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287 Real-life efficacy of a multi-ingredient coriolus versicolor-based vaginal gel in high-risk hpv patients: interim analysis
  1. Yann Gaslain1,
  2. Javier Cortés2,
  3. Javier de Santiago3,
  4. María Pilar Sanjuán4,
  5. Marta Agenjo5,
  6. Gabriel Fiol2,
  7. Carmen Garcia6,
  8. Marta Gurrea7 and
  9. Perla Hernández2
  1. 1Procare Health
  2. 2Private Practice
  3. 3Centro Oncológico MD Anderson
  4. 4Clínica Ginemed
  5. 5Hospital Sanitas La Zarzuela
  6. 6Hm San Francisco
  7. 7Hospital La Fe


Introduction/Background Real-life studies inform on the ‘effectiveness’ of a treatment what is intended to do in routine circumstances. The aim of this study is to evaluate the efficacy of Papilocare® - a multi-ingredient Coriolus versicolor-based vaginal gel- on repairing high-risk (HR) HPV-dependent low-degree cervical lesions and HR-HPV clearance in real-life practice.

Methodology Observational, multicenter, prospective, one-cohort study (PAPILOBS study NCT04199260). Currently recruiting 300 vaccinated or not HPV-positive women aged > 25y with Pap smear of ASCUS or LSIL and concordant colposcopy during routine clinical visits in Spain. Patients are treated with Papilocare® 1 cannula/day for 21 days the first month + 1 cannula/alternate days for 5 months. After this 6-month period, patients with altered cytology and/or HPV persistency are treated for a 6-month extension treatment period with the same dosage.

Interim analysis of HR-HPV patients with normal Pap smear and concordant colposcopy image (primary endpoint) and patient with HR-HPV cleared (patients with total clearance or partial clearance together with negative Pap smear and normal colposcopy) at 6/12 months is presented. The study was approved by the ethical committee of Public University Hospital of Puerta de Hierro (Madrid). Informed consent was signed by all patients.

Results At 6 months, data of 148 and 146 patients for Pap smear/colposcopy and HR-HPV presence, respectively, were available. 67.6% of patients (100/148) had negative Pap smear and concordant colposcopy. HR-HPV clearance was observed in 58.9% of patients (86/146). Data of 46 and 44 patients included in the 6-month extension treatment period for Pap smear/colposcopy and HR-HPV presence, respectively, were available. At 12 months, 78.3% (36/46) of patients had negative Pap smear and concordant colposcopy and HR-HPV clearance was observed in 70.5% (31/44). Considering all study period, 77% (114/148) and 72.6% (106/146) of patients repaired HR-HPV-dependent cervical lesions and cleared HR-HPV, respectively.

Conclusion In this interim analysis, repairing of HR-HPV-dependent low-degree cervical lesions and clearing HR-HPV, in real life conditions, was achieved after 6-month treatment with Papilocare® (or extending it up to 12-months if needed) in 3 out of 4 patients. These findings need to be confirmed upon study completion.

Disclosures Funding: Procare Health Disclosure: J.Cortés: Advisory/Consulting Role and Speaker at Procare Health. Y. Gaslain: CEO of Procare Health. All other authors have declared no conflicts of interest.

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