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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

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: Cavallari, Eugenio Nelson, Ceccarelli, Giancarlo, Santinelli, Letizia, Innocenti, Giuseppe Pietro, De Girolamo, Gabriella, Borrazzo, Cristian, Spagnolello, Ornella, Scagnolari, Carolina, Arcieri, Stefano, Ciardi, Antonio, Pierangeli, Alessandra, Mastroianni, Claudio Maria, d’Ettorre, Gabriella
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8615833/
https://www.ncbi.nlm.nih.gov/pubmed/34829967
http://dx.doi.org/10.3390/biomedicines9111738
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author Cavallari, Eugenio Nelson
Ceccarelli, Giancarlo
Santinelli, Letizia
Innocenti, Giuseppe Pietro
De Girolamo, Gabriella
Borrazzo, Cristian
Spagnolello, Ornella
Scagnolari, Carolina
Arcieri, Stefano
Ciardi, Antonio
Pierangeli, Alessandra
Mastroianni, Claudio Maria
d’Ettorre, Gabriella
author_facet Cavallari, Eugenio Nelson
Ceccarelli, Giancarlo
Santinelli, Letizia
Innocenti, Giuseppe Pietro
De Girolamo, Gabriella
Borrazzo, Cristian
Spagnolello, Ornella
Scagnolari, Carolina
Arcieri, Stefano
Ciardi, Antonio
Pierangeli, Alessandra
Mastroianni, Claudio Maria
d’Ettorre, Gabriella
author_sort Cavallari, Eugenio Nelson
collection PubMed
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 (p = 0.002), lower rate of onset of new anal dysplasia (p = 0.023) and lower rates of worsening of persistent lesions (p = 0.004). Clearance of anal HPV infection was more frequently observed in the bacteriotherapy group (p = 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.
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spelling pubmed-86158332021-11-26 Clinical Effects of Oral Bacteriotherapy on Anal HPV Infection and Related Dysplasia in HIV-Positive MSM: Results from the “HPVinHIV” Trial Cavallari, Eugenio Nelson Ceccarelli, Giancarlo Santinelli, Letizia Innocenti, Giuseppe Pietro De Girolamo, Gabriella Borrazzo, Cristian Spagnolello, Ornella Scagnolari, Carolina Arcieri, Stefano Ciardi, Antonio Pierangeli, Alessandra Mastroianni, Claudio Maria d’Ettorre, Gabriella Biomedicines Article 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 (p = 0.002), lower rate of onset of new anal dysplasia (p = 0.023) and lower rates of worsening of persistent lesions (p = 0.004). Clearance of anal HPV infection was more frequently observed in the bacteriotherapy group (p = 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. MDPI 2021-11-22 /pmc/articles/PMC8615833/ /pubmed/34829967 http://dx.doi.org/10.3390/biomedicines9111738 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
Cavallari, Eugenio Nelson
Ceccarelli, Giancarlo
Santinelli, Letizia
Innocenti, Giuseppe Pietro
De Girolamo, Gabriella
Borrazzo, Cristian
Spagnolello, Ornella
Scagnolari, Carolina
Arcieri, Stefano
Ciardi, Antonio
Pierangeli, Alessandra
Mastroianni, Claudio Maria
d’Ettorre, Gabriella
Clinical Effects of Oral Bacteriotherapy on Anal HPV Infection and Related Dysplasia in HIV-Positive MSM: Results from the “HPVinHIV” Trial
title 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_short 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
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8615833/
https://www.ncbi.nlm.nih.gov/pubmed/34829967
http://dx.doi.org/10.3390/biomedicines9111738
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