Title: Effectiveness of antiviral treatment in HBeAg-negative chronic hepatitis B patients with
normal or mildly elevated alanine aminotransferase: A retrospective study
Version: 1 Date: 04 May 2022
Reviewer's report:
Although the study selected LSM as the efficacy observation index, and reflected the benefit of
antiviral treatment for this part of patients. The study has certain value. However, study design
and manuscript writing should clarify the following issues.
The definitions in the text should be based on the latest international guidelines.
The actual study population is Phase 4: HBeAg-negative chronic hepatitis B. (EASL 2017)
The unprofessional term "HBeAg-negative patients" cannot be used in the full text.
What antiviral drugs should be identified? Although the antiviral efficacy of nucleoside analogs
is currently comparable, the case screening of the study began in 2010, and there are inevitably
different types of nucleoside analog applications.
If it is a single nucleoside analog, it should be clear.
The keyword is completely inappropriate. Please redraft according to the revision of the article.
Background
The mechanism of formation of this part of HBV infection should be described. Such as "HBV
variants in the precore and/or the basal core promoter regions", etc. Is this mechanism related
to the efficacy of antiviral therapy?
The last paragraph should be placed in the penultimate paragraph and should reflect sufficient
evidence that LSM can replace liver biopsy in this study (should be discussed further in the
discussion).
According to 2017 EASL, “All patients with HBeAg-positive or -negative chronic hepatitis
B, defined by HBV DNA >2,000 IU/ml, ALT >ULN and/or at least moderate liver
necroinflammation or fibrosis, should be treated (Evidence level I, grade of recommendation
1)”.
Judging from the pre-treatment LSM of the study subjects (F2-3), although no liver biopsy
was performed, they clearly met the antiviral treatment criteria of "at least moderate liver
necroinflammation or fibrosis".
The last paragraph, the description of “To date, however, there is insufficient data on the
antiviral outcomes of NAs in HBeAg-negative patients with normal or mildly elevated ALT” is
inappropriate. The qualification "no histological evidence" should be added.
Methods
"A total of 432 HBeAg-negative patients..." is a description of a prospective study, not a
retrospective study. It is sufficient to directly describe the inclusion criteria of "128 HBeAg-
negative...".
Inclusion criteria “4) ALT level < 2 times the ULN twice in 6 months” was not specific and clear
enough. Whether there is ALT fluctuation in these patients, but the fluctuation range is within
2 ULN. If these patients are not included, they should be specified in the exclusion criteria.
LSM, VR, etc. in the title should use the full name.
RESULT
Baseline characteristics
As described later, not all patients had LSM results at baseline, and the number of cases
performed should be indicated.
This paragraph should specifically describe the baseline results of the LSM. From the existing
data, although the liver function of the research subjects is normal or slightly elevated, the
histological changes are more obvious.
Figure 1 should be deleted and is not part of this study.
LSM improvement
This paragraph is the essence of this article, but unfortunately, the number of cases is too small.
If there are more similar patients in the database, it is recommended to re-include the study.
DISCUSSION
The LSM paragraph is not sufficiently discussed. It should include: What are the advantages of
choosing LSM as an observation indicator for this group of people? Is it an alternative to liver
biopsy? What pathological characteristics do the results at baseline reflect in this population? Is
LSM recommended for routine examination of this population? The results of LSM are affected
by certain factors. How does it affect this population?
Conclusions
Therefore, antiviral therapy is recommended for HBeAg-negative patients regardless of ALT
level.
The description in the conclusion must conform to the conceptual definition of the guideline.
"HBeAg-negative patients regardless of ALT level" is not a standard HBV infection population.
The above recommendations should be reflected in the abstract.
Title: Effectiveness of antiviral treatment in HBeAg-negative chronic hepatitis B patients with
normal or mildly elevated alanine aminotransferase: A retrospective study
Version: 1 Date: 04 May 2022
Reviewer's report:
Although the study selected LSM as the efficacy observation index, and reflected the benefit of
antiviral treatment for this part of patients. The study has certain value. However, study design
and manuscript writing should clarify the following issues.
The definitions in the text should be based on the latest international guidelines.
The actual study population is Phase 4: HBeAg-negative chronic hepatitis B. (EASL 2017)
The unprofessional term "HBeAg-negative patients" cannot be used in the full text.
What antiviral drugs should be identified? Although the antiviral efficacy of nucleoside analogs
is currently comparable, the case screening of the study began in 2010, and there are inevitably
different types of nucleoside analog applications.
If it is a single nucleoside analog, it should be clear.
The keyword is completely inappropriate. Please redraft according to the revision of the article.
Background
The mechanism of formation of this part of HBV infection should be described. Such as "HBV
variants in the precore and/or the basal core promoter regions", etc. Is this mechanism related
to the efficacy of antiviral therapy?
The last paragraph should be placed in the penultimate paragraph and should reflect sufficient
evidence that LSM can replace liver biopsy in this study (should be discussed further in the
discussion).
According to 2017 EASL, “All patients with HBeAg-positive or -negative chronic hepatitis
B, defined by HBV DNA >2,000 IU/ml, ALT >ULN and/or at least moderate liver
necroinflammation or fibrosis, should be treated (Evidence level I, grade of recommendation
1)”.
Judging from the pre-treatment LSM of the study subjects (F2-3), although no liver biopsy
was performed, they clearly met the antiviral treatment criteria of "at least moderate liver
necroinflammation or fibrosis".
The last paragraph, the description of “To date, however, there is insufficient data on the
antiviral outcomes of NAs in HBeAg-negative patients with normal or mildly elevated ALT” is
inappropriate. The qualification "no histological evidence" should be added.
Methods
"A total of 432 HBeAg-negative patients..." is a description of a prospective study, not a
retrospective study. It is sufficient to directly describe the inclusion criteria of "128 HBeAg-
negative...".
Inclusion criteria “4) ALT level < 2 times the ULN twice in 6 months” was not specific and clear
enough. Whether there is ALT fluctuation in these patients, but the fluctuation range is within
2 ULN. If these patients are not included, they should be specified in the exclusion criteria.
LSM, VR, etc. in the title should use the full name.
RESULT
Baseline characteristics
As described later, not all patients had LSM results at baseline, and the number of cases
performed should be indicated.
This paragraph should specifically describe the baseline results of the LSM. From the existing
data, although the liver function of the research subjects is normal or slightly elevated, the
histological changes are more obvious.
Figure 1 should be deleted and is not part of this study.
LSM improvement
This paragraph is the essence of this article, but unfortunately, the number of cases is too small.
If there are more similar patients in the database, it is recommended to re-include the study.
DISCUSSION
The LSM paragraph is not sufficiently discussed. It should include: What are the advantages of
choosing LSM as an observation indicator for this group of people? Is it an alternative to liver
biopsy? What pathological characteristics do the results at baseline reflect in this population? Is
LSM recommended for routine examination of this population? The results of LSM are affected
by certain factors. How does it affect this population?
Conclusions
Therefore, antiviral therapy is recommended for HBeAg-negative patients regardless of ALT
level.
The description in the conclusion must conform to the conceptual definition of the guideline.
"HBeAg-negative patients regardless of ALT level" is not a standard HBV infection population.
The above recommendations should be reflected in the abstract.
Please review this paper.
user
Title: Effectiveness of antiviral treatment in HBeAg-negative chronic hepatitis B patients with
normal or mildly elevated alanine aminotransferase: A retrospective study
Version: 1 Date: 04 May 2022
Reviewer's report:
Although the study selected LSM as the efficacy observation index, and reflected the benefit of
antiviral treatment for this part of patients. The study has certain value. However, study design
and manuscript writing should clarify the following issues.
The definitions in the text should be based on the latest international guidelines.
The actual study population is Phase 4: HBeAg-negative chronic hepatitis B. (EASL 2017)
The unprofessional term "HBeAg-negative patients" cannot be used in the full text.
What antiviral drugs should be identified? Although the antiviral efficacy of nucleoside analogs
is currently comparable, the case screening of the study began in 2010, and there are inevitably
different types of nucleoside analog applications.
If it is a single nucleoside analog, it should be clear.
The keyword is completely inappropriate. Please redraft according to the revision of the article.
Background
The mechanism of formation of this part of HBV infection should be described. Such as "HBV
variants in the precore and/or the basal core promoter regions", etc. Is this mechanism related
to the efficacy of antiviral therapy?
The last paragraph should be placed in the penultimate paragraph and should reflect sufficient
evidence that LSM can replace liver biopsy in this study (should be discussed further in the
discussion).
According to 2017 EASL, “All patients with HBeAg-positive or -negative chronic hepatitis
B, defined by HBV DNA >2,000 IU/ml, ALT >ULN and/or at least moderate liver
necroinflammation or fibrosis, should be treated (Evidence level I, grade of recommendation
1)”.
Judging from the pre-treatment LSM of the study subjects (F2-3), although no liver biopsy
was performed, they clearly met the antiviral treatment criteria of "at least moderate liver
necroinflammation or fibrosis".
The last paragraph, the description of “To date, however, there is insufficient data on the
antiviral outcomes of NAs in HBeAg-negative patients with normal or mildly elevated ALT” is
inappropriate. The qualification "no histological evidence" should be added.
Methods
"A total of 432 HBeAg-negative patients..." is a description of a prospective study, not a
retrospective study. It is sufficient to directly describe the inclusion criteria of "128 HBeAg-
negative...".
Inclusion criteria “4) ALT level < 2 times the ULN twice in 6 months” was not specific and clear
enough. Whether there is ALT fluctuation in these patients, but the fluctuation range is within
2 ULN. If these patients are not included, they should be specified in the exclusion criteria.
LSM, VR, etc. in the title should use the full name.
RESULT
Baseline characteristics
As described later, not all patients had LSM results at baseline, and the number of cases
performed should be indicated.
This paragraph should specifically describe the baseline results of the LSM. From the existing
data, although the liver function of the research subjects is normal or slightly elevated, the
histological changes are more obvious.
Figure 1 should be deleted and is not part of this study.
LSM improvement
This paragraph is the essence of this article, but unfortunately, the number of cases is too small.
If there are more similar patients in the database, it is recommended to re-include the study.
DISCUSSION
The LSM paragraph is not sufficiently discussed. It should include: What are the advantages of
choosing LSM as an observation indicator for this group of people? Is it an alternative to liver
biopsy? What pathological characteristics do the results at baseline reflect in this population? Is
LSM recommended for routine examination of this population? The results of LSM are affected
by certain factors. How does it affect this population?
Conclusions
Therefore, antiviral therapy is recommended for HBeAg-negative patients regardless of ALT
level.
The description in the conclusion must conform to the conceptual definition of the guideline.
"HBeAg-negative patients regardless of ALT level" is not a standard HBV infection population.
The above recommendations should be reflected in the abstract.
assistant