Hepatobiliary system and intestinal injury in new coronavirus infection (COVID-19): A retrospective study.

BACKGROUND: An important area of effective control of the coronavirus disease 19 (COVID-19) pandemic is the study of the pathogenic features of severe acute respiratory syndrome coronavirus 2 infection, including those based on assessing the state of the intestinal microbiota and permeability. AIM: To study the clinical features of the new COVID-19 in patients with mild and moderate severity at the stage of hospitalization, to determine the role of hepatobiliary injury, intestinal permeability disorders, and changes in the qualitative and quantitative composition of the microbiota in the development of systemic inflammation in patients with COVID-19. METHODS: The study was performed in 80 patients with COVID-19, with an average age of 45 years, 19 of whom had mild disease, and 61 had moderate disease severity. The scope of the examination included traditional clinical, laboratory, biochemical, instrumental, and radiation studies, as well as original methods for studying microbiota and intestinal permeability. RESULTS: The clinical course of COVID-19 was studied, and the clinical and biochemical features, manifestations of systemic inflammation, and intestinal microbiome changes in patients with mild and moderate severity were identified. Intestinal permeability characteristics against the background of COVID-19 were evaluated by measuring levels of proinflammatory cytokines, insulin, faecal calprotectin, and zonulin. CONCLUSION: This study highlights the role of intestinal permeability and microbiota as the main drivers of gastroenterological manifestations and increased COVID-19 severity.

Efficacy and safety of 8-week combination therapy for chronic hepatitis C with protease inhibitor narlaprevir

Aim of investigation - to estimate efficacy and safety of direct-acting antivirus agents narlaprevir/ritonavir and sofosbuvir in non-cirrhotic patients with chronic hepatitis C. Material and methods. Treatment naive patients with chronic HCV infection GT1 were enrolled at the study (ClinicalTrials.gov ID: NCT04246723). Patients received therapy with the combination of narlaprevir 200 mg QD, ritonavir 100 mg QD and sofosbuvir 400 mg QD. Treatment duration was 12 weeks in group A and 8 weeks in group B. Primary endpoint is sustained virologic response 12 weeks post treatment (SVR12). The results of the study (group B) are presented. Results and discussion. Most patients from group B (23/25) had fibrosis (F0-F1) and 2 patients had fibrosis F2. All enrolled 25 patients completed therapy and 96.0% (24/25) patients reached SVR12 (95% CI 79.6-99.9%). Virologic failure was confirmed for one patient (697 000 IU/ml on follow-up week 12). In total, 23/24 patients passed FU week 24 and reached SVR24. One patient was discontinued from the study before last visit (FU24) due to COVID-19 outbreak. Adverse events (AEs) were registered in 5 (20%) patients. No serious AEs occurred. In total, therapy of narlaprevir/ritonavir and sofosbuvir for 8 weeks demonstrated good efficacy and safety profile. Цель исследования - изучение эффективности и безопасности препаратов прямого противовирус ного действия нарлапревир/ритонавир и софосбувир у пациентов с хроническим гепатитом C без цирроза печени. Материал и методы. В исследование были включены пациенты с хронической инфекцией, вызванной вирусом гепатита С (ВГС) генотипа 1, ранее не получавшие противовирусную терапию (ClinicalTrials.gov ID: NCT04246723). Пациенты получали комбинацию препаратов: нарлапревир 200 мг 1 раз в сутки, ритонавир 100 мг 1 раз в сутки и софосбувир 400 мг 1 раз в сутки. Длительность терапии составила 12 нед в группе А и 8 нед в группе В. Первичная конечная точка исследования - устойчивый вирусологический ответ через 12 нед после терапии (УВО12). Представлены результаты исследования для группы В. Результаты и обсуждение. У большинства (23 из 25) пациентов из группы B был фиброз стадии F0-F1, у 2 пациентов - стадии F2. Все включенные в исследование 25 пациентов завершили терапию, 24 (96,0%) из них достигли УВО12 (95% доверительный интервал 79,6-99,9). Вирусологическая неудача была подтверждена у 1 пациента (697 000 МЕ/мл на 12-й неделе наблюдения). В общей сложности 23 из 24 пациентов достигли УВО24. 1 пациент выбыл из исследования перед последним визитом (24-я неделя наблюдения) в связи с пандемией COVID-19. Нежелательные явления во время терапии зарегистрированы у 5 (20%) пациентов. Серьезных нежелательных явлений не отмечено. В целом терапия нарлапревиром/ритонавиром и софосбувиром в течение 8 нед продемонстрировала хороший профиль эффективности и безопасности.