Impact of a new carrageenan-based vaginal microbicide in a female population with genital HPV-infection: first experimental results

A. Perino, P. Consiglio, M. Maranto, P. De Franciscis, R. Marci, V. Restivo, M. Manzone, G. Capra, G. Cucinella, G. Calagna

Gynecology and Obstetrics, “Villa Sofia Cervello” Hospital, University of Palermo, Palermo, Italy. gloria.calagna83@gmail.com

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• Pharmacology

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.

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