Reviewer's report
Title:Extent of liver inflammation in predicting response to Interferon alpha &
Ribavirin in chronic hepatitis C patients: a cohort study
Version: 1Date:4 June 2011
Reviewer: Claudio Puoti
Reviewer's report:
This is a retrospective study aimed at comparing the rate of End of Treatment
Response (ETR) according to the severity of liver inflammation in 672 patients
with chronic hepatitis C (CHC), treated for 24 weeks with Interferon # plus
Ribavirin.
The first goal of this study was to compare ETR in CHC patients with higher
grades to those with lower grades of pretreatment liver inflammation, while the
secondary objective was to determine diagnostic accuracy ALT for pretreatment
grades of inflammation ascertained by modified HAI for grading liver
inflammation on liver biopsy in CHC patients.
The study is interesting and well written, and the sample size is actually huge;
furthermore, the aim of this paper is interesting, as in the majority of available
studies the role of fibrosis rather than liver histological activity has been
examined.
However, this paper presents two major pitfalls, that the authors should better
explain:
- in first, it is well known that the current standard of care (SoC) of CHC is PEG
IFN plus RBV; I have not understood if the patients in study were treated with
recombinant IFN or Pegylated IFN. If r-IFN was offered, the authors should
specify the reasons for a rather outdated treatment (e.g., local resources, etc).
- secondly, having this huge sample of patients, the authors should have to
evaluate the sustained virological response (SVR), which is more relevant than
the simple ETR.
I look forward the response to these two questions, that could immensely
increase the strength of this paper.
Other comments:
1. In Table 1 (5th column) the reported total number is 672 (410+262) and not
876.
2. the genotype distribution in this series of patients should be reported in the
result section and in Table 1, rather than in the discussion (page 15).
3. HCV type was available only in 101 patients (page 15); thus it is possible that
patients with genotype 1, requiring at least 48 wk of treatment, were treated only
for 24 weeks. If this is true, this is an important bias that the authors should
absolutely clarify.
4. I strongly suggest to add HCV RNA data, if this information is available.
5. Dosage of IFN and ribavirin are not reported.
6. several typing errors should be checked (e.g., (TLC)), Hepatology 199624(4),
etc).
7. References should be updated, at least adding the more recent EASL 2011
Clinical Practice Guidelines on the management of HCV infection, available
online.
Level of interest: An article of limited interest
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
Claudio Puoti, MD
Reviewer's report
Title:Extent of liver inflammation in predicting response to Interferon alpha &
Ribavirin in chronic hepatitis C patients: a cohort study
Version: 1Date:4 June 2011
Reviewer: Claudio Puoti
Reviewer's report:
This is a retrospective study aimed at comparing the rate of End of Treatment
Response (ETR) according to the severity of liver inflammation in 672 patients
with chronic hepatitis C (CHC), treated for 24 weeks with Interferon # plus
Ribavirin.
The first goal of this study was to compare ETR in CHC patients with higher
grades to those with lower grades of pretreatment liver inflammation, while the
secondary objective was to determine diagnostic accuracy ALT for pretreatment
grades of inflammation ascertained by modified HAI for grading liver
inflammation on liver biopsy in CHC patients.
The study is interesting and well written, and the sample size is actually huge;
furthermore, the aim of this paper is interesting, as in the majority of available
studies the role of fibrosis rather than liver histological activity has been
examined.
However, this paper presents two major pitfalls, that the authors should better
explain:
- in first, it is well known that the current standard of care (SoC) of CHC is PEG
IFN plus RBV; I have not understood if the patients in study were treated with
recombinant IFN or Pegylated IFN. If r-IFN was offered, the authors should
specify the reasons for a rather outdated treatment (e.g., local resources, etc).
- secondly, having this huge sample of patients, the authors should have to
evaluate the sustained virological response (SVR), which is more relevant than
the simple ETR.
I look forward the response to these two questions, that could immensely
increase the strength of this paper.
Other comments:
1. In Table 1 (5th column) the reported total number is 672 (410+262) and not
876.
2. the genotype distribution in this series of patients should be reported in the
result section and in Table 1, rather than in the discussion (page 15).
3. HCV type was available only in 101 patients (page 15); thus it is possible that
patients with genotype 1, requiring at least 48 wk of treatment, were treated only
for 24 weeks. If this is true, this is an important bias that the authors should
absolutely clarify.
4. I strongly suggest to add HCV RNA data, if this information is available.
5. Dosage of IFN and ribavirin are not reported.
6. several typing errors should be checked (e.g., (TLC)), Hepatology 199624(4),
etc).
7. References should be updated, at least adding the more recent EASL 2011
Clinical Practice Guidelines on the management of HCV infection, available
online.
Level of interest: An article of limited interest
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
Claudio Puoti, MD
Please review this paper.
user
Reviewer's report
Title:Extent of liver inflammation in predicting response to Interferon alpha &
Ribavirin in chronic hepatitis C patients: a cohort study
Version: 1Date:4 June 2011
Reviewer: Claudio Puoti
Reviewer's report:
This is a retrospective study aimed at comparing the rate of End of Treatment
Response (ETR) according to the severity of liver inflammation in 672 patients
with chronic hepatitis C (CHC), treated for 24 weeks with Interferon # plus
Ribavirin.
The first goal of this study was to compare ETR in CHC patients with higher
grades to those with lower grades of pretreatment liver inflammation, while the
secondary objective was to determine diagnostic accuracy ALT for pretreatment
grades of inflammation ascertained by modified HAI for grading liver
inflammation on liver biopsy in CHC patients.
The study is interesting and well written, and the sample size is actually huge;
furthermore, the aim of this paper is interesting, as in the majority of available
studies the role of fibrosis rather than liver histological activity has been
examined.
However, this paper presents two major pitfalls, that the authors should better
explain:
- in first, it is well known that the current standard of care (SoC) of CHC is PEG
IFN plus RBV; I have not understood if the patients in study were treated with
recombinant IFN or Pegylated IFN. If r-IFN was offered, the authors should
specify the reasons for a rather outdated treatment (e.g., local resources, etc).
- secondly, having this huge sample of patients, the authors should have to
evaluate the sustained virological response (SVR), which is more relevant than
the simple ETR.
I look forward the response to these two questions, that could immensely
increase the strength of this paper.
Other comments:
1. In Table 1 (5th column) the reported total number is 672 (410+262) and not
876.
2. the genotype distribution in this series of patients should be reported in the
result section and in Table 1, rather than in the discussion (page 15).
3. HCV type was available only in 101 patients (page 15); thus it is possible that
patients with genotype 1, requiring at least 48 wk of treatment, were treated only
for 24 weeks. If this is true, this is an important bias that the authors should
absolutely clarify.
4. I strongly suggest to add HCV RNA data, if this information is available.
5. Dosage of IFN and ribavirin are not reported.
6. several typing errors should be checked (e.g., (TLC)), Hepatology 199624(4),
etc).
7. References should be updated, at least adding the more recent EASL 2011
Clinical Practice Guidelines on the management of HCV infection, available
online.
Level of interest: An article of limited interest
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
Claudio Puoti, MD
assistant