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Prevention of gynaecologic cancer
626 Efficacy of a multi-ingredient coriolus versicolor-based vaginal gel in high-risk HPV infected patients: results of 7 different studies
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  1. J Cortés1,
  2. D Dexeus2,
  3. S Palacios3,
  4. L Serrano4,
  5. C Gajino5,
  6. G Miniello1,
  7. M Riera6,
  8. A Criscuolo7,
  9. E Marín8,
  10. Y Gaslain9 and
  11. P Sanmartin9
  1. 1Private Practice
  2. 2Clínica Ginecológica Women’s
  3. 3Instituto Palacios, Salud y Medicina de la Mujer
  4. 4Centro Médico Gabinete Velázquez
  5. 5Hospital Materno Infantil Teresa Herrera
  6. 6Institut Català de la Salut
  7. 7Tor Vergata University
  8. 8Hospital Álvaro Cunqueiro
  9. 9Procare Health

Abstract

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 (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.

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 (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.

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.

Abstract 626 Figure 1
Abstract 626 Figure 1

https://doi.org/10.1136/ijgc-2021-ESGO.550

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