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EP274 Effect of a Coriolus versicolor-based vaginal gel in HPV infected women: normalizing HPV-dependent cervical lesions (ASCUS/LSIL) and high-risk HPV clearance
  1. L Serrano1,
  2. AC López2,
  3. S González1,
  4. S Palacios3,
  5. D Dexeus4,
  6. C Centeno5,
  7. P Coronado6,
  8. J de la Fuente7,
  9. JA López Fernández8,
  10. C Vanrell9,
  11. J Combalia10 and
  12. J Cortés11
  1. 1Centro Médico Gabinete Velázquez, Madrid
  2. 2Hospital Quironsalud, Málaga
  3. 3Instituto Palacios Salud y Medicina de la Mujer, Madrid
  4. 4Women’s Health Institute
  5. 5Clínica Diatros, Barcelona
  6. 6Hospital Clínico San Carlos
  7. 7Hospital Universitario Infanta Leonor, Madrid
  8. 8Hospital General Universitario, Alicante
  9. 9Hospital de la Santa Creu i Sant Pau
  10. 10Medical Affairs, Procare Health Iberia, Barcelona
  11. 11Private Practice, Palma de Mallorca, Spain


Introduction/Background To evaluate the efficacy of Papilocare® -a Coriolus versicolor-based vaginal gel- in repairing HPV-dependent cervical lesions (ASCUS/LSIL) and in the clearance of high-risk HPV (HR-HPV).

Methodology Randomized, open-label, parallel-group, controlled clinical trial (Paloma Clinical Trial). HPV+ women aged between 30 and 65 with cytology of ASCUS or LSIL with concordant colposcopy image were randomized into 3 groups: A) Papilocare®1 cannula/day for 1 month + 1 cannula/alternate days for 5 months; B) Papilocare®1 cannula/day for 3 months + 1 cannula/alternate days for 3 months; C) Control group: no treatment (usual clinical practice). Main results of the Paloma trial are presented: Percentage of patients with normal cytology and concordant colposcopy image at 6 months (primary endpoint), and percentage of patients with HR-HPV clearance at 6 months (clearance: total and partial clearance with concordant cytological normalization). Pap smear evaluation was being centrally-conducted at the IECM laboratory (Lugo, Spain). Papilocare® arms (A+B) were combined for this per-protocol analysis.

Results A total of 84 all HPV genotype patients (total population) of which 66 with High Risk -HPV (HR-HPV subpopulation) were evaluated. In the total population, 85% (45/53) of patients treated with Papilocare® had normal cytology with concordant colposcopy vs. 65% (20/31) in control group (p=0.0311; Chi-square test; figure 1). In the HR-HPV subpopulation, normal cytology and concordant colposcopy image was observed in 88% (36/41) of patients treated with Papilocare® vs 56% (14/25) of control group patients (p=0.0034; Chi-square test; figure 2).

HR-HPV clearance was observed in 63% (25/40) vs 40% (10/24) of patients treated with Papilocare® vs. control group (p=0.07; Chi-square), respectively.

Conclusion Papilocare showed a statistically significant efficacy in normalizing HPV-dependent cervical lesions (ASCUS/LSIL) versus control group. The normalization rate of HPV-dependent lesions was even higher in the HR-HPV subpopulation, in which a positive trend in HR-HPV clearance was also observed at 6 months.

Disclosure Nothing to disclose.

Abstract EP274 Figure 1

Papilocare® on repairing cervical esions (ASCUS/LSIL)

Abstract EP274 Figure 2

Papilocare® on high-risk HPV clearance

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