Phase 2 Randomised Study of Bulevirtide as Monotherapy or Combined With Peg-IFNα-2a as Treatment for Chronic Hepatitis Delta.

Background And Aim: Bulevirtide (BLV) leads to beneficial virologic and biochemical responses when given alone to treat hepatitis delta virus (HDV) infection, which causes the most severe form of chronic viral hepatitis. We evaluated 48 weeks of BLV monotherapy, BLV + tenofovir disoproxil fumarate (TDF) and BLV + pegylated interferon alfa-2a (Peg-IFNα-2a), with 24-week follow-up.

Methods: Ninety patients were enrolled into six arms of 15 each (A-F); 60 patients were included in the main randomisation (arms A-D), and 30 patients (arms E-F) were randomised to the extension phase: (A) Peg-IFNα-2a 180 μg once weekly (QW); (B) BLV 2 mg once daily (QD) + Peg-IFNα-2a 180 μg QW; (C) BLV 5 mg QD + Peg-IFNα-2a 180 μg QW; (D) BLV 2 mg QD; (E) BLV 10 mg QD + Peg-IFNα-2a 180 μg QW and (F) BLV 10 mg (5 mg twice daily) + TDF QD.

Patient-reported outcomes in chronic hepatitis delta: An exploratory analysis of the phase III MYR301 trial of bulevirtide.

Background & Aims: Once-daily treatment of chronic hepatitis delta (CHD) with bulevirtide is well tolerated and associated with significant reductions in HDV RNA in the blood and in biochemical liver disease activity. This study explored the effects of 48-week bulevirtide treatment on health-related quality of life (HRQoL) in patients with CHD.

Methods: In an open-label, randomised, phase III trial, 150 patients with CHD and compensated liver disease were stratified by cirrhosis status and randomised 1:1:1 to no treatment (control), bulevirtide 2 mg/day, or bulevirtide 10 mg/day for 48 weeks.

Bulevirtide monotherapy in patients with chronic HDV: Efficacy and safety results through week 96 from a phase III randomized trial.

Background & Aims: Bulevirtide (BLV), a first-in-class entry inhibitor, is approved in Europe for the treatment of chronic hepatitis delta (CHD). BLV monotherapy was superior to delayed treatment at week (W) 48, the primary efficacy endpoint, in the MYR301 study (NCT03852719). Here, we assessed if continued BLV therapy until W96 would improve virologic and biochemical response rates, particularly among patients who did not achieve virologic response at W24.

Effects of Button Mushroom Agaricus bisporus (Agaricomycetes) and Soybean Oil on Storage Characteristics of Chicken Sausage.

To investigate the effect of Agaricus bisporus and soybean oil as complex fat substitutes on the storage characteristics of chicken sausages, a pre-mixture of A. bisporus and soybean oil (1:2) was used to replace 0% (CK), 30% (T30), 60% (T60), and 90% (T90) of pork back fat in chicken sausages. The changes in color (brightness value, L*; redness value, a*; and yellowness value, b*), texture, pH, and total viable count of the sausages were examined at 1, 5, 10, 15, 20, 25, 30 and 35 d of storage at 4°C, respectively.

A Phase 3, Randomized Trial of Bulevirtide in Chronic Hepatitis D.

Background: Coinfection with hepatitis D virus (HDV) accelerates the progression of liver disease associated with chronic hepatitis B. Bulevirtide inhibits the entry of HDV into hepatocytes.

Methods: In this ongoing phase 3 trial, patients with chronic hepatitis D, with or without compensated cirrhosis, were randomly assigned, in a 1:1:1 ratio, to receive bulevirtide subcutaneously at 2 mg per day (2-mg group) or 10 mg per day (10-mg group) for 144 weeks or to receive no treatment for 48 weeks followed by bulevirtide subcutaneously at 10 mg per day for 96 weeks (control group).

Efficacy and Safety of Bepirovirsen in Chronic Hepatitis B Infection.

Background: Bepirovirsen is an antisense oligonucleotide that targets all hepatitis B virus (HBV) messenger RNAs and acts to decrease levels of viral proteins.

Methods: We conducted a phase 2b, randomized, investigator-unblinded trial involving participants with chronic HBV infection who were receiving or not receiving nucleoside or nucleotide analogue (NA) therapy. Participants were randomly assigned (in a 3:3:3:1 ratio) to receive weekly subcutaneous injections of bepirovirsen at a dose of 300 mg for 24 weeks (group 1), bepirovirsen at a dose of 300 mg for 12 weeks then 150 mg for 12 weeks (group 2), bepirovirsen at a dose of 300 mg for 12 weeks then placebo for 12 weeks (group 3), or placebo for 12 weeks then bepirovirsen at a dose of 300 mg for 12 weeks (group 4).

Safety and efficacy of bulevirtide in combination with tenofovir disoproxil fumarate in patients with hepatitis B virus and hepatitis D virus coinfection (MYR202): a multicentre, randomised, parallel-group, open-label, phase 2 trial.

Background: Bulevirtide is a first-in-class peptidic entry inhibitor for hepatitis B virus (HBV) and hepatitis D virus infection. In July, 2020, bulevirtide 2 mg received conditional marketing authorisation by the European Medical Agency for treatment of chronic hepatitis D virus infection. We investigated the antiviral activity of bulevirtide in patients chronically infected with HBV and hepatitis D virus.

Diabetic Nephropathy - possibilities of early laboratory diagnostics and course prediction (review of literature).

The medical and social significance of diabetes mellitus is determined by a progressive increase in the incidence of the disease, as well as the development of disabling and reducing the quality of life of macro- and microvascular complications in patients of working age, in particular, with the development of diabetic nephropathy (DN), which develops in one third of patients with type 1 and 2 diabetes. DN is the third leading cause of death after diseases of the cardiovascular system and oncological pathologies. In this regard, the identification of DN at the early stages is an important task both from the standpoint of prevention and a more favorable prognosis of the course of diabetes.

SARS-CoV-2 Seroprevalence Structure of the Russian Population during the COVID-19 Pandemic.

The SARS-CoV-2 pandemic, which came to Russia in March 2020, is accompanied by morbidity level changes and can be tracked using serological monitoring of a representative population sample from Federal Districts (FDs) and individual regions. In a longitudinal cohort study conducted in 26 model regions of Russia, distributed across all FDs, we investigated the distribution and cumulative proportions of individuals with antibodies (Abs) to the SARS-CoV-2 nucleocapsid antigen (Ag), in the period from June to December 2020, using a three-phase monitoring process. In addition, during the formation of the cohort of volunteers, the number of seropositive convalescents, persons who had contact with patients or COVID-19 convalescents, and the prevalence of asymptomatic forms of infection among seropositive volunteers were determined.

Effect of liraglutide on microcirculation in rat model with absolute insulin deficiency.

Introduction: The investigations of angiotropic effects of liraglutide are an issue of significant scientific and practical interest. The successful application of liraglutide has been shown in glycemic control in patients with the type 2 diabetes mellitus (DM), but the effect of liraglutide in patients with type 1 DM has not been completely studied yet in clinical practice. Therefore, the present study is aimed to investigate the effect of liraglutide which is agonist of glucagon-like peptide-1 receptors, on microcirculation in white outbred rats with the alloxan-induced diabetes.

Influence of the new formulation based on silver alginate microcapsules loaded with tannic acid on the microcirculation of the experimental periodontitis in rats.

The microvascular changes caused by disorders of host immune response to oral microorganisms resulting in long-lasting inflammation of gums play a critical role in the periodontal lesion in the pathogenesis of chronic periodontitis. Current strategies of non-surgical periodontal therapy are aimed at the attainment of anti-inflammatory effects. We hypothesized that the usage of the microencapsulated form of anti-inflammatory substances with vasoactive effects could enhance the efficiency of the therapy by the prolonged release of active components.

[The role of diabetes in the onset and development of endothelial dysfunction].

The vascular endothelium performs many functions. It is a key regulator of vascular homeostasis, maintains a balance between vasodilation and vasoconstriction, inhibition and stimulation of smooth muscle cell migration and proliferation, fibrinolysis and thrombosis, and is involved to regulation of platelet adhesion and aggregation. Endothelial dysfunction (ED) plays the critical role in pathogenesis of diabetes mellitus (DM) vascular complications.

[Characterization of B1-cells during experimental leukomogenesis.].

Background: Bovine leukemia causes a significant polyclonal expansion of CD5+, IgM+ B lymphocytes, known as persistent lymphocytosis (PL), in approximately 30% of infected cattle. However, it is not yet clear what happens to this subpopulation of B cells in the early period of infection of animals.

Purpose: Quantitative characterization of IgM+ and CD5+ B cells during the immune response, which can provide important information on the mechanisms of lymphocyte priming in BLV infection.

Analysis of tuberculosis/hiv co-infection trends in Ukraine in 2008-2017.

Objective: Introduction: According to WHO estimates for the European Region in 2017, Ukraine had the highest proportion of active tuberculosis cases co-infected with HIV - 21.6%, with an average of 12% in the Region, and the absolute number of tuberculosis/HIV co-infection cases in Ukraine was estimated at the level of 8,000. The aim: carry out a comprehensive analysis of the epidemical situation regarding tuberculosis/HIV co-infection in Ukraine according to selected epidemiological and clinical characteristics.

[Markers of endothelial dysfunction: pathogenetic role and diagnostic significance.].

Endothelial dysfunction (ED) is considered one of the pathogenetic mechanisms of a whole range of diseases. Detection of specific biochemical markers in the blood is an effective way to ED diagnostics that characterize the vascular endothelium state. This review highlights the pathogenetic role of the factors synthesized by endotheliocytes whose level changes in biological fluids reflect violations of the endothelium basic physiological properties: vasomotor function, thromboresistance, angiogenesis regulation, barrier and adhesion functions.

[Detection of specific antibodies of classes G and M to bovine leukemia virus in the blood serum.].

Introduction: Bovine leukemia is a widespread infection worldwide, the causative agent of which is the bovine leukemia virus (BLV) in structural structure and functional features similar to human T-cell leukemia virus (HTLV-1 and HTLV-2) and It is considered as an actual medical and social problem. The study of the immune response in experimentally infected calves at an early stage of the disease development, synthesis of specific antibodies of classes G and M (IgG and IgM), diagnostic informativeness of detection of IgM in cattle leukemia is relevant and determines the purpose of this study.

Material And Methods: Samples of blood and serum of cattle: animals experimentally infected with VLCRS, patients with cattle leukemia; control negative; specific to heterologous pathogens of cattle diseases.

Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial.

Background: The novel prodrug tenofovir alafenamide delivers the nucleotide reverse transcriptase inhibitor tenofovir to target cells more efficiently at a lower dose than tenofovir disoproxil fumarate, thereby reducing systemic exposure. We compared the efficacy and safety of the two drugs in patients with HBeAg-negative chronic hepatitis B virus (HBV) infection in a non-inferiority study.

Methods: In this ongoing randomised, double-blind, phase 3, non-inferiority study in 105 centres in 17 countries, patients with HBeAg-negative chronic HBV were randomly assigned (2:1) by a computer-generated allocation sequence (block size six), stratified by plasma HBV DNA concentration and previous treatment status, to receive once-daily oral doses of tenofovir alafenamide 25 mg or tenofovir disoproxil fumarate 300 mg, each with matching placebo.

[(INFESTATION OF FISHES OF THE FAMILY CYPRINIDAE IN THE FOCI OF TREMATODES OF THE ECOSYSTEM OF THE BELAYA RIVER (THE REPUBLIC OF BASHKORTOSTAN)].

In the ecosystem of the Belaya River, fishes of the family Cyprinidae were infected with three epidemically important species oftrematodes of the family Opisthorchidae: Opisthorchisfelineus, Metorchis bilis, and Pseudamphistomum truncatumn. No biotopes of mollusks of the genus Codiella were detected. The contamination of underyearlings with-Ofelineus and M.

[BIOLOGICAL PROPERTIES OF BACTERIA OF THE FAMILY ENTEROBACTERIACEAE AS COMPONENTS OF MICROSYMBIOCENOSIS OF THE FIRST INTERMEDIATE HOSTS OF O.FELINEUS].

The objective of the investigation was to study the biological properties (antilysozyme activity (ALA), biofilm formation (BFF), and virulence factors) of different Enterobacteriaceae species isolated from Bithyniidae mollusks and their habitats. A total of 117 strains isolated from Bithyniidae mollusks of the genera Codiella and Bithynia and those from their habitats were the material to be studied. Thus, comparison of the mean values of ALA in Enterobacteriaceae species suggests that the strains isolated from the mollusks and their aqueous habitat did not virtually differ in this indicator.

[Characteristics of the nutrition organization and nutrient consumption in toddlers' living in the Central Federal District, Russian Federation (Moscow, Ivanovo, Yaroslavl)].

A multicenter cross-sectional study with the participation of 356 healthy children aged 1 to 3 years from the cities of the Central Federal District: Moscow (n=106), Ivanovo (n=126), Yaroslavl (n=124) has been carried out. Questionnaire method, the method of 24-hour diet recall for 3 days (2 weekdays and 1 weekend) and the method of diary recording of food intake were used. The average daily volumes of food were consistent with the recommended age norms only in 31.

[MICROBIAL COMMUNITIES ON KIDNEY STONES].

The clinical material obtained surgically in patients with kidney stone disease (KSD) was tested for content of the stone microflora using PCR and standard microbiological methods. It was demonstrated that about 50% of stones in patients with KSD were infected with various infection agents as observed using standard microbiological and molecular genetic methods. The percentage of detection of the Mycoplasma hominis using cultural method is lower than the percentage detected using PCR, which is due to difficult isolation and cultivation, as well as DNA fragments of mycoplasma observed after antibiotic therapy.

[THE STRUCTURE AND SOME BIOLOGICAL PROPERTIES OF GRAM-NEGATIVE BACTERIA CONSTITUTING THE MICROSYMBIOCENOSIS OF PROSOBRANCHIA MOLLUSKS (BITHYNIIDAE). COMMUNICATION 2].

The goal of this investigation was to study the structure and biological properties (antilysozymic, activity and biofilm formation) of gram-negative bacteria isolated from Bithyniidae mollusks and their habitat (water reservoir waters and soil). A total of 160 gram-negative bacterial strains isolated from the mollusks of the Bithyniidae family and their habitat were the material to be, studied. Psedomonas, Comamonas, and Acinetobacter held the lead in the structure of microbiocenosis of Bithyniidae mollusks, the first intermediate host of Opisthorchis filineus, while Acinetobacter did in the habitat.

[AEROMONAS BACTERIA ISOLATED FROM BITHYNIIDAE MOLLUSKS AND THEIR HABITATS: SPECIES COMPOSITION AND BIOLOGICAL PROPERTIES. COMMUNICATION 1].

The purpose of this investigation was to study the species composition and biological properties of Aeromonas bacteria isolated from Bithyniidae mollusks and their habitat (a water reservoir). The Bithyniidae mollusks and water from their habitat were the material to be studied. A total of 176 Aeromonas strains were isolated from the mollusks and water.