A HOSPITAL BASED OBSERVATIONAL STUDY ON HIV-TB COINFECTION

  1. Akansha Soni
  2. Vimala Venkatesh
  3. Parul Jain
  4. AMITA JAIN
  5. D HIMANSHU
  6. NEETU GUPTA
  7. RITU TANDON

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Abstract

ABSTRACT     BACKGROUND: Human immunodeficiency virus (HIV) is the major cause of failure to reach targets of tuberculosis (TB) control in settings with high HIV load. TB on the other hand enhances the progression of HIV infection to acquired immunodeficiency syndrome (AIDS). METHODOLOGY: An observational study was conducted in which 573 patients who were newly diagnosed with HIV infection and enrolled at an antiretroviral therapy (ART) center, King Georges Medical University (KGMU), Lucknow between May 2021 to June 2022 were taken, of which 80 patients had newly diagnosed TB. These HIV-TB co-infected patients were analyzed for demographic factors. Also, clusters of differentiation 4 (CD4) counts were done at the time of enrolment on ART and then about six to eight months later. For comparison, of the 493 HIV-only patients, 50 age and sex-matched consecutive patients for whom both the baseline and follow-up CD4 counts were available and were not investigated for tuberculosis during the study period were enrolled as controls. The change from baseline CD4 count was calculated with the use of paired t-test and Wilcoxon signed rank test. RESULTS : In the present study, among HIV-TB coinfected patients, baseline CD4 levels were 194.52±162.27, and follow-up CD4 levels were 285.09±170.33. An increment of 90.57±165.60 in mean CD4 levels was observed which was statistically significant(t=4.019; p<0.001 ). Likewise, in only HIV-positive patients a statistically significant increment of 125.26±191.48 (35.75%) cells in mean CD4 levels was observed (t=4.626; p<0.001). CONCLUSION : A significant rise in CD4 counts was observed in both HIV-TB coinfected patients started on ART plus anti-tubercular treatment (ATT) and HIV-only patients started on ART. Still, the rise is significantly higher among the HIV-only group as compared to the HIV-TB co-positive group.

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  1. Access Microbiology

    Thank you for submitting the revised version of your manuscript titled "A Hospital-Based Observational Study on HIV-TB Coinfection" to Access Microbiology. We appreciate the time and effort you have invested in addressing the reviewers’ and editorial comments. We note that many of the major content-related concerns have been adequately addressed. Specifically, you have provided clarification on control group selection, included relevant Indian references, corrected statistical reporting, and revised the Discussion and Conclusion sections to improve focus. Additionally, Table 3 has been appropriately removed, and the findings have been integrated into the narrative as advised. However, while these revisions are appreciated, we must highlight that the language and grammar throughout the manuscript remain suboptimal, with continued issues in phrasing, terminology consistency, and sentence structure. These affect the readability and clarity of the scientific message. Despite your revisions, the manuscript would have benefited from a thorough professional edit prior to submission. That said, as the scientific content is now acceptable and the major structural concerns have been addressed, we are proceeding with acceptance of your manuscript, with the expectation that these language issues can be corrected during the post-acceptance typesetting and editorial process. We kindly request that you remain available during the production phase to review proofs carefully and respond promptly to any further language or formatting queries from our production team to ensure the final version meets the journal’s standards. Congratulations on the acceptance of your work, and thank you for choosing Access Microbiology.

  2. Version published to 10.1099/acmi.0.000787.v3 on Access Microbiology
  3. Access Microbiology

    Many thanks for authors for submitting their revised manuscript. On review, authors have adequately addressed comments raised from initial reviewers. However, the language remains poor with multiple errors in grammar throughout. The manuscript requires a careful thorough proof-read to address these errors and ensure consistency in writing. Whilst acronyms are explained in the Abstract, this is not the case in the body of the manuscript. Please define acronyms when they first appear in the main body, before using the defined acronym in the remainder. This is true for HIV, TB, WHO, ART, ATT, UP and PLHIVS when first mentioned. This has to be corrected. Additionally, there is a lot of variation in your use of HIV-TB co-infected, HIV-TB co-positive, TB/HIV, TB-HIV, TB / HIV – please ensure consistency of writing, and I can see that the invited Reviewer has also flagged this. Furthermore, there is a lot of back and forth with the use of acronyms and then the entire word – for TB, PTB and EPTB. Please be consistent in your writing. There is also an instance of inconsistency with the style of brackets used. Please proof-read your manuscript before submission. Line 71-72 also need further clarification. You are saying that all persons with HIV/TB will die, but only 45% of those with TB only. This is a stark statistic and needs further explanation. What was the mortality due to? HIV? And where was this study conducted and when? I appreciate you have referenced the statement, but stating a shocking statistic in your Introduction requires clarification. Line 83 also has an error. Please use universal metric units. In Line 89 you mention previous Indian studies but not a reference was made. I also note the Reviewer has commented on the lack of Indian study references. Similarly, references should be made for the previously described risk factors as stated in Line 113. Regarding your controls, you mention that they were not investigated for TB, I presume you mean that they were not investigated as there was no clinical concern for TB and not for some other reason? Please state. In Line 143 you can remove, “and outnumbered the other modes of transmission” as you have already stated that sexual transmission was the most common mode. Whilst you have reported your findings as percentages, placing the n values as well would add more meaningful context to your Results. There is a typo in Line 152. Please remove Table 3. It adds nothing more to your study, these studies should be referenced accordingly throughout your manuscript, with findings compared in the Discussion. Your Discussion relates your findings to published literature well. However, it is very long and a lot of the Discussion can be rewritten so that is far more concise. Additionally, your attempted explanation for change in CD4+ counts between your groups in Lines 269-273 is very confusing and not expressed clearly. This requires a re-write. Similarly, your Conclusion could be better reported. Overall, while your manuscript for the most part has improved on this revision, it would benefit from a focused and thorough proof-read. Scientific reports need to be consistent, and this is a major flaw at present. Please dedicate the time to revise your manuscript in line with my comments above and those of the Reviewer below, please ensure a thorough proof-read for any similar errors.

  4. Access Microbiology

    Comments to Author

    I have gone through the manuscript entitled, "A HOSPITAL BASED OBSERVATIONAL STUDY ON HIV-TB CO-INFECTION" carefully. It is a good study but the manuscript needs some revisions. There are some concerns which need to be addressed. These have been highlighted in yellow in the manuscript. The comments are given below : Comments : 1. First of all, I have received a revised version of the manuscript. The authors have already revised the original article with answers to the comments of the previous reviewers. 2. Abstract : Include the place of study in Keywords. It is important. 3. Sex may be replaced with gender in the manuscript. 4. Please maintain uniformity throughout the manuscript. HIV-TB co-infected patients may be retained throughout the manuscript. HIV-TB co-positives looks different as the title is about HIV-TB co-infection. 5. The authors have included very few references of Indian studies. 6. References - there are 27 references. Plz. give at least 30-35 relevant ones.

    Please rate the manuscript for methodological rigour

    Good

    Please rate the quality of the presentation and structure of the manuscript

    Good

    To what extent are the conclusions supported by the data?

    Partially support

    Do you have any concerns of possible image manipulation, plagiarism or any other unethical practices?

    No

    Is there a potential financial or other conflict of interest between yourself and the author(s)?

    No

    If this manuscript involves human and/or animal work, have the subjects been treated in an ethical manner and the authors complied with the appropriate guidelines?

    Yes

  5. Version published to 10.1099/acmi.0.000787.v2 on Access Microbiology
  6. Access Microbiology

    Many thanks to authors for their submission, where they aim to examine the epidemiological and clinical profile of TB-HIV co-infected patients in Northern India; and to assess the impact of TB on recovery of CD4+ T cells. Overall, while the manuscript addresses interesting and informative points, it is poorly written. It needs to be re-written with a particular focus and grammar, namely sentence structure, and spelling. Abbreviations are also used throughout the manuscript, these should be stated explicitly what they stand for when first used, not randomly within the body of the manuscript. I also have major reservations on the results and participant selection. 80 patients were co-infected with HIV/TB, but data was only available for 54 patients – 7 transfers, 4 lost to follow-up and 14 died. That leaves 1 patient unaccounted for. There were 493 HIV-only patients. Yet, only 50 matched age and sex controls. This seems highly implausible. A full detailed description is warranted to validate this claim. Additionally, a waiver of consent was taken for these controls, yet their data is collected and compared. Informed consent should have been taken for this cohort as well, unless directed by the Ethics Committee – which should be stated. I also have significant reservations on the diagnosis of TB. Majority (80%) of cases of TB were diagnosed clinically. Why? I understand that resources are limited but only a very limited proportion of the participants had any pathological investigations. What were the clinical parameters that physicians used to label a patient as having someone with TB. I understand that the prevalence among this cohort is high, so likely possibility; but were other opportunistic respiratory diseases out-ruled? Like MAC, CMV, PJP etc? MTB GeneXpert was done for only 20% of people; furthermore, was this on sputum samples or deeper respiratory samples like a bronchoalveolar lavage? Are Mantoux or Quantiferon not available? Additionally, if TB was not diagnosed on the GeneXpert to detect rifampicin-resistance, and culture was not positive in any cases, how was a decision made on which anti-tubercular medications to administer? I also agree with the Reviewer in that it is difficult to draw meaningful conclusion on the effect of ART on CD4+ T cell count as the baseline CD4+ T cell count was not the same between compared groups. I appreciate that this was attempted to be addressed by measuring the proportional increase, but even that is affected by many confounding factors. Was compliance assessed? Was ART therapy the same across all patients? Were HIV Viral loads collected and examined?

  7. Access Microbiology

    Comments to Author

    For the first page, I prefer the conclusion in page 13 to be written in the abstract. Table 3 need to be reviewed - South Sudan and Tamil Nadu is not included in the table.

    Please rate the manuscript for methodological rigour

    Satisfactory

    Please rate the quality of the presentation and structure of the manuscript

    Good

    To what extent are the conclusions supported by the data?

    Strongly support

    Do you have any concerns of possible image manipulation, plagiarism or any other unethical practices?

    No

    Is there a potential financial or other conflict of interest between yourself and the author(s)?

    No

    If this manuscript involves human and/or animal work, have the subjects been treated in an ethical manner and the authors complied with the appropriate guidelines?

    Yes

  8. Access Microbiology

    Comments to Author

    In this study, the authors examined 573 HIV patients and followed them up for 6-8 weeks, comparing the clinical characteristics of HIV-TB coinfected patients (n=54) and those with HIV only (n=50), particularly focusing on the differences in baseline CD4+ T cell counts between the two groups and their response to antiretroviral therapy. This is an interesting study. However, I have some questions regarding the study's results that the authors need to address in order: 1. There were a total of 493 HIV only patients, but only 50 were ultimately matched for age and gender, which is quite implausible. The authors need to provide detailed explanations on how the samples were excluded and list the gender and age of the other patients. 2. The authors compared the recovery of CD4+ T cells in both patient groups after treatment and concluded that the effect of treatment on increasing CD4+ T cells was more pronounced in HIV only patients. However, since the baseline CD4+ T cell counts of HIV-TB co-infected patients and HIV only patients were not consistent, the recovery of CD4+ T cells through antiretroviral therapy may be influenced by the baseline CD4+ T cell counts. Additionally, despite the greater increase in CD4+ T cell counts in the HIV only group through antiretroviral therapy, the proportion of baseline increase was lower compared to HIV-TB co-infected patients. The authors need to provide a detailed explanation of this result in the discussion section. 3. One of the main objectives of the authors was to study the impact of TB on the recovery of CD4 counts. Similarly, since the baseline CD4+ T cell counts of the two groups are not consistent, the effect of antiretroviral therapy on increasing CD4+ T cells may not only be influenced by TB infection but also by baseline CD4+ T cell counts. The authors need to address this in the discussion. 4. Abbreviations should be avoided in the abstract as much as possible. If necessary, provide the full term, such as ART. 5. The results section of the abstract is incomplete, and it should also describe the CD4+ T cell status of HIV only patients. The conclusion section should also reflect the differences between HIV-TB co-infected and HIV only patients. 6. There are some spelling errors, such as "Table 3 clinico," which should be corrected to "Table 3 clinical."

    Please rate the manuscript for methodological rigour

    Satisfactory

    Please rate the quality of the presentation and structure of the manuscript

    Satisfactory

    To what extent are the conclusions supported by the data?

    Partially support

    Do you have any concerns of possible image manipulation, plagiarism or any other unethical practices?

    No

    Is there a potential financial or other conflict of interest between yourself and the author(s)?

    No

    If this manuscript involves human and/or animal work, have the subjects been treated in an ethical manner and the authors complied with the appropriate guidelines?

    Yes

  9. Version published to 10.1099/acmi.0.000787.v1 on Access Microbiology