Clinical Effects of Oral Bacteriotherapy on Anal HPV Infection and Related Dysplasia in HIV-Positive MSM: Results from the “HPVinHIV” Trial

Background. Anal HPV infection, anal dysplasia and, ultimately, anal cancer are particularly common in HIV-infected men who have sex with men. Treatment of anal dysplasia, aiming to prevent evolution to squamous cell carcinoma of the anus, is currently limited to direct ablation and/or application o...

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Autores principales:	Eugenio Nelson Cavallari, Giancarlo Ceccarelli, Letizia Santinelli, Giuseppe Pietro Innocenti, Gabriella De Girolamo, Cristian Borrazzo, Ornella Spagnolello, Carolina Scagnolari, Stefano Arcieri, Antonio Ciardi, Alessandra Pierangeli, Claudio Maria Mastroianni, Gabriella d’Ettorre
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	HPV HIV MSM anal dysplasia probiotics oral bacteriotherapy Biology (General) QH301-705.5
Acceso en línea:	https://doaj.org/article/6668e92557594a998016b950d0bd5075
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spelling	oai:doaj.org-article:6668e92557594a998016b950d0bd50752021-11-25T16:51:37ZClinical Effects of Oral Bacteriotherapy on Anal HPV Infection and Related Dysplasia in HIV-Positive MSM: Results from the “HPVinHIV” Trial10.3390/biomedicines91117382227-9059https://doaj.org/article/6668e92557594a998016b950d0bd50752021-11-01T00:00:00Zhttps://www.mdpi.com/2227-9059/9/11/1738https://doaj.org/toc/2227-9059Background. Anal HPV infection, anal dysplasia and, ultimately, anal cancer are particularly common in HIV-infected men who have sex with men. Treatment of anal dysplasia, aiming to prevent evolution to squamous cell carcinoma of the anus, is currently limited to direct ablation and/or application of topical therapy. The aim of the present study is to investigate the effect of oral bacteriotherapy (Vivomixx® in EU, Visbiome® in USA) on anal HPV infection and HPV-related dysplasia of the anal canal in HIV-infected men who have sex with men. Methods. In this randomized, placebo-controlled, quadruple-blinded trial (NCT04099433), HIV-positive men who have sex with men with anal HPV infection and HPV-related dysplasia were randomized to receive oral bacteriotherapy or placebo for 6 months. Anal HPV test, anal cytology and high resolution anoscopy with biopsies of anal lesions were performed at baseline and at the end of the study. Safety and tolerability of oral bacteriotherapy were also evaluated. Interim analysis results were presented. Results. 20 participants concluded the study procedures to date. No serious adverse events were reported. In respect to participants randomized to placebo, individuals in the experimental arm showed higher rate of anal dysplasia regression (<i>p</i> = 0.002), lower rate of onset of new anal dysplasia (<i>p</i> = 0.023) and lower rates of worsening of persistent lesions (<i>p</i> = 0.004). Clearance of anal HPV infection was more frequently observed in the bacteriotherapy group (<i>p</i> = 0.067). Conclusion. Being an interim analysis, we limit ourselves to report the preliminary results of the current study. We refer the conclusions relating to the possible effectiveness of the intervention to the analysis of the definitive data.Eugenio Nelson CavallariGiancarlo CeccarelliLetizia SantinelliGiuseppe Pietro InnocentiGabriella De GirolamoCristian BorrazzoOrnella SpagnolelloCarolina ScagnolariStefano ArcieriAntonio CiardiAlessandra PierangeliClaudio Maria MastroianniGabriella d’EttorreMDPI AGarticleHPVHIVMSManal dysplasiaprobioticsoral bacteriotherapyBiology (General)QH301-705.5ENBiomedicines, Vol 9, Iss 1738, p 1738 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	HPV HIV MSM anal dysplasia probiotics oral bacteriotherapy Biology (General) QH301-705.5
spellingShingle	HPV HIV MSM anal dysplasia probiotics oral bacteriotherapy Biology (General) QH301-705.5 Eugenio Nelson Cavallari Giancarlo Ceccarelli Letizia Santinelli Giuseppe Pietro Innocenti Gabriella De Girolamo Cristian Borrazzo Ornella Spagnolello Carolina Scagnolari Stefano Arcieri Antonio Ciardi Alessandra Pierangeli Claudio Maria Mastroianni Gabriella d’Ettorre Clinical Effects of Oral Bacteriotherapy on Anal HPV Infection and Related Dysplasia in HIV-Positive MSM: Results from the “HPVinHIV” Trial
description	Background. Anal HPV infection, anal dysplasia and, ultimately, anal cancer are particularly common in HIV-infected men who have sex with men. Treatment of anal dysplasia, aiming to prevent evolution to squamous cell carcinoma of the anus, is currently limited to direct ablation and/or application of topical therapy. The aim of the present study is to investigate the effect of oral bacteriotherapy (Vivomixx® in EU, Visbiome® in USA) on anal HPV infection and HPV-related dysplasia of the anal canal in HIV-infected men who have sex with men. Methods. In this randomized, placebo-controlled, quadruple-blinded trial (NCT04099433), HIV-positive men who have sex with men with anal HPV infection and HPV-related dysplasia were randomized to receive oral bacteriotherapy or placebo for 6 months. Anal HPV test, anal cytology and high resolution anoscopy with biopsies of anal lesions were performed at baseline and at the end of the study. Safety and tolerability of oral bacteriotherapy were also evaluated. Interim analysis results were presented. Results. 20 participants concluded the study procedures to date. No serious adverse events were reported. In respect to participants randomized to placebo, individuals in the experimental arm showed higher rate of anal dysplasia regression (<i>p</i> = 0.002), lower rate of onset of new anal dysplasia (<i>p</i> = 0.023) and lower rates of worsening of persistent lesions (<i>p</i> = 0.004). Clearance of anal HPV infection was more frequently observed in the bacteriotherapy group (<i>p</i> = 0.067). Conclusion. Being an interim analysis, we limit ourselves to report the preliminary results of the current study. We refer the conclusions relating to the possible effectiveness of the intervention to the analysis of the definitive data.
format	article
author	Eugenio Nelson Cavallari Giancarlo Ceccarelli Letizia Santinelli Giuseppe Pietro Innocenti Gabriella De Girolamo Cristian Borrazzo Ornella Spagnolello Carolina Scagnolari Stefano Arcieri Antonio Ciardi Alessandra Pierangeli Claudio Maria Mastroianni Gabriella d’Ettorre
author_facet	Eugenio Nelson Cavallari Giancarlo Ceccarelli Letizia Santinelli Giuseppe Pietro Innocenti Gabriella De Girolamo Cristian Borrazzo Ornella Spagnolello Carolina Scagnolari Stefano Arcieri Antonio Ciardi Alessandra Pierangeli Claudio Maria Mastroianni Gabriella d’Ettorre
author_sort	Eugenio Nelson Cavallari
title	Clinical Effects of Oral Bacteriotherapy on Anal HPV Infection and Related Dysplasia in HIV-Positive MSM: Results from the “HPVinHIV” Trial
title_short	Clinical Effects of Oral Bacteriotherapy on Anal HPV Infection and Related Dysplasia in HIV-Positive MSM: Results from the “HPVinHIV” Trial
title_full	Clinical Effects of Oral Bacteriotherapy on Anal HPV Infection and Related Dysplasia in HIV-Positive MSM: Results from the “HPVinHIV” Trial
title_fullStr	Clinical Effects of Oral Bacteriotherapy on Anal HPV Infection and Related Dysplasia in HIV-Positive MSM: Results from the “HPVinHIV” Trial
title_full_unstemmed	Clinical Effects of Oral Bacteriotherapy on Anal HPV Infection and Related Dysplasia in HIV-Positive MSM: Results from the “HPVinHIV” Trial
title_sort	clinical effects of oral bacteriotherapy on anal hpv infection and related dysplasia in hiv-positive msm: results from the “hpvinhiv” trial
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/6668e92557594a998016b950d0bd5075
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Clinical Effects of Oral Bacteriotherapy on Anal HPV Infection and Related Dysplasia in HIV-Positive MSM: Results from the “HPVinHIV” Trial

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