A specific probiotic formulation might control anal HPV infection and HPV-related dysplasia in HIV-infected patients.

Researchers at the University of Rome La Sapienza evaluated the potential clinical effects of oral bacteriotherapy on anal HPV infection (Human Papilloma Virus) related dysplasia in highly active anti-retroviral therapy (HAART) HIV-infected men having sex with men (MSM). The prevalence of anal dysplasia among HIV+MSM ranges between 50% and 90%. The preliminary results from this randomized controlled trial are very encouraging and in line with the evidence from similar studies in female patients with HPV-related cervical lesions.

In people living with HIV, some specific probiotic formulations restore the local microbiome and epithelial lining, replenish immune cells of the mucosal compartment and interfere with pathogen colonization. In this scenario, 20 participants were randomly assigned to receive a 6-month course of oral supplementation with daily probiotics (De Simone Formulation, trade name: Vivomixx® in EU and Visbiome® in the USA) or placebo. At the end of the study, individuals in the experimental group showed a 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), with respect to participants randomized to placebo. Clearance of anal HPV infection was more frequently observed in the bacteriotherapy group (p = 0.067).

The trial is still ongoing, and the authors reported the interim analysis of the results of the first 20 participants that concluded the protocol.

These data are very encouraging for the patient community. They suggest new potential indications of the De Simone Formulation to enhance immunity and promote the prevention of anal dysplasia recurrence in HAART-treated HIV+ MSM.

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Cavallari EN, Ceccarelli G, Santinelli L, Innocenti GP, De Girolamo G, Borrazzo C, Spagnolello O, Scagnolari C, Arcieri S, Ciardi A, Pierangeli A, Mastroianni CM, and d’Ettorre G. Clinical Effects of Oral Bacteriotherapy on Anal HPV Infection and Related Dysplasia in HIV-Positive MSM: Results from the “HPVinHIV” Trial. Biomedicines 2021, 9, 1738.

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