Efficacy of a multi-ingredient coriolus versicolor-based vaginal gel in high-risk hpv infected patients: Results of 6 different studies

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Javier Cortes Bordoy

Private Practice, Spain

: Androl Gynecol: Curr Res

Abstract

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Objectives: To evaluate the consistency of the efficacy of a multi-ingredient Coriolus versicolor-based vaginal gel, Papilocare®, on high-risk human papillomavirus (HR-HPV) clearance in 6 different studies1. Methods: Results from 4 independent observational studies (6 month-treatment period with Papilocare®) were compared to results from a randomized, open, parallel, controlled trial (Paloma: NCT04002154)2 and an observational, multicenter, prospective, one-cohort study (PapilOBS: NCT04199260)3. Vigo study: Prospective one-cohort (POC). Secondary endpoint (SE), HPV clearance in 86 patients infected by HPV 16 and/or 18. Coruña study: Retrospective one-cohort (ROC). Primary endpoint (PE), HPV clearance assessed in 86 medical patients’ records. Hospitalet study: ROC. PE, Composite efficacy variable (patients with normal cytology and/or HPV clearance) in 91 HR-HPV patients. Roma study4: Retrospective controlled. PE, HR-HPV clearance in 183 patients. Paloma trial: RCT, SE, HR-HPV clearance in 91 patients. PapilOBS study: POC, SE, HR-HPV clearance in 192 patients. Results: 48% of patients cleared 16/18HPV in Vigo study. 58% of reduction was observed in the number of HR-HPV patients (Coruña) and 72.5% normalized cytology and/or cleared HR-HPV (Hospitalet). 67% HR-HPV clearance was observed (treated group) vs 37.2% (control group), in the Roma study. In the Paloma trial, HR-HPV clearance reached 63% (treated group) vs 40% (control group). 57.4% HR-HPV clearance was observed in the PapilOBS study. Conclusions: Papilocare® has shown significant consistent rates of efficacy with a 64% of HR-HPV clearance in weighted average in 6 different studies involving more than 700 patients. These data reinforce the beneficial effect in HR-HPV patients.

Biography

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Javier Cortés Bordoy, MD, PhD is a Senior Consultant in Oncological Gynecology and Genital Pathology (Private practice). He is an Expert Advisory Group on Cytopathology, Ministry of Health. He is a former member of National Council, National Executive and Technical Committee of the aecc, Madrid. He is a former member of European Task Force of Women Against Cervical Cancer (WACC), Cervical Cancer Education Coalition and Support to Affected Women. He is a former member of Executive Board of EUROGIN. He is a former member of European Cervical Cancer Association (ECCA) (representation in Spain), a body dependent on the European Community that promotes and facilitates information and assistance for women who have suffered or suffer from cervical cancer.