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

Duygu Durukan, Tiffany R. Phillips, Gerald L. Murray, Jason J. Ong, Andrew E. Grulich, I. Mary Poynten, Fengyi Jin, Catriona S. Bradshaw, Ivette Aguirre, Julie Silvers, Helen Kent, Steph Atchison, Prisha Balgovind, Alyssa Cornall, Marcus Y. Chen, Christopher K. Fairley, Eric P.F. Chow

Research output: Contribution to journalArticleResearchpeer-review


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.

Original languageEnglish
Article number4477
Number of pages12
JournalJournal of Clinical Medicine
Issue number19
Publication statusPublished - 1 Oct 2021


  • Anal cancer
  • Anus
  • HPV
  • Intervention
  • Men
  • Prevention

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