Therapeutic options for urogenital herpes and chlamydia using a double-stranded RNA sodium salt (lyophilisate): Results of the All-Russian Observational Program INTEGRA

The aim. To evaluate the efficacy and safety of the double-stranded RNA sodium salt drug RADAMIN®VIRO (lyophilisate) in everyday practice with men and women having genital herpes and/or chronic urogenital chlamydial infection.

Materials and methods. A multicenter observational non-randomized clinical trial was performed. The study included records of 2 714 patients: 488 patients suffering from chlamydia or a combined infection, 2 226 individuals with a confirmed diagnosis of herpes infection, of both sexes, aged over 18 years, who met the inclusion/exclusion criteria and for whom the attending physician prescribed a course of treatment with RADAMIN®VIRO as part of complex therapy prior to inclusion in this study. The efficacy of the drug was assessed during the course of treatment (as part of complex therapy for genital herpes/chronic urogenital chlamydial infection) in relation to: dynamics of symptoms (objective and subjective); speed of regression of clinical manifestations of the infection; frequency of relapses during the observation period; duration of the inter-relapse period; dynamics of quality of life according to the “Dermatological Quality of Life Index” questionnaire; and the safety of the drug was assessed.

Results. It was shown that as early as day 14 of observation (visit B2), the proportion of patients with low severity or absence of subjective symptoms characteristic of chlamydial, herpetic, or combined infection increased to an average level of 86.62–91.65 %; the proportion of patients with the absence of objective symptoms characteristic of chlamydial, herpetic, or combined infection increased to an average level of 87.09–99.69 %. It was shown that by day 7 of observation, the severity of subjective symptoms decreased from 1.27–1.72 to 0.39–0.55 in group A56 (chlamydia or combined infection), and in group A60 (herpes), it also decreased from 1.45–1.63 to an average level of 1.21–1.30; by day 14 of observation — in 32.9 % of patients, by day 90 of observation — in 1.2 % of patients, by day 180 of the study — in 0.7 % of patients. Thus, recovery occurred within 3 months from the start of therapy and observation in 99.3 % of patients — all study participants (p < 0.001).

Conclusion. Based on the obtained data, a conclusion can be drawn regarding the efficacy, safety, and appropriateness of including RADAMIN®VIRO in the complex therapy for patients with genital herpes and urogenital chlamydial infection.

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