PMID- 34640496 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20211016 IS - 2077-0383 (Print) IS - 2077-0383 (Electronic) IS - 2077-0383 (Linking) VI - 10 IP - 19 DP - 2021 Sep 28 TI - 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. LID - 10.3390/jcm10194477 [doi] LID - 4477 AB - 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. FAU - Durukan, Duygu AU - Durukan D AD - Central Clinical School, Monash University, Melbourne, VIC 3004, Australia. AD - Melbourne Sexual Health Centre, Alfred Health, Carlton, VIC 3053, Australia. FAU - Phillips, Tiffany R AU - Phillips TR AD - Central Clinical School, Monash University, Melbourne, VIC 3004, Australia. AD - Melbourne Sexual Health Centre, Alfred Health, Carlton, VIC 3053, Australia. FAU - Murray, Gerald L AU - Murray GL AD - Murdoch Children's Research Institute, Parkville, VIC 3052, Australia. AD - Centre for Women's Infectious Diseases, The Royal Women's Hospital, Parkville, VIC 3052, Australia. AD - Department of Obstetrics and Gynaecology, The University of Melbourne, Parkville, VIC 3052, Australia. FAU - Ong, Jason J AU - Ong JJ AUID- ORCID: 0000-0001-5784-7403 AD - Central Clinical School, Monash University, Melbourne, VIC 3004, Australia. AD - Melbourne Sexual Health Centre, Alfred Health, Carlton, VIC 3053, Australia. FAU - Grulich, Andrew E AU - Grulich AE AD - The Kirby Institute, UNSW Sydney, Sydney, NSW 2052, Australia. FAU - Poynten, I Mary AU - Poynten IM AD - The Kirby Institute, UNSW Sydney, Sydney, NSW 2052, Australia. FAU - Jin, Fengyi AU - Jin F AD - The Kirby Institute, UNSW Sydney, Sydney, NSW 2052, Australia. FAU - Bradshaw, Catriona S AU - Bradshaw CS AD - Central Clinical School, Monash University, Melbourne, VIC 3004, Australia. AD - Melbourne Sexual Health Centre, Alfred Health, Carlton, VIC 3053, Australia. AD - Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, VIC 3052, Australia. FAU - Aguirre, Ivette AU - Aguirre I AD - Melbourne Sexual Health Centre, Alfred Health, Carlton, VIC 3053, Australia. FAU - Silvers, Julie AU - Silvers J AD - Melbourne Sexual Health Centre, Alfred Health, Carlton, VIC 3053, Australia. FAU - Kent, Helen AU - Kent H AD - Melbourne Sexual Health Centre, Alfred Health, Carlton, VIC 3053, Australia. FAU - Atchison, Steph AU - Atchison S AD - Murdoch Children's Research Institute, Parkville, VIC 3052, Australia. AD - Centre for Women's Infectious Diseases, The Royal Women's Hospital, Parkville, VIC 3052, Australia. FAU - Balgovind, Prisha AU - Balgovind P AD - Murdoch Children's Research Institute, Parkville, VIC 3052, Australia. AD - Centre for Women's Infectious Diseases, The Royal Women's Hospital, Parkville, VIC 3052, Australia. FAU - Cornall, Alyssa AU - Cornall A AD - Murdoch Children's Research Institute, Parkville, VIC 3052, Australia. AD - Centre for Women's Infectious Diseases, The Royal Women's Hospital, Parkville, VIC 3052, Australia. AD - Department of Obstetrics and Gynaecology, The University of Melbourne, Parkville, VIC 3052, Australia. FAU - Chen, Marcus Y AU - Chen MY AD - Central Clinical School, Monash University, Melbourne, VIC 3004, Australia. AD - Melbourne Sexual Health Centre, Alfred Health, Carlton, VIC 3053, Australia. FAU - Fairley, Christopher K AU - Fairley CK AD - Central Clinical School, Monash University, Melbourne, VIC 3004, Australia. AD - Melbourne Sexual Health Centre, Alfred Health, Carlton, VIC 3053, Australia. FAU - Chow, Eric P F AU - Chow EPF AUID- ORCID: 0000-0003-1766-0657 AD - Central Clinical School, Monash University, Melbourne, VIC 3004, Australia. AD - Melbourne Sexual Health Centre, Alfred Health, Carlton, VIC 3053, Australia. AD - Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, VIC 3052, Australia. LA - eng GR - GNT568971/National Health and Medical Research Council/ GR - GNT1172873/National Health and Medical Research Council/ GR - GNT1172900/National Health and Medical Research Council/ GR - GNT1173361/National Health and Medical Research Council/ PT - Journal Article DEP - 20210928 PL - Switzerland TA - J Clin Med JT - Journal of clinical medicine JID - 101606588 PMC - PMC8509144 OTO - NOTNLM OT - HPV OT - anal cancer OT - anus OT - intervention OT - men OT - prevention COIS- The authors declare no conflict of interest. EDAT- 2021/10/14 06:00 MHDA- 2021/10/14 06:01 PMCR- 2021/09/28 CRDT- 2021/10/13 01:10 PHST- 2021/08/12 00:00 [received] PHST- 2021/09/23 00:00 [revised] PHST- 2021/09/25 00:00 [accepted] PHST- 2021/10/13 01:10 [entrez] PHST- 2021/10/14 06:00 [pubmed] PHST- 2021/10/14 06:01 [medline] PHST- 2021/09/28 00:00 [pmc-release] AID - jcm10194477 [pii] AID - jcm-10-04477 [pii] AID - 10.3390/jcm10194477 [doi] PST - epublish SO - J Clin Med. 2021 Sep 28;10(19):4477. doi: 10.3390/jcm10194477.