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

Gaspare Cucinella, Giuseppina Capra, Antonino Perino, Gloria Calagna, Vincenzo Restivo, Maria Manzone, Marci, Pasquale De Franciscis, Maria Manzone, Marianna Maranto, Paola Consiglio

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Abstract

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.
Lingua originaleEnglish
pagine (da-a)6744-6752
Numero di pagine9
RivistaEUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES
Volume23
Stato di pubblicazionePublished - 2019

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Papillomavirus Infections
Carrageenan
Anti-Infective Agents
Population
Human Papillomavirus DNA Tests
Gels
Propionibacterium
Human papillomavirus 18
Human papillomavirus 16
Infection
Italy
Therapeutics
Genotype
Safety
Control Groups

All Science Journal Classification (ASJC) codes

  • Pharmacology (medical)

Cita questo

@article{3b286dbfb1154396906c429164df58f4,
title = "Impact of a new carrageenan-based vaginal microbicide in a female population with genital HPV-infection: first experimental results",
abstract = "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.",
author = "Gaspare Cucinella and Giuseppina Capra and Antonino Perino and Gloria Calagna and Vincenzo Restivo and Maria Manzone and Marci and {De Franciscis}, Pasquale and Maria Manzone and Marianna Maranto and Paola Consiglio",
year = "2019",
language = "English",
volume = "23",
pages = "6744--6752",
journal = "EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES",
issn = "2284-0729",

}

TY - JOUR

T1 - Impact of a new carrageenan-based vaginal microbicide in a female population with genital HPV-infection: first experimental results

AU - Cucinella, Gaspare

AU - Capra, Giuseppina

AU - Perino, Antonino

AU - Calagna, Gloria

AU - Restivo, Vincenzo

AU - Manzone, Maria

AU - Marci, null

AU - De Franciscis, Pasquale

AU - Manzone, Maria

AU - Maranto, Marianna

AU - Consiglio, Paola

PY - 2019

Y1 - 2019

N2 - 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.

AB - 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.

UR - http://hdl.handle.net/10447/367607

M3 - Article

VL - 23

SP - 6744

EP - 6752

JO - EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES

JF - EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES

SN - 2284-0729

ER -