Impact of a new carrageenan-based vaginal microbicide in a female population with genital HPV-infection: First experimental results
| Autor: | Perino A., Consiglio P., Maranto M., De Franciscis P., Marci R., Restivo V., Manzone M., Capra G., Cucinella G., Calagna G. |
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| Přispěvatelé: | A. PERINO, P. CONSIGLIO, M. MARANTO, P. DE FRANCISCIS, R. MARCI, V. RESTIVO, M. MANZONE, G. CAPRA, G. CUCINELLA, G. CALAGNA, Perino, A., Consiglio, P., Maranto, M., De Franciscis, P., Marci, R., Restivo, V., Manzone, M., Capra, G., Cucinella, G., Calagna, G. |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Adult
Settore MED/07 - Microbiologia E Microbiologia Clinica HPV Adolescent Socio-culturale Microbicide Carrageenan Carrageenan Papillomavirus Microbicide Female population HPV Young Adult Anti-Infective Agents Chondrus Humans Prospective Studies Papillomaviridae Female population Papillomavirus Infections Middle Aged Papillomavirus Seaweed Administration Intravaginal Treatment Outcome Colposcopy Patient Satisfaction Case-Control Studies DNA Viral Vagina Vaginal Creams Foams and Jellies Female Follow-Up Studies |
| Popis: | OBJECTIVE: The objective of this study was to assess safety, satisfaction, and anti- viral effect of a new carrageenan-based vaginal microbicide in a population of fertile female patients with genital human papillomavirus (HPV) infection. PATIENTS AND METHODS: Forty healthy and sexually active women aged 18-45 years with genital HPV infection were enrolled. Each subject was treated with a gel formulated with 0.02% carrageenan and Propionibacterium extract (CGP) (Carvir, Depofarma SpA, Mogliano Veneto, Treviso, Italy). The subjects were evaluated at baseline, after the I cycle of therapy and after the II cycle. At final status, treatment acceptability and satisfaction were evaluated using a 5-point Likert scale. Furthermore, the rate of HPV genital infection clearance at final follow-up was evaluated. These data were compared with the HPV genital infection clearance rate in a control group of patients not subjected to any therapy. RESULTS: Overall, 68 HPV infections were detected at baseline, among 40 subjects enrolled. The HPV 16 genotype was the most frequent (12%) followed by HPV 18 (10%), and HPV 53 (9%). At the end of the study, 22 (55%) patients were very satisfied, 14 (35%) were satisfied, 3 (7.5%) were uncertain, and only 1 (2.5%) was dissatisfied, with 0 very dissatisfied. Only 2 patients complained of a local adverse event. Analysing infection clearance at the end of the study, 60% of patients became HPV negative. Among these, 13 cases were high-risk HPV infection. There were 16 patients with persistent infection (“non-responders”). No patient developed a “de novo” genital lesion. After controlling for age, the intervention had an adjusted OR of 4.9 (95% CI 1.6-15.1) to clear HPV. CONCLUSIONS: The results of this work suggest that Carvir vulvovaginal microbicide gel is safe and well-tolerated. Furthermore, this experience supports the hypothesis that CG has a role in accelerating the normal clearance of genital HPV infection in women with a positive HPV-DNA test. |
| Databáze: | OpenAIRE |
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