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698 Real-life efficacy of a multi-ingredient coriolus versicolor-based vaginal gel in high-risk HPV patients: the PAPILOBS study final results
  1. Y Gaslain1,
  2. J Cortés2,
  3. J De Santiago3,
  4. S González4,
  5. AE Del Villar5,
  6. C Garcia6,
  7. P Hernández2,
  8. M Agenjo7,
  9. M Gurrea8,
  10. P Sanjuan9 and
  11. P Sanmartin1
  1. 1Procare Health
  2. 2Private Practice
  3. 3Centro Oncológico MD Anderson
  4. 4HM Gabinete Velázquez
  5. 5Clínica Millenium-Dent
  6. 6HM San Francisco
  7. 7Hospital Sanitas La Zarzuela
  8. 8Hospital La Fe
  9. 9Clínica Ginemed


Introduction/Background*The objective was 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). Vaccinated or not HPV-positive women aged > 25y with Pap smear (Ps) of ASCUS or LSIL and concordant colposcopy were included during routine clinical visits in Spain. Patients were treated with Papilocare® 1 cannula/day for 21 days during first month + 1 cannula/alternate days for 5 months. After this 6-month period, patients with altered cytology and/or HPV persistency were treated for a 6-month extension treatment period with the same dosage. Analysis of HR-HPV patients with normal Ps and concordant colposcopy image (primary endpoint) and patients with HR-HPV cleared (totally or partially together with negative Ps and normal colposcopy) at 6/12 months is presented. The study was approved by an IRB and informed consent was signed by patients.

Result(s)*At 6 months, data of 178 and 176 patients for Ps/colposcopy and HR-HPV presence, respectively, were available. 68% of patients (121/178) had negative Ps and concordant colposcopy. HR-HPV clearance was observed in 57.4% of patients (101/176). Data of 68 patients included in the 6-month extension treatment period for Ps/colposcopy and HR-HPV presence were available. At 12 months, 79.4% (54/68) of patients had negative Ps and concordant colposcopy and HR-HPV clearance was observed in 61.7% (42/68). Considering all study period, 76.4% and 70.6% of patients repaired HR-HPV-dependent cervical lesions and cleared HR-HPV, respectively.

Conclusion*In this real-life study, repairing of HR-HPV-dependent low-degree cervical lesions and clearing HR-HPV were achieved after 6-month treatment with Papilocare® (extending it up to 12-months if needed) in 3 out of 4 patients. These findings are consistent with the Paloma Trial’s’ ones ( NCT04002154) and other observational studies results.

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