Intra-anal imiquimod cream against human papillomavirus infection in men who have sex with men living with hiv: A single-arm, open-label pilot study
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2021-10-01
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Journal of Clinical Medicine
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MDPI
Melbourne Authors
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Melbourne School of Population and Global Health
Medical Education
Obstetrics and Gynaecology
Medical Education
Obstetrics and Gynaecology
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Journal Article
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Durukan, D., Phillips, T. R., Murray, G. L., Ong, J. J., Grulich, A. E., Poynten, I. M., Jin, F., Bradshaw, C. S., Aguirre, I., Silvers, J., Kent, H., Atchison, S., Balgovind, P., Cornall, A., Chen, M. Y., Fairley, C. K. & Chow, E. P. F. (2021). Intra-anal imiquimod cream against human papillomavirus infection in men who have sex with men living with hiv: A single-arm, open-label pilot study. Journal of Clinical Medicine, 10 (19), https://doi.org/10.3390/jcm10194477.
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Abstract
Men who have sex with men (MSM) living with HIV have a high prevalence and incidence of anal high-risk human papillomavirus (hrHPV) and anal cancer. We conducted an open-label, single-arm pilot study to examine the tolerability of imiquimod cream among MSM aged ≥18 years, living with HIV, who tested positive for anal hrHPV at Melbourne Sexual Health Centre between April 2018 and June 2020. We instructed men to apply 6.25 mg imiquimod intra-anally and peri-anally 3 doses per week for 16 weeks (period 1) and then one dose per week for a further 48 weeks (period 2). Twenty-seven MSM enrolled in period 1 and 24 (86%) applied at least 50% of doses. All men reported adverse events (AEs), including 39.5% grade 1, 39.5% grade 2, and 21% grade 3 AEs on at least one occasion. Eighteen MSM (67%) temporarily stopped using imiquimod during period 1, most commonly due to local AEs (n = 11) such as irritation and itching. Eighteen MSM continued in period 2 and all applied at least 50% of doses with no treatment-limiting AEs reported. Imiquimod 3 doses per week caused local AEs in most men and was not well tolerated. In contrast, once-a-week application was well tolerated over 48-weeks with no treatment-limiting AEs.