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Article
Peer-Review Record

Noncompliance with Therapeutic Guidelines for Chronic Hepatitis B Patients in Minas Gerais, Brazil

Infect. Dis. Rep. 2022, 14(6), 955-966; https://doi.org/10.3390/idr14060094
by Cristiane Faria Oliveira Scarponi 1,*, Marco Antônio Ferreira Pedrosa 2, Marcos Paulo Gomes Mol 1 and Dirceu Bartolomeu Greco 3
Reviewer 1:
Reviewer 2: Anonymous
Infect. Dis. Rep. 2022, 14(6), 955-966; https://doi.org/10.3390/idr14060094
Submission received: 23 September 2022 / Revised: 17 November 2022 / Accepted: 22 November 2022 / Published: 28 November 2022
(This article belongs to the Special Issue Viral Hepatitis: Epidemiological Features and Prevention)

Round 1

Reviewer 1 Report

Dear Authors,

This is a very interesting and well-written paper. The authors have obviously put a lot of effort and thought into the CHB treatment proposed guideline. I found the paper to be well written and the conclusion to be well explained. Therefore, I support the publication of this work following minor revisions:

 

o   If possible author should consider adding a table form of data.

o   Also need to add more introduction regarding available data from the other country.  

Author Response

Date: 24th Oct/2022

 

Dear editors,

 

Thank you very much for reviewing our manuscript ID idr-1960496, entitled Noncompliance to the therapeutic guidelines for chronic hepatitis B patients, submitted to Infectious Disease Reports journal. Your suggestions were valuable in contributing to our discussion of this topic.

The present letter provides point-by-point responses of the reviewer’ previous comments. We hope to have responded to all of them.

 

Kind regards,

Authors

 

 

Reviewer 1: Dear Authors,

This is a very interesting and well-written paper. The authors have obviously put a lot of effort and thought into the CHB treatment proposed guideline.

I found the paper to be well written and the conclusion to be well explained. Therefore, I support the publication of this work following minor revisions:

  • If possible author should consider adding a table form of data.

A: thank you for your suggestion. A data table was included. Partial of data were not available due to ethical committee requirement.

 

  • Also need to add more introduction regarding available data from the other country.

A: We included more information about other countries context, however, few scientific literature were found about this topic. Information included was presented here:

“Information on routine compliance with such therapeutic recommendations in medical practice are rare. A large study conducted in the United States showed that adherence to AASLD guidelines for the management of CHB is very low particularly with regard to criteria for initiating treatment and monitoring the serologic response6. However, Other studies have shown some reluctance and/or lack of knowledge of the cur-rent guidelines for CHB therapeutic management, as evidenced by the poor adherence of this tool by physicians from different countries13-17. The present study examined the application of treatment guidelines in daily practice, using CPTG-CHB (v.2011) as a reference standard12. It assessed at four key recommendations compared with data from patients who received treatment by the Unified Health System (SUS) in Minas Gerais, Brazil.”

Author Response File: Author Response.docx

Reviewer 2 Report

The manuscript by Cristiane Faria Oliveira et al., presents the results of the analysis of treatment conditions against Hepatitis B and their non-concordance with the standard regimen in Brazil. 

1) The English language throughout the manuscript is poor and hard to comprehend.

2) The manuscript is badly conceptualized and does not flow well with readers, making it hard to understand the results of the study.

3) A lot of abbreviations are used in the figures without proper explanation in the legend.

4) the main "CPTG-CHB" needs to properly described. without getting a proper undestanding of these guidelines the reader is completely lost

5) highly suggest redesign the study and present the findings in a simplified way 

Author Response

Date: 24th Oct/2022

 

Dear editors,

 

Thank you very much for reviewing our manuscript ID idr-1960496, entitled Noncompliance to the therapeutic guidelines for chronic hepatitis B patients, submitted to Infectious Disease Reports journal. Your suggestions were valuable in contributing to our discussion of this topic.

The present letter provides point-by-point responses of the reviewer’ previous comments. We hope to have responded to all of them.

 

Kind regards,

Authors

 

 

Reviewer 2: The manuscript by Cristiane Faria Oliveira et al., presents the results of the analysis of treatment conditions against Hepatitis Band their non-concordance with the standard regimen in Brazil.

1) The English language throughout the manuscript is poor and hard to comprehend.

A: We reviewed all the text and did corrections.

 

2) The manuscript is badly conceptualized and does not flow well with readers, making it hard to understand the results of the study.

A: Many changes were done according to the reviewer’s suggestion. We hope that our paper was more fluid, as suggested by the reviewer 2.

 

3) A lot of abbreviations are used in the figures without proper explanation in the legend.

A: The legend of all figures was more explained (including all abbreviations).

 

4) the main "CPTG-CHB" needs to properly described. Without getting a proper undestanding of these guidelines the reader is completely lost

A: Sorry for this. We included basic information about the Brazilian procedures. Find here:

“At the beginning of the 21st century, more two million people chronically infected with HBV resided in Brazil10. Thus in 2002, the Ministry of Health standardized the "Clinical Protocol and Therapeutic Guidelines for Chronic viral Hepatitis B and Co-infections" (CPTG-CHB), aiming at guarantee the integrality of the treatment and the prescription of safe and effective medications11. Later updates introduced new drugs with a sequential treatment approach, preserving future alternatives for possible viral resistance and therapeutic failure12. The national therapeutic guidelines for hepatitis B help physicians to prescribe drugs according to each clinical and laboratory situation, seeking the rational use of the therapeutic arsenal and the best cost-effectiveness11-12. The Brazilian therapeutic guidelines were based on the best published scientific evidence and agreed with the main international consensuses for the management of patients with CHB7-9,12.”

 

5) highly suggest redesign the study and present the findings in a simplified way

A: Many changes were done according to the reviewer’s suggestion. We hope our paper was more flow, as suggested by the reviewer 2.

Author Response File: Author Response.docx

Reviewer 3 Report

The manuscript is well written, but the information presented largely overlaps with the research that the research team has done and already published in the Revista da Sociedade Brasileira de Medicina Tropical "Low eligibility for hepatitis B treatment in the Brazilian public health system"

April 2022 Revista da Sociedade Brasileira de Medicina Tropical 55; DOI: 10.1590/0037-8682-0297-2021.

In the manuscript submitted for review, the authors use data from 2012-2013. Also, it is now 2022, have the practices of treating chronic hepatitis B in Brazil not changed in the past 10 years?

Why don't you report more recent data?

Author Response

Date: 24th Oct/2022

 

Dear editors,

 

Thank you very much for reviewing our manuscript ID idr-1960496, entitled Noncompliance to the therapeutic guidelines for chronic hepatitis B patients, submitted to Infectious Disease Reports journal. Your suggestions were valuable in contributing to our discussion of this topic.

The present letter provides point-by-point responses of the reviewer’ previous comments. We hope to have responded to all of them.

 

Kind regards,

Authors

 

 

Reviewer 3: The manuscript is well written, but the information presented largely overlaps with the research that the research team has done and already published in the Revista da Sociedade Brasileira de Medicina Tropical "Low eligibility for hepatitis B treatment in the Brazilian public health system"

April 2022 Revista da Sociedade Brasileira de Medicina Tropical55; DOI: 10.1590/0037-8682-0297-2021.

A: We clarify that the information presented in this manuscript does not overlap with that described in the aforementioned article previously published by our team.

Despite addressing the same topic, it is a complementary research (as described in the box on the right in figure 1 of the previous article). The number of participants consisted of 641 patients with CHB, 461 of whom had not yet received any treatment included in a previous study (article mentioned above), which was clearly exposed in the first paragraph of the topic Results of the article already published.

Also, the present study focuses on the subset of participants considered excluded at the time, according to criteria established in the previous study (180 patients who had already undergone treatment for hepatitis B). The objective of this study was to verify whether the physicians were complying with the therapeutic indication recommendations established in the official guidelines according to the clinical and laboratory profile of the patients undergoing treatment at that time.

We chose to rewrite the first paragraph of the topic Methodology – Study population and design, in order to provide more clarity of information from the data included in the present study.

 

In the manuscript submitted for review, the authors use data from 2012-2013. Also, it is now 2022, have the practices of treating chronic hepatitis B in Brazil not changed in the past 10years?

A: Regarding the current national guidelines for CHB (2017 version), there were few changes compared to the 2011 version, which we believe does not compromise the data of our study.

 

Why don't you report more recent data?

A: It would be difficult to obtain complete data from patients with CHB in a period subsequent to the one studied. The data regarding the clinical-laboratory profile of the patients were simplified by the Ministry of Health since 2014, and currently containing only the patient's demographic data and justification for HBV-DNA quantification requesting exam.

 

Author Response File: Author Response.docx

Round 2

Reviewer 2 Report

The authors have made the necessary and requested changes to the manuscript.

Minor grammatical changes need to be made throughout the manuscript.

Author Response

Date: 11th Nov/2022

 

Dear editors,

 

Thank you very much for reviewing our manuscript ID idr-1960496 R1, entitled Noncompliance to the therapeutic guidelines for chronic hepatitis B patients, submitted to Infectious Disease Reports journal. Your suggestions were valuable in contributing to our discussion of this topic.

The present letter provides point-by-point responses of the reviewer’ previous comments. We hope to have responded to all of them.

 

Kind regards,

Authors

 

 

Reviewer 2:

The authors have made the necessary and requested changes to the manuscript.

Minor grammatical changes need to be made throughout the manuscript.

A: Thank you very much for your suggestion. We made grammatical corrections in all paper.

 

 

Reviewer 3:

Let's assume that you set different goals in the presented manuscript, to me the weakness of your work is related to the fact that you provide information that is outdated.

I think you would improve your manuscript if you made a comparison with the recommendations for the treatment of chronic hepatitis according to the World Health Organization and the current norms in Brazil. Comment on the changes in the guidelines for the prevention and treatment of chronic hepatitis that occurred in the 2017 amendment.

A: Thank your for your comments, that improved our paper. We included a paragraph about Brazilian and WHO current recommendations.

 

If possible, provide data on the prevalence of Hepatitis B in the territory of Brazil by age group at the moment. Is the Anti-HBc quantification test currently used in Brasil for the prediction of the efficacy of peg-IFN-α? Also, provide information on recommendations for HBV RNA quantification test during the CHV and the usefulness of the new markers to determine disease progression.

A: We included a paragraph about Brazilian prevalence information, in particular, data about Minas Gerais state (where data were extracted to this study).

 

My idea is to enrich your article with information that will be useful to clinicians.

A: Thank you! Your suggestion help us increasing our paper. We hope to attend all of them.

Author Response File: Author Response.docx

Reviewer 3 Report

Let's assume that you set different goals in the presented manuscript, to me the weakness of your work is related to the fact that you provide information that is outdated.

I think you would improve your manuscript if you made a comparison with the recommendations for the treatment of chronic hepatitis according to the World Health Organization and the current norms in Brazil. Comment on the changes in the guidelines for the prevention and treatment of chronic hepatitis that occurred in the 2017 amendment.

If possible, provide data on the prevalence of Hepatitis B in the territory of Brazil by age group at the moment. Is the Anti-HBc quantification test currently used in Brasil for the prediction of the efficacy of peg-IFN-α? Also, provide information on recommendations for HBV RNA quantification test during the CHV and the usefulness of the new markers to determine disease progression.

My idea is to enrich your article with information that will be useful to clinicians.

Author Response

Date: 11th Nov/2022

 

Dear editors,

 

Thank you very much for reviewing our manuscript ID idr-1960496 R1, entitled Noncompliance to the therapeutic guidelines for chronic hepatitis B patients, submitted to Infectious Disease Reports journal. Your suggestions were valuable in contributing to our discussion of this topic.

The present letter provides point-by-point responses of the reviewer’ previous comments. We hope to have responded to all of them.

 

Kind regards,

Authors

 

 

Reviewer 2:

The authors have made the necessary and requested changes to the manuscript.

Minor grammatical changes need to be made throughout the manuscript.

A: Thank you very much for your suggestion. We made grammatical corrections in all paper.

 

 

Reviewer 3:

Let's assume that you set different goals in the presented manuscript, to me the weakness of your work is related to the fact that you provide information that is outdated.

I think you would improve your manuscript if you made a comparison with the recommendations for the treatment of chronic hepatitis according to the World Health Organization and the current norms in Brazil. Comment on the changes in the guidelines for the prevention and treatment of chronic hepatitis that occurred in the 2017 amendment.

A: Thank your for your comments, that improved our paper. We included a paragraph about Brazilian and WHO current recommendations.

 

If possible, provide data on the prevalence of Hepatitis B in the territory of Brazil by age group at the moment. Is the Anti-HBc quantification test currently used in Brasil for the prediction of the efficacy of peg-IFN-α? Also, provide information on recommendations for HBV RNA quantification test during the CHV and the usefulness of the new markers to determine disease progression.

A: We included a paragraph about Brazilian prevalence information, in particular, data about Minas Gerais state (where data were extracted to this study).

 

My idea is to enrich your article with information that will be useful to clinicians.

A: Thank you! Your suggestion help us increasing our paper. We hope to attend all of them.

Author Response File: Author Response.docx

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