Journal of Drug Assessment最新文献

Background: The main objective of this study was to analyse the spread of hepatitis C virus (HCV) genotype in patients with chronic liver disease; commenting on the molecular characterization of HCV and gender and age in Varna, Bulgaria. Across Europe and the world, HCV is a significant economic concern and public health crisis. Defined by genotype variations, HCV is the leading cause of chronic liver disease, liver related morbidity, and mortality worldwide. Active examination for asymptomatic patients is essential, initiating early treatment aimed at the specific HCV genotype, effective outcomes, and reducing transmission and mortality in Bulgaria. Methods and materials: Nucleic acid extraction and amplification were performed with commercially available test kits on 115 patients blood samples collected from March 2018 to October 2018. Male (n = 58) (50.43%, 95% CI = 41.29%-59.57%) and female (n = 57) (49.57%, 95% CI = 41.29%-59.57%) samples were equally distributed (mean age = 51.4 years; SD = ±16.5 years; range = 17-87 years old). Results: Genotype 1b predominated (73%, 95% CI = 64.89%-81.11%), followed by high prevalence of 1a (13.9%, 95% CI = 7.58%-20.22%) and 3 genotypes (11.3%, 95% CI = 5.51%-17.09%). Genotypes 2 and 4 were equally the least prevalent (0.9%, 95% CI = -0.83%-2.63%). In genotype 1b, 60.7% were women and 39.3% were men; in genotype 1a, 25% were women and 75% were men; and in genotype 3, only 7.7% were women and 92.3% were men. Males were most prevalent in genotypes 1a (75%) and 3 (92.3%), while women were most prevalent in genotype 1b (60.7%). Conclusions: HCV genotype lb is the predominant variant within the epidemiological pattern of HCV genotypes in patients with chronic liver diseases in North Eastern Bulgaria.

Objective: To assess the effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting in adults with moderate-to-severe active Crohn's disease (CD) or ulcerative colitis (UC). Methods: This multi-centre, observational cohort study was conducted at medical centres in Romania, Czech Republic, and Bulgaria. Effectiveness was measured using the Crohn's Disease Activity Index (CDAI) for CD or partial Clinical Activity Index (pCAI) for UC. Quality-of-life (QoL) was measured using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Safety was assessed according to treatment withdrawals and adverse events (AEs) monitoring. Analyses were performed in the safety population and were reported based on the observed case (OC) or last observation carried forward (LOCF) method. Results: Altogether, 85 patients with CD (n = 38) or UC (n = 47) received biosimilar infliximab for up to 30 weeks. Most patients (n = 68; 80.0%) had no prior exposure to infliximab. At the end of treatment, 65.8% (95% CI = 49.8-78.9) of CD patients and 55.3% (95% CI = 41.2-68.6) of UC patients showed a clinical response, and 47.4% (95% CI = 32.5-62.7) and 48.9% (95% CI = 35.3-62.8), respectively, were in remission. Statistically significant (p < 0.0001) improvements from baseline were observed in CDAI and pCAI scores (both LOCF). In the combined CD and UC population, SIBDQ was significantly improved (p < 0.0001) from baseline to end of treatment (OC). Two AEs (moderately severe infusion reactions) were judged by investigators to be definitely related to treatment, one of which led to treatment withdrawal. Conclusion: Results align with those of previous studies demonstrating the effectiveness and safety of biosimilar infliximab in CD and UC.

Atopic dermatitis (AD) is a chronic inflammatory disease persisting predominantly in the pediatric population. Its development is most presumably multifactorial and a derivative of interplay between genetic, immunologic, and environmental causes. To the authors' knowledge, no multinational and systematic database of AD prevalence is established and maintained for Europe. Thus, epidemiologic data originating from the multinational studies was compiled to draw a picture of AD in both pediatric and adult populations in Europe. The outcomes of this exercise support the general observation that AD prevalence follows the latitudinal pattern with higher prevalence values in northern Europe and decreases progressively towards southern Europe. Noteworthy, the data shows significant differences on the country-level, with higher prevalence in municipal areas than rural. Finally, and unsurprisingly, the collected data reinforces the observation of AD prevalence being highest in pediatric populations in contrast to adults. Herein, data presented was additionally supplemented with the information on current standing on AD etiology.