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288 Efficacy of a multi-ingredient coriolus versicolor-based vaginal gel in high-risk HPV+ patients: results of different studies
  1. Yann Gaslain1,
  2. Javier Cortés2,
  3. Damian Dexeus3,
  4. Santiago Palacios4,
  5. Clara Gajino5,
  6. Giovanni Miniello2,
  7. Margarita Riera6 and
  8. Elena Marin7
  1. 1Procare Health
  2. 2Private Practice
  3. 3Women’s Health Institute
  4. 4Instituto Palacios Salud Y Medicina de la Mujer
  5. 5Hospital Materno Infantil Teresa Herrera
  6. 6Institut Catala de la Salut
  7. 7Hospital Alvaro Cunqueiro


Introduction/Background To evaluate the consistency of the efficacy of a non-hormonal multi-ingredient Coriolus versicolor-based vaginal gel, Papilocare®, on HPV clearance in patients infected by high-risk HPV (HR-HPV) in several studies.

Methodology Results at 6 months from independent observational non-comparative studies carried out in three different public centers and in a one private center were compared to results from both a randomized, open, parallel and controlled clinical trial comparing the Papilocare® vs wait and see approach (The Paloma RCT) and a observational, multicenter, prospective, one-cohort study (Papilobs real-life study). Two prospective (Vigo and Bari studies) and two retrospective studies (Coruña and Hospitalet studies) have been performed.

Vigo study: HPV clearance of 25 patients infected by HPV 16 and/or 18 was evaluated as a secondary endpoint.

Bari study: HPV clearance of 98 HR-HPV patients was evaluated as primary endpoint.

Coruña study: 57 medical records of patients with HR-HPV were analyzed. HPV clearance was evaluated as primary endpoint.

Hospitalet study: Data of 91 HR-HPV patients were evaluated. Primary endpoint: composite efficacy variable (percentage of patients with normal cytology and/or HPV clearance).

Papilobs study: Interim data of 148 HR-HPV patients is presented. HR-HPV clearance was evaluated as secondary endpoint.

Paloma RCT: 66 HR-HPV patients were evaluated. Percentage of patients with HR-HPV clearance was assessed as a secondary endpoint.

Results After the 6-month treatment period, 48% and 57% of patients cleared HPV 16–18 and HR-HPV in Vigo and Bari studies, respectively. A reduction of 58% was observed in number of HR-HPV patients (Coruña) and 72.5% of patients negativized cytology and/or cleared HR-HPV (Hospitalet) (p≤0.0001 vs baseline for all results, Chi-square). In the Paloma RCT, HR-HPV clearance was observed in 63% of patients treated with Papilocare® vs 40% in the control group. Similar rate of 59% HR-HPV clearance was observed in the interim analysis of the Papilobs study.

Conclusion Papilocare® has shown significant and consistent rates of HR-HPV clearance ranging from 50% to 70% in the 6 different studies. This high consistently rate of HR-HPV clearance should be further confirmed in ongoing studies.

Disclosures Funding: Procare Health. Disclosures: J.Cortés, S.Palacios, D. Dexeus, L. Serrano: Advisory/Consulting Role and Speakers at Procare Health. Y.Gaslain: CEO of Procare Health. All other authors have declared no conflicts of interest.

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