Effect of a Multi-Ingredient Coriolus-versicolor -Based Vaginal Gel in Women with HPV-Dependent Cervical Lesions: The Papilobs Real-Life Prospective Study

• Published in: Cancers Vol. 15; no. 15; p. 3863
• Main Authors: Cortés Bordoy, Javier, de Santiago García, Javier, Agenjo González, Marta, Dexeus Carter, Damián, Fiol Ruiz, Gabriel, García Ferreiro, Carmen, González Rodríguez, Silvia P, Gurrea Soteras, Marta, Martínez Lamela, Ester, Palacios Gil-Antuñano, Santiago, Romo de Los Reyes, José María, Sanjuán Cárdenas, María Del Pilar, Serrano Cogollor, Luis, Del Villar Vázquez, Ana E
• Format: Journal Article
• Language: English
• Published: Switzerland MDPI AG 29-07-2023; MDPI
• Subjects: Cellular biology; Cervical cancer; Clinical medicine; Clinical trials; Colposcopy; Confidence intervals; Coriolus; Cytology; Human papillomavirus; Infections; Lesions; Patients; Sample size; Vagina; Women; Spain; cervical lesions; real life; vaginal gel; Coriolus versicolor; human papillomavirus
• ISSN: 2072-6694; 2072-6694
• DOI: 10.3390/cancers15153863

Human papillomavirus (HPV) is responsible for virtually all cervical cancers in women. HPV infection and persistency may lead to different-grade squamous intraepithelial lesions that can result in high-grade lesions and cancer. The objective was to prospectively evaluate the results of using a
-based vaginal gel (Papilocare
) on HPV-dependent low-grade cervical lesion repair in a real-life scenario. HPV-positive women ≥ 25 years with ASCUS/LSIL cervical cytology results and concordant colposcopy images were included, receiving the vaginal gel one cannula/day for 21 days (first month) + one cannula/alternate days (five months). A 6-month second treatment cycle was prescribed when needed. Repair of the cervical low-grade lesions through cytology and colposcopy, HPV clearance, and level of satisfaction, and tolerability were evaluated. In total, 192 and 201 patients accounted for the total and safety analyses, respectively, and 77.1% repaired cervical lesions at 6 or 12 months (76.0% for high-risk HPV). Additionally, 71.6% achieved HPV clearance throughout the study's duration (70.6% for high-risk HPV). Satisfaction level was rated 7.9 and 7.5 out of 10 at 6 and 12 months, respectively. Only three mild-moderate product-related adverse events were reported, and all of them were resolved by the end of the study. In our study, we observed higher regression rates of low-grade cervical lesions in women treated with Papilocare
vaginal gel than spontaneous regression rates reported in the literature.