Prevalence of oral HPV among people living with HIV (PLHIV) in Pune, India

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However, there is little data on the prevalence of oral HPV among PLHIV in India, limiting the planning of oral HPV preventive strategies. Methods: We used cross-sectional data from an oral cancer screening study conducted at the antiretroviral therapy (ART) centre of Byramjee-Jeejeebhoy Government Medical College-Sassoon General Hospitals (BJGMC-SGH). PLHIV ≥21 years of age with no prior history of HNCs were enrolled. We determined the prevalence of high-risk oncogenic HPV (hrHPV) and low-risk non-oncogenic HPV (lrHPV) using real-time PCR and Next-Generation Sequencing. We used multinomial logistic regression to determine the prevalence ratios (PRs) of different sociodemographic, clinical, and behavioural predictors with hrHPV and lrHPV. Multivariable models were adjusted for age, sex, CD4 count and duration on ART. Results: Of the 582 PLHIV enrolled, the median age was 40 years (IQR: 34–46) and 54% were male. More than a fourth (25.8%) had multiple sexual partners and 11% had given oral sex. Median CD4 counts were 510 cells/mm3 (IQR: 338–700). The prevalence of hrHPV was 4.5% and lrHPV was 3.4%. Of those with hrHPV, 77% had HPV16. There were no significant associations with any predictors for both lrHPV and hrHPV in adjusted analyses. Conclusions: We found the prevalence of any oral HPV (hrHPV and lrHPV) to be 7.9% among PLHIV in India. Larger studies are required to better understand risk factors for oral HPV among Indian PLHIV." } { "@context": "http://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": "1", "item": { "@id": "https://f1000research.com/", "name": "Home" } }, { "@type": "ListItem", "position": "2", "item": { "@id": "https://f1000research.com/browse/articles", "name": "Browse" } }, { "@type": "ListItem", "position": "3", "item": { "@id": "https://f1000research.com/articles/12-285", "name": "Prevalence of oral HPV among people living with HIV (PLHIV) in Pune,..." } } ] } Home Browse Prevalence of oral HPV among people living with HIV (PLHIV) in Pune,... ALL Metrics - Views Downloads Get PDF Get XML Cite How to cite this article Marbaniang I, Joshi S, Borse R et al. Prevalence of oral HPV among people living with HIV (PLHIV) in Pune, India [version 1; peer review: 3 approved with reservations] . F1000Research 2023, 12 :285 ( https://doi.org/10.12688/f1000research.127474.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Brief Report Prevalence of oral HPV among people living with HIV (PLHIV) in Pune, India [version 1; peer review: 3 approved with reservations] Ivan Marbaniang https://orcid.org/0000-0002-8446-9943 1,2 , Samir Joshi 3 , Rohidas Borse 4 , [...] Samir Khaire https://orcid.org/0000-0002-4367-0077 5 , Rahul Thakur 3 , Prasad Deshpande 2 , Vandana Kulkarni 2 , Amol Chavan 2 , Smita Nimkar 2 , Vidya Mave 2,6 Ivan Marbaniang https://orcid.org/0000-0002-8446-9943 1,2 , Samir Joshi 3 , [...] Rohidas Borse 4 , Samir Khaire https://orcid.org/0000-0002-4367-0077 5 , Rahul Thakur 3 , Prasad Deshpande 2 , Vandana Kulkarni 2 , Amol Chavan 2 , Smita Nimkar 2 , Vidya Mave 2,6 PUBLISHED 14 Mar 2023 Author details Author details 1 Department of Epidemiology, McGill University, Montreal, Québec, H3A 1Y7, Canada 2 Byramjee Jeejeebhoy Government Medical College – Johns Hopkins University Clinical Research Site, Pune, Maharashtra, 411001, India 3 Department of Otorhinolaryngology and Head & Neck Surgery, Byramjee Jeejeebhoy Government Medical College, Pune, Maharashtra, 411001, India 4 Department of Medicine, Byramjee Jeejeebhoy Government Medical College, Pune, Maharashtra, 411001, India 5 Department of Dentistry, Byramjee Jeejeebhoy Government Medical College, Pune, Maharashtra, 411001, India 6 Center for Infectious Diseases in India, School of Medicine, Johns Hopkins University, Baltimore, Maryland, 21202, USA Ivan Marbaniang Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Software, Writing – Original Draft Preparation, Writing – Review & Editing Samir Joshi Roles: Conceptualization, Investigation, Resources, Supervision, Writing – Review & Editing Rohidas Borse Roles: Conceptualization, Investigation, Supervision, Writing – Review & Editing Samir Khaire Roles: Investigation, Methodology, Writing – Review & Editing Rahul Thakur Roles: Investigation, Writing – Review & Editing Prasad Deshpande Roles: Investigation, Methodology, Writing – Review & Editing Vandana Kulkarni Roles: Investigation, Methodology, Writing – Review & Editing Amol Chavan Roles: Formal Analysis, Writing – Review & Editing Smita Nimkar Roles: Investigation, Project Administration, Writing – Review & Editing Vidya Mave Roles: Conceptualization, Funding Acquisition, Methodology, Project Administration, Resources, Supervision, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS This article is included in the Pathogens gateway. This article is included in the Global Public Health gateway. Abstract Background: People living with HIV (PLHIV) are at an increased risk of human papillomavirus (HPV)-related head and neck cancers (HNCs). However, there is little data on the prevalence of oral HPV among PLHIV in India, limiting the planning of oral HPV preventive strategies. Methods: We used cross-sectional data from an oral cancer screening study conducted at the antiretroviral therapy (ART) centre of Byramjee-Jeejeebhoy Government Medical College-Sassoon General Hospitals (BJGMC-SGH). PLHIV ≥21 years of age with no prior history of HNCs were enrolled. We determined the prevalence of high-risk oncogenic HPV (hrHPV) and low-risk non-oncogenic HPV (lrHPV) using real-time PCR and Next-Generation Sequencing. We used multinomial logistic regression to determine the prevalence ratios (PRs) of different sociodemographic, clinical, and behavioural predictors with hrHPV and lrHPV. Multivariable models were adjusted for age, sex, CD4 count and duration on ART. Results: Of the 582 PLHIV enrolled, the median age was 40 years (IQR: 34–46) and 54% were male. More than a fourth (25.8%) had multiple sexual partners and 11% had given oral sex. Median CD4 counts were 510 cells/mm 3 (IQR: 338–700). The prevalence of hrHPV was 4.5% and lrHPV was 3.4%. Of those with hrHPV, 77% had HPV16. There were no significant associations with any predictors for both lrHPV and hrHPV in adjusted analyses. Conclusions: We found the prevalence of any oral HPV (hrHPV and lrHPV) to be 7.9% among PLHIV in India. Larger studies are required to better understand risk factors for oral HPV among Indian PLHIV. READ ALL READ LESS Keywords oral HPV, HIV, India Corresponding Author(s) Ivan Marbaniang ( [email protected] ) Close Corresponding author: Ivan Marbaniang Competing interests: No competing interests were disclosed. Grant information: This work was supported by amfAR, The Foundation for AIDS Research, with support from the U.S. National Institutes of Health’s National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Cancer Institute, the National Institute of Mental Health, the National Institute on Drug Abuse, the National Heart, Lung, and Blood Institute, the National Institute on Alcohol Abuse and Alcoholism, the National Institute of Diabetes and Digestive and Kidney Diseases, and the Fogarty International Center, as part of the International Epidemiology Databases to Evaluate AIDS (IeDEA; U01AI069907) and the NIH-funded Johns Hopkins Baltimore-Washington-India Clinical Trials Unit for NIAID Networks (UM1AI069465). The content and views expressed are those of the authors and does not necessarily represent the official views of any of the governments or institutions mentioned above. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright: © 2023 Marbaniang I et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Marbaniang I, Joshi S, Borse R et al. Prevalence of oral HPV among people living with HIV (PLHIV) in Pune, India [version 1; peer review: 3 approved with reservations] . F1000Research 2023, 12 :285 ( https://doi.org/10.12688/f1000research.127474.1 ) First published: 14 Mar 2023, 12 :285 ( https://doi.org/10.12688/f1000research.127474.1 ) Latest published: 14 Mar 2023, 12 :285 ( https://doi.org/10.12688/f1000research.127474.1 ) Introduction People living with HIV (PLHIV) have a 2–3 times higher odds of oral human papillomavirus (HPV) prevalence compared to HIV-uninfected individuals. 1 This is estimated to increase their risk of HPV-associated head and neck cancers (HNCs) 1.2–2.1 times relative to HIV-uninfected individuals. 2 However, estimates of oral HPV prevalence among PLHIV are mostly derived from high income countries (HICs) and data from low- and middle-income countries (LMICs) remain scarce, despite the burden of HIV in LMICs being considerably higher than HICs. 3 Globally, India has the third highest number of PLHIV (approximately 2.3 million). 4 Only one study from the country has previously reported on oral HPV prevalence among PLHIV, restricted to a key population, men who have sex with men (MSM). 5 To develop comprehensive strategies for oral HPV prevention that are geographically relevant for PLHIV, it is also important to report on the prevalence of oral HPV among PLHIV that are not key populations. In this manuscript, we estimate the prevalence of oral HPV and assess associated factors among PLHIV in Pune, India. Methods Ethics The Ethics Committee of Byramjee Jeejeebhoy Government Medical College – Sassoon General Hospitals (BJGMC-SGH) (Date of approval: 19 September 2016) and the Institutional Review Board of Johns Hopkins University (IRB00118708, Date of approval: 13 December 2016) approved the study. It should be noted that the Ethics Committee of BJGMC does not issue ethical approval numbers, nor does it have an Ethics Number itself. Study population We used data from a parent oral cancer screening study conducted between June 2017 and June 2019 at Byramjee Jeejeebhoy Government Medical College – Sassoon General Hospitals (BJGMC-SGH), a tertiary health care centre in Pune, India. 6 The parent study enrolled 1,234 participants, including 633 HIV-uninfected individuals and 601 PLHIV. For this analysis, data from HIV-uninfected participants and PLHIV with missing data for oral HPV (n=19) were excluded. Details of the study including enrolment procedures are provided elsewhere. 6 This analysis included data of PLHIV≥21 years of age attending the ART centre for care, with no prior history of HNCs who provided a 30 seconds oral rinse and gargle sample, and written informed consent. Sociodemographic (age, biological sex), behavioural factors (smoking, smokeless tobacco (SLT) and alcohol use), sexual history (men who have sex with men (MSM), oral sex, lifetime sexual partners), clinical history (CD4 counts, duration on antiretroviral therapy, suspected oral potentially malignant disorder (OPMD), HPV results including genotype) data were extracted from the database of the parent study. 6 These data were collected by trained non-medical health care professionals of the study team in the parent study. Assuming that the prevalence of oral HPV was 24%, consistent with the previous study that reported on oral HPV prevalence among Indian MSM living with HIV, 5 our sample size of 582 was >95% powered at an alpha of 0.05. Laboratory methods The parent study 6 used polymerase chain reaction (PCR) and next-generation sequencing (NGS) to obtain the prevalence of oral HPV. PCR and NGS were performed at a private laboratory (GenePath Diagnostics, Pune). These procedures are described below. Reagents Platinum Taq DNA polymerase (Invitrogen, Cat No. 10966034), HotStarTaq DNA polymerase (Qiagen, Cat No. 203205), dNTP (deoxyribonucleotide triphosphate) 25 micromolar (mM) (Lucigen, Cat No. D59104) were used. [Note - Invitrogen PCR buffer and MgCl 2 are provided by Invitrogen along with Platinum Taq DNA polymerase]. Thermal cycling conditions, primers used and model of PCR machine A nested PCR approach targeting the L1 gene was used. The outer PCR was carried out using an equimolar mixture of each PGMY09 and PGMY11 primer pool 7 at a concentration of 80 nanomolar (nM) each, which generated a 450 base pairs (bp) product. This product was used as a template for the inner PCR. The inner PCR was carried out using custom tagged GP5+ and GP6+ primers 7 at a final concentration 200 nM each, which generated a 150 bp product. The tagged inner PCR products were used for library generation where specific barcodes were incorporated for each sample. The library was sequenced on an Illumina MiSeq or a NextSeq next generation sequencer in a shared run using the Illumina V2 2*250 (MiSeq) or Mid-output 2*150 (NextSeq) paired-end sequencing by synthesis chemistry. The resulting .fastq raw read files were aligned against HPV DNA database using in-house bioinformatics pipeline and read counts generated were analysed for presence/absence and type of HPV DNA in each sample. The outer PCR was carried out at 20 microlitre (μl) reaction volume, with 1X Invitrogen PCR buffer, 4 mM MgCl2, 0.2 mM dNTP and a blend of two polymerases, 0.5U of Platinum Taq DNA polymerase (Invitrogen) and 0.5U of HotStarTaq DNA polymerase (Qiagen). The outer PCR was carried out on Veriti 96-well thermal cycler (Applied Biosystems) with initial incubation at 37°C, initial denaturation at 95°C for 15 min, followed by 35 cycles of denaturation at 95°C for 20 sec, annealing at 56.5°C for 30 sec, extension at 72°C for 1 min. The amplified outer PCR products were diluted 100 times with ultrapure nuclease free PCR grade water and used as a template for inner PCR. For the inner PCR, custom tagged GP5+ and GP6+ primers 7 were used at a final concentration of 200 nM each. The inner PCR was carried out at 20 μl reaction volume with 1X Invitrogen PCR buffer, 4 mM MgCl 2 , 0.2 mM dNTP, 0.5 mg/ml BSA, and a blend of two polymerases, 0.5U of Platinum Taq DNA polymerase (Invitrogen) and 0.5U of HotStarTaq DNA polymerase (Qiagen). The inner PCR was carried out on Veriti 96-well thermal cycler (Applied Biosystems) with initial incubation at 37°C, initial denaturation at 95°C for 15 min, followed by eight cycles of denaturation at 95°C for 20 sec, ramp up annealing from 40°C to 72°C for 30 sec, extension at 72°C for 30 sec, followed by 27 cycles of denaturation at 95°C for 20 sec and extension at 72°C for 1 min. Statistical analyses PCR (and NGS) results were treated as the outcome, classified into three groups: 1) no HPV; 2) high risk or oncogenic HPV (hrHPV i.e. , if they belonged to any of the following genotypes HPV16, HPV18, HPV31, HPV33, HPV35, HPV39, HPV45, HPV51, HPV52, HPV56, HPV58, HPV59, HPV66, HPV68) 8 ; and 3) low risk HPV (6/11, 7, 13, 27, 32/42, 34, 43/91, 44, 53, 62, 71, 72, 73, 81, 82, 83, 84, 86/87, 89/102, 90/106, 107, 114, and 120). 8 Medians and proportions across the outcome were compared using Kruskal Wallis and Fisher’s exact tests, respectively, for different sociodemographic, behavioural, sexual history and clinical predictors ( Table 1 ). We used multinomial logistic regression to obtain prevalence ratios (PRs) comparing lrHPV and hrHPV groups (comparison groups) against the no HPV group (reference group) for different predictors. Multivariable models were adjusted for variables chosen a priori as predictors of oral HPV and that had a minimum of five participants when cross tabulated against the outcome. These were age, sex, CD4 counts and duration on ART. Table 1. Characteristics of PLHIV in Pune, India, and associations with oral hrHPV and lrHPV prevalence. Characteristics Total N (%, IQR) hrHPV * N (%, IQR) lrHPV * N (%, IQR) No HPV * N (%, IQR) PR (95% CI) Ref (No HPV) Comp (hrHPV) PR (95% CI) Ref (No HPV) Comp (lrHPV) aPR (95% CI) Ref (No HPV) Comp (hrHPV) aPR (95% CI) Ref (No HPV) Comp (lrHPV) Total N 582 26 (4.5) 20 (3.4) 536 (92.1) - - - - Median age in years (IQR) 40 (34 – 46) 38.5 (31 – 48) 43.5 (40 – 47.5) 40 (34 – 46) 0.99 (0.95, 1.04) 1.05 (1.01, 1.10) 0.99 (0.95, 1.04) 1.04 (1.00, 1.09) Biological sex Male 312 (53.6) 14 (53.8) 15 (75.0) 283 (52.8) Ref Ref Ref Ref Female 270 (46.4) 12 (46.2) 5 (25.0) 253 (47.2) 0.96 (0.44, 2.11) 0.37 (0.13, 1.04) 0.97 (0.43, 2.21) 0.50 (0.17, 1.45) Ever smoked No 475 (81.8) 20 (76.9) 14 (70.0) 441 (82.4) Ref Ref - - Yes 106 (18.2) 6 (23.1) 6 (30.0) 94 (17.6) 1.41 (0.55, 3.60) 2.01 (0.75, 5.37) Ever consumed alcohol No 377 (64.8) 18 (69.2) 10 (50.0) 349 (65.1) Ref Ref - - Yes 205 (35.2) 8 (30.8) 10 (50.0) 187 (34.9) 0.83 (0.35, 1.94) 1.87 (0.76, 4.56) Ever used SLT a No 343 (58.9) 19 (73.1) 13 (65.0) 311 (58.0) Ref Ref - - Yes 239 (41.1) 7 (26.9) 7 (35.0) 225 (42.0) 0.51 (0.21, 1.23) 0.74 (0.29, 1.89) Ever smoked, used SLT or consumed alcohol No 281 (48.3) 16 (61.5) 10 (50.0) 349 (65.1) Ref Ref - - Yes 301 (51.7) 10 (38.5) 10 (50.0) 187 (34.9) 0.83 (0.35, 1.94) 1.87 (0.76,4.56) Ever given oral sex No 521 (89.5) 24 (92.3) 16 (80.0) 481 (89.7) Ref Ref - - Yes 61 (10.5) 2 (7.7) 4 (20.0) 55 (10.3) 0.73 (0.17, 3.17) 2.19 (0.71, 6.77) Lifetime multiple sexual partners No 431 (74.2) 22 (84.6) 12 (60.0) 397 (74.2) Ref Ref - - Yes 150 (25.8) 4 (15.4) 8 (40.0) 138 (25.8) 0.52 (0.18, 1.54) 1.92 (0.77, 4.79) Self identifies as MSM b No 568 (97.6) 26 (100.0) 20.0 (100.0) 522 (97.4) - - - - Yes 14 (2.4) 0 (0) 0 (0) 14 (2.61) Median time- updated CD4 counts (cells/mm 3 ) c 510 (338 – 700) 475 (242 – 651) 467 (311 – 611) 512 (349 – 708) 0.97 (0.90, 1.05) 0.93 (0.85, 1.02) 0.97 (0.90, 1.05) 0.96 (0.87, 1.05) Median duration on ART (in years) d 8 (4-12) 8.5 (2 – 16) 6.5 (4 – 9.5) 8 (4-12) 1.03 (0.97, 1.09) 0.95 (0.87, 1.03) 1.05 (0.65, 1.72) 0.68 (0.38, 1.23) Suspected OPMD e No 470 (80.8) 22 (84.6) 18 (90.0) 430 (80.2) Ref Ref - - Yes 112 (19.2) 4 (15.4) 2 (10.0) 106 (19.8) 0.74 (0.25, 2.18) 0.45 (0.10, 1.97) * There are no significant differences between the medians or proportions across no HPV, hrHPV (high risk HPV) and lrHPV (low risk HPV) groups (p-value associated with Kruskal- Wallis and Fisher’s exact test >0.10 for all characteristics. a SLT: Smokeless tobacco, which are forms of tobacco that are not burned. Locally available forms available: khaini (tobacco + slaked lime); gutka (tobacco + areca nut + slaked lime); mishri (roasted powdered tobacco); paan (tobacco + areca nut + slaked lime + condiments, wrapped in a betel leaf); paan masala; snuff. b MSM: Men who have sex with men. c ART: Antiretroviral therapy. d Regression estimates are interpreted with respect to an increase in 50 CD4 cell counts; CD4 count values were missing for 8 participants. e OPMD: Oral potentially malignant disorder. We performed three sensitivity analyses, comparing primary results with: 1) Findings in which CD4 counts were categorized into <200 and ≥200 cells/mm; 2) Findings from models in which PRs were obtained for a binary outcome i.e. , no HPV and any HPV (collapsing hrHPV and lrHPV into a single group); 3) Findings from regression models in which imputations using chained equations for those with missing HPV were performed. Statistical significance was set to a two-sided p-value of 0.05. All analyses were performed in Stata 17.0 (RRID:SCR_012763) (free alternative, RStudio). Results A total of 582 PLHIV were enrolled. The median age was 40 years (IQR: 34–46), 46.4% (n=270) were biologically female, 18.2% (n=106) had smoked, 41.1% (n=239) had used smokeless tobacco (SLT) and 35.2% (n=205) had consumed alcohol. Approximately 2.5% (n=14) self-identified as MSM, 10.5% (n=61) had given oral sex and 25.8% (n=150) had multiple sexual partners, in their lifetime. Median time updated CD4 counts were 510 cells/mm 3 (IQR: 338–700) and median duration on ART was eight years (IQR: 4–12). None of the participants were vaccinated against HPV. The prevalence of hrHPV was 4.5% (n=26) and lrHPV was 3.4% (n=20). Of those with hrHPV, 76.9% (n=20) had HPV16. Approximately 40% of those with hrHPV (n=8) and 50% (n=10) of those with lrHPV had never smoked, used SLT or consumed alcohol. The distribution of hrHPV was HPV16: n=20, HPV18: n=2, HPV35: n=1, HPV66: n=2 and HPV68: n=1; and that of lrHPV was HPV7: n=1, HPV13: n=1, HPV27: n=1, HPV32: n=1, HPV42: n=1, HPV44: n=3, HPV72: n=3, HPV81: n=1, HPV84: n=1, HPV90: n=1, HPV107: n=4, HPV120: n=2 ( Table 1 ). The prevalence of hrHPV and lrHPV were not statistically significantly different ( i.e. , p>0.05) by age, biological sex, tobacco and alcohol use habits, and sexual and clinical history. In the univariate analysis, relative to the no HPV group, a unit increase in age was associated with 5% increase in the prevalence of lrHPV (PR: 1.05; 95% CI: 1.01, 1.10). There were no predictors significantly associated with hrHPV in univariate analysis. When adjusted for age, sex, time updated CD4 counts and ART duration, no predictors were significantly associated with either lrLPV or hrHPV ( Table 1 ). Sensitivity analyses findings were consistent with results presented in Table 1 . However, when CD4 counts were categorized into <200 and ≥200 cells/mm 3 , participants with <200 cells/mm 3 had a 3.14- (95% CI: 1.20, 8.22) and 3.12- (95% CI: 1.19, 8.20) fold higher prevalence of hrHPV in univariate and multivariable analyses, respectively, but associations with lrHPV were non-significant. We do not present these as primary findings because there were no female participants with CD4 counts <200 cells/mm 3 in the hrHPV group and multivariable results are likely an extrapolation by the model. Discussion Using oral rinse samples, we found the overall prevalence of any HPV to be 7.6%, lrHPV to be 3.4% and hrHPV to be 4.5% among PLHIV. To our knowledge this is the first study from India to report on oral HPV among PLHIV that are not exclusively MSM and the largest study from the country to date to report on the prevalence of oral HPV. 9 , 10 We found combined oral HPV ( i.e. , any oral HPV: lrHPV and hrHPV) and hrHPV (only) prevalence to be lower than what has been reported among studies in PLHIV from the United States. 1 However, the sample size of the present study is larger than most of these studies. Compared to the study conducted among MSM living with HIV in India, our overall prevalence of any oral HPV was lower (7.6% versus 23.7%), hrHPV prevalence was higher (4.5% versus 2.4%) and hrHPV was almost exclusively HPV16 (77% versus 0%). 5 These findings indicate the heterogeneity of oral HPV prevalence and genotypes among different subgroups of PLHIV in India and the need for larger studies to better characterize oral HPV in them. Most previous studies in India have only reported on oral HPV among HIV-uninfected individuals with HNCs. The prevalence of oral HPV in these studies varies between 0–79%, with HPV16 being the most common genotype. 9 , 10 More than three-fourths of those with hrHPV in our study had HPV16. Further, 40% of those with hrHPV reported to have never smoked, used SLT or consumed alcohol, which are traditional risk factors for HNCs. Oral HPV screening is not routinely performed as part of HIV care at present. Given the strong association between HPV16 and HNCs, 1 and the increased vulnerability of PLHIV for HNCs, 1 oral HPV assessment for PLHIV must be considered. We found no association with CD4 counts in our primary analysis. This may be due to the high median CD4 counts of the study population. Immunosuppression is an important risk factor for oral HPV, 1 , 8 and our sensitivity analysis indicates that those with CD4 counts <200 cells/mm 3 may be more likely to have prevalent hrHPV. A previous publication from our site showed that a large proportion of PLHIV consistently presented with CD4 counts <200 cells/mm 3 over a 12-year period (2005–2017). 11 This underlines the need to facilitate earlier engagement of PLHIV in HIV care, to reduce their risk of oral HPV acquisition. There are several limitations in our study that merit discussion. We did not measure HIV viral loads and are unable to comment on the association between viral suppression and oral HPV prevalence. We did not find associations between oral HPV with either multiple sexual partners or oral sex. This is likely due to participants underreporting these behaviours, driven by social desirability. We are committed to improving on this aspect and have organized a series of workshops for sexual history assessment. While this is the largest study till date to report on oral HPV from India, we were not powered to detect significant associations especially in multivariable models. Our findings may also not be generalizable to other PLHIV living elsewhere in India. PLHIV are a vulnerable group for HPV-associated HNCs and those living in LMICs may be particularly at risk because oral HPV screening is not routinely performed as part of HIV care. We reiterate the need for larger studies to better understand oral HPV prevalence and associated risk factors among PLHIV in India, simultaneously with the scaling-up of oral HPV screening measures among them. Data availability Underlying data Data cannot be shared publicly because it comes from people living with HIV in India, many of whom have not disclosed their HIV status except to their HIV health care provider and spouses. Data are available from the Ethics Committee - Byramjee Jeejeebhoy Medical College & Sassoon General Hospitals, Pune, India (contact via email @ [email protected] ) for researchers who meet the criteria for access to confidential data. Acknowledgements We would like to thank the non-medical health care workers involved: Suhasini Surwase, Archana Pawar and Kanta Zarekar; the data entry operator: Rohini Kamble; all the ART staff and the study participants without whom this work would not be possible. References 1. Beachler DC, D'Souza G: Oral human papillomavirus infection and head and neck cancers in HIV-infected individuals. Curr. Opin. Oncol. 2013; 25 (5): 503–510. PubMed Abstract | Publisher Full Text | Free Full Text 2. Chaturvedi AK, Madeleine MM, Biggar RJ, et al. : Risk of human papillomavirus-associated cancers among persons with AIDS. J. Natl. Cancer Inst. 2009; 101 (16): 1120–1130. PubMed Abstract | Publisher Full Text | Free Full Text 3. Shao Y, Williamson C: The HIV-1 epidemic: low- to middle-income countries. Cold Spring Harb. Perspect. Med. 2012; 2 (3): a007187. PubMed Abstract | Publisher Full Text | Free Full Text 4. Press Trust of India: India has 3rd-highest number of HIV-infected people: UN. The Hindu; 2014. Accessed August 15, 2022. Reference Source 5. Hernandez AL, Karthik R, Sivasubramanian M, et al. : Prevalence of oral human papillomavirus infection among Indian HIV-positive men who have sex with men: a cross-sectional study. BMC Infect. Dis. 2021; 21 (1): 675. [published Online First: 20210712]. PubMed Abstract | Publisher Full Text | Free Full Text 6. Marbaniang I, Joshi S, Sangle S, et al. : Smokeless tobacco use and oral potentially malignant disorders among people living with HIV (PLHIV) in Pune, India: Implications for oral cancer screening in PLHIV. PLoS One. 2022; 17 (7): e0270876. [published Online First: 20220705]. PubMed Abstract | Publisher Full Text | Free Full Text 7. Gravitt PE, Peyton CL, Alessi TQ, et al. : Improved amplification of genital human papillomaviruses. J. Clin. Microbiol. 2000; 38 (1): 357–361. PubMed Abstract | Publisher Full Text | Free Full Text 8. Muller K, Kazimiroff J, Fatahzadeh M, et al. : Oral Human Papillomavirus Infection and Oral Lesions in HIV-Positive and HIV-Negative Dental Patients. J. Infect. Dis. 2015; 212 (5): 760–768. PubMed Abstract | Publisher Full Text | Free Full Text 9. Nair D, Mair M, Singh A, et al. : Prevalence and Impact of Human Papillomavirus on Head and Neck Cancers: Review of Indian Studies. Indian J. Surg. Oncol. 2018; 9 (4): 568–575. PubMed Abstract | Publisher Full Text | Free Full Text 10. Bruni L, Albero G, Serrano B, et al. : Human Papillomavirus and Related Diseases in India. ICO/IARC Information Centre on HPV and Cancer (HPV Information Centre). Summary Report 22 October 2021. Accessed August 5, 2022. Reference Source 11. Raichur P, Salvi SP, Sangle S, et al. : Trends and Sex Differences in Access to HIV Care with Scale Up of National HIV Treatment Guidelines in Pune, India. J. Int. Assoc. Provid. AIDS Care. 2020; 19 : 2325958220931735. PubMed Abstract | Publisher Full Text | Free Full Text Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 14 Mar 2023 ADD YOUR COMMENT Comment Author details Author details 1 Department of Epidemiology, McGill University, Montreal, Québec, H3A 1Y7, Canada 2 Byramjee Jeejeebhoy Government Medical College – Johns Hopkins University Clinical Research Site, Pune, Maharashtra, 411001, India 3 Department of Otorhinolaryngology and Head & Neck Surgery, Byramjee Jeejeebhoy Government Medical College, Pune, Maharashtra, 411001, India 4 Department of Medicine, Byramjee Jeejeebhoy Government Medical College, Pune, Maharashtra, 411001, India 5 Department of Dentistry, Byramjee Jeejeebhoy Government Medical College, Pune, Maharashtra, 411001, India 6 Center for Infectious Diseases in India, School of Medicine, Johns Hopkins University, Baltimore, Maryland, 21202, USA Ivan Marbaniang Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Software, Writing – Original Draft Preparation, Writing – Review & Editing Samir Joshi Roles: Conceptualization, Investigation, Resources, Supervision, Writing – Review & Editing Rohidas Borse Roles: Conceptualization, Investigation, Supervision, Writing – Review & Editing Samir Khaire Roles: Investigation, Methodology, Writing – Review & Editing Rahul Thakur Roles: Investigation, Writing – Review & Editing Prasad Deshpande Roles: Investigation, Methodology, Writing – Review & Editing Vandana Kulkarni Roles: Investigation, Methodology, Writing – Review & Editing Amol Chavan Roles: Formal Analysis, Writing – Review & Editing Smita Nimkar Roles: Investigation, Project Administration, Writing – Review & Editing Vidya Mave Roles: Conceptualization, Funding Acquisition, Methodology, Project Administration, Resources, Supervision, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information This work was supported by amfAR, The Foundation for AIDS Research, with support from the U.S. National Institutes of Health’s National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Cancer Institute, the National Institute of Mental Health, the National Institute on Drug Abuse, the National Heart, Lung, and Blood Institute, the National Institute on Alcohol Abuse and Alcoholism, the National Institute of Diabetes and Digestive and Kidney Diseases, and the Fogarty International Center, as part of the International Epidemiology Databases to Evaluate AIDS (IeDEA; U01AI069907) and the NIH-funded Johns Hopkins Baltimore-Washington-India Clinical Trials Unit for NIAID Networks (UM1AI069465). The content and views expressed are those of the authors and does not necessarily represent the official views of any of the governments or institutions mentioned above. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Article Versions (1) version 1 Published: 14 Mar 2023, 12:285 https://doi.org/10.12688/f1000research.127474.1 Copyright © 2023 Marbaniang I et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics Views Downloads F1000Research - - PubMed Central info_outline Data from PMC are received and updated monthly. - - Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Marbaniang I, Joshi S, Borse R et al. Prevalence of oral HPV among people living with HIV (PLHIV) in Pune, India [version 1; peer review: 3 approved with reservations] . F1000Research 2023, 12 :285 ( https://doi.org/10.12688/f1000research.127474.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 14 Mar 2023 Views 0 Cite How to cite this report: Gelanew T. Reviewer Report For: Prevalence of oral HPV among people living with HIV (PLHIV) in Pune, India [version 1; peer review: 3 approved with reservations] . F1000Research 2023, 12 :285 ( https://doi.org/10.5256/f1000research.139984.r246084 ) The direct URL for this report is: https://f1000research.com/articles/12-285/v1#referee-response-246084 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 05 Mar 2024 Tesfaye Gelanew , Armauer Hansen Research Institute, Addis Ababa, Addis Ababa, Ethiopia Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.139984.r246084 The study on oral HPV prevalence among people living with HIV (PLHIV) in Pune, India, where there is currently a dearth of data, provides valuable insights, but indeed, there are several points of contention that warrant further attention by authors: ... Continue reading READ ALL The study on oral HPV prevalence among people living with HIV (PLHIV) in Pune, India, where there is currently a dearth of data, provides valuable insights, but indeed, there are several points of contention that warrant further attention by authors: Risk Factors for Oral HPV in PLHIV : There is ongoing debate about the risk factors for oral HPV infection in PLHIV. Multiple studies indicate that HPV prevalence (both low-risk and carcinogenic types) is higher in PLHIV compared to the HIV-negative population. However, the specific risk factors contributing to the high prevalence of HPV infection in PLHIV were identified in the present study. Low HPV Prevalence and ART : The observed low prevalence of oral HPV in PLHIV might be attributed to participants being on antiretroviral therapy (ART) for an extended period. ART could potentially lead to clearance of HPV infection, but the current study does not directly address or support this hypothesis. Age Group Selection : The authors chose to focus on PLHIV aged 21 years and older. I'm not sure why the authors chose to focus on PLHIV who were 21 years of age and older. It would have been relevant to investigate rates of persistent HPV infection and precancerous lesions across different age groups. Understanding how HPV behaves over time in PLHIV of varying ages could provide valuable insights. Low HPV prevalence and HPV Vaccination : Being vaccinated could account for reduced oral HPV prevalence in PLHIV of the present study. Unfortunately, the study does not report whether participants had received the HPV vaccine. Given the rollout of the HPV vaccine in India, this information would have been crucial in interpreting the observed low prevalence. Inclusion and Exclusion Criteria : The study lacks clarity regarding its inclusion and exclusion criteria. Ambiguities in these criteria may contribute to the inconsistent results reported in the study. In summary, while the study shed light on oral HPV prevalence in PLHIV, addressing the aforementioned points could enhance the quality of the paper and our understanding of HPV dynamics in this population and geography. Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? No Are sufficient details of methods and analysis provided to allow replication by others? Yes If applicable, is the statistical analysis and its interpretation appropriate? Yes Are all the source data underlying the results available to ensure full reproducibility? Partly Are the conclusions drawn adequately supported by the results? Partly Competing Interests: No competing interests were disclosed. Reviewer Expertise: Viral Immunologist I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Gelanew T. Reviewer Report For: Prevalence of oral HPV among people living with HIV (PLHIV) in Pune, India [version 1; peer review: 3 approved with reservations] . F1000Research 2023, 12 :285 ( https://doi.org/10.5256/f1000research.139984.r246084 ) The direct URL for this report is: https://f1000research.com/articles/12-285/v1#referee-response-246084 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Dias BDC. Reviewer Report For: Prevalence of oral HPV among people living with HIV (PLHIV) in Pune, India [version 1; peer review: 3 approved with reservations] . F1000Research 2023, 12 :285 ( https://doi.org/10.5256/f1000research.139984.r246090 ) The direct URL for this report is: https://f1000research.com/articles/12-285/v1#referee-response-246090 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 01 Mar 2024 Bianca Da Costa Dias , National Institute for Communicable Diseases, National Health Laboratory Service, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.139984.r246090 The article provides the prevalence of oral HPV amongst HIV infected individuals on ART in Pune India and is described as the largest study of this nature to date. However, the authors fail to identify any associated risk factors and ... Continue reading READ ALL The article provides the prevalence of oral HPV amongst HIV infected individuals on ART in Pune India and is described as the largest study of this nature to date. However, the authors fail to identify any associated risk factors and concede that larger studies are required to establish risk factors for oral HPV in PLHIV in India. Overall, the article is well written, and the data presented is of importance. Throughout the manuscript however I feel it is important to emphasise that this cohort is PLHIV on ART- and may thus differ substantially from PLHIV who are not on ART. Introduction: The manuscript would benefit from data regarding the Prevalence/ Incidence of Head and Neck Cancers in India as stratified by HIV status (if available)- to put this study into context. Methods: Details regarding the processing of oral rinse samples is lacking - the volume of sample collected per patient, how these were treated prior to DNA extraction etc. The authors base their sample size estimates on a prevalence of 24%, however, the actual observed prevalence of HPV is much lower. How did this affect the power of the study? This should be commented on in the discussion. The heading "Thermal cycling conditions....PCR machine" should be changed to PCR amplification and Sequencing. In this section, the paragraphs detailing the nested PCR procedures (outer and inner PCR) should be moved prior to NGS methods. Could the choice of method- PCR amplification using PGMY primers have introduced bias based on the preferential amplification of most abundant genotypes? Perhaps this can be briefly commented on if the authors feel it appropriate. Since data was generated for individual HPV genotypes- these should be available as supplementary tables. The authors discuss "any HPV" results, but these are not presented in the tables. This should be included. The data could also be analysed to assess number of multiple HPVs/ co-infections and if this variable is maybe associated with specific risk factors. Although the variables are those usually included in such studies- the lack of quantification is a limitation that the authors must mention. Often it is not just having had multiple lifetime partners but the actual NUMBER of lifetime vaginal/oral sex partners or number of smoked packs etc that are associated with oral HPV risk. Furthermore, some of these variables could be past vs current use (smoking, alcohol use). Perhaps stratification in this way may allow for differences to be observed. If not, and these were already considered, then the authors should mention this. Table 1: The denominator of MSM should be men only (N=312) and not all participants. Furthermore, the high prevalence of OPMD, particularly amongst those with NO detectable HPV warrants discussion. Discussion: The authors fail to provide a rationale for the low prevalence of HPV in this cohort- especially when compared to the HIV uninfected prevalence they cite from literature. This sub-study explicitly excluded the HIV uninfected participants enrolled in the larger study as mentioned in the methods. This would have been a better comparator group to put these findings into context and to advocate for the screening recommended in the concluding paragraph as the low prevalence of HR-HPV does not support this recommendation (in my opinion). Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? Yes Are sufficient details of methods and analysis provided to allow replication by others? Partly If applicable, is the statistical analysis and its interpretation appropriate? I cannot comment. A qualified statistician is required. Are all the source data underlying the results available to ensure full reproducibility? Partly Are the conclusions drawn adequately supported by the results? Partly References 1. Riddell J, Brouwer AF, Walline HM, Campredon LP, et al.: Oral human papillomavirus prevalence, persistence, and risk-factors in HIV-positive and HIV-negative adults. Tumour Virus Res . 2022; 13 : 200237 PubMed Abstract | Publisher Full Text Competing Interests: No competing interests were disclosed. Reviewer Expertise: HPV, STIs I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Dias BDC. Reviewer Report For: Prevalence of oral HPV among people living with HIV (PLHIV) in Pune, India [version 1; peer review: 3 approved with reservations] . F1000Research 2023, 12 :285 ( https://doi.org/10.5256/f1000research.139984.r246090 ) The direct URL for this report is: https://f1000research.com/articles/12-285/v1#referee-response-246090 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Sethi S. Reviewer Report For: Prevalence of oral HPV among people living with HIV (PLHIV) in Pune, India [version 1; peer review: 3 approved with reservations] . F1000Research 2023, 12 :285 ( https://doi.org/10.5256/f1000research.139984.r180179 ) The direct URL for this report is: https://f1000research.com/articles/12-285/v1#referee-response-180179 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 04 Sep 2023 Sneha Sethi , Australian Research Centre for Population Oral Health, Faculty of Health Sciences, University of Adelaide, Adelaide, Australia Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.139984.r180179 Reviewer comments: This is very important and highly significant study, very few studies report on this prevalence although very common in PHIV and should be reported more. Although, I would suggest some major revisions before proceeding towards submission and ... Continue reading READ ALL Reviewer comments: This is very important and highly significant study, very few studies report on this prevalence although very common in PHIV and should be reported more. Although, I would suggest some major revisions before proceeding towards submission and publication. Introduction: The introduction is very brief, I would suggest adding another section in the beginning related to global statistics of Oral HPV associated HNC’s in PHIV populations, also describing high and low risk HPV infection and also a reference of why PHIV would be more susceptible for this infection. This will make the introduction more engaging and informative for a wider audience instead of people from a very specialized niche. Methods: I would like to applaud the efforts of the author team on compiling the methods and seeking proper ethical approval from both institutions before commencing the study. Result and discussion are satisfactory with minor grammatical errors. Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? Yes Are sufficient details of methods and analysis provided to allow replication by others? Yes If applicable, is the statistical analysis and its interpretation appropriate? Yes Are all the source data underlying the results available to ensure full reproducibility? Yes Are the conclusions drawn adequately supported by the results? Yes Competing Interests: No competing interests were disclosed. Reviewer Expertise: Oral cancers, HPV, Minority populations, racism I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Sethi S. Reviewer Report For: Prevalence of oral HPV among people living with HIV (PLHIV) in Pune, India [version 1; peer review: 3 approved with reservations] . F1000Research 2023, 12 :285 ( https://doi.org/10.5256/f1000research.139984.r180179 ) The direct URL for this report is: https://f1000research.com/articles/12-285/v1#referee-response-180179 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 14 Mar 2023 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 2 3 Version 1 14 Mar 23 read read read Sneha Sethi , University of Adelaide, Adelaide, Australia Bianca Da Costa Dias , National Institute for Communicable Diseases, National Health Laboratory Service, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa Tesfaye Gelanew , Armauer Hansen Research Institute, Addis Ababa, Ethiopia Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert Browse by related subjects keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Gelanew T. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 05 Mar 2024 | for Version 1 Tesfaye Gelanew , Armauer Hansen Research Institute, Addis Ababa, Addis Ababa, Ethiopia 0 Views copyright © 2024 Gelanew T. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions The study on oral HPV prevalence among people living with HIV (PLHIV) in Pune, India, where there is currently a dearth of data, provides valuable insights, but indeed, there are several points of contention that warrant further attention by authors: Risk Factors for Oral HPV in PLHIV : There is ongoing debate about the risk factors for oral HPV infection in PLHIV. Multiple studies indicate that HPV prevalence (both low-risk and carcinogenic types) is higher in PLHIV compared to the HIV-negative population. However, the specific risk factors contributing to the high prevalence of HPV infection in PLHIV were identified in the present study. Low HPV Prevalence and ART : The observed low prevalence of oral HPV in PLHIV might be attributed to participants being on antiretroviral therapy (ART) for an extended period. ART could potentially lead to clearance of HPV infection, but the current study does not directly address or support this hypothesis. Age Group Selection : The authors chose to focus on PLHIV aged 21 years and older. I'm not sure why the authors chose to focus on PLHIV who were 21 years of age and older. It would have been relevant to investigate rates of persistent HPV infection and precancerous lesions across different age groups. Understanding how HPV behaves over time in PLHIV of varying ages could provide valuable insights. Low HPV prevalence and HPV Vaccination : Being vaccinated could account for reduced oral HPV prevalence in PLHIV of the present study. Unfortunately, the study does not report whether participants had received the HPV vaccine. Given the rollout of the HPV vaccine in India, this information would have been crucial in interpreting the observed low prevalence. Inclusion and Exclusion Criteria : The study lacks clarity regarding its inclusion and exclusion criteria. Ambiguities in these criteria may contribute to the inconsistent results reported in the study. In summary, while the study shed light on oral HPV prevalence in PLHIV, addressing the aforementioned points could enhance the quality of the paper and our understanding of HPV dynamics in this population and geography. Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? No Are sufficient details of methods and analysis provided to allow replication by others? Yes If applicable, is the statistical analysis and its interpretation appropriate? Yes Are all the source data underlying the results available to ensure full reproducibility? Partly Are the conclusions drawn adequately supported by the results? Partly Competing Interests No competing interests were disclosed. Reviewer Expertise Viral Immunologist I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (0) Gelanew T. Peer Review Report For: Prevalence of oral HPV among people living with HIV (PLHIV) in Pune, India [version 1; peer review: 3 approved with reservations] . F1000Research 2023, 12 :285 ( https://doi.org/10.5256/f1000research.139984.r246084) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/12-285/v1#referee-response-246084 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Dias B. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 01 Mar 2024 | for Version 1 Bianca Da Costa Dias , National Institute for Communicable Diseases, National Health Laboratory Service, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa 0 Views copyright © 2024 Dias B. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions The article provides the prevalence of oral HPV amongst HIV infected individuals on ART in Pune India and is described as the largest study of this nature to date. However, the authors fail to identify any associated risk factors and concede that larger studies are required to establish risk factors for oral HPV in PLHIV in India. Overall, the article is well written, and the data presented is of importance. Throughout the manuscript however I feel it is important to emphasise that this cohort is PLHIV on ART- and may thus differ substantially from PLHIV who are not on ART. Introduction: The manuscript would benefit from data regarding the Prevalence/ Incidence of Head and Neck Cancers in India as stratified by HIV status (if available)- to put this study into context. Methods: Details regarding the processing of oral rinse samples is lacking - the volume of sample collected per patient, how these were treated prior to DNA extraction etc. The authors base their sample size estimates on a prevalence of 24%, however, the actual observed prevalence of HPV is much lower. How did this affect the power of the study? This should be commented on in the discussion. The heading "Thermal cycling conditions....PCR machine" should be changed to PCR amplification and Sequencing. In this section, the paragraphs detailing the nested PCR procedures (outer and inner PCR) should be moved prior to NGS methods. Could the choice of method- PCR amplification using PGMY primers have introduced bias based on the preferential amplification of most abundant genotypes? Perhaps this can be briefly commented on if the authors feel it appropriate. Since data was generated for individual HPV genotypes- these should be available as supplementary tables. The authors discuss "any HPV" results, but these are not presented in the tables. This should be included. The data could also be analysed to assess number of multiple HPVs/ co-infections and if this variable is maybe associated with specific risk factors. Although the variables are those usually included in such studies- the lack of quantification is a limitation that the authors must mention. Often it is not just having had multiple lifetime partners but the actual NUMBER of lifetime vaginal/oral sex partners or number of smoked packs etc that are associated with oral HPV risk. Furthermore, some of these variables could be past vs current use (smoking, alcohol use). Perhaps stratification in this way may allow for differences to be observed. If not, and these were already considered, then the authors should mention this. Table 1: The denominator of MSM should be men only (N=312) and not all participants. Furthermore, the high prevalence of OPMD, particularly amongst those with NO detectable HPV warrants discussion. Discussion: The authors fail to provide a rationale for the low prevalence of HPV in this cohort- especially when compared to the HIV uninfected prevalence they cite from literature. This sub-study explicitly excluded the HIV uninfected participants enrolled in the larger study as mentioned in the methods. This would have been a better comparator group to put these findings into context and to advocate for the screening recommended in the concluding paragraph as the low prevalence of HR-HPV does not support this recommendation (in my opinion). Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? Yes Are sufficient details of methods and analysis provided to allow replication by others? Partly If applicable, is the statistical analysis and its interpretation appropriate? I cannot comment. A qualified statistician is required. Are all the source data underlying the results available to ensure full reproducibility? Partly Are the conclusions drawn adequately supported by the results? Partly References 1. Riddell J, Brouwer AF, Walline HM, Campredon LP, et al.: Oral human papillomavirus prevalence, persistence, and risk-factors in HIV-positive and HIV-negative adults. Tumour Virus Res . 2022; 13 : 200237 PubMed Abstract | Publisher Full Text Competing Interests No competing interests were disclosed. Reviewer Expertise HPV, STIs I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (0) Dias BDC. Peer Review Report For: Prevalence of oral HPV among people living with HIV (PLHIV) in Pune, India [version 1; peer review: 3 approved with reservations] . F1000Research 2023, 12 :285 ( https://doi.org/10.5256/f1000research.139984.r246090) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/12-285/v1#referee-response-246090 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2023 Sethi S. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 04 Sep 2023 | for Version 1 Sneha Sethi , Australian Research Centre for Population Oral Health, Faculty of Health Sciences, University of Adelaide, Adelaide, Australia 0 Views copyright © 2023 Sethi S. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer comments: This is very important and highly significant study, very few studies report on this prevalence although very common in PHIV and should be reported more. Although, I would suggest some major revisions before proceeding towards submission and publication. Introduction: The introduction is very brief, I would suggest adding another section in the beginning related to global statistics of Oral HPV associated HNC’s in PHIV populations, also describing high and low risk HPV infection and also a reference of why PHIV would be more susceptible for this infection. This will make the introduction more engaging and informative for a wider audience instead of people from a very specialized niche. Methods: I would like to applaud the efforts of the author team on compiling the methods and seeking proper ethical approval from both institutions before commencing the study. Result and discussion are satisfactory with minor grammatical errors. Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? Yes Are sufficient details of methods and analysis provided to allow replication by others? Yes If applicable, is the statistical analysis and its interpretation appropriate? Yes Are all the source data underlying the results available to ensure full reproducibility? Yes Are the conclusions drawn adequately supported by the results? Yes Competing Interests No competing interests were disclosed. Reviewer Expertise Oral cancers, HPV, Minority populations, racism I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (0) Sethi S. Peer Review Report For: Prevalence of oral HPV among people living with HIV (PLHIV) in Pune, India [version 1; peer review: 3 approved with reservations] . F1000Research 2023, 12 :285 ( https://doi.org/10.5256/f1000research.139984.r180179) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/12-285/v1#referee-response-180179 Alongside their report, reviewers assign a status to the article: Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. 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