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 ClinicalTrial.gov: 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 (ClinicalTrials.gov NCT04002154) and other observational studies results.
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