Founded in 1993
  Year: 2001 | Volume: 9 | Issue: 2 | Pages: 89-94
  Original Article
  A PHASE II TRIAL OF RIBAVIRIN (VIRAZOLEŽ) IN PATIENTS WITH GENITAL INFECTION CAUSED BY HUMAN PAPILLOMAVIRUSES
Violeta STANIMIROVIC, Branko STANIMIROVIC, Dejan NIKOLIC, Aleksandra NIKOLIC, Spomenka CUCAK
  DOI:
  Abstract:
  Background: Human papillomaviruses (HPV) are widely spread all over the world, particularly in young, sexually active persons. Diseases caused by them are highly contagious. Latent period can vary from several months to several years. A larger number of HPV (22 types) infect mucous membranes of the genital tract and due to their high oncogenic potential, the presence of these viruses in the genital tract represents a medium for developing premalignant and malignant lesions. Different treatments were used in the therapy of HPV infections: chemical, ablative and immunotherapy. This study was conducted in order to evaluate efficacy and predict the response rate to ribavirin (VirazoleŽ) in patients with genital infection caused by HPV, types 6 and 11, as well as to determine the tolerance of this drug in the study group.
Methods: During the single-center, open-label controlled study 50 eligible patients were treated with ribavirin (VirazoleŽ) 7.5% cream, applied in a thin layer on each HPV lesion 3 times a day, during 28 days. Patients were considered eligible according to the presence of the clinical and subclinical forms of HPV (types 6 and 11) changes, detect- ed on the skin and mucous membrane of the lower genital tract. These changes had been clinically and/or colposcopically confirmed before the treatment, as well as viro- logically verified (HPV DNA in situ hybridization technique).
Results: Partial clinical and/or laboratory response to treatment was detected in 96% patients. The onset of the total lesion area regression occurred after day 14 of the treat- ment. After the end of treatment, virological analysis showed decreased positiveness of HPV types 6 and 11 results, however this was not statistically significant. Local symptoms relief began to appear after 8 days of treatment. After 14 days of treatment, 96% of patients responded to therapy, and after 21 days, all patients were without symptoms.
Conclusion: This study is a good basis for further research in treatment of HPV gen- ital infection by ribavirin.
  Key words: Ribavirin; Papillomavirus, Human; Genital Diseases, Female; Condylomata Acuminata Condylomata Acuminata
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Founder, owner and publisher: Oncology Institute of Vojvodina, Serbia
Online since 1997 (Abstracts only); 2000 (Abstracts and Full text)
ISSN: 0354-7310 eISSN: 1450-9520