 
Controlled  Trial in China  
 
Version: 1 Date: 11 Feb 2018  
 
Reviewer: Florian MAYER  
 
Reviewer's report:  
 
Major points:  
 
1) The "long -term follow up" should be explained in more detail. You are mixing the methods of 
the original study ("Peginterferon alfa -2b in the treatment of Chine se patients with HBeAg -
positive chronic hepatitis B: a randomized trial") with the methods of your follow up study. The 
authors need to clarify and outline which of the study investigations were solely carried out for 
the "long -term follow up" and those wh ich belong to the original study.  
 
2) Did you obtain an approval of your local ethics committee for your long -term follow study, 
and if so, did all patients give written and informed consent for both the original (48 weeks) as 
well as the 6 year follow up  study? Please clarify and state in the method section whether you 
obtained the above mentioned agreements.  
 
3) Most of your  presented data (including the tables and the figure) has been published in your 
previous publication: Cheng J, Wang Y, Hou J, Luo D, Xie Q, Ning Q, et al. Peginterferon alfa -
2b in the treatment of Chinese patients with HBeAg -positive chronic hepatitis B: a randomized 
trial. J Clin Virol. 2014;  
 
 
 
 
 
Minor points:  
 
1) This belongs to the method section: 3.3; Line 1 -10 : "We used univariat e and multivariate Cox 
regression analysis to analyze factors associated with SR and CR (Table 3). Factors with p<0.05 
in univariate analysis were included in the multivariate analysis" AND 3.1, Line 6.: and were 
requested to participate in long -term follo w-up by returning for an onsite visit.  
 
2) Your endpoint is the sustained combined response and the sustained serological response after 
6 years.  You do not provide any data regarding the median follow -up (I highly doubt that all 
patients were investigated   EXACTLY after 6 years).  
 
3) Table 2. What kind of statistical test did you use for the determination of the p -value?  
 
4) Table 3. This table doesnt make any sense. What are you trying to present here? Do you want 
to show which variables you included in your stepwise model ? If so, simply show which 
variables you included in the final model.  Or do you want to show the difference between the 
PEG -IFN dosing schemes after 6 years?  
 
 
 
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the authors.  
 
No 
 
Does the work include the necessary controls?  
If not, please specify which controls are required in your comments to the authors.  
 
No 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, p lease explain in your comments to the authors.  
 
Unable to assess  
 
Are you able to assess any statistics in the manuscript or would you recommend an  
additional statistical review?  
If an additional statistical review is recommended, please specify what aspects  require further  
assessment in your comments to the editors.  
 
I am able to assess the statistics  
 
Quality of written English  
Please indicate the quality of language in the manuscript:  
 
Needs some language corrections before being published  
 
 
 
 
 
Declaration of competing interests  
Please complete a declaration of competing interests, considering the following questions:  
 
1. Have you in the past five years received reimbursements, fees, funding, or salary from an  
organisation that may in any way gain  or lose financially from the publication of this  
manuscript, either now or in the future?  
 
2. Do you hold any stocks or shares in an organisation that may in any way gain or lose  
financially from the publication of this manuscript, either now or in the fut ure? 
 
3. Do you hold or are you currently applying for any patents relating to the content of the  
manuscript?  
 
4. Have you received reimbursements, fees, funding, or salary from an organization that 
holds  or has applied for patents relating to the content of  the manuscript?  
 
5. Do you have any other financial competing interests?  
 
6. Do you have any non -financial competing interests in relation to this paper?  
 
 
 
 
If you can answer no to all of the above, write 'I declare that I have no competing interests' 
below.  If your reply is yes to any, please give details below.  
 
I declare that I have no competing interests.  
 
I agree to the open peer review policy of the journal. I understand that my name will be included  
on my report to the aut hors and, if the manuscript is accepted for publication, my named report  
including any attachments I upload will be posted on the website along with the authors'  
responses. I agree for my report to be made available under an Open Access Creative Commons  
CC-BY license ( http://creativecommons.org/licenses/by/4.0/ ). I understand that any comments  
which I do not wish to be included in my named report can be included as confidential comments  
to the editors, which will not be published.  
 
I agree to the open peer re view policy of the journal  
assistant