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Objective. To clarify the features of the defect in the function of NK cells, T lymphocytes, the interferon system in patients with moderate and severe COVID-19. Patients and methods. Tests of the peripheral blood of 50 COVID-19 patients aged 61(57–71) and having the moderate and severe disease were performed. The following parameters were measured: the quantity of CD3+CD19–, CD3+CD4+, CD3+CD8+ T lymphocytes, NK – (CD3–CD16+CD56+), and TNK – CD3+CD16+CD56+ with expression density considered membrane receptors (MFI) (FC 500 Beckman Coulter, USA), the levels of IFN-α, IFN-γ, IL-6, TNF-α cytokines (IFA). Results. Combined immunodeficiency associated with quantitative and functional defects in NK, T lymphocytes and their subsets was revealed in moderate and severe COVID-19. An imbalance of cytokines has been established: blockade of the production of IFN-α and IFN-γ against the background of a significant increase in IL-6 and TNF-α, which negatively affects both the number and functionality of the participants in the immune response and is associated with a severe course and poor prognosis of COVID-19. Conclusion. The data obtained demonstrate the need to develop new strategies and tactics for the treatment of COVID-19, including replacement systemic therapy with recombinant IFN-α2b in combination with antioxidants (Viferon®) in adequate therapeutic doses, aimed at restoring the normal functioning of T lymphocytes, NK and the interferon system.
ABSTRACT
In 2020-2021, the world was engulfed by the pandemic of a new coronavirus infection (COVID-19) caused by the SARS-CoV-2 virus. The low population coverage with vaccination against COVID-19 and the lack of herd immunity result in the need to find an effective and safe etiotropic treatment. Medicinal agents for treatment of COVID-19, approved while preparing this publication, have several limitations related to the conditions of their use and/or population category. In this situation, interferon-containing drugs widely used in Russia and the CIS for prevention and treatment of viral infectious diseases, i.e. ARVI and influenza, may hold promise. This study aims to confirm in vitro antiviral activity against SARS-CoV-2 for the preparation VIFERON (R) containing recombinant human interferon alpha-2b (IFN alpha-2b). Materials and methods. Vero CCL-81 cells were infected with hCoV-19/StPetersburg-RII3524VR4/2020 strain of SARS-CoV-2 at doses of 10 TCID50 or 100 TCID50 per well. The suppressive effect of IFN alpha-2b, extracted from VIFERON (R) in dosage form of rectal suppositories, was evaluated by qRT-PCR at 24 h and 48 h after the infection of cells in two schemes, simulating preventive (24 h before infection) and therapeutic (2 h after infection) use of drugs. Results. IFN alpha-2b at concentrations of 800, 400, 200, 100 and 50 IU/ml, extracted from rectal suppositories of VIFERON (R), showed high biological activity, displayed as inhibition of SARS-CoV-2 strain replication in both infectious doses evaluated either at 24 h or at 48 h after cell infection. The "preventive" vs. "therapeutic" scheme was found to be more effective. In the "preventive" scheme the virus titre decreased by more than 3 lg TCID50 at 24 hours post-infection and by 5-6 lg TCID50 at 48 hours post-infection after administration of 800 IU/ml IFN alpha-2b. Conclusion. The study results evidence that VIFERON (R) in dosage form of rectal suppositories may be promising for prevention and treatment of new coronavirus infection in clinical practice.
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Objective. To evaluate pregnancy and childbirth outcomes after the combined use of VIFERON® (interferon α-2b with antioxidants) rectal suppositories (3,000,000 IU) and VIFERON® gel for external and local use (36,000 IU/g) in the treatment of new coronavirus infection (COVID-19) in pregnant women against the background of standard complex therapy. Patients and methods. A total of 140 pregnant women diagnosed with COVID-19 were examined and divided into two groups: group 1 consisted of 70 patients who received VIFERON® and standard complex therapy;group 2 – 70 patients who received only standard therapy. Results. Patients from group 1 had a significantly decreased incidence of preterm birth, perinatal loss, and severe birth asphyxia. Most of these pregnant women gave birth at 38-40 weeks of gestation, and no antenatal fetal death was recorded. Conclusion. Inclusion of VIFERON® (rectal suppositories and gel for external and local use) in the complex treatment of COVID-19 in pregnant women contributed to more prompt relief of symptoms and improved pregnancy and childbirth outcomes.
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Objective. To evaluate the efficacy and safety of VIFERON® (recombinant interferon α-2b) rectal suppositories and gel for external and local use in the complex therapy of COVID-19 in adult patients. Patients and methods. 140 patients with COVID-19 were included in a prospective comparative controlled research study. The main group consisted of 71 patients who received standard therapy for coronavirus infection in combination with VIFERON® (rectal suppositories 3.000.000 IU for 1 supp. 3 times a day and gel 36.000 IU/g 5 times a day on the surface of nasal mucosa and palatine tonsils for 14 days);the comparison group – 69 patients who received standard therapy. Results. Patients who received VIFERON® complex therapy demonstrated more rapid clinical improvement by reducing the duration of symptoms of weakness and intoxication compared to the patients who received only standard therapy. The high activity of VIFERON® in elimination rate of SARS-CoV-2 RNA in nasopharyngeal samples was shown. The use of VIFERON® made it possible to achieve a stable concentration of IL-6 in the blood serum during the entire follow-up period. There were no adverse events associated with the administration of VIFERON®. Conclusion. The results obtained indicate the superiority of therapy with the inclusion of VIFERON® over standard therapy. Given the favorable safety profile, the studied regimen can be recommended for the treatment of adult patients, especially from risk groups, where the possibilities of conventional etiotropic therapy are limited due to possible toxicological effects.
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Objective. To evaluate the efficacy and safety of combined administration of interferon alfa-2b in combination with antioxidants, Viferon as rectal suppositories 3,000,000 IU and gel for topical use 36,000 IU/g in pregnant patients with new coronavirus infection (NCI) COVID-19. Materials and methods. The study included 140 pregnant women with a confirmed diagnosis of COVID-19 NCI. Pregnant women were divided into two groups of 70 subjects each: Group 1 received Viferon and complex standard of care;Group 2 received standard of care only. The efficacy of therapy was evaluated by a comparative analysis of the course of disease symptoms, laboratory parameters, and birth outcomes. Results. The addition of interferon alfa-2b with an antioxidant complex into the regimen of complex standard of care in pregnant women with NCI COVID-19 resulted in quicker relief of the main disease symptoms and development of a persistent antiviral immune response. Significant decrease in the level of proinflammatory cytokine IL-6 due to the complex therapy with Viferon (interferon alfa-2b with antioxidants) is a favorable prognostic index for recovery after the disease. Based on the analysis of birth outcomes depending on the therapy, the efficacy and safety of complex therapy with Viferon in Group 1 pregnant women was confirmed. Most of the births occurred at 38—40 weeks of gestation and no perinatal losses were recorded. In group 2 pregnant women receiving only standard of care, two cases of antenatal fetal death were recorded. Conclusion. The addition of interferon alpha-2b with antioxidant, Viferon in the form of rectal suppositories and gel for topical use for COVID-19 treatment in pregnant women results in a quicker relief of symptoms, development of a sustained immune response and birth of infants with no abnormalities. © 2021, Media Sphera Publishing Group. All rights reserved.
ABSTRACT
Objective. To identify risk factors for acute respiratory viral infections (ARVI) (influenza and novel coronavirus infection (NCI) COVID-19) in pregnant women and evaluate the effectiveness of pharmacological prevention. Patients and methods. During the first phase, 152 individual medical records of pregnant women were retrospectively studied: 102 women (the first main group) with acute respiratory viral infections and 50 pregnant women who had no acute respiratory viral infections (the control group). The second phase was a prospective comparative study: the second main group (n = 100) – pregnant women who received recombinant interferon α-2b (IFN-α2b) with vitamins E and C as preventive treatment;the comparison group (n = 100) – without preventive treatment. Results. Risk factors for the incidence of ARVI included anemia (χ2 = 0.003), obesity (χ2 = 0.026), cardiovascular diseases (χ2 = 0.060), diabetes mellitus (χ2 = 0.050), frequent ARVI in medical history (χ2 = 0.028), nicotine intoxication (χ2 = 0.008), urinary tract infections (χ2 < 0.001). The second phase: 10% of pregnant women who received preventive treatment had mild forms of influenza and NCI;2% of women had a moderate form. In the second main group, 33% of pregnant women were sick (OR = 2.852, 95% CI = 1.354–6.005, χ2 = 0.005): 26% of women had a mild form, 6% of women had a moderate form and 1% of women had a severe form. In the second main group, threatened miscarriage (χ2 < 0.001), preterm birth (χ2 < 0.001), gestational pyelonephritis (χ2 = 0.006), placental insufficiency (χ2 < 0.001), pre-eclampsia (χ2 = 0.006), congenital anomalies of the fetus (χ2 = 0.017) and intrauterine infection (χ2 < 0.001) were more frequent. Conclusions. Among risk factors for ARVI during pregnancy were anemia, obesity, diabetes mellitus, and nicotine intoxication. Preventive treatment with recombinant IFNα-2b with vitamins E and C reduced the incidence of acute respiratory viral infections in pregnant women by 2.8 times and improved perinatal outcomes by 4.7 times.
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Objective. To study the prophylactic effectiveness of the intranasal application of VIFERON®, the gel for external and local use (interferon α-2b) 36,000 IU/g, against ARVI in newborns and their mothers during the COVID-19 pandemic. Patients and methods. A total of 227 mother–newborn couples were examined, randomized into three groups: Group 1 (n = 63) – the VIFERON® gel was used according to the instructions;Group 2 (n = 50) – the VIFERON® gel was used in violation of the recommended scheme;Group 3 (control, n = 114) – did not use the medication. The main criteria for the effectiveness of prevention were: the incidence of ARVI in a mother–child couple for 3 months after inclusion in the study;the duration and severity of clinical symptoms of the disease;evaluation of the frequency of adverse events associated with the use of the drug under study. Results. The use of the VIFERON® gel led to a decrease in the number of ARVI cases in mothers (11.1 and 14.9%) and newborns (7.9 and 20.2%;p = 0.034) in Group 1 compared with Group 3, respectively, as well as to a significant reduction in the duration of the disease (p = 0.001), a decrease in the severity of clinical symptoms: the level of hyperthermia (p = 0.015), the duration of febrile (p = 0.021), cough (p = 0.032), rhinitis (p = 0.033). There were no statistically significant differences between these indicators in Groups 2 and 3, which requires to follow drug instructions in order to achieve the maximum effect. The timing of onset of diseases in Group 1 in the third month of observation from the beginning of drug administration makes it possible to justify the need for repeated courses of prophylaxis at high risk of respiratory diseases. In 100% of cases, the drug was well tolerated, and there were no adverse effects. Conclusion. The high preventive efficacy and safety of interferon α-2b with antioxidants in the form of gel for external and local use (VIFERON®, gel) in newborns and their mothers against ARVI were proved, which makes it possible to recommend its use to prevent the new coronavirus infection COVID-19 in newborns and confirms the validity of its inclusion in clinical guidelines for the treatment of COVID-19 in children.