P96. Efficacy of a coriolus versicolor-based vaginal gel to repair cervical mucosa with high-risk hpv lesions. Interim analysis results

Andres Carlos Lopez (ES), Javier Cortes (ES), Silvia Gonzalez (ES), Luis Serrano (ES), Santiago Palacios (ES), Damian Dexeus (ES), Cristina Centeno (ES), Josep Combalia (ES)

[Lopez] Hospital Quironsalud, Malaga, [Cortes] Private Practice, Palma de Mallorca, [Gonzalez] Gabinete Medico Velazquez. Madrid, [Serrano] Gabinete Medico Velazquez, Madrid, [Palacios] Instituto Palacios de Salud y Medicina de la Mujer, Madrid, [Dexeus] Women Health Institute, Barcelona, [Centeno] Clinica Diatros, Barcelona, [Combalia ] Procare Health, Barcelona

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 clearance 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 HPV-related pap alterations and consistent colposcopy image. Methods: Randomized, open-label, 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 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) 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 in the subgroup of patients with high-risk HPV are presented. Papilocare® arms (A+B) were combined for this evaluation. Results: Data from 28 patients at 3 months and 18 at 6 months are available. At 3 months, 67% of patients using Papilocare® (n=18) normalized pap and colposcopy vs. 20% in control group (n=10) (p=0.046; Fisher test). At 6 months, 73% (n=11) vs 33% (n=6) of patients repaired cervical lesions in Papilocare® and control groups, respectively (p=ns). HPV clearance at 6 months was observed in 50% of high-risk patients in Papilocare® group vs 17% in control group (p=ns) Conclusion: In these interim analysis results, Papilocare® shows a significant 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.