P158 Efficacy of a coriolus versicolor-based vaginal gel in repairing HPV-dependent cervical lesions (ASCUS/LSIL) in three patients groups according to the risk of HPV strains

Abstract

Introduction/Background High‐risk strains of HPV are well established as the causative agents for cervical dysplasia and cervical cancer. It is also well known that pre‐cancerous cervical lesions persist longer and progress quickly in women infected by high‐risk HPV than in women with non‐oncogenic HPV strains. The aim of this study was to evaluate the efficacy of Papilocare ® ‐a Coriolus versicolor‐based vaginal gel‐ in repairing HPV‐dependent cervical lesions (ASCUS/LSIL) in three groups of patients according to the oncogenic potential of HPV strains. Methodology Randomized, open‐label, parallel‐group, controlled clinical trial (Paloma Clinical Trial). HPV+ women aged between 30 and 65 with cytology of ASCUS or LSIL with concordant colposcopy image were randomized into 3 groups. Primary endpoint of the Paloma Clinical trial: percentage of patients with normal cytology and concordant colposcopy image at 6 months, evaluated in total population, highrisk subpopulation (16,18,31,33,35,39,45,51,52,56,58,59,68) subpopulation and the subpopulation infected by any combination of 16, 18 and 31, is presented. Pap smear evaluation was being centrally‐conducted at the IECM laboratory (Lugo, Spain). Papilocare® arms (A+B) were combined for this perprotocol analysis. Results A total of 84, 66 and 29 patients corresponding to total population, and high‐risk and 16‐18‐31 subpopulations were evaluated, respectively. At 6 months, normal cytology and concordant colposcopy image was observed in 85% (45/53), 88% (36/41) and 73% (11/15) of patients treated with Papilocare® vs 65% (20/31), 56% (14/25) and 43% (6/14) of patients in control group, in the total population, and high‐risk and 16‐18‐31 subpopulations (p=0.0311; p=0.0034; p=0.0959, chi‐square test; figure1) respectively. Conclusion While the spontaneous normalizations of HPVdependent cervical lesions clearly decreased according to the risk of HPV strains (Total population = 65%, HRHPV= 56%, and HPV‐16‐18‐31=42%), the robust efficacy of Papilocare in normalizing cervical lesions was maintained in the 3 patients groups with statistically significant difference versus control. (Figure Presented).