[Application of HS221GI in treatment of influenza and ARVI in adults: a new approach - managing virus-induced inflammation. Results of a double-blind, randomized, placebo-controlled, multicenter clinical trial].

AIM: Evaluation of the efficacy and safety of the drug Aterixen® (XC221GI, 1-[2-(1-methylimidazole-4-yl)-ethyl]perhydroazine-2,6-dione), in the treatment of uncomplicated forms of influenza and other ARVI in adults. MATERIALS AND METHODS: The phase III clinical trial enrolled 260 people aged 18-65 years with mild and moderate forms of influenza or other ARVI. Patients were randomly assigned to two groups: in group 1 (n=130), patients were prescribed the drug Aterixen® in tablets of 100 mg 2 times a day for 5 days; in group 2 (n=130) - a placebo corresponding to the drug, in the same regimen. The primary endpoint of the efficacy assessment was the time in hours from the first administration of the drug to clinical improvement. The main efficacy analysis was performed in a population of patients with PCR-confirmed influenza or ARVI who completed the study according to the protocol (per protocol infected). Additionally, efficacy was evaluated in ITT and PP populations, including patients with both identified and undetected pathogen. The population for safety analysis included all patients, without exception, who were exposed to at least one exposure to the study drug or placebo. RESULTS: A statistically significant superiority of the drug Aterixen® over placebo in primary endpoint was revealed in both the main and additional analysis in all studied populations: clinical improvement in the group of the studied drug occurred 24 hours faster compared with the placebo group. The evaluation of the effectiveness of secondary endpoints confirmed the superiority of the drug Aterixen® over placebo in terms of relief of catarrhal symptoms and symptoms of intoxication. A favorable safety profile of the drug has been demonstrated. CONCLUSION: The drug has demonstrated a favorable safety profile for use in outpatient practice. Aterixen® is an effective and safe treatment for influenza and other ARVI in adults.

[New opportunities for preventive anti-inflammatory therapy in the management of patients with moderate and severe COVID-19].

The specific feature of new coronavirus infection (COVID-19) is high risk of hyperinflammatory response or cytokine storm development, which underly the pathogenesis of several life-threatening conditions and determine the disease outcomes. Pathophysiological features of COVID-19 justify the search of effective drugs capable to control the hyperinflammatory response. AIM: To evaluate the efficacy and safety of Aterixen (1-[2-(1-Мethylimidazol-4-yl)-ethyl]perhydroazin-2,6-dion) for achieving clinical improvement in adult patients hospitalized with moderate and severe COVID-19. MATERIALS AND METHODS: Multicenter, adaptive, randomized, double-blind, placebo-controlled, phase III study to evaluate the efficacy and safety of Aterixen , tablets, 100 mg, in patients with COVID-19. The study analysis included 116 patients who, by randomization, were divided into 2 groups: 57 patients were included in the Aterixen drug group and 59 patients were in the placebo group. RESULTS AND CONCLUSION: Obtained results have shown high efficacy and statistically significant superiority of Aterixen over placebo. Thus, it allows us to consider it as viable medication for COVID-19 pathogenetic therapy.

[Evaluating the effectiveness of Solanum tuberosum shoots extract in experimental ocular herpes].

UNLABELLED: Ocular herpes (OH) is an infectious disease caused by the herpes simplex virus (HSV) characterized by a variable clinical presentation and often accompanied by complications that may lead to deterioration of visual functions, cataract development, or even blindness. Its treatment is arduous. The aim of this work was to evaluate the effectiveness, tolerability, and safety of Panavir eye drops in a rabbit model of OH. MATERIAL AND METHODS: Ocular infection was induced with HSV-1 (EU strain) in grey rabbits (all males, 2.5-3.0 kg) according to the standard technique. The treatment included Panavir-GLA (Panavir-gamma-linolenic acid) and Panavir medications. RESULTS: Panavir eye drops instilled 6 times daily for 8 days showed a pronounced therapeutic effect and prevented the development of severe corneal opacities. The most rapid and significant results were seen in rabbits with epithelial keratitis and those with short-term persistence of the virus. Generally, the effectiveness of Panavir eye drops was comparable with that of the reference drug (Oftalmoferon). Panavir instillations caused no irritation, toxic and/or allergic effects and were well tolerated by the rabbits. CONCLUSION: The data obtained suggest that Panavir eye drops may be included in OH treatment schemes.