<h3>Introduction/Background*</h3> 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. <h3>Methodology</h3> 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 (Coruña 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. Coruña 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. <h3>Result(s)*</h3> 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 (Coruña) 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<0,0001 in the Roma study. In the Paloma trial, HR-HPV clearance reached 63% (treated group) vs 40% (control group). Similar rate of 57.4% HR-HPV clearance was observed in the PapilOBS study. <h3>Conclusion*</h3> 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.
