P110. Efficacy of a coriolus versicolor-based vaginal gel to repair cervical mucosa with hpv lesions. preliminary results of a clinical trial

Santiago Palacios (ES), Cristina Centeno (ES), Javier Cortés (ES), Damiám Dexeus (ES), Silvia González (ES), Andrés Carlos López (ES), Luís Serrano (ES)

[Palacios] Instituto Palacios de Salud y Medicina de la Mujer, [Centeno] Clínica Diatros, [Cortés] Private Practice, [Dexeus] Woman´s Health Institute, [González] Gabinete Médico Velazquez, [López] Hospiatal Quironsalud , [Serrano] Gabinete Médico Velazquez

Context: Papilocare® is a non-hormonal Coriolus versicolor-based vaginal gel. In patients with HPV infection, a regression effect of the LSIL in cervix and a significant virus negativization have been observed after 1-year administration of oral Coriolus versicolor. Objective: To evaluate the efficacy of Papilocare® to repair cervical mucosa in women with precancerous HPV lesions and consistent colposcopy image. Methods: Pilot, randomized, open, parallel group, controlled clinical trial. Patients: Currently recruiting 96 positive-HPV women age 30 to 65 with pap result of ASC-US, LSIL or AG-US and concordant colposcopy image. Interventions: Patients are randomized to 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) no treatment as usual practice. Main outcome measures: Preliminary analysis of primary endpoint (% of patients with normal pap and concordant colposcopy image) at 3 and 6 months and the secondary endpoint (% of patients with HPV cleared) at 6 months are presented. Papilocare® arms (A+B) were combined for this evaluation. Results: Data from 41 patients at 3 months and 25 at 6 months are available. At 3 months, 69.2% of patients using Papilocare® (n=26) negativized pap and colposcopy vs. 33.3% in control group (n=15) (p=0.048; Fisher test). At 6 months, 73% (n=15) vs 60% (n=10) of patients negativized cervical lesions for Papilocare® and control groups, respectively (p=ns). The % of patients who cleared the HPV at 6 months was 56% in Papilocare® group vs 30% in control group (p=ns). Conclusion: In these preliminary results, Papilocare® shows a significative difference in repairing HPV-cervical lesions at 3 months versus control and a positive trend in both HPV clearance and HPV-cervical lesions repairing at 6 months; these findings need to be confirmed upon study completion.