Search results for "MEP"

Incidence of DAA failure and the clinical impact of retreatment in real-life patients treated in the advanced stage of liver disease: Interim evaluat…

2017

Background: Few data are available on the virological and clinical outcomes of advanced liver disease patients retreated after first-line DAA failure. Aim: To evaluate DAA failure incidence and the retreatment clinical impact in patients treated in the advanced liver disease stage. Methods: Data on HCV genotype, liver disease severity, and first and second line DAA regimens were prospectively collected in consecutive patients who reached the 12-week post-treatment and retreatment evaluations from January 2015 to December 2016 in 23 of the PITER network centers. Results: Among 3,830 patients with advanced fibrosis (F3) or cirrhosis, 139 (3.6%) failed to achieve SVR. Genotype 3, bilirubin lev…

Efficacy of a 12-Week Simeprevir Plus Peginterferon/Ribavirin (PR) Regimen in Treatment-Naïve Patients with Hepatitis C Virus (HCV) Genotype 4 (GT4) …

2017

Background HCV GT4 accounts for up to 20% of HCV infections worldwide. Simeprevir, given for 12 weeks as part of a 24- or 48-week combination regimen with PR is approved for the treatment of chronic HCV GT4 infection. Primary study objectives were assessment of efficacy and safety of simeprevir plus PR in treatment-naïve patients with HCV GT4 treated for 12 weeks. Primary efficacy outcome was sustained virologic response 12 weeks post-treatment (SVR12). Additional objectives included investigation of potential associations of rapid virologic response and baseline factors with SVR12. Methods This multicentre, open-label, single-arm study (NCT01846832) evaluated efficacy and safety of simepre…

A new decision model for economic evaluation of novel therapies for HCV

2014

In 2014, the European Medicines Agency (EMA) has given the license to two new direct-acting antiviral: sofosbuvir and simeprevir. The evidence provided by the studies, reported a high rate of SVR even in patients with decompensated cirrhosis. This and other innovative elements are potentially adept at changing the entire natural course of HCV. However, the dramatic prevalence rates of HCV observed in Italy, and the high prices that are expected to be required by the pharmaceutical industry, raises some critical issues about how to regulate access to such drugs. The objective of this article is to present a new decision model for the evaluation of novel therapies for HCV. This model is inten…

Delisting of liver transplant candidates with chronic hepatitis C after viral eradication: A European study

2016

Background & Aims: All oral direct acting antivirals (DAA) have been shown to improve the liver function of patients with decompensated cirrhosis but it is presently unknown whether this clinical improvement may lead to the delisting of some patients. The aim of this study was to assess if and which patients can be first inactivated due to clinically improvement and subsequently delisted in a real life setting. Methods: 103 consecutive listed patients without hepatocellular carcinoma were treated with different DAA combinations in 11 European centres between February 2014 and February 2015. Results: The cumulative incidence of inactivated and delisted patients by competing risk analysis…

LP24 : Safety, efficacy and impact on liver function of simeprevir (SMV) in combination with daclatasvir (DCV) or sofosbuvir (SOF) in patients with s…

2015

P0792 : Baseline factors associated with increased SVR rates in 123 treatment-naïve chronic HCV genotype 1 patients treated with a shortened 12-week …

2015

PTH-137 Safety and efficacy of simeprevir (SMV) plus PEG-IFN/RBV in treatment-naÏve chronic hepatitis c genotype 1 patients eligible for 12 weeks of …

2015

Introduction HPC3014 is a Phase 3, open-label study to assess if response to SMV+Peg-IFN/RBV at Week 2 can allow shortening of treatment to 12 weeks, irrespective of baseline and on-treatment factors. Method Treatment-naive chronic HCV G1-infected patients with no-to-moderate fibrosis (METAVIR F0–F2) were recruited. In patients with HCV-RNA ® Taqman ® lower limit of quantification: 25 IU/mL, lower limit of detection: 15 IU/mL]) at Week 2 and undetectable at Weeks 4 and 8, all treatments were stopped at Week 12 (12-week group). If these criteria were not met, Peg-IFN/RBV was continued to Week 24 (in one case extended to Week 48). Results 123/163 (76%) patients treated were eligible for the 1…

Morality in Let’s Play narrations : Moral evaluations of Gothic monsters in gameplay videos of Fallout 3

2018

Performative Let’s Play gaming videos are a part of contemporary Internet culture through which morality becomes shared. Many digital games draw on Gothic traditions to feature human-like monsters who demand morally complex interpretations from players. This study examines what kinds of moral evaluations players form of ambiguous Gothic monsters in Let’s Play videos of the action role-playing game Fallout 3. With a discourse analysis of transcribed speech obtained from 20 Let’s Play series on YouTube, it argues that the moral evaluations that players actively produce impact significantly on the play experience, that players take diverse moral stances whose (in)determinacy varies based on w…

Clinical and economic consequences of switching from omalizumab to mepolizumab in uncontrolled severe eosinophilic asthma

2021

AbstractSevere asthma is burdened by frequent exacerbations and use of oral corticosteroids (OCS), which worsen patients’ health and increase healthcare spending. The aim of this study was to assess the clinical and economic impact of switching from omalizumab (OMA) to mepolizumab (MEP) in patients eligible for both biologics, but not optimally controlled by omalizumab. We retrospectively enrolled uncontrolled severe asthmatic patients who switched from OMA to MEP during the last two years. Information included blood eosinophil count, asthma control test (ACT), spirometry, serum IgE, fractional exhaled nitric oxide (FeNO), OCS intake, drugs, exacerbations/hospitalizations, visits and diagno…

Serum eosinophil cationic protein as a potential biomarker for interleukin-5 antibody treatment in patients with severe uncontrolled eosinophilic ast…

2018

Serum eosinophil cationic protein (ECP) has been described as a marker reflecting activation of eosinophils in asthma, potentially correlating to airway inflammation. Our aim was to examine the role of serum ECP to predict treatment efficacy in asthmatics starting interleukin-5 antibody (anti-IL5) therapy. We evaluated 65 patients with severe, uncontrolled eosinophilic asthma (≥300 eosinophils per µl blood) before and approx. 4 months after initiation of anti-IL5 therapy with mepolizumab; 35 patients completed a 12 month follow-up. Evaluation of treatment efficacy included medical history, asthma questionnaires, physical examination, spirometry, exhaled NO and blood tests. Depending on the …