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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

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...

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Autores principales: Durukan, Duygu, Phillips, Tiffany R., Murray, Gerald L., Ong, Jason J., Grulich, Andrew E., Poynten, I. Mary, Jin, Fengyi, Bradshaw, Catriona S., Aguirre, Ivette, Silvers, Julie, Kent, Helen, Atchison, Steph, Balgovind, Prisha, Cornall, Alyssa, Chen, Marcus Y., Fairley, Christopher K., Chow, Eric P. F.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8509144/
https://www.ncbi.nlm.nih.gov/pubmed/34640496
http://dx.doi.org/10.3390/jcm10194477
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author Durukan, Duygu
Phillips, Tiffany R.
Murray, Gerald L.
Ong, Jason J.
Grulich, Andrew E.
Poynten, I. Mary
Jin, Fengyi
Bradshaw, Catriona S.
Aguirre, Ivette
Silvers, Julie
Kent, Helen
Atchison, Steph
Balgovind, Prisha
Cornall, Alyssa
Chen, Marcus Y.
Fairley, Christopher K.
Chow, Eric P. F.
author_facet Durukan, Duygu
Phillips, Tiffany R.
Murray, Gerald L.
Ong, Jason J.
Grulich, Andrew E.
Poynten, I. Mary
Jin, Fengyi
Bradshaw, Catriona S.
Aguirre, Ivette
Silvers, Julie
Kent, Helen
Atchison, Steph
Balgovind, Prisha
Cornall, Alyssa
Chen, Marcus Y.
Fairley, Christopher K.
Chow, Eric P. F.
author_sort Durukan, Duygu
collection PubMed
description 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.
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spelling pubmed-85091442021-10-13 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 Durukan, Duygu Phillips, Tiffany R. Murray, Gerald L. Ong, Jason J. Grulich, Andrew E. Poynten, I. Mary Jin, Fengyi Bradshaw, Catriona S. Aguirre, Ivette Silvers, Julie Kent, Helen Atchison, Steph Balgovind, Prisha Cornall, Alyssa Chen, Marcus Y. Fairley, Christopher K. Chow, Eric P. F. J Clin Med Article 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. MDPI 2021-09-28 /pmc/articles/PMC8509144/ /pubmed/34640496 http://dx.doi.org/10.3390/jcm10194477 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Durukan, Duygu
Phillips, Tiffany R.
Murray, Gerald L.
Ong, Jason J.
Grulich, Andrew E.
Poynten, I. Mary
Jin, Fengyi
Bradshaw, Catriona S.
Aguirre, Ivette
Silvers, Julie
Kent, Helen
Atchison, Steph
Balgovind, Prisha
Cornall, Alyssa
Chen, Marcus Y.
Fairley, Christopher K.
Chow, Eric P. F.
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8509144/
https://www.ncbi.nlm.nih.gov/pubmed/34640496
http://dx.doi.org/10.3390/jcm10194477
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