O11.1 Tolerability of topical imiquimod against high-risk human papillomavirus infection in men-who-have-sex-with-men living with HIV

Background Men-who-have-sex-with-men (MSM) living with HIV have a high prevalence of high-risk human papillomavirus (hrHPV) in the anus, and a high incidence of anal cancer. We conducted an open-label, single-arm pilot study to assess the utility of imiquimod cream against hrHPV among MSM living with HIV.[ACTRN12617001355369] Methods The study was conducted at Melbourne Sexual Health Centre between April 2018 and June 2020. MSM aged ≥18 years, living with HIV, who tested positive for any anal hrHPV on clinician-collected swabs were eligible. We instructed men to apply 5% imiquimod cream (6.25 mg) intra-anally and peri-anally 3 doses per-week for 16-weeks (Phase 1), followed by a maintenance period of 1 dose per-week for 48-weeks (Phase 2). We collected adverse events (AE) using text messages and questionnaires. Results Thirty MSM were enrolled to phase 1 and 27 completed the week 16 follow-up(median age 50). Twenty-four MSM (86%) applied at least 50% of imiquimod doses. All men reported AE, with 39.5% reporting grade 1,39.5% grade 2, and 21% grade 3 AEs. Eighteen MSM (67%) required treatment interruption. The reasons for interruption were haemorrhoids (n=3), herpes genitalis reactivation (n=2), and grade 2–3 AEs (n=11) such as irritation, itching and tenderness. 60% of MSM with grade 2(n=6) and 33% with grade 3 AEs (n=2) opted to continue to phase 2. Eighteen MSM were enrolled to phase 2 and 13 completed the week 48 follow-up. All MSM took at least 50% of doses. No treatment-limiting AEs were reported. 10 MSM in phase 1 (37%) and none in phase 2 reported their sex life was negatively impacted from imiquimod use. Conclusion Intra-anal and peri-anal imiquimod at 3 doses per-week was poorly tolerated over 16 weeks and most men required treatment interruption due to AEs. In contrast, once-a-week application was well tolerated with no treatment-limiting AEs reported over 48-weeks.