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https://www.readbyqxmd.com/read/29453451/prevalence-and-impact-of-baseline-resistance-associated-substitutions-on-the-efficacy-of-ledipasvir-sofosbuvir-or-simeprevir-sofosbuvir-against-gt1-hcv-infection
#1
Gary P Wang, Norah Terrault, Jacqueline D Reeves, Lin Liu, Eric Li, Lisa Zhao, Joseph K Lim, Giuseppe Morelli, Alexander Kuo, Josh Levitsky, Kenneth E Sherman, Lynn M Frazier, Ananthakrishnan Ramani, Joy Peter, Lucy Akuskevich, Michael W Fried, David R Nelson
Baseline resistance-associated substitutions (RASs) have variable impacts in clinical trials but their prevalence and impact in real-world patients remains unclear. We performed baseline resistance testing using a commercial assay (10% cutoff) for 486 patients treated with LDV/SOF or SMV/SOF, with or without ribavirin, in the multi-center, observational HCV-TARGET cohort. Linkage of RASs was evaluated in selected samples using a novel quantitative single variant sequencing assay. Our results showed that the prevalence of NS3, NS5A, NS5B RASs was 45%, 13%, and 8%, respectively, and 10% of patients harbored RASs in 2 or more drug classes...
February 16, 2018: Scientific Reports
https://www.readbyqxmd.com/read/29451090/study-of-changes-in-lipid-profile-and-insulin-resistance-in-egyptian-patients-with-chronic-hepatitis-c-genotype-4-in-the-era-of-daas
#2
Ghada El Sagheer, Elwy Soliman, Asmaa Ahmad, Lamiaa Hamdy
Chronic hepatitis C virus (HCV) infection is associated with altered metabolism, including dyslipidemia and insulin resistance. These contribute to disease progression and influences the response to therapy. To investigate the relationships of new direct-acting antiviral drugs, simeprevir/sofosbuvir, with lipid profile and insulin resistance (IR). Eighty chronic hepatitis C genotype 4 patients were included; they were divided into four groups according to the severity of fibrosis as detected by fibroscan. Forty healthy persons volunteered as a control group...
December 2018: Libyan Journal of Medicine
https://www.readbyqxmd.com/read/29435907/sustained-virological-response-in-special-populations-with-chronic-hepatitis-c-using-interferon-free-treatments-a-systematic-review-and-meta-analysis-of-observational-cohort-studies
#3
REVIEW
Vinicius Lins Ferreira, Letícia Paula Leonart, Fernanda Stumpf Tonin, Helena Hiemisch Lobo Borba, Roberto Pontarolo
BACKGROUND AND OBJECTIVES: Hepatitis C treatment has changed considerably in recent years, and many interferon (IFN)-free therapies are now available. Considering the high rates of sustained virological response (SVR) presented by clinical trials for these treatments, high rates of effectiveness are also expected in real-world clinical practice. Hence, this study aimed to conduct a systematic review and meta-analysis of observational cohort studies to evaluate the clinical effectiveness and safety of IFN-free therapies for hepatitis C...
February 12, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29378602/a-3-year-follow-up-study-after-treatment-with-simeprevir-in-combination-with-pegylated-interferon-%C3%AE-and-ribavirin-for-chronic-hepatitis-c-virus-infection
#4
Fabien Zoulim, Christophe Moreno, Samuel S Lee, Peter Buggisch, Andrzej Horban, Eric Lawitz, Chris Corbett, Oliver Lenz, Bart Fevery, Thierry Verbinnen, Umesh Shukla, Wolfgang Jessner
BACKGROUND: Simeprevir is approved with pegylated interferon and ribavirin (PR) for chronic hepatitis C virus (HCV) genotype (GT) 1 and GT4 infection in the USA and the European Union. METHODS: This 3-year follow-up study assessed the durability of sustained virologic response (SVR) (undetectable HCV RNA 12 or 24 weeks after treatment end), and evaluated the persistence of treatment-emergent NS3/4A protease inhibitor resistance in patients not achieving SVR following treatment with simeprevir plus PR in the parent study...
January 30, 2018: Virology Journal
https://www.readbyqxmd.com/read/29377274/all-oral-daa-therapy-against-hcv-in-hiv-hcv-coinfected-subjects-in-real-world-practice-madrid-core-findings
#5
Juan Berenguer, Ángela Gil-Martin, Inmaculada Jarrin, Ana Moreno, Lourdes Dominguez, Marisa Montes, Teresa Aldámiz-Echevarría, María J Téllez, Ignacio Santos, Laura Benitez, José Sanz, Pablo Ryan, Gabriel Gaspar, Beatriz Alvarez, Juan E Losa, Rafael Torres-Perea, Carlos Barros, Juan V San Martin, Sari Arponen, María Teresa de Guzmán, Raquel Monsalvo, Ana Vegas, María T Garcia-Benayas, Regino Serrano, Luis Gotuzzo, María Antonia Menendez, Luis M Belda, Eduardo Malmierca, María J Calvo, Encarnación Cruz-Martos, Juan J González-García
We evaluated treatment outcomes in a prospective registry of HIV/HCV-coinfected patients treated with interferon-free direct-acting antiviral agent (DAA)-based therapy in hospitals from the region of Madrid between November 2014 and August 2016. We assessed sustained viral response (SVR) at 12 weeks after completion of treatment and used multivariable logistic regression to identify predictors of treatment failure. We evaluated 2,369 patients, of whom 59.5% were non-cirrhotic (Non-C), 33.9% had compensated cirrhosis (Co-C), and 6...
January 29, 2018: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/29374597/ghrelin-gene-polymorphism-as-a-genetic-biomarker-for-prediction-of-therapy-induced-clearance-in-egyptian-chronic-hcv-patients
#6
Marwa Hamdy, Samar Kamal Kassim, Eman Khairy, Mohsen Maher, Khaled Amr Mansour, Ashraf Mohammad Albreedy
Ghrelin (GHRL) has important implications for liver disease. It has anti-inflammatory effects, regulates cell proliferation, modulates the fibrogenic response and protects liver tissue. Genetic variations in the GHRL gene may play a crucial role in the development of chronic hepatitis (CH), liver cirrhosis (LC) and hepatocellular carcinoma (HCC). Therefore, we examined the association of GHRL gene polymorphisms (rs26312 and rs27647), and its serum level to virologic responses to combined sofosbuvir and Simeprevir therapy for a course of 12 successive weeks in Egyptian chronic hepatitis C (CHC) patients...
January 25, 2018: Gene
https://www.readbyqxmd.com/read/29345798/clinical-impact-of-pharmacokinetic-interactions-between-the-hcv-protease-inhibitor-simeprevir-and-frequently-used-concomitant-medications
#7
Fiona Marra, Christoph Höner Zu Siederdissen, Saye Khoo, David Back, Michael Schlag, Sivi Ouwerkerk-Mahadevan, Ceyhun Bicer, Isabelle Lonjon-Domanec, Wolfgang Jessner, Maria Beumont-Mauviel, Ronald Kalmeijer, Markus Cornberg
AIMS: Direct-acting antivirals (DAAs) for the treatment of hepatitis C (HCV) can be associated with drug-drug interactions (DDIs) with concomitant medications. The practical clinical implications of such DDIs are poorly understood. We assessed the clinical impact of possible pharmacokinetic (PK) interactions between simeprevir and frequently prescribed concomitant medications. METHODS: This post-hoc analysis pooled data from 9 studies which evaluated simeprevir (SMV)-based interferon-free HCV treatment...
January 18, 2018: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29316059/cost-effectiveness-analyses-of-anti-hcv-treatments-using-qol-scoring-among-patients-with-chronic-liver-disease-in-the-hiroshima-prefecture
#8
Terumi Kaishima, Tomoyuki Akita, Masayuki Ohisa, Kazuaki Sakamune, Akemi Kurisu, Aya Sugiyama, Hiroshi Aikata, Kazuaki Cyayama, Junko Tanaka
AIM: We estimated the cost-effectiveness of direct acting antiviral treatment (DAA) compared to triple therapy (simeprevir, pegylated interferon-α and ribavirin) (scenario-1) and Peg-IFN+RBV(scenario-2) and non-antiviral therapy(scenario-3). METHODS: The Cost-effectiveness was evaluated as incremental cost-effectiveness ratios (ICERs) using direct costs and indirect costs which included loss of wages during the patient's lifetime due to early death caused by viral hepatitis infection...
January 5, 2018: Hepatology Research: the Official Journal of the Japan Society of Hepatology
https://www.readbyqxmd.com/read/29315640/virological-patterns-of-hcv-patients-with-failure-to-interferon-free-regimens
#9
Starace Mario, Minichini Carmine, De Pascalis Stefania, Macera Margherita, Occhiello Laura, Messina Vincenzo, Sangiovanni Vincenzo, Adinolfi Luigi Elio, Claar Ernesto, Precone Davide, Stornaiuolo Gianfranca, Stanzione Maria, Ascione Tiziana, Caroprese Mara, Zampino Rosa, Parrilli Gianpaolo, Gentile Ivan, Brancaccio Giuseppina, Iovinella Vincenzo, Martini Salvatore, Masarone Mario, Fontanella Luca, Masiello Addolorata, Evangelista Sagnelli, Punzi Rodolfo, Salomone Megna Angelo, Santoro Renato, Gaeta Giovanni Battista, Coppola Nicola
BACKGROUND: The study characterized the virological patterns and the resistance-associated substitutions (RASs) in patients with failure to IFN-free regimens enrolled in the real-life setting. PATIENTS AND METHODS: All 87 consecutive HCV patients with failed IFN-free regimens, observed at the laboratory of the University of Campania, were enrolled. All patients had been treated with DAA regimens according to the HCV genotype, international guidelines and local availability...
January 9, 2018: Journal of Medical Virology
https://www.readbyqxmd.com/read/29299156/inhibition-of-pi4k-iii%C3%AE-radiosensitizes-in-human-tumor-xenograft-and-immune-competent-syngeneic-murine-tumor-model
#10
Younghee Park, Ji Min Park, Dan Hyo Kim, Jeanny Kwon, In Ah Kim
Phosphatidylinositol (PI) 4-kinase (PI4K) has emerged as a potential target for anti-cancer treatment. We recently reported that simeprevir, an anti-hepatitis C viral (HCV) agent, radiosensitized diverse human cancer cells by inhibiting PI4K IIIα in vitro. In this study, we investigated the radiosensitizing effect of simeprevir in an in vivo tumor xenograft model and the mechanism of its interaction. The immune modulatory effect of PI4K IIIα was evaluated in an immune-competent syngeneic murine tumor model...
December 15, 2017: Oncotarget
https://www.readbyqxmd.com/read/29297968/comparison-between-core-shell-and-totally-porous-particle-stationary-phases-for-fast-and-green-lc-determination-of-five-hepatitis-c-antiviral-drugs
#11
Adel Ehab Ibrahim, Hisham Hashem, Magda Elhenawee, Hanaa Saleh
The performances of core-shell 2.7 μm and fully porous sub-2 μm particles packed in narrow diameter columns were compared under the same chromatographic conditions. The stationary phases were compared for fast separation and determination of five new antiviral drugs; daclatasvir, sofosbuvir, velpatasvir, simeprevir and ledipasvir. The gradient elution was done using ethanol as green organic modifier which is more environmentally friendly. Although both columns provided very good resolution of the five drugs, core-shell particles had proven to be of better efficiency...
January 3, 2018: Journal of Separation Science
https://www.readbyqxmd.com/read/29274193/efficacy-and-safety-of-6-or-8-weeks-of-simeprevir-daclatasvir-sofosbuvir-for-hcv-genotype-1-infection
#12
M S Sulkowski, J J Feld, E Lawitz, F Felizarta, A M Corregidor, O Khalid, R Ghalib, W B Smith, V Van Eygen, D Luo, L Vijgen, M Gamil, T N Kakuda, S Ouwerkerk-Mahadevan, P Van Remoortere, M Beumont
The phase 2, open-label ACCORDION (ClinicalTrials. gov: NCT02349048) study investigated the efficacy, safety and pharmacokinetics of a 6- or 8-week regimen of simeprevir, daclatasvir and sofosbuvir in treatment-naïve patients with chronic hepatitis C virus (HCV) genotype (GT) 1 infection and either early-stage fibrosis or compensated cirrhosis. Patients were assigned to treatment groups according to their fibrosis stage. Early-stage fibrosis: simeprevir 150 mg, daclatasvir 60 mg, sofosbuvir 400 mg once daily for 6 weeks; compensated cirrhosis: same regimen for 8 weeks...
December 23, 2017: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/29197145/long-term-follow-up-of-ribavirin-free-daa-based-treatment-in-hcv-recurrence-after-orthotopic-liver-transplantation
#13
Sandra Beinhardt, Ramona Al-Zoairy, Karin Kozbial, Albert Friedrich Stättermayer, Andreas Maieron, Rudolf Stauber, Michael Strasser, Heinz Zoller, Ivo Graziadei, Susanne Rasoul-Rockenschaub, Michael Trauner, Peter Ferenci, Harald Hofer
BACKGROUND & AIMS: Excellent efficacy and safety-profile of second generation DAA-combinations improved treatment of chronic hepatitis C (HCV) as well as in HCV-recurrence after orthothopic liver transplantation (OLT). The need of ribavirin-addition is under debate as anemia and decreased renal function are prevalent in transplant-cohorts. Aim of this study was thus to assess safety and long-term efficacy of RBV-free DAA-combinations in HCV-recurrent patients after OLT. PATIENTS & METHODS: 62 OLT-recipients (male:50/81%; age:60...
December 2, 2017: Liver International: Official Journal of the International Association for the Study of the Liver
https://www.readbyqxmd.com/read/29169329/micro-costing-analysis-of-guideline-based-treatment-by-direct-acting-agents-the-real-life-case-of-hepatitis-c-management-in-brazil
#14
Hugo Perazzo, Marcelino Jose Jorge, Julio Castro Silva, Alexandre Monken Avellar, Patrícia Santos Silva, Carmen Romero, Valdilea Gonçalves Veloso, Ruben Mujica-Mota, Rob Anderson, Chris Hyde, Rodolfo Castro
BACKGROUND: Eradication of hepatitis C virus (HCV) using direct-acting agents (DAA) has been associated with a financial burden to health authorities worldwide. We aimed to evaluate the guideline-based treatment costs by DAAs from the perspective of the Brazilian Ministry of Health (BMoH). METHODS: The activity based costing method was used to estimate the cost for monitoring/treatment of genotype-1 (GT1) HCV patients by the following strategies: peg-interferon (PEG-IFN)/ribavirin (RBV) for 48 weeks, PEG-IFN/RBV plus boceprevir (BOC) or telaprevir (TEL) for 48 weeks, and sofosbuvir (SOF) plus daclastavir (DCV) or simeprevir (SIM) for 12 weeks...
November 23, 2017: BMC Gastroenterology
https://www.readbyqxmd.com/read/29147645/real-world-cure-rates-for-hepatitis-c-virus-treatments-that-include-simeprevir-and-or-sofosbuvir-are-comparable-to-clinical-trial-results
#15
Kian Bichoupan, Neeta Tandon, James F Crismale, Joshua Hartman, David Del Bello, Neal Patel, Sweta Chekuri, Alyson Harty, Michel Ng, Keith M Sigel, Meena B Bansal, Priya Grewal, Charissa Y Chang, Jennifer Leong, Gene Y Im, Lawrence U Liu, Joseph A Odin, Nancy Bach, Scott L Friedman, Thomas D Schiano, Ponni V Perumalswami, Douglas T Dieterich, Andrea D Branch
AIM: To assess the real-world effectiveness and cost of simeprevir (SMV), and/or sofosbuvir (SOF)-based therapy for chronic hepatitis C virus (HCV) infection. METHODS: The real-world performance of patients treated with SMV/SOF ± ribavirin (RBV), SOF/RBV, and SOF/RBV with pegylated-interferon (PEG) were analyzed in a consecutive series of 508 patients with chronic HCV infection treated at a single academic medical center. Patients with genotypes 1 through 4 were included...
November 12, 2017: World Journal of Virology
https://www.readbyqxmd.com/read/29146520/patterns-of-resistance-associated-substitutions-in-patients-with-chronic-hcv-infection-following-treatment-with-direct-acting-antivirals
#16
Julia Dietz, Simone Susser, Johannes Vermehren, Kai-Henrik Peiffer, Georgios Grammatikos, Annemarie Berger, Peter Ferenci, Maria Buti, Beat Müllhaupt, Bela Hunyady, Holger Hinrichsen, Stefan Mauss, Jörg Petersen, Peter Buggisch, Gisela Felten, Dietrich Hüppe, Gaby Knecht, Thomas Lutz, Eckart Schott, Christoph Berg, Ulrich Spengler, Thomas von Hahn, Thomas Berg, Stefan Zeuzem, Christoph Sarrazin
BACKGROUND & AIMS: Little is known about substitutions that mediate resistance of HCV to direct-acting antivirals (DAAs), due to the small number of patients with treatment failure in approval studies. It is important to identify resistance patterns to select effective salvage treatments. METHODS: We performed a comprehensive analysis for resistance-associated substitutions (RASs) in HCV genes (NS3, NS5A, NS5B) targeted by DAAs. We compared NS3, NS5A, and NS5B sequences from 626 patients in Europe with DAA failure with sequences from 2322 DAA-naïve patients, infected with HCV genotypes 1-4...
November 13, 2017: Gastroenterology
https://www.readbyqxmd.com/read/29124899/simeprevir-oxidative-degradation-product-molecular-modeling-in-silico-toxicity-and-resolution-by-synchronous-spectrofluorimetry
#17
Khalid A M Attia, Nasr M El-Abasawi, Ahmed El-Olemy, Ahmed Serag
In this article, one of the potential degradation products of the novel antiviral drug simeprevir was isolated and characterized by means of infrared (IR) and mass spectrometry. Moreover, comparative molecular docking, ADMET (absorption, distribution, metabolism, excretion - toxicity) and insilico toxicity prediction studies were applied to evaluate the activity of simeprevir and its degradation product. Furthermore,a simple, accurate and selective second derivative synchronous spectrofluorimetric method was developed for the determination of simeprevir in the presence of its oxidative degradation product...
November 10, 2017: Luminescence: the Journal of Biological and Chemical Luminescence
https://www.readbyqxmd.com/read/29091196/efficacy-and-safety-of-direct-antiviral-agents-in-a-cohort-of-cirrhotic-hcv-hiv-coinfected-patients
#18
Jordi Navarro, Montserrat Laguno, Helem Haydee Vilchez, Jose M Guardiola, Jose A Carrion, Luis Force, Mireia Cairó, Carmen Cifuentes, Josep Vilaró, Josep Cucurull, Andrés Marco, Mercè Roget, Eva Erice, Manuel Crespo
Background: New direct-acting antiviral agents (DAAs) have shown great efficacy and tolerability in clinical trials and real-life cohorts. However, data are scarce regarding efficacy and safety in cirrhotic HCV/HIV-coinfected patients. Methods: A multicentre prospective analysis was performed in 13 Spanish hospitals, including all cirrhotic HCV/HIV-coinfected patients starting DAA combinations from January to December 2015. Sustained virological response 12 weeks after treatment (SVR12) was analysed...
October 1, 2017: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/29029135/small-increase-in-dolutegravir-trough-but-equivalent-total-dolutegravir-exposure-with-simeprevir-in-hiv-hcv-seronegative-volunteers
#19
Christine E MacBrayne, Jose Castillo-Mancilla, James R Burton, Samantha MaWhinney, Charlotte B Wagner, Kestutis Micke, Jordan Fey, Ryan T Huntley, Bayli Larson, Lane R Bushman, Jennifer J Kiser
Background: Dolutegravir, an HIV integrase strand-transfer inhibitor, and simeprevir, an HCV NS3/4A PI, have the potential to interact as dolutegravir is a P-glycoprotein, uridine glucuronosyl transferase 1A1 and cytochrome P450 3A substrate and simeprevir has been shown to mildly inhibit these. Objectives: To compare dolutegravir and simeprevir pharmacokinetics (PK) when given separately versus in combination. Methods: Healthy volunteers received: (i) 150 mg of simeprevir once daily for 7 days; (ii) 50 mg of dolutegravir once daily for 7 days; and (iii) 150 mg of simeprevir once daily plus 50 mg of dolutegravir once daily for 7 days, with randomization to treatment sequence...
October 4, 2017: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/28992878/peginterferon-alfa-2a-for-the-treatment-of-chronic-hepatitis-c-in-the-era-of-direct-acting-antivirals
#20
REVIEW
Yan Huang, Ming-Hui Li, Min Hou, Yao Xie
BACKGROUND: The availability of novel direct-acting antivirals (DAAs) represents a new era of curative hepatitis C virus (HCV) treatment, with over 95% of patients infected with HCV genotype 1 achieving sustained virological response (SVR). Nevertheless, the majority of patients globally are unable to access these treatments because of cost and infrastructure constraints and, thus, remain untreated and uncured. DATA SOURCE: Relevant articles of peginterferon (PegIFN)-based treatments in HCV and sofosbuvir-based treatments, simeprevir, daclatasvir/asunaprevir, ritonavir-boosted paritaprevir/ombitasvir/dasabuvir, and grazoprevir/elbasvir, were searched in PubMed database, including general population and special population...
October 15, 2017: Hepatobiliary & Pancreatic Diseases International: HBPD INT
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