Title: Changes in liver stiffness values assessed using transient elastography in chronic hepatitis
B patients treated with tenofovir disoproxil fumarate: a prospective observational study
Version: 1 Date: 18 Dec 2022
Reviewer's report:
In this prospective cohort of treatment-naïve CHB patients, the authors demonstrated that the
LS values decreased significantly over time during the 144-week TDF therapy. Besides, they
also found a higher LS value at baseline was a sole predictor associated with the decline in LS
values at week 96 from baseline.
However, there are still some questions to be addressed.
1. In your exclusion criteria, the 6th criterion (line 20, page 8) defined significant alcohol
consumption as more than 210 g per week. However, the definition may be different between
males and females. Would you please check whether the definition is different between males
and females in your study?
2. In line 4, page 10, I think you used two verbs in the same sentence “…4 patients did not meet
the inclusion criteria at screening were excluded from the study…” without a conjunction or a
relative pronoun.
3. I am confused about your sentences in lines 14-15, page 12. You mentioned “…significant
decline in LS value from baseline…” (I know you define it as LS value decline #30% from
baseline) and “Pearson correlation analysis revealed that the reduction in LS value at week 96
from baseline…”. Do “significant decline in LS” and “reduction in LS” have the same meaning?
4. In tables 1 and 2, you mentioned mild fibrosis and significant fibrosis. However, your article
didn’t define the cut-off values or the difference between “mild” and “significant” fibrosis.
5. I am curious about how you chose those variables in table 3. Could you more clearly show
why you chose them? Besides, ALT and GGT were demonstrated as IU/L in table 1, but in table
3, you presented them as Log IU/L. I think you should explain it.
6. In lines 4-7, page 16, you said severe hepatic inflammation might affect the LS values.
You also mentioned you had put ALT in multiple linear regression analysis. However, in lines
17-18, page 12, you selected “statistically significant factors in the Pearson correlation analysis”
for multiple linear regression analysis. I think you mean you selected statistically significant
variables in table 3 for multiple linear regression analysis. Nevertheless, I saw only GGT and
LS values were both statistically significant in table 3, and it seemed that ALT was not included
in them. Actually, you have said “severe” hepaic inflammation might affect LS values. In your
studied population, the ALT values didn’t show “severe” inflammation. Moreover, because
hepatic inflammation (or elevated ALT) may be a limitation in your study. I think you can
provide a supplement table to show the LS values changes between those with normal ALT and
those with abnormal ALT.
7. Because transient elastography is a kind of noninvasive method to measure liver stiffness, a
comparison between this method and other commonly used methods such as FIB-4 score may be
valuable. I think you should provide one supplement table to show the FIB-4 score evolutions,
like table 2.
8. I think you should also show, in another supplement table, that the LS value evolutions among
those with and without biochemical responses at week 96, like table 2.
Title: Changes in liver stiffness values assessed using transient elastography in chronic hepatitis
B patients treated with tenofovir disoproxil fumarate: a prospective observational study
Version: 1 Date: 18 Dec 2022
Reviewer's report:
In this prospective cohort of treatment-naïve CHB patients, the authors demonstrated that the
LS values decreased significantly over time during the 144-week TDF therapy. Besides, they
also found a higher LS value at baseline was a sole predictor associated with the decline in LS
values at week 96 from baseline.
However, there are still some questions to be addressed.
1. In your exclusion criteria, the 6th criterion (line 20, page 8) defined significant alcohol
consumption as more than 210 g per week. However, the definition may be different between
males and females. Would you please check whether the definition is different between males
and females in your study?
2. In line 4, page 10, I think you used two verbs in the same sentence “…4 patients did not meet
the inclusion criteria at screening were excluded from the study…” without a conjunction or a
relative pronoun.
3. I am confused about your sentences in lines 14-15, page 12. You mentioned “…significant
decline in LS value from baseline…” (I know you define it as LS value decline #30% from
baseline) and “Pearson correlation analysis revealed that the reduction in LS value at week 96
from baseline…”. Do “significant decline in LS” and “reduction in LS” have the same meaning?
4. In tables 1 and 2, you mentioned mild fibrosis and significant fibrosis. However, your article
didn’t define the cut-off values or the difference between “mild” and “significant” fibrosis.
5. I am curious about how you chose those variables in table 3. Could you more clearly show
why you chose them? Besides, ALT and GGT were demonstrated as IU/L in table 1, but in table
3, you presented them as Log IU/L. I think you should explain it.
6. In lines 4-7, page 16, you said severe hepatic inflammation might affect the LS values.
You also mentioned you had put ALT in multiple linear regression analysis. However, in lines
17-18, page 12, you selected “statistically significant factors in the Pearson correlation analysis”
for multiple linear regression analysis. I think you mean you selected statistically significant
variables in table 3 for multiple linear regression analysis. Nevertheless, I saw only GGT and
LS values were both statistically significant in table 3, and it seemed that ALT was not included
in them. Actually, you have said “severe” hepaic inflammation might affect LS values. In your
studied population, the ALT values didn’t show “severe” inflammation. Moreover, because
hepatic inflammation (or elevated ALT) may be a limitation in your study. I think you can
provide a supplement table to show the LS values changes between those with normal ALT and
those with abnormal ALT.
7. Because transient elastography is a kind of noninvasive method to measure liver stiffness, a
comparison between this method and other commonly used methods such as FIB-4 score may be
valuable. I think you should provide one supplement table to show the FIB-4 score evolutions,
like table 2.
8. I think you should also show, in another supplement table, that the LS value evolutions among
those with and without biochemical responses at week 96, like table 2.
Please review this paper.
user
Title: Changes in liver stiffness values assessed using transient elastography in chronic hepatitis
B patients treated with tenofovir disoproxil fumarate: a prospective observational study
Version: 1 Date: 18 Dec 2022
Reviewer's report:
In this prospective cohort of treatment-naïve CHB patients, the authors demonstrated that the
LS values decreased significantly over time during the 144-week TDF therapy. Besides, they
also found a higher LS value at baseline was a sole predictor associated with the decline in LS
values at week 96 from baseline.
However, there are still some questions to be addressed.
1. In your exclusion criteria, the 6th criterion (line 20, page 8) defined significant alcohol
consumption as more than 210 g per week. However, the definition may be different between
males and females. Would you please check whether the definition is different between males
and females in your study?
2. In line 4, page 10, I think you used two verbs in the same sentence “…4 patients did not meet
the inclusion criteria at screening were excluded from the study…” without a conjunction or a
relative pronoun.
3. I am confused about your sentences in lines 14-15, page 12. You mentioned “…significant
decline in LS value from baseline…” (I know you define it as LS value decline #30% from
baseline) and “Pearson correlation analysis revealed that the reduction in LS value at week 96
from baseline…”. Do “significant decline in LS” and “reduction in LS” have the same meaning?
4. In tables 1 and 2, you mentioned mild fibrosis and significant fibrosis. However, your article
didn’t define the cut-off values or the difference between “mild” and “significant” fibrosis.
5. I am curious about how you chose those variables in table 3. Could you more clearly show
why you chose them? Besides, ALT and GGT were demonstrated as IU/L in table 1, but in table
3, you presented them as Log IU/L. I think you should explain it.
6. In lines 4-7, page 16, you said severe hepatic inflammation might affect the LS values.
You also mentioned you had put ALT in multiple linear regression analysis. However, in lines
17-18, page 12, you selected “statistically significant factors in the Pearson correlation analysis”
for multiple linear regression analysis. I think you mean you selected statistically significant
variables in table 3 for multiple linear regression analysis. Nevertheless, I saw only GGT and
LS values were both statistically significant in table 3, and it seemed that ALT was not included
in them. Actually, you have said “severe” hepaic inflammation might affect LS values. In your
studied population, the ALT values didn’t show “severe” inflammation. Moreover, because
hepatic inflammation (or elevated ALT) may be a limitation in your study. I think you can
provide a supplement table to show the LS values changes between those with normal ALT and
those with abnormal ALT.
7. Because transient elastography is a kind of noninvasive method to measure liver stiffness, a
comparison between this method and other commonly used methods such as FIB-4 score may be
valuable. I think you should provide one supplement table to show the FIB-4 score evolutions,
like table 2.
8. I think you should also show, in another supplement table, that the LS value evolutions among
those with and without biochemical responses at week 96, like table 2.
assistant