Title: SUCCESSFUL THERAPY WITH TENOFOVIR DISOPROXIL FUMARATE (TDF)
IN PATIENTS WITH CHRONIC HEPATITIS B (CHB) DOES NOT GUARANTEE
AMELIORATION OF LIVER DAMAGE ASSESSING BY TRANSIENT ELASTOGRAPHY.
A RETROSPECTIVE - PROSPECTIVE MULTICENTER STUDY
Version: 1 Date: 22 Jan 2024
Reviewer:  Francesca Di Cosimo
Reviewer's report:
Review for BMC Gastroenterology of the manuscript "Successful therapy with tenofovir
disoproxil fumarate (tdf) in patients with chronic hepatitis b (chb) does not guarantee
amelioration of liver damage assessing by transient elastography".
I think that this study can give a valid scientific contribution as a retrospective and prospective
study.
In this regard, the title should specify the type of study for quiker identification.
Analyzing the abstract I believe there is a concept that need to be clarified more
explicitly: if Multivariate analysis showed that BMI #25 (overweight) (OR, 0.014; 95% CI,
0.001-0.157; p=0.001) and advanced fibrosis (OR, 5.169; 95% CI, 1.240-21.540; p=0.024) were
independently associated with a fibrosis regression of >30% of liver stiffness compared to
baseline value, the conclusion that obesity was the main and independent factor associated with
no significant liver fibrosis regression seems to be in contrast. this concept is not clarified in the
section “liver stiffness” either :”We did not find any significant difference in age, BMI and the
presence of metabolic risk factors between the regressor and progressor groups. “
The phrase that clarifies the concept is  “Liver stiffness and metabolic risk factors: Significant
liver stiffness regression was observed in 58% of the patients with BMI <25 vs 2.6% of those
with BMI #25 (p <0.0001) (Figure 3). None of the patients with BMI #30 achieved significant
regression in liver stiffness”.
Overall the abstract in appropriate compared to the article itself, as wells as the introduction/
background.
The introduction reports the purpose of the study and the attempt to fill a gap in scientific
literature. The concept is well explained and, reviewing the literature data, this study can actually
be a valid contribution.
The study was conducted in various centers in Greece, however is not specified the departments
(Internal medice? Hepatology? Hospitalized patients or outpatients?)
I would like to know more specifically the time interval considered for the retrospective part
of the study, however, for the perspective part, it is well specified (we found out the data 90
months of therapy only in the conclusions)
The study was approved by the Ethics committee of the participating centers and was conducted
according to the principles of the Declaration of Helsinki.
The methods section should clarify better which clinical and laboratory parameters were
analyzed (All patients were followed by their physicians every 6 months with clinical and
laboratory assessments ..)
From a methodological point of view the study is correct and the statistics well performed.
The results are well reported and structured, organizing them according to Demographic
characteristics , Clinical remission, Liver stiffness (with and without metabolic risk factors).
However, the strengths and limitations of the study are not described. what are the aspects that
still need to be addressed in the future and need to be clarified in future studies?
This aspect can be inserted at the end of the conclusions section.
Title: SUCCESSFUL THERAPY WITH TENOFOVIR DISOPROXIL FUMARATE (TDF)
IN PATIENTS WITH CHRONIC HEPATITIS B (CHB) DOES NOT GUARANTEE
AMELIORATION OF LIVER DAMAGE ASSESSING BY TRANSIENT ELASTOGRAPHY.
A RETROSPECTIVE - PROSPECTIVE MULTICENTER STUDY
Version: 1 Date: 22 Jan 2024
Reviewer:  Francesca Di Cosimo
Reviewer's report:
Review for BMC Gastroenterology of the manuscript "Successful therapy with tenofovir
disoproxil fumarate (tdf) in patients with chronic hepatitis b (chb) does not guarantee
amelioration of liver damage assessing by transient elastography".
I think that this study can give a valid scientific contribution as a retrospective and prospective
study.
In this regard, the title should specify the type of study for quiker identification.
Analyzing the abstract I believe there is a concept that need to be clarified more
explicitly: if Multivariate analysis showed that BMI #25 (overweight) (OR, 0.014; 95% CI,
0.001-0.157; p=0.001) and advanced fibrosis (OR, 5.169; 95% CI, 1.240-21.540; p=0.024) were
independently associated with a fibrosis regression of >30% of liver stiffness compared to
baseline value, the conclusion that obesity was the main and independent factor associated with
no significant liver fibrosis regression seems to be in contrast. this concept is not clarified in the
section “liver stiffness” either :”We did not find any significant difference in age, BMI and the
presence of metabolic risk factors between the regressor and progressor groups. “
The phrase that clarifies the concept is  “Liver stiffness and metabolic risk factors: Significant
liver stiffness regression was observed in 58% of the patients with BMI <25 vs 2.6% of those
with BMI #25 (p <0.0001) (Figure 3). None of the patients with BMI #30 achieved significant
regression in liver stiffness”.
Overall the abstract in appropriate compared to the article itself, as wells as the introduction/
background.
The introduction reports the purpose of the study and the attempt to fill a gap in scientific
literature. The concept is well explained and, reviewing the literature data, this study can actually
be a valid contribution.
The study was conducted in various centers in Greece, however is not specified the departments
(Internal medice? Hepatology? Hospitalized patients or outpatients?)
I would like to know more specifically the time interval considered for the retrospective part
of the study, however, for the perspective part, it is well specified (we found out the data 90
months of therapy only in the conclusions)
The study was approved by the Ethics committee of the participating centers and was conducted
according to the principles of the Declaration of Helsinki.
The methods section should clarify better which clinical and laboratory parameters were
analyzed (All patients were followed by their physicians every 6 months with clinical and
laboratory assessments ..)
From a methodological point of view the study is correct and the statistics well performed.
The results are well reported and structured, organizing them according to Demographic
characteristics , Clinical remission, Liver stiffness (with and without metabolic risk factors).
However, the strengths and limitations of the study are not described. what are the aspects that
still need to be addressed in the future and need to be clarified in future studies?
This aspect can be inserted at the end of the conclusions section.
Please review this paper.
user
Title: SUCCESSFUL THERAPY WITH TENOFOVIR DISOPROXIL FUMARATE (TDF)
IN PATIENTS WITH CHRONIC HEPATITIS B (CHB) DOES NOT GUARANTEE
AMELIORATION OF LIVER DAMAGE ASSESSING BY TRANSIENT ELASTOGRAPHY.
A RETROSPECTIVE - PROSPECTIVE MULTICENTER STUDY
Version: 1 Date: 22 Jan 2024
Reviewer:  Francesca Di Cosimo
Reviewer's report:
Review for BMC Gastroenterology of the manuscript "Successful therapy with tenofovir
disoproxil fumarate (tdf) in patients with chronic hepatitis b (chb) does not guarantee
amelioration of liver damage assessing by transient elastography".
I think that this study can give a valid scientific contribution as a retrospective and prospective
study.
In this regard, the title should specify the type of study for quiker identification.
Analyzing the abstract I believe there is a concept that need to be clarified more
explicitly: if Multivariate analysis showed that BMI #25 (overweight) (OR, 0.014; 95% CI,
0.001-0.157; p=0.001) and advanced fibrosis (OR, 5.169; 95% CI, 1.240-21.540; p=0.024) were
independently associated with a fibrosis regression of >30% of liver stiffness compared to
baseline value, the conclusion that obesity was the main and independent factor associated with
no significant liver fibrosis regression seems to be in contrast. this concept is not clarified in the
section “liver stiffness” either :”We did not find any significant difference in age, BMI and the
presence of metabolic risk factors between the regressor and progressor groups. “
The phrase that clarifies the concept is  “Liver stiffness and metabolic risk factors: Significant
liver stiffness regression was observed in 58% of the patients with BMI <25 vs 2.6% of those
with BMI #25 (p <0.0001) (Figure 3). None of the patients with BMI #30 achieved significant
regression in liver stiffness”.
Overall the abstract in appropriate compared to the article itself, as wells as the introduction/
background.
The introduction reports the purpose of the study and the attempt to fill a gap in scientific
literature. The concept is well explained and, reviewing the literature data, this study can actually
be a valid contribution.
The study was conducted in various centers in Greece, however is not specified the departments
(Internal medice? Hepatology? Hospitalized patients or outpatients?)
I would like to know more specifically the time interval considered for the retrospective part
of the study, however, for the perspective part, it is well specified (we found out the data 90
months of therapy only in the conclusions)
The study was approved by the Ethics committee of the participating centers and was conducted
according to the principles of the Declaration of Helsinki.
The methods section should clarify better which clinical and laboratory parameters were
analyzed (All patients were followed by their physicians every 6 months with clinical and
laboratory assessments ..)
From a methodological point of view the study is correct and the statistics well performed.
The results are well reported and structured, organizing them according to Demographic
characteristics , Clinical remission, Liver stiffness (with and without metabolic risk factors).
However, the strengths and limitations of the study are not described. what are the aspects that
still need to be addressed in the future and need to be clarified in future studies?
This aspect can be inserted at the end of the conclusions section.
assistant