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https://www.readbyqxmd.com/read/29582685/-real-life-experience-with-direct-acting-antiviral-agents-for-hepatitis-c-virus-in-end-stage-renal-disease
#1
Rebeca García-Agudo, Sami Aoufi-Rabih, Mercedes Salgueira-Lazo, Carmen González-Corvillo, Fabrizio Fabrizi
BACKGROUND AND AIMS: The advent of direct-acting antiviral agents promises to change the management of hepatitis C in patients with end-stage renal disease, a patient group where the treatment of hepatitis C was historically challenging. We investigated the safety and efficacy of all-oral, interferon-free direct-acting antiviral agents for the treatment of hepatitis C in a 'real-world' group of patients with end-stage renal disease. METHODS: We performed a single-arm, multi-centre study in a cohort (n=30) of patients with advanced chronic kidney disease (mostly on dialysis) who underwent antiviral therapy with direct-acting antiviral agents...
March 1, 2018: International Journal of Artificial Organs
https://www.readbyqxmd.com/read/29579872/therapy-with-direct-acting-antiviral-agents-for-hepatitis-c-in-liver-transplant-recipients
#2
F Nogueras López, A López Garrido, E J Ortega Suazo, F Vadillo Calles, F Valverde López, M D Espinosa Aguilar
BACKGROUND: Recurrent infection with the hepatitis C virus (HCV) after liver transplantation (LT) is associated with decreased graft and patient survival. Direct-acting antiviral (DAA) therapies have changed the landscape of HCV due to their excellent safety profile and cure rates. Our aim was to evaluate the efficacy and tolerability of antiviral therapy in recurrent HCV after LT with DAA therapy. METHODS: Our retrospective analysis included 46 LT recipients with HCV recurrence...
March 2018: Transplantation Proceedings
https://www.readbyqxmd.com/read/29572811/teledermatologist-expert-skin-advice-a-unique-model-of-care-for-managing-skin-disorders-and-adverse-drug-reactions-in-hepatitis-c-patients
#3
Samuel Charlston, Gregory Siller
OBJECTIVES: To conduct an audit of teledermatologist expert skin advice, a store and forward tele-dermatological service, to determine its effectiveness and user satisfaction in managing cutaneous adverse drug reactions in patients with hepatitis C, and to demonstrate a unique collaborative model of care for patients receiving specialised drug therapy. METHODS: A retrospective analysis of data on teledermatologist expert skin advice referrals from January 2014 to December 2015 was performed...
March 23, 2018: Australasian Journal of Dermatology
https://www.readbyqxmd.com/read/29572333/risk-of-clinically-relevant-pharmacokinetic-based-drug-drug-interactions-with-drugs-approved-by-the-u-s-food-and-drug-administration-between-2013-and-2016
#4
Jingjing Yu, Zhu Zhou, Jessica Tay-Sontheimer, Rene H Levy, Isabelle Ragueneau-Majlessi
A total of 103 drugs (including 14 combination drugs) were approved by the U.S. Food and Drug Administration from 2013 to 2016. Pharmacokinetic-based drug interaction profiles were analyzed using the University of Washington Drug Interaction Database and the clinical relevance of these observations was characterized based on information from New Drug Application reviews. CYP3A was identified as a major contributor to clinical drug-drug interactions (DDIs), involved in approximately 2/3 of all interactions. Transporters (alone or with enzymes) were found to participate in about half of all interactions, although most of these were weak-to-moderate interactions...
March 23, 2018: Drug Metabolism and Disposition: the Biological Fate of Chemicals
https://www.readbyqxmd.com/read/29569736/safety-and-efficacy-of-ledipasvir-sofosbuvir-with-or-without-ribavirin-in-hepatitis-c-genotype-1-patients-including-those-with-decompensated-cirrhosis-who-failed-prior-treatment-with-simeprevir-sofosbuvir
#5
A A Modi, H E Nazario, G R Gonzales, S A Gonzalez
BACKGROUND: Combination therapy of simeprevir (SIM)/sofosbuvir (SOF) is an approved treatment for hepatitis C genotype (gen) 1 with overall SVR12 rate of 85%-95%. The single tablet fixed-dose combination of ledipasvir (LDV)/SOF is also approved for gen 1 with sustained virologic response at 12 weeks (SVR12) rates ≥95%. No data are available on the efficacy of retreatment with LDV/SOF in patients who failed initial treatment with SIM/SOF. AIM: Our aim was to evaluate the efficacy of retreatment with LDV/SOF ± ribavirin (RBV) in gen 1 patients who had previously failed treatment with SIM/SOF...
March 23, 2018: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29549787/identification-of-nucleotides-in-the-5-utr-and-amino-acids-substitutions-that-are-essential-for-the-infectivity-of-5-utr-ns5a-recombinant-of-hepatitis-c-virus-genotype-1b-strain-con1
#6
Jinqian Li, Shengjun Feng, Xi Liu, Mingzhe Guo, Mingxiao Chen, Yiyi Chen, Liang Rong, Jinyu Xia, Yuanping Zhou, Jin Zhong, Yi-Ping Li
Genotype 1b strain Con1 represents an important reference in the study of hepatitis C virus (HCV). Here, we aimed to develop an advanced infectious Con1 recombinant. We found that previously identified mutations A1226G/F1464L/A1672S/Q1773H permitted culture adaption of Con1 Core-NS5A (C-5A) recombinant containing 5'UTR and NS5B-3'UTR from JFH1 (genotype 2a), thus acquired additional mutations L725H/F886L/D2415G. C-5A containing all seven mutations (C-5A_7m) replicated efficiently in Huh7.5 and Huh7.5.1 cells and had an increased infectivity in SEC14L2-expressing Huh7...
March 14, 2018: Virology
https://www.readbyqxmd.com/read/29504152/the-adverse-effects-of-interferon-free-regimens-in-149-816-chronic-hepatitis-c-treated-egyptian-patients
#7
D Attia, K El Saeed, W Elakel, T Elbaz, A Omar, A Yosry, M H Elsayed, M El Raziky, M Anees, W Doss, Y El Shazly, H Wedemeyer, G Esmat
BACKGROUND: Interferon-free regimens are associated with high sustained virological response; however, associated adverse effects have yet to be fully reported. AIM: To evaluate the adverse effects associated with the different direct-acting antiviral drug (DAA) regimens in Egyptian patients. METHODS: This multicenter retrospective study included all adverse effects during and after treatment with DAA regimens of 149 816 chronic hepatitis C treated Egyptian patients...
March 5, 2018: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29493385/use-of-next-generation-sequencing-in-the-chat-study-acute-hcv-in-hiv-effect-of-baseline-resistance-associated-ns3-variants-on-treatment-failure
#8
Gurmit Kaur Jagjit Singh, Steve Kaye, James C Abbott, Christoph Boesecke, Juergen Rockstroh, Myra O McClure, Mark Nelson
Background The epidemic of acute HCV infection among HIV-infected men who have sex with men (MSM) is ongoing. Transmission of drug-resistant variants (DRVs) after HCV treatment failure could pose a major threat to the effectiveness of future therapies. We determined the baseline prevalence of pre-existing DRVs in the HCV NS3 protease gene and their effects on the addition of telaprevir (TVR) to standard pegylated interferon and ribavirin (PEG-IFN/RBV) for acute HCV infection in individuals enrolled in a multicentre randomized controlled trial (2013 and 2014)...
March 1, 2018: HIV Clinical Trials
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
#9
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
#10
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
#11
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
#12
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
#13
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
#14
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
#15
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-hepatitis-c-virus-treatments-using-quality-of-life-scoring-among-patients-with-chronic-liver-disease-in-hiroshima-prefecture-japan
#16
Terumi Kaishima, Tomoyuki Akita, Masayuki Ohisa, Kazuaki Sakamune, Akemi Kurisu, Aya Sugiyama, Hiroshi Aikata, Kazuaki Chayama, Junko Tanaka
AIM: We estimated the cost-effectiveness of direct-acting antiviral treatment (DAA) compared to triple therapy (simeprevir, pegylated interferon-α [Peg-IFN], and ribavirin [RBV]) (scenario 1), Peg-IFN + RBV (scenario 2), and non-antiviral therapy (scenario 3). METHODS: 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
#17
Mario Starace, Carmine Minichini, Stefania De Pascalis, Margherita Macera, Laura Occhiello, Vincenzo Messina, Vincenzo Sangiovanni, Luigi E Adinolfi, Ernesto Claar, Davide Precone, Gianfranca Stornaiuolo, Maria Stanzione, Tiziana Ascione, Mara Caroprese, Rosa Zampino, Gianpaolo Parrilli, Ivan Gentile, Giuseppina Brancaccio, Vincenzo Iovinella, Salvatore Martini, Mario Masarone, Luca Fontanella, Addolorata Masiello, Evangelista Sagnelli, Rodolfo Punzi, Angelo Salomone Megna, Renato Santoro, Giovanni B Gaeta, Nicola Coppola
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. 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. Sanger sequencing of NS3, NS5A, and NS5B regions was performed at failure by home-made protocols...
May 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
#18
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
#19
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
#20
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
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