PONE-D-20-23615

Magnitude, Outcome, and Associated Factors of Anti-tuberculosis Drug-induced Hepatitis among Tuberculosis patients in a Tertiary hospital in North Ethiopia: A Cross-sectional study

PLOS ONE

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Bin Su, Ph.D.

Academic Editor

PLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: No

Reviewer #2: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: I Don't Know

Reviewer #2: Yes

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Reviewer #1: No

Reviewer #2: Yes

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Reviewer #1: No

Reviewer #2: Yes

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5. Review Comments to the Author

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Reviewer #1: The authors described a an institution-based cross-sectional study of DILI due to short course chemotherapy in the treatment of tuberculosis (TB). There are several other reported studies with more sophisticated designs for the same purpose. The overall quality of the presented clinical study is limited by the nature of the study design. The authors may also want to improve the preparation of the manuscript.

1. Small sample size as a cross-sectional study limited the power of the study.

2. More clinical details need to provided. For example,

a. Details of drug combination and dosing regimen need to be added. This is important because drug-drug interaction is a known factor for DILI of the chemotherapy for TB. The details of drug combination and dosing regimen are critical to understand the risk of DILI due to DDI.

b. What are "other hepatotoxic drugs" discussed in the manuscript?

c. What are the "preexisting liver disease" discussed in the manuscript? The severity of the preexisting conditions?

3. Language quality of the manuscript need to be improved.

a. Many spaces are missing cause readability issues.

b. Scientific and accurate description is preferred.

Reviewer #2: The manuscript by Liwam et al. describes the importance, outcome, and the other factors associated with anti-tuberculosis drug-induced hepatitis among tuberculosis patients. Tuberculosis is one of the major global health issues, which is associated with hepatitis as an adverse effect causing interruption to the treatment. Since the drug induces hepatotoxicity is unpredictable, it is necessary to identify and categorize patients into different risk levels. The study has shown that patients with low baseline serum albumin, taking other hepatotoxic drugs, and having the preexisting liver disease are at high risk of anti-TB drug induces hepatitis. The authors made an interesting study and have collected and considered a unique dataset from the cross-sectional study. The paper is generally well written and structured. However, in my opinion, attention should be given to the following issues described below.

1. Data from Table-2, for calculating frequency and percentage for Stage 4 defining illness and CD4 count, the total participants number N, will be 55 (HIV positive status) and not 188. The calculations were made using N=55; So, the authors are encouraged to mention the N value specifically.

2. Grammar and spacing errors are present in the manuscript; the authors should carefully proofread the paper for language errors.

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Reviewer #1: No

Reviewer #2: No

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Magnitude, Outcome, and Associated Factors of Anti-tuberculosis Drug-induced Hepatitis among Tuberculosis patients in a Tertiary hospital in North Ethiopia: A Cross-sectional study

PONE-D-20-23615R1

Dear Dr. %Gezahegn%,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

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Kind regards,

Bin Su, Ph.D.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments: