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#907 Real life efficacy of a multi-ingredient coriolus versicolor-based vaginal gel in women with hpv dependent cervical lesions: a subanalysis of the papilobs study in women over 40
  1. Javier Bordoy Cortés1,
  2. Javier De Santiago2,
  3. Damián Dexeus Carter3,
  4. Gabriel Fiol Ruiz4,
  5. Santiago Palacios Gil-Antuñano5 and
  6. Luis Serrano6
  1. 1Private Practice, Palma, Spain
  2. 2MD Anderson Cancer Center, Madrid, Spain
  3. 3Clínica Ginecológica Women’s CD, Barcelona, Spain
  4. 4Clínica Alborán CMM, Almería, Spain
  5. 5Instituto Palacios de Salud de la Mujer, Madrid, Spain
  6. 6HM Hospitales Gabinete Velázquez, Madrid, Spain

Abstract

Introduction/Background HPV clearance and resolution of cervical lesions become difficult in postmenopausal women. Therefore, therapies that are effective at dealing with this condition in this population are essential. Papilocare®, a Coriolus versicolor-based vaginal gel has proven to be effective and safe in repairing low-grade cervical lesions and enhancing HPV clearance in various studies. However, no multicentric prospective studies had been performed in a real-world setting.

Methodology The Papilobs study (NCT04199260) was an observational, multicentric, prospective, non-comparative clinical study conducted on HPV-positive women with ASCUS or LSIL cervical cytology and concordant colposcopy images, to evaluate the effectiveness of Papilocare® in repairing low-grade cervical lesions and clearing HPV in routine clinical practice. This study was approved by the Ethics Committee of Puerta de Hierro Majadahonda Hospital (Madrid) and all patients signed the Informed Consent Form. Patients received one cannula/day for 21 days (first month) +one cannula/alternate days (five months). Results of a sub-analysis in patients over 40 are presented.

Results The Papilobs study included 201 patients. When solely looking at patients over 40, and patients over 40 with high-risk (HR) HPV, 74 and 69 patients accounted for the analysis, respectively. 82.4% of patients over 40 and 81.2% of patients over 40 with HR-HPV, repaired their cervical lesions after treatment with Papilocare®. Additionally, a total of 75.3% and 73.5% of patients over 40; and patients over 40 with HR-HPV, respectively, were observed to clear HPV.

Conclusion The Coriolus versicolor-based vaginal gel was shown to successfully repair HPV-dependent low-grade cervical lesions and lead to HPV clearance in those patients over 40, and over 40 with HR-HPV in real life conditions. These results are in line with those observed in the PALOMA trial and in other observational studies, which strengthens the role of Papilocare® as a beneficial alternative to the watchful waiting approach in HPV-related low-grade cervical lesions.

Disclosures .

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