Umifenovir (Arbidol) and acute rotavirus gastroenteritis: antiviral activity, mechanism of action, review and meta-analysis of clinical studies; Умифеновир (Арбидол) и острый ротавирусный гастроэнтерит: противовирусная активность, механизм действия, обзор и метаанализ клинических исследований

Acute viral gastroenteritis (AGE) remains a significant public health concern, especially among children under 5 years old, where it is a leading cause of hospitalization. Due to the lack of specific antiviral agents, the treatment of AGE is mainly symptomatic, with only a few antiviral options available. The goals of antiviral therapy for viral AGE include reducing viral load, accelerating recovery, preventing complications, and minimizing viral shedding, thereby lowering the risk of transmission. Umifenovir (Arbidol) is a broad-spectrum antiviral drug active against respiratory viruses, enteroviruses, and several other pathogens. It is of interest for the treatment of viral gastroenteritis. Etiological diagnosis of viral gastrointestinal infections is complicated by overlapping clinical presentations and diagnostic limitations, highlighting the need for antivirals with broad-spectrum activity. Objective. Analysis of the results of experimental and clinical studies of the effectiveness of umifenovir in rotavirus infection. Material and methods. Experiments were performed using the MA-104 cell line with quantitative real-time reverse transcription PCR and cytopathic effect viral titration methods. Clinical data were analyzed using metaanalysis, focusing on the duration of diarrhea, fever, and viral clearance rates. Results. Experimental studies demonstrated significant antiviral activity of umifenovir in both prophylactic and therapeutic regimens. The CC50 value for umifenovir was 8.95 μg/ml (range: 6.02–11.88 μg/ml). Viral replication was significantly suppressed at day 3 (5.8 vs 9.1 log RNA copies/ml, p<0.05) at the optimal concentration of 12 μg/ml. The systematic review included 10 clinical studies involving more than 600 children and 500 adults. Meta-analysis revealed that the addition of umifenovir to standard symptomatic and pathogenetic therapy (rehydration, adsorbents, probiotics) resulted in: a reduction in diarrhea duration by an average of 1.84 days [1.78–1.89]; a reduction in fever duration by 0.73 days [0.68–0.78]; and an increase in the proportion of patients achieving complete viral clearance by day 5 by 44.3% (25.7–62.9%), corresponding to a 7.5-fold increase in the probability of clearance. Prophylactic use of umifenovir showed a protective efficacy against rotavirus gastroenteritis of 89.5%, with an effectiveness index of 9.5, contributing to reduced incidence and severity of subsequent viral gastrointestinal infections. Conclusion. Umifenovir is an important component of combination therapy for rotavirus gastroenteritis. Its mechanism of action is based on blocking viral fusion with the host cell membrane, thus preventing viral entry into enterocytes. The accumulation of the drug in the gastrointestinal tract enhances its direct antiviral effect. The broad-spectrum antiviral activity and favorable safety profile of umifenovir make it particularly useful even when the specific causative agent is unidentified. The Level of Evidence and Recommendation (LEUR) for umifenovir in the treatment of viral AGE is estimated at not lower than 2B. © 2025 Elsevier B.V., All rights reserved.