Immunomodulatory therapy in the complex treatment of HPV-associated cervical lesions

Relevance: Dysplasia is one of the results of the transformative effects of the human papillomavirus (HPV). Exposure to the virus more frequently leads to cervical dysplasia, and its progressive development leads to tumor progression. Monitoring and medical examination of HPV-carriers, timely selection of methods for their recovery is a reserve for reducing cervical neoplasia and cervical cancer. The probable benefit of immunomodulatory therapy as a way to reduce the risk of HPV-associated cervical lesions cannot be considered proven due to insufficient number and quality of evidence-based medicine studies. Objective: To evaluate the effect of immunomodulating medications on changes in colposcopic and cytological characteristics in HPV-associated cervical lesions. Materials and methods: This was an open multicenter randomized study conducted in 2020-2021. Five hundred women with HPV-associated cervical lesions registered electronically and monitored in women’s health clinics in 7 regions of the Russian Federation were included in the study. The research followed the multicenter comparative observational program “Evaluation of the efficacy and safety of Immunomax in the complex therapy of benign cervical dysplasia with confirmed HPV infection” which was developed in 2020-2021 in the Russian Federation (http://richt.ru/; http://greta.pro/). There were the following criteria for inclusion in the program: HPV-associated cervical diseases (ICD-10: N87.X + B97.7 CIN I-II), age from 18 to 55 years (median age 33 years). The main therapy was destructive or excisional exposure, which was prescribed to all participants of the study after signing an informed consent. Immunomax, Allokin-alfa, medications with INN inosine pranobex, which have immunotropic effects, were selected as immunomodulatory medications and were used in complex therapy. The participants of the study were randomized into groups depending on the administered immunomodulatory medications: 114 women received Immunomax, 95 women received Allokin-alfa, 154 women took INN inosine pranobex, 59 women underwent surgical treatment but they did not receive immunomodulatory therapy. Control studies confirming the effectiveness of the therapy were conducted 3 and 6months after the completion of treatment. Results: Statistical analysis of the results of the study confirmed the importance of immunomodulatory therapy in eliminating HPV and normalizing colposcopic picture. The effectiveness of combined treatment with the use of immunomodulatory medications was higher than one after destruction without administration of immunotropic medications. The study conducted 3 and 6 months after the treatment showed that frequency of elimination of highly oncogenic HPV was significantly higher in groups of patients who received surgical treatment in combination with Immunomax, Allokin-alpha, medications with INN inosine pranobex; normalization of colposcopic picture was observed in all comparison groups. Conclusion: The data obtained from 7 regions of the Russian Federation were added to a specially developed electronic register of patients with HPV-associated cervical lesions. The findings showed that surgical treatment in combination with immunomodulatory therapy resulted in a higher frequency of HPV elimination and normalization of the colposcopic picture than surgery without the use of immunomodulatory therapy.

human papillomavirus, cervical dysplasia, immunomodulatory therapy