Reviewer's report
Title:Multicenter Comparison of PEG-IFN 2a or 2b Plus Ribavirin for
Treatment-naive HCV Patient in Favorable IL-28B Polymorphism Dominant Area
Version: 1Date:27 December 2012
Reviewer: Eckart Schott
Reviewer's report:
Jin et al. provide a retrospective analysis of Korean patients with chronic hepatitis
C treated with either pegIFNa2a oder a2b. They find no difference regarding the
efficacy or tolerability of both treatment regimens.
This is a well performed study in a large patient cohort, which sheds more light
on a much disputed issue, namely the question whether one of the both available
interferons is superior. The main difference between this and prior studies ist hat
this is an excusively Asian population.
Apart from the fact that, while important and adequately addressed, the issue is
somewhat outdated in the era of protease inhibitors, I have several comments:
• The title should be changed. It should state that this is a retrospective analysis
in Asia. While the authors are right to point out that this is an area of favorable
IL28B genotypes, the title implicates that IL28B was actually analyzed. IL28B
should not be part of the title.
• Since ribavirin dosing has always been an issue in the European studies, the
authors should provide actual ribavirin doses in both groups.
• While it is correct to use an ITT analysis for the primary outcome, PP data
should also be presented for SVR, since more patients discontinued treatment in
the a2a group.
• In Table 1, the line entitled SVR does not state the numbers/% of SVR but the
numbers/% of patients treated with a2a vs. a2b
• No statistics should be calculated for n=5-6 (patients with stage 3-4 fibrosis)
since groups are just too small.
• 80-80-80 rule should be used consistenly throughout the ms (tables).
• More details regarding the propensity score matching need to be provided. How
exactly were the patients matched? If they were matched for age and gender,
age and gender cannot be an outcome in table 3.
• The numbers for SVR don’t add up in table 2 (HCV-RNA, upper part)
• The numbers for male gender don’t add up in table 3. This makes me a bit
uneasy about all the other numbers which I can’t easily recapitulate.
• I don’t understand the statistics in table 4. What does the p value stand for?
Comparison of patients with any AE or just grades 1-2? Or just stage 3? Why is
there no p-value for flu-like symptoms? Please clarify and provide p-values for
the comparison of patients with any event and with grade 3-4 events.
Level of interest: An article of importance in its field
Quality of written English: Needs some language corrections before being
published
Statistical review: Yes, but I do not feel adequately qualified to assess the
statistics.
Declaration of competing interests:
I have received lecture and consulting fees from Roche and MSD.
Reviewer's report
Title:Multicenter Comparison of PEG-IFN 2a or 2b Plus Ribavirin for
Treatment-naive HCV Patient in Favorable IL-28B Polymorphism Dominant Area
Version: 1Date:27 December 2012
Reviewer: Eckart Schott
Reviewer's report:
Jin et al. provide a retrospective analysis of Korean patients with chronic hepatitis
C treated with either pegIFNa2a oder a2b. They find no difference regarding the
efficacy or tolerability of both treatment regimens.
This is a well performed study in a large patient cohort, which sheds more light
on a much disputed issue, namely the question whether one of the both available
interferons is superior. The main difference between this and prior studies ist hat
this is an excusively Asian population.
Apart from the fact that, while important and adequately addressed, the issue is
somewhat outdated in the era of protease inhibitors, I have several comments:
• The title should be changed. It should state that this is a retrospective analysis
in Asia. While the authors are right to point out that this is an area of favorable
IL28B genotypes, the title implicates that IL28B was actually analyzed. IL28B
should not be part of the title.
• Since ribavirin dosing has always been an issue in the European studies, the
authors should provide actual ribavirin doses in both groups.
• While it is correct to use an ITT analysis for the primary outcome, PP data
should also be presented for SVR, since more patients discontinued treatment in
the a2a group.
• In Table 1, the line entitled SVR does not state the numbers/% of SVR but the
numbers/% of patients treated with a2a vs. a2b
• No statistics should be calculated for n=5-6 (patients with stage 3-4 fibrosis)
since groups are just too small.
• 80-80-80 rule should be used consistenly throughout the ms (tables).
• More details regarding the propensity score matching need to be provided. How
exactly were the patients matched? If they were matched for age and gender,
age and gender cannot be an outcome in table 3.
• The numbers for SVR don’t add up in table 2 (HCV-RNA, upper part)
• The numbers for male gender don’t add up in table 3. This makes me a bit
uneasy about all the other numbers which I can’t easily recapitulate.
• I don’t understand the statistics in table 4. What does the p value stand for?
Comparison of patients with any AE or just grades 1-2? Or just stage 3? Why is
there no p-value for flu-like symptoms? Please clarify and provide p-values for
the comparison of patients with any event and with grade 3-4 events.
Level of interest: An article of importance in its field
Quality of written English: Needs some language corrections before being
published
Statistical review: Yes, but I do not feel adequately qualified to assess the
statistics.
Declaration of competing interests:
I have received lecture and consulting fees from Roche and MSD.
Please review this paper.
user
Reviewer's report
Title:Multicenter Comparison of PEG-IFN 2a or 2b Plus Ribavirin for
Treatment-naive HCV Patient in Favorable IL-28B Polymorphism Dominant Area
Version: 1Date:27 December 2012
Reviewer: Eckart Schott
Reviewer's report:
Jin et al. provide a retrospective analysis of Korean patients with chronic hepatitis
C treated with either pegIFNa2a oder a2b. They find no difference regarding the
efficacy or tolerability of both treatment regimens.
This is a well performed study in a large patient cohort, which sheds more light
on a much disputed issue, namely the question whether one of the both available
interferons is superior. The main difference between this and prior studies ist hat
this is an excusively Asian population.
Apart from the fact that, while important and adequately addressed, the issue is
somewhat outdated in the era of protease inhibitors, I have several comments:
• The title should be changed. It should state that this is a retrospective analysis
in Asia. While the authors are right to point out that this is an area of favorable
IL28B genotypes, the title implicates that IL28B was actually analyzed. IL28B
should not be part of the title.
• Since ribavirin dosing has always been an issue in the European studies, the
authors should provide actual ribavirin doses in both groups.
• While it is correct to use an ITT analysis for the primary outcome, PP data
should also be presented for SVR, since more patients discontinued treatment in
the a2a group.
• In Table 1, the line entitled SVR does not state the numbers/% of SVR but the
numbers/% of patients treated with a2a vs. a2b
• No statistics should be calculated for n=5-6 (patients with stage 3-4 fibrosis)
since groups are just too small.
• 80-80-80 rule should be used consistenly throughout the ms (tables).
• More details regarding the propensity score matching need to be provided. How
exactly were the patients matched? If they were matched for age and gender,
age and gender cannot be an outcome in table 3.
• The numbers for SVR don’t add up in table 2 (HCV-RNA, upper part)
• The numbers for male gender don’t add up in table 3. This makes me a bit
uneasy about all the other numbers which I can’t easily recapitulate.
• I don’t understand the statistics in table 4. What does the p value stand for?
Comparison of patients with any AE or just grades 1-2? Or just stage 3? Why is
there no p-value for flu-like symptoms? Please clarify and provide p-values for
the comparison of patients with any event and with grade 3-4 events.
Level of interest: An article of importance in its field
Quality of written English: Needs some language corrections before being
published
Statistical review: Yes, but I do not feel adequately qualified to assess the
statistics.
Declaration of competing interests:
I have received lecture and consulting fees from Roche and MSD.
assistant