The results and findings of studies of preclinical and clinical efficacy and safety of the Company’s medications and their components are published in Russian and international peer-reviewed scientific journals, including those indexed by international bibliographic databases.
From clinical-laboratory features acute respiratory infections and the incidence of hospital infections often ill children versus rarely suffering from the children's wards of St.Petersburg has developed guidelines for the prevention of respiratory infections. Was shown efficiency of causal and immunorehabilitation therapy for routine and emergency prevention in different groups often ill children.
Study Objective: To assess the efficacy of Anaferon for children, a Russian preparation of anti-interferon gamma antibodies, in preventing and treating repeated acute respiratory viral infections (ARVI) in children with asthma.
Study Design: This was a double-blind, placebo-controlled, randomized clinical study. Materials and Methods: Children, aged 1 to 5, with mild or moderate-to-severe asthma were randomized into the main group (n = 100) or the control group (n = 100). In the main group, children received a standard preventive regimen of Anaferon for children for 3 months and were temporally switched to a standard therapeutic regimen in case of ARVI. In the control group, subjects received the same regimens of placebo. In both groups, pathogenesis-based and symptomatic treatment was additionally used in case of ARVI.
Results: In the main group, 40 children had ARVI and 20 of them had these infections twice (60 ARVI events in total). In the control group, 76 children had ARVI, while 36 had had two events and 10 had had three events (132 ARVI events in total). The mean duration of the first and second ARVI episodes was 5.7 ± 0.4 and 5.2 ± 0.5 days in the main group and 9.4 ± 0.6 and 9.1 ± 0.8 days in the control group. Asthma exacerbations were reported in 20% and 64% of children in the main and control groups, respectively (p < 0.001).
Conclusion: The study showed that, compared to a placebo, preventive and therapeutic treatment with Anaferon for children in patients with asthma reduced the rates of ARVI, including the rates of repeated episodes, and the duration of ARVI episodes. Such treatment also contributed to a reduction in the frequency and duration of virus-induced asthma exacerbations in these patients and, therefore, improved asthma control.
The Acute Respiratory Viral Infections (ARVI) and flu are still the most widespread diseases in pediatric practice (90% of all infectious pathology in children). It is well-known more often ARVI develop at the children visiting the preschool institutions (PI) - this category of children is characterized by frequent emergence of repeated episodes of ARVI (recurrent infections). Anaferon for children is effective drug for the treatment and prevention of ARVI. The effectiveness of Anaferon for children during secondary preventive and therapeutic courses is not reduced.
Childhood acute respiratory infections (ARIs) are still a subject of much discussion. The reasons are that these infections are highly prevalent and largely “uncontrolled”, and they occur in individuals who, due to their age, are limited in choice of antiviral medications. Current clinical practice in Russia has shifted towards greater use of domestically produced medicines. Anaferon for children is an innovative drug product developed by OOO “NPF “Materia Medica Holding”, a Russian research and manufacturing pharmaceutical company, and authorized for marketing in Russia in 2002. The aim of this review was to systematize and analyze the Russian and internationally published literature on the results of pre-clinical and clinical studies of the efficacy and safety of Anaferon for children in ARIs and other viral infections. Research method: search and analysis. Results. This review reports on pre-clinical study results that demonstrate the product’s molecular mechanism of action underlying its combined antiviral and immunomodulating efficacy. The obtained results are supported by clinical data, and have been described in many scientific publications, including international. The paper also summarizes the results obtained in clinical trials with the product in pediatric subjects with ARI, including influenza. Anaferon for children has been shown to significantly reduce the duration of major clinical symptoms of ARI and influenza, decrease the incidence of bacterial complications, be well-tolerated and have high safety profile. Anaferon for children has been compared to Oseltamivir in an open-label randomized comparative trial that evaluated the efficacy and safety of the two drugs in subjects with influenza. The numerous publications indicate that Anaferon for children not only exerts antiviral effect against most viruses that cause acute respiratory infections, but also has activity against herpes viruses, enteric viruses, and tick-borne encephalitis virus. Studies on Anaferon for children have been discussed in around 800 scientific publications, 50 of which being in foreign languages (including in highly-cited journals).
AIM: To study efficacy of anaferon pediatric in mice infected by pandemic influenza virus A(H1N1/09)v.
MATERIALS AND METHODS: Influenza virus strain A/California/07/2009 (H1N1)v was used. Three groups of BALB/c mice intranasally inoculated with influenza virus were studied. First group received solution of Anaferon pediatric during 5 days before and 8 days after inoculation, 2nd group received Tamiflu during 5 days after inoculation. Distilled water was administered orally to mice from control group.
RESULTS: It was shown that Anaferon pediatric used as preventive and treatment agent in mice intranasally inoculated with 100% infectious dose of influenza virus strain A/ California/07/2009 (H1N1)v had antiviral effect, which expressed in 10-fold decreased reproduction of influenza virus in lungs of infected mice compared to control group measured 4, 6, and 8 days after inoculation.
CONCLUSION: Use of anaferon pediatric before and after inoculation with influenza virus A(H1N1/09)v was not less effective than use of Tamiflu after inoculation.
Anaferon and pediatric anaferon based on release-active antibodies to interferon-gamma (R-A antibodies to INF-gamma) proved to be efficient in the treatment of many viral infections. Immunomodulating (immunotropic) properties of the drugs were revealed in the preclinical studies at many Russian and foreign research medical institutions and are reviewed herein. Anaferon and pediatric anaferon stimulated the humoral and cellular immune responses and increased the neutrophil and macrophage activity. The crucial mechanism of the immunotropic action of R-A antibodies to INF-gamma was the effect on the system of interferons and in particular on INF-gamma and functionally conjugated cytokines, resulting in normalization of the functional activity of the innate factors of the immune defense and increasing of the antiviral action. The broad spectrum of the immunotropic activity provided the success of anaferon and anaferon pediatric for more than 10 years in the treatment and prophylaxis of the diseases associated with disorders in the immune system functional state.
In preliminary ELISA studies where released-active forms (RAF) of antibodies (Abs) to interferon-gamma (IFNg) were added to the antigen-antibody system, a statistically significant difference in absorbance signals obtained in their presence in comparison to placebo was observed. A piezoelectric immunosensor assay was developed to support these data and investigate the effects of RAF Abs to IFNg on the specific interaction between Abs to IFNg and IFNg. The experimental conditions were designed and optimal electrode coating, detection circumstances and suitable chaotropic agents for electrode regeneration were selected. The developed technique was found to provide high repeatability, intermediate precision and specificity. The difference between the analytical signals of RAF Ab samples and those of the placebo was up to 50.8%, whereas the difference between non-specific controls and the placebo was within 5%–6%. Thus, the piezoelectric immunosensor as well as ELISA has the potential to be used for detecting the effects of RAF Abs to IFNg on the antigen-antibody interaction, which might be the result of RAF’s ability to modify the affinity of IFNg to specific/related Abs.
The assessment of dose-response is an essential part of drug development in terms of the determination of a drug's effective dose, finding the safety endpoint, estimation of the pharmacokinetic profile, and even validation of drug activity, especially for therapeutic agents with a principally novel mechanism of action. Drugs based on released-active forms of antibodies are a good example of such a target. In this study, the efficacy of the antiviral drug Anaferon for children (released-active form of antibodies to interferon-gamma) was tested in a dose-dependent manner (at doses of 0.13, 0.2, 0.4, 0.8 ml/mouse/day) in a murine model of acute pneumonia induced by influenza virus pandemic strain A/California/07/09 (H1N1). Administration of the drug at the two highest doses led to: a reduction in the virus infectious titer in lung tissue up to 4.2 lgEID50/20 mg of tissue; infected animals' life prolongation up to 6.7 days; an increase in the survival rate of up to 40% and a decrease in morphological signs of inflammation when compared to the control animals. In this study, the dose-response effect of Anaferon for Children was demonstrated on mice for the first time. This finding is especially important for drugs with a principally novel mechanism of action like drugs based on released-active forms of antibodies. J. Med. Virol. 89:759-766, 2017.