High Risk Human Papillomavirus genital infections in asymptomatic population: effectiveness of Micro-Immunotherapy

Abstract

Background: persistent infection with high-risk human papillomavirus (HR-HPV) is the primary cause for the development of various anogenital cancers in females and males. Most infections are either latent or subclinical and the majority occur as asymptomatic. HPV infections are not currently treatable by antiviral compounds. Micro-immunotherapy (MI) medications using high dilutions of cytokines and specific nucleotide sequences have been developed to treat targeted viral infections and are currently prescribed in medical practice as immune regulators: 2L®PAPI (Labo’Life) is indicated for HPV infection and may represent a new therapeutic approach. Aims: this exploratory study was to assess the effectiveness of 2L®PAPI on HPV infection eradication in HR-HPV infected asymptomatic patients attending an STD Centre in a long-term microbiological follow-up population survey. Methodology: adult patients of both genders, diagnosed with HR-HPV infection, with no evidence of symptomatic HPV or anogenital cancer, were followed during a 2 year-period (2009-2010). Selected patients had not previously been vaccinated for HPV or treated with medications having an impact on the immune system. HPV testing was performed on biological samples using PCR detection (Innogenetics, Italy). In addition, detection of E6/E7 mRNA of five carcinogenic HPV types was performed by EasyQ HPV (BioMerieux, Italy). HPV-positives were requested by their urology specialist to take 2L®PAPI (composition in table 1) during 4 months (1 caps/day by sublingual route). Globally 46 patients were followed: 23 treated with MI medication, and 23 not treated. Results: one third of selected patients were lost at the control visit (15/46). At the end of the study period, HR-HPV negativity was observed in 50% (8/16) of patients under MI medication in comparison with only 7% (1/15) of the non treated patients who were HPV-DNA negative at the follow-up visit (p=0.01071, Mid-P exact test). This result is in accordance with our previous results which showed long lasting persistence of HR-HPV infection in a male cohort. Conclusions: the relevant percentage of lost patients at follow-up reflects the scarce information and awareness of this infection within asymptomatic people in Italy. 2L®PAPI was efficient in eradicating 50% of HR-HPV infections in treated patients, including 60% of HPV-16. These promising data emphasize the importance of redirecting immune responses in viral infections. Table 1: 2L®PAPI composition Compounds Dilutions Interleukin-1 (IL-1): 17-10 CH* Interleukin-2 (IL-2): 17-10 CH Interferon-α (IFN-α): 17-10 CH SNA-HLA II: 16-10 CH Ciclosporin A (CsA): 7-10-17 CH Ribonucleic acid (RNA): 18-10 CH SNA-PAPI: 16-10 CH * CH: Centesimal Hahnemannian (1/100)