Influence of maternal use of tenofovir disoproxil fumarate or zidovudine in Vietnamese pregnant women with HIV on infant growth, renal function, and bone health

Ei Kinai; Hoai Dung Thi Nguyen; Ha Quan Do; Shoko Matsumoto; Moeko Nagai; Junko Tanuma; Kinh Van Nguyen; Thach Ngoc Pham; Shinichi Oka

doi:10.1371/journal.pone.0250828

Peer Review History

Original SubmissionFebruary 17, 2021
15 Mar 2021 Decision Letter - Linglin Xie, Editor PONE-D-21-05310 Influence of maternal use of tenofovir disoproxil fumarate or zidovudine in Vietnamese pregnant women with HIV on infant growth, renal function, and bone health PLOS ONE Dear Dr. Kinai, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by 04/12/2021. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. 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Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: Yes: Lauren Coheley Reviewer #2: Yes:** Jay Cao [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. 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Revision 1
12 Apr 2021 Author Response March 31, 2021 Dr. Linglin Xie Academic Editor PLOS ONE Manuscript ID: PONE-D-21-05310 Manuscript title: Influence of maternal use of tenofovir disoproxil fumarate or zidovudine in Vietnamese pregnant women with HIV on infant growth, renal function, and bone health Authors: Kinai E, et al Dear Dr. Xie We were pleased to know of the positive evaluation of our manuscript and its potential acceptance for publication in PLOS ONE, subject to adequate revision and response to the reviewers' comments. Based on the instructions, we logged into the journal website and submitted the file of the revised manuscript (file name: PONE-D-21-05310-R1) and the file of the point-by-point response to the comments raised by the reviewers (file name: PONE-D-21-05310-response) in Microsoft Word format. We responded to all the comments raised by the reviewers and modified the text based on those comments. The added new text appears red in the revised manuscript. We take this opportunity to express our gratitude to the reviewers for their constructive and useful remarks. Their comments allowed us to identify areas in our manuscript that needed modification and clarification. We also thank you for allowing us to resubmit a revised copy of the manuscript. I hope that the revised manuscript is now acceptable for publication in PLOS ONE. Sincerely Yours, Ei Kinai, MD, PhD Department of Laboratory Medicine, Tokyo Medical University 6-7-1, Nishi-shinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan Phone: +81-3-3342-6111 Fax: +81-3-3340-5548 E-mail: ekinai@tokyo-med.ac.jp ===================================================== Point-by-point response to the comments of Reviewer 1 Reviewer #1: Overall it was a nicely written paper. Please see the attached document which contains my edits and comments. We thank the reviewer for the comments and help to improve the presentation. We replaced the original text with the text recommended by the reviewer (the revised text appears in red). In the abstract, the reviewer modified “worse” to “lower?”. However, in the radiographic scoring system used in this study, a lower score represents better condition and a higher score reflects worse condition. In the abstract, LPV/r is associated with “higher” score, but such descriptor could be misleading and misinterpreted. Therefore, we prefer to stick to “worse” score used in the original manuscript (page 3, line 45). A few things: 1. Please be sure to write out the entire word first before abbreviating it. We thank the reviewer for the comment. We spell out all abbreviations, including “HIV” (abstract page 3, lines 27-28 and page 5, lines 52-3), “CD4” (page 7, line 111), and many others throughout the manuscript and Tables. The “Apgar” score refers to the physician who established the scoring system; “Virginia Apgar”, and we added the brief information on this scoring system (page 7, lines 115-117). 2. Be sure to include which BMD site you were referring to whole body ? lumbar spine? etc. We thank the reviewer for the comment. We specified the site of bone mineral density used in each reference. Thus, ref. 13 measured whole-body bone mineral contents, while ref.14 measured BMD of the lumbar spine (page 5-6, lines 70-75). 3. Several sentences are extremely long and frankly don't make sense. Please modify. In response to the comment, we went through the entire text and shortened any long sentence found in the original manuscript (page 5 lines 70-74, and page 10 lines 171-172). We also corrected a misprinted sentence (page 11 lines 195-6). <Note to the reviewer> We like to clarify here one issue related to the inclusion of non-HIV mother-infant pairs. As described in the manuscript, our study was designed to collect data on both HIV-infected and non-HIV mother-infant pairs. However, only two non-HIV mother-infant pairs participated in the study, and, unfortunately, neither of them visited the research center after birth. Consequently, the data of non-HIV mother-infants pairs was too small for proper comparisons with those of HIV-infected pairs. To avoid any confusion, we deleted the data of non-HIV group infants from Table 2, and deleted the text “not shown in Fig.1” (page 7, line 102, and page 10, line 174). Point-by-point response to the comments of Reviewer 2 Reviewer #2: The study investigated the effects of maternal use of TDF on renal function, infant growth, and bone related parameter in Vietnamese women, as compared to AZT. The study is important in that whether Asian women and infants are more susceptible to the detrimental impact of TDF on renal function and bone health has not been studied. We thank the reviewer for the positive evaluation. Since Asian women and infants are considered vulnerable to the toxicity of antiretroviral drugs due to their small body size, our study provides important information about the safety of TDF on pregnant women and infants. Introduction Need to briefly introduce the use of zidovudine and if AZT has any effects on renal function and bone. We thank the reviewer for the comment. We expanded the Introduction by adding information about the history of AZT use as perinatal prophylaxis for mother-to-child transmission of HIV (page 5, line 53-55). Methods Please provide the methods of serum 25(OH) vitamin D, and other measurements, as well as the precision and accuracy of these measurements Bone-related markers such as P1NP should have been measured. We thank the reviewer for the comment. For measurement of serum 25 (OH) vitamin D, we used the delayed 1-step chemiluminescence microparticle immunoassay (CMIA) (Abbott ARCHITECT 25-OH Vitamin D assay). We added brief information about the method of measurement of serum 25(OH) vitamin D (page 8, lines 131-136). The ARCHITECT assay has been validated and widely used worldwide. However, we do not have the original validation data. Instead, we elected to cite one validation paper as a reference (ref. 17). In addition to 25(OH) Vitamin D, we also expanded the text to describe the methods used for measurements of U-BMG and %TRP (page 8, lines 124-131). We also added the coefficient of variation of the methods of U-BMG employed in this study (page 8, line 125). We agree with the reviewer that we should have measured bone-specific markers such as P1NP. <Note to the reviewer> We like to clarify here one issue related to the inclusion of non-HIV mother-infant pairs. As described in the manuscript, our study was designed to collect data on both HIV-infected and non-HIV mother-infant pairs. However, only two non-HIV mother-infant pairs participated in the study, and, unfortunately, neither of them visited the research center after birth. Consequently, the data of non-HIV mother-infants pairs was too small for proper comparisons with those of HIV-infected pairs. To avoid any confusion, we deleted the data of non-HIV group infants from Table 2, and deleted the text “not shown in Fig.1” (page 7, line 102, and page 10, line 174). Attachments Attachment Submitted filename: PONE-D-21-05310-response final.docx https://doi.org/10.1371/journal.pone.0250828.r002
15 Apr 2021 Decision Letter - Linglin Xie, Editor Influence of maternal use of tenofovir disoproxil fumarate or zidovudine in Vietnamese pregnant women with HIV on infant growth, renal function, and bone health PONE-D-21-05310R1 Dear Dr. Kinai, 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. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Linglin Xie Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0250828.r003
Formally Accepted
19 Apr 2021 Acceptance Letter - Linglin Xie, Editor PONE-D-21-05310R1 Influence of maternal use of tenofovir disoproxil fumarate or zidovudine in Vietnamese pregnant women with HIV on infant growth, renal function, and bone health Dear Dr. Kinai: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Linglin Xie Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0250828.r004

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