626 Efficacy of a multi-ingredient coriolus versicolor-based vaginal gel in high-risk HPV infected patients: results of 7 different studies

Introduction/Background* To evaluate the consistency of the efficacy of a multi-ingredient Coriolus versicolor-based vaginal gel, Papilocare®, on high-risk HPV (HR-HPV) clearance in 7 different studies. Methodology Results of the 6 month-treatment period of Papilocare ® from 5 independent observational (3 Spanish and 2 Italian hospitals) were compared to results from a randomized, open, parallel, controlled trial (Paloma: ClinicalTrials.gov NCT04002154) and an observational, multicenter, prospective, one-cohort study (PapilOBS: ClinicalTrial.gov NCT04199260). Two prospective one-cohort (Vigo and Bari), 2 retrospective one-cohort (Coruna and Hospitalet) and 1 retrospective controlled (Roma) studies have been performed. Vigo study. Secondary endpoint (SE): HPV clearance in 25 patients infected by HPV 16 and/or 18. Bari study. Primary endpoint (PE): HPV clearance in 98 HR-HPV patients. Coruna study: PE; HPV clearance assessed in 57 medical patients’ records. Hospitalet study. PE: composite efficacy variable (patients with normal cytology and/or HPV clearance) in 91 HR-HPV patients. Roma study. PE: HPV clearance in 183 HR-HPV patients. PapilOBS study. SE: HR-HPV clearance in 178 patients. Paloma trial. SE: HR-HPV clearance in 66 patients. Result(s)* After the 6-month treatment period, 48% and 57% of patients cleared HPV 16-18 and HR-HPV in Vigo and Bari studies, respectively. 58% of reduction was observed in the number of HR-HPV patients (Coruna) and 72.5% of patients negativized cytology and/or cleared HR-HPV (Hospitalet). 67% HR-HPV clearance was observed (treated group) vs 37.2% (control group), p Conclusion* Papilocare® has shown clinically significant consistent rates of HR-HPV clearance ranging from 50% to 70% in 7 different studies and 827 patients. These results reinforce the evidence of its beneficial effect for HR-HPV patients.