In areas with a low prevalence of MDR bacteria.

No abstract

Aim.Clinical guidelines for the management of adult patients suffering from drug-induced liver injuries (DILI) are intended for all medical specialists, who treat such patients in their clinical practice.Key findings.The presented recommendations contain information about the epidemiological data, terminology, diagnostic principles, classification, prognosis and management of patients with DILI. The recommendations list pharmacological agents that most commonly cause DILI, including its fatal cases. Dose-dependent and predictable (hepatotoxic), as well as dose-independent and unpredictable (idiosyncratic) DILI forms are described in detail, which information has a particular practical significance. The criteria and types of DILI are described in detail, with the most reliable diagnostic and prognostic scales and indices being provided. The pathogenesis and risk factors for the development of DILI are considered. The clinical and morphological forms (phenotypes) of DILI are described. The diseases that are included into the differential diagnosis of DILI, as well as the principles of its implementation, are given. The role and significance of various diagnostic methods for examining a patient with suspected DILI is described, with the liver biopsy role being discussed. Clinical situations, in which DILI can acquire a chronic course, are described. A section on the assessment of causal relationships in the diagnosis of DILI is presented; the practical value of using the CIOMS-RUCAM scale is shown. All possible therapeutic measures and pharmacological approaches to the treatment of patients with various DILI phenotypes are investigated in detail. A particular attention is paid to the use of glucocorticosteroids in the treatment of DILI.Conclusion.The presented clinical recommendations are important for improving the quality of medical care in the field of hepatology.

Background While no "gold-standard" pharmacotherapy for nonalcoholic fatty liver disease (NAFLD) is yet established, essential phospholipids (EPLs) are reported to decrease steatosis and improve laboratory parameters. Objective This analysis evaluated adherence and satisfaction with EPL treatment as patient-reported outcomes and their relationship with changes in laboratory and ultrasound parameters among Russian patients with NAFLD. Methods Data were pooled from three observational Russian studies- MANPOWER (2015MANPOWER ( -2016, LIDER 1 (2012-2013), and LIDER 2 (2013)-in which EPLs were used for at least 12 weeks in the treatment of liver diseases and which measured both subjective and objective endpoints. Only patients who had NAFLD were included in this analysis. The main endpoints were to determine treatment adherence and satisfaction with 12 weeks of EPL therapy, relationship between adherence/satisfaction and changes in the laboratory and ultrasound parameters. A secondary subgroup analysis was performed to identify patients with NAFLD who responded better (or worse) to 24 weeks of adjunctive EPL treatment. Results Overall, 3384 patients were included. A total of 82.2% of patients were adherent to 12 weeks of EPL treatment; high/very high satisfaction was reported by 15.3%/65.9% of clinicians and 15.9%/64.4% of patients. There was positive correlation between patients' adherence and satisfaction and significant improvement in laboratory (transaminases, lipid profile; p < 0.001) and ultrasound (steatosis, p < 0.001) parameters, and improvement in symptoms (p < 0.001) after 24 weeks of EPL. Male patients, patients with unhealthy lifestyles, and those with more comorbidities showed a better response in laboratory and ultrasound parameters. Conclusions Patients with NAFLD treated with adjunctive EPL therapy in real-world clinical practice in Russia showed good treatment adherence and treatment satisfaction. Improvements in laboratory and ultrasound parameters, as well as dynamics of patient symptoms, were positively correlated with adherence and satisfaction.

Background & Aims:The efficacy and tolerability of faldaprevir, a potent hepatitis C virus (HCV) NS3/4A protease inhibitor, plus peginterferon (PegIFN) and ribavirin (RBV) was assessed in a double-blind, placebo-controlled phase 3 study of treatment-naïve patients with HCV genotype-1 infection. Methods: Patients were randomly assigned (1:2:2) to PegIFN/ RBV plus: placebo (arm 1, n = 132) for 24 weeks; faldaprevir (120 mg, once daily) for 12 or 24 weeks (arm 2, n = 259); or faldaprevir (240 mg, once daily) for 12 weeks (arm 3, n = 261). In arms 2 and 3, patients with early treatment success (HCV-RNA <25 IU/ml at week 4 and undetectable at week 8) stopped all treatment at week 24. Other patients received PegIFN/RBV until week 48 unless they met futility criteria. The primary endpoint was sustained virologic response 12 weeks post-treatment (SVR12). Results: SVR12 was achieved by 52%, 79%, and 80% of patients in arms 1, 2, and 3, respectively (estimated difference for arms 2 and 3 vs. arm 1: 27%, 95% confidence interval 17%-36%; and 29%, 95% confidence interval, 19%-38%, respectively; p <0.0001 for both). Early treatment success was achieved by 87% (arm 2) and 89% (arm 3) of patients, of whom 86% and 89% achieved SVR12. Adverse event rates were similar among groups; few adverse events led to discontinuation of all regimen components. Conclusions: Faldaprevir plus PegIFN/RBV significantly increased SVR12, compared with PegIFN/RBV, in treatment-naïve patients with HCV genotype-1 infection. No differences were seen in responses of patients given faldaprevir once daily at 120 or 240 mg. Ó