Results of an international multicenter study of release-active antibodies to interferon gamma in the treatment of influenza and acute respiratory viral infections in children
Influenza and other acute respiratory viral infections (SARS) are the most common diseases in the child population. Annual ARVI outbreaks are caused by respiratory viruses of 5 groups, including more than 300 subtypes, which determines a variety of clinical symptoms, on the one hand, and the complexity of etiotropic therapy and vaccine prevention, on the other. The most severe forms of respiratory infections are caused by influenza viruses. Of particular danger are pandemic strains of the influenza virus. Other acute respiratory viral infections caused by various respiratory viruses are also highly contagious, the formation of mixed infections and the development of secondary bacterial complications.
It is quite difficult to conduct etiotropic ARVI therapy, since the doctor’s choice is limited by neuraminidase inhibitors active against influenza viruses and drugs whose antiviral effect is mediated by an interferon-inducing or other primary effect. In recent years, it is inducers of endogenous interferons that have become the drugs of choice for the treatment of influenza and other acute respiratory viral infections in outpatient practice, due primarily to the ability to provide an antiviral response against a wide range of pathogens.
Interferon gamma (IFNγ) is known to be the key cytokine of the antiviral immune response; its cellular effects are diverse and include regulation of viral antigen recognition, participation in antigen processing and antigen presentation, activation of microbicidal effector functions, effect on leukocyte migration, integration of functions of other cytokines, etc. Targeted effects on IFNγ and target-associated receptors – A distinctive property of the drug Anaferon children, created by Materia Medica Holding LLC based on antibodies to IFNγ. The most important effect of the drug in the treatment of influenza and other acute respiratory viral infections is the adequate production of endogenous interferons, including IFNγ and IFNα / β, which in most cases provides a mild or abortive course of the viral infection.
The antiviral activity of Anaferon children during therapeutic, prophylactic and therapeutic prophylactic administration has been proven in a series of preclinical studies in conditions of infection of experimental animals with influenza viruses, including influenza A (H1N1)
pdm09. Therapeutic efficacy was demonstrated in randomized clinical trials in which more than 11 thousand children aged 1 month and older participated. and older with respiratory infections caused by various respiratory viruses.
Objective: to obtain additional data on the therapeutic efficacy of Anaferon children, taking into account the etiology of ARVI, as well as data on its effect on the rate of elimination of influenza viruses from the nasopharynx.
Material and methods
A multicenter, double-blind, placebo-controlled, randomized, parallel-group clinical trial was conducted at 29 outpatient centers in the Russian Federation, Belarus, and Ukraine from October 2014 to April 2018 during a seasonal increase in incidence.
The study included children of both sexes aged 3 to 12 years with clinical manifestations of influenza / SARS during the first days from the onset of the disease.
The inclusion criteria were: a clinically established diagnosis of acute respiratory viral infection (body temperature at least 38 ° C at the time of examination, severity of symptoms ≥4 points: at least 1 general symptom ≥2 points and 1 symptom from the nose / throat / chest, ≥2 points or more the number of symptoms with a severity of ≥1 points), the first 24 hours from the onset of the manifestations of influenza / SARS, the possibility of initiating therapy within 24 hours from the onset of the first symptoms of SARS.
Criteria for non-inclusion were: the presence of indications for hospitalization or the appointment of antibacterial drugs, a suspicion of the initial manifestations of diseases having symptoms similar to SARS (other infectious diseases, flu-like syndrome in the onset of systemic diseases of the connective tissue), primary or secondary immunodeficiency, oncological and autoimmune diseases in the anamnesis , polyvalent allergy, intolerance to any component of the drugs used in treatment, malabsorption syndrome, exacerbation or dec chronic disease sensation, the use of prohibited concomitant drugs for 1 month. prior to inclusion in the study, as well as mental disorder or alcohol / drug abuse of the patient’s parents / adoptive parents.
After signing the informed consent form, screening procedures were carried out, including: collection of complaints and medical history, objective examination, sampling of nasopharyngeal biosamples for rapid diagnosis of influenza and subsequent detection of respiratory virus antigens, registration of flu / ARVI symptoms.