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Wart clearance and recurrence were similar with either topical treatment and, though a benefit of vaccine was not demonstrated in this study, further research appears justified.

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Richard Gilson, Diarmuid Nugent, Kate Bennett, Caroline J Doré, Macey L Murray, Jade Meadows, Lewis J Haddow, Charles Lacey, Frank Sandmann, Mark Jit, Kate Soldan, Michelle Tetlow, Emilia Caverly, Mayura Nathan & Andrew J Copas.

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Richard Gilson ^1,2,*, Diarmuid Nugent ^1,2, Kate Bennett ³, Caroline J Doré ³, Macey L Murray ³, Jade Meadows ³, Lewis J Haddow ^1,2, Charles Lacey ⁴, Frank Sandmann ^5,6, Mark Jit ^5,6, Kate Soldan ⁶, Michelle Tetlow ³, Emilia Caverly ³, Mayura Nathan ⁷, Andrew J Copas ^3,8

¹ University College London Centre for Clinical Research in Infection and Sexual Health, Institute for Global Health, University College London, London, UK
² Mortimer Market Centre, Central and North West London NHS Foundation Trust, London, UK
³ Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK
⁴ Centre for Immunology and Infection, Hull York Medical School, University of York, York, UK
⁵ Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK
⁶ Statistics, Modelling and Economics Department, Public Health England, London, UK
⁷ Homerton Anogenital Neoplasia Service, Homerton University Hospital NHS Foundation Trust, London, UK
⁸ Medical Research Council Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK
^* Corresponding author Email: r.gilson@ucl.ac.uk

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Response by Associate Professor Electra Nicolaidou on 18 November 2020 at 10:46 AM
Does anatomic location of anogenital warts affect response to topical treatment?
Dear Editor, I read with great interest the results of the HIPvac trial that were recently published in Health Technology Assessment. Anogenital warts (AGW), with an annual incidence rate between 100 and 200 new cases per 100,000 general adult population,1 rank among the most frequent sexually transmitted infections and high-quality data from randomized controlled trials, such as those reported from the HIPvac trial, are scarce and therefore very welcomed. From the everyday clinical practice with patients with AGW, we have noticed that anatomic location of lesions may play a significant role in response to topical treatments. To substantiate this observation, we conducted a retrospective study that included 347 patients with AGW treated at our department with topical therapy. In this study,2 which was published after the preparation of the HIPvac trial manuscript, we compared a short, 8-week course of imiquimod to the standard 4-week regime of podophyllotoxin. We decided to evaluate an 8-week course of imiquimod instead of the licensed 16-week course because, in our everyday clinical practice, we usually use cryotherapy after an 8-week course of imiquimod to treat lesions that have not cleared. For the purposes of the study, anatomic sites of AGW were divided into 2 groups. The first group included sites covered by dry, keratinized skin, such as pubic area, penile shaft, scrotum, groin, and outer surface of labia majora of the vulva (“keratinized” sites). The second group included sites covered by moist, partially keratinized skin, such as perianal area, perineum, preputial cavity, inner surface of labia majora and labia minora of the vulva (“partially keratinized” sites). The study revealed that, for lesions on “keratinized” sites, the difference between imiquimod and podophyllotoxin both in clearance rates (7.6% and 27.9%, respectively) and in > 50% reduction in wart area (54.3% and 76.0%, respectively) was statistically significant. For lesions on “partially keratinized” sites, the two treatments yielded comparable results. Multivariate analysis using a logistic regression model adjusted for treatment used (imiquimod vs. podophyllotoxin), gender of patient, location of lesions (“keratinized” sites vs. “partially keratinized” sites), disease extent and patient’s age showed that only treatment with podophyllotoxin [OR (95% CI): 1.9 (1.11-3.23), p<0.018] and location on “partially keratinized” sites [OR (95% CI): 3.75 (1.88-7.49), p<0.0001] were statistically significantly associated with >50% reduction in wart area. Since a major limitation of our study was its retrospective design, it would be of great interest to see if these differences (better response of “keratinized” sites to podophyllotoxin, compared with imiquimod, and better response of “partially keratinized” sites to both treatments, compared with “keratinized” sites) were also evident in HIPvac clinical trial. These data, in addition to the ones already published from the trial, can be of great help to clinicians, in their effort for an evidenced-based selection of treatment for patients with AGW. Once again, I would like to express my thanks and my appreciation to the authors and all involved in the design and the implementation of this randomized clinical trial, in a field where such high-quality data are missing. References 1.Patel H, Wagner M, Singhal P, Kothari S. Systematic review of the incidence and prevalence of genital warts. BMC Infec Dis 2013; 13: 39 2.Nicolaidou E, Kanelleas A, Nikolakopoulos S, et al. A short, 8-week course of imiquimod 5% cream versus podophyllotoxin in the treatment of anogenital warts: A retrospective comparative cohort study. Indian J Dermatol Venereol Leprol 2019 Oct 22. doi: 10.4103/ijdvl.IJDVL_148_19