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

Duygu Durukan¹  Jason J. Ong¹  Tiffany R. Phillips¹  Christopher K. Fairley¹  Catriona S. Bradshaw¹  Eric P. F. Chow¹  Marcus Y. Chen¹  Julie Silvers²  Helen Kent²  Ivette Aguirre²  Alyssa Cornall³  Steph Atchison³  Prisha Balgovind³  Gerald L. Murray³  Andrew E. Grulich⁴  I. Mary Poynten⁴  Fengyi Jin⁴ 

[1] Central Clinical School, Monash University, Melbourne, VIC 3004, Australia;Melbourne Sexual Health Centre, Alfred Health, Carlton, VIC 3053, Australia;Murdoch Children’s Research Institute, Parkville, VIC 3052, Australia;The Kirby Institute, UNSW Sydney, Sydney, NSW 2052, Australia;

关键词: prevention;    anal cancer;    intervention;    HPV;    men;    anus;   

DOI  :  10.3390/jcm10194477

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown