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https://www.readbyqxmd.com/read/28425406/curing-chronic-hepatitis-c-a-cost-comparison-of-the-combination-simeprevir-plus-sofosbuvir-vs-protease-inhibitor-based-triple-therapy
#1
Jacob A Langness, David Tabano, Amanda Wieland, Sarah Tise, Lindsay Pratt, Lauren Ayres Harrington, Sonia Lin, Vahram Ghuschcyan, Kavita V Nair, Gregory T Everson
INTRODUCTION: Interferon-free, multi-direct acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection is highly effective and well tolerated, but costly. To gain perspective on the evolving economics of HCV therapy, we compared the cost per cure of a multi-DAA regimen with the prior standard of triple therapy. MATERIAL AND METHODS: Patients infected with HCV genotype 1 who were treated through the University of Colorado Hepatology Clinic between May 2011 and December 2014 comprised the study population...
May 2017: Annals of Hepatology
https://www.readbyqxmd.com/read/28416232/experience-in-real-clinical-practice-with-new-direct-acting-antivirals-in-chronic-hepatitis-c
#2
Fernando Manuel Jiménez-Macías, Manuel Cabanillas-Casafranca, Marta Maraver-Zamora, Gema Romero-Herrera, Federico García-García, Antonio Correia-Varela-Almeida, Ana Cabello-Fernández, Manuel Ramos-Lora
INTRODUCTION AND OBJECTIVE: Inclusion of direct-acting antivirals into clinical practice in patients with chronic HCV (CHC) has been a milestone in medicine. PATIENTS AND METHODS: Analytical, prospective study, involving 126 patients with chronic HCV treated with direct-acting antivirals. Efficacy and safety of treatment and factors associated with failure treatment were evaluated. RESULTS: Age 54±10. Male (70%). Cirrhosis (60%). Distribution according to genotypes: G1a (31%), G1b (42%); G3 (14%); G4 (13%)...
April 14, 2017: Medicina Clínica
https://www.readbyqxmd.com/read/28412381/optimal-efficacy-of-interferon-free-hcv-retreatment-after-protease-inhibitors-failure-in-real-life
#3
Valeria Cento, Silvia Barbaliscia, Ilaria Lenci, Tina Ruggiero, Carlo Federico Magni, Stefania Paolucci, Sergio Babudieri, Massimo Siciliano, Caterina Pasquazzi, Alessia Ciancio, Carlo Federico Perno, Francesca Ceccherini-Silberstein
OBJECTIVES: First-generation protease-inhibitors (PIs) had suboptimal efficacy in GT-1 patients with advanced liver disease, and those who failed may need urgent retreatment. Our objective was to analyze the real-life efficacy of interferon (IFN)-free retreatment after PI-failure, and the role of genotypic-resistance-testing (GRT) in guiding retreatment choice. METHODS: In this multi-center observational study, patients retreated with IFN-free regimens after first-generation PI-failure (telaprevir-boceprevir-simeprevir) were included...
April 12, 2017: Clinical Microbiology and Infection
https://www.readbyqxmd.com/read/28370880/long-term-outcomes-of-daas-in-post-transplant-advanced-hcv-recurrence-and-fibrosing-cholestatic-hepatitis
#4
Ranka Vukotic, Fabio Conti, Stefano Fagiuoli, Maria Cristina Morelli, Luisa Pasulo, Maria Colpani, Francesco Giuseppe Foschi, Sonia Berardi, Paolo Pianta, Michele Mangano, Maria Francesca Donato, Federica Malinverno, Sara Monico, Mariarosa Tamè, Giuseppe Mazzella, Luca Saverio Belli, Raffaella Viganò, Paola Carrai, Patrizia Burra, Francesco Paolo Russo, Ilaria Lenci, Pierluigi Toniutto, Manuela Merli, Laura Loiacono, Rosamaria Iemmolo, Anna Maria Degli Antoni, Antonietta Romano, Antonio Picciotto, Maria Rendina, Pietro Andreone
Long-term functional outcomes of sofosbuvir-based antiviral treatment were evaluated in a cohort-study involving 16 Italian centers within the international compassionate-use program for post-transplant HCV-recurrence. Seventy-three patients with cirrhosis (n=52) or fibrosing cholestatic hepatitis (FCH, n=21) received 24-weeks sofosbuvir with ribavirin±pegylated interferon or interferon-free sofosbuvir-based regimen with daclatasvir/simeprevir+ribavirin. The patients were observed for a median time of 103 (82-112) weeks...
March 28, 2017: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/28369411/sofosbuvir-daclatasvir-simeprevir-plus-ribavirin-in-direct-acting-antiviral-experienced-hepatitis-c-patients
#5
Christophe Hézode, Slim Fourati, Stéphane Chevaliez, Giovanna Scoazec, Alexandre Soulier, Anne Varaut, Murielle François, Isaac Ruiz, Françoise Roudot-Thoraval, Ariane Mallat, Jean-Michel Pawlotsky
We assessed the broadly-used, off-label combination of sofosbuvir, daclatasvir, simeprevir and ribavirin in DAA-experienced patients, as recommended in current guidelines despite scarce data. After 24 weeks' treatment, six patients (60%) achieved sustained virologic response at 12 weeks. Two cirrhotic patients relapsed and two discontinued treatment due to serious adverse events.
March 10, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/28322919/evaluation-of-preclinical-antimalarial-drugs-which-can-overcome-direct-acting-antivirals-resistant-hepatitis-c-viruses-using-the-viral-reporter-assay-systems
#6
Youki Ueda, Hiromichi Dansako, Shinya Satoh, Hye-Sook Kim, Yusuke Wataya, Hiroyuki Doi, Masanori Ikeda, Nobuyuki Kato
Persistent hepatitis C virus (HCV) infection causes chronic liver diseases and is a major global health problem. Recently developed treatments with direct-acting antivirals (DAAs) have largely improved the sustained virologic response rate of patients with chronic hepatitis C. However, this approach is still hindered by its great expense and the problem of drug resistance. Using our cell-based HCV assay systems, we reported that the preclinical antimalarial drugs N-89 and N-251 exhibited potent anti-HCV activities...
March 18, 2017: Virus Research
https://www.readbyqxmd.com/read/28321163/optimizing-hepatitis-c-virus-treatment-through-pharmacist-interventions-identification-and-management-of-drug-drug-interactions
#7
Jacob A Langness, Matthew Nguyen, Amanda Wieland, Gregory T Everson, Jennifer J Kiser
AIM: To quantify drug-drug-interactions (DDIs) encountered in patients prescribed hepatitis C virus (HCV) treatment, the interventions made, and the time spent in this process. METHODS: As standard of care, a clinical pharmacist screened for DDIs in patients prescribed direct acting antiviral (DAA) HCV treatment between November 2013 and July 2015 at the University of Colorado Hepatology Clinic. HCV regimens prescribed included ledipasvir/sofosbuvir (LDV/SOF), paritaprevir/ritonavir/ombitasvir/dasabuvir (OBV/PTV/r + DSV), simeprevir/sofosbuvir (SIM/SOF), and sofosbuvir/ribavirin (SOF/RBV)...
March 7, 2017: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/28320588/herpes-zoster-reactivation-in-patients-with-chronic-hepatitis-c-under-treatment-with-directly-acting-antiviral-agents-a-case-series
#8
Mohamed El Kassas, Mohamed Naguib Wifi, Reem Mahdy, Shimaa Afify, Enas Hafez, Yasmeen Abd El Latif, Marwa Ezzat, Adel El Tahan, Naglaa Youssef, Gamal Esmat
We report a series of cutaneous Herpes Zoster (HZ) reactivation cases in patients with hepatitis C virus (HCV) infection treated with directly acting antiviral (DAA) agents. Five cases were detected among 2133 treated patients with DAAs at one of the specialized viral hepatitis treatment centers in Egypt. A control group including 2300 age and sex matched HCV patients who were previously treated with pegylated interferon and ribavirin did not show any HZ reactivation reports while on treatment. None of cases had an evidence of immunosuppression or a risk factor for HZ reactivation...
March 2017: Arab Journal of Gastroenterology: the Official Publication of the Pan-Arab Association of Gastroenterology
https://www.readbyqxmd.com/read/28295849/efficacy-safety-and-pharmacokinetics-of-simeprevir-daclatasvir-and-ribavirin-in-patients-with-recurrent-hepatitis-c-virus-genotype-1b-infection-after-orthotopic-liver-transplantation-the-phase-ii-saturn-study
#9
Xavier Forns, Marina Berenguer, Kerstin Herzer, Martina Sterneck, Maria Francesca Donato, Pietro Andreone, Stefano Fagiuoli, Tomasz Cieciura, Magdalena Durlik, Jose Luis Calleja, Zoe Mariño, Umesh Shukla, Thierry Verbinnen, Oliver Lenz, Sivi Ouwerkerk-Mahadevan, Monika Peeters, Katrien Janssen, Ronald Kalmeijer, Wolfgang Jessner
BACKGROUND: Recurrent hepatitis C virus (HCV) infection following liver transplantation is associated with accelerated progression to graft failure and reduced patient survival. METHODS: The Phase II, open-label SATURN study (NCT01938625) investigated the combination of simeprevir (SMV), daclatasvir (DCV), and ribavirin (RBV) administered for 24 weeks in 35 patients with recurrent HCV genotype (GT) 1b infection after orthotopic liver transplantation (OLT). RESULTS: High rates of both on-treatment and sustained virologic response 12 weeks after end of treatment (SVR12) were achieved in patients who were either treatment-naïve or had failed post-OLT treatment with peginterferon and RBV...
March 13, 2017: Transplant Infectious Disease: An Official Journal of the Transplantation Society
https://www.readbyqxmd.com/read/28286567/grazoprevir-elbasvir-combination-therapy-for-hcv-infection
#10
REVIEW
Anaïs Vallet-Pichard, Stanislas Pol
Interferon-free regimens combine different second-wave direct-acting antiviral agents (DAAs), which target the main viral proteins involved in the replication cycle of hepatitis C virus (HCV): NS3/4A protease inhibitors (simeprevir or paritaprevir boosted by ritonavir), NS5B nucleos(t)idic (sofosbuvir) and nonnucleos(t)idic (dasabuvir) polymerase inhibitors, NS5A replication complex inhibitors (daclatasvir, ledipasvir, elbasvir, velpatasvir). Combinations of two or three DAAs, given for 8-24 weeks reach sustained virology response (SVR) rates greater than 90% with good tolerance...
January 2017: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/28286560/prevalence-of-end-of-treatment-rna-positive-sustained-viral-response-in-hcv-patients-treated-with-sofosbuvir-combination-therapies
#11
Miguel Malespin, Tamara Benyashvili, Susan L Uprichard, Alan S Perelson, Harel Dahari, Scott J Cotler
BACKGROUND: Some chronic hepatitis C virus (HCV), genotype 1 infected patients treated with direct antiviral agents (DAAs) remain viremic at end of treatment (EOT+), yet go on to achieve sustained virological response 12 weeks after completion of therapy (SVR12). The incidence of EOT+/SVR in patients with genotype 1 and other genotypes, as well as whether such patients achieve SVR24 remain in question. The aims of this study were to evaluate the frequency and durability of EOT+/SVR12&24 and other response categories in HCV genotype 1, 2, or 3 infected patients treated with DAA in clinical practice...
January 2017: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/28280374/optimizing-choice-of-oral-interferon-free-treatment-for-genotype-1-hepatitis-c-virus-using-testing-for-ns5a-resistance-a-cost-utility-analysis-from-the-perspective-of-the-italian-national-health-service
#12
Kirsten Y Westerhout, Walter Bouwmeester, Inge Duchesne, Marta Pisini, Marjanne A Piena, Francesco Damele, Beatrice Gueron, Maarten Treur, Jonathan Belsey
BACKGROUND: Patients with genotype-1 hepatitis C virus infection who have failed to respond to standard therapy or who relapse following treatment may be considered for an interferon-free regimen incorporating a nonstructural protein 5A (NS5A) inhibitor. Sustained virologic response (SVR) with these regimens is typically >90%, but this is reduced in patients with NS5A resistance. European Association for Study of the Liver guidelines recommend simeprevir + sofosbuvir ± ribavirin (SMV+SOF±R) for re-treating patients failing an NS5A inhibitor-containing regimen...
2017: ClinicoEconomics and Outcomes Research: CEOR
https://www.readbyqxmd.com/read/28274850/direct-acting-antiviral-therapy-restores-immune-tolerance-to-patients-with-hepatitis-c-virus-induced-cryoglobulinemia-vasculitis
#13
Cloé Comarmond, Marlène Garrido, Stanislas Pol, Anne-Claire Desbois, Myrto Costopoulos, Magali Le Garff-Tavernier, Si Nafa Si Ahmed, Laurent Alric, Hélène Fontaine, Bertrand Bellier, Anna Maciejewski, Michelle Rosenzwajg, David Klatzmann, Lucile Musset, Thierry Poynard, Patrice Cacoub, David Saadoun
BACKGROUND & AIMS: Interferon-free direct-acting antiviral (DAA) therapies are effective in patients with hepatitis C virus-induced cryoglobulinemia vasculitis (HCV-CV). We analyzed blood samples from patients with HCV-CV before and after DAA therapy to determine mechanisms of these drugs and their effects on cellular immunity. METHODS: We performed a prospective study of 27 consecutive patients with HCV-CV (median age 59 years) treated with DAA therapy (21 patients received sofosbuvir plus ribavirin for 24 weeks, 4 patients received sofosbuvir plus daclatasvir for 12 weeks, and 2 patients received sofosbuvir plus simeprevir for 12 weeks) in Paris, France...
March 5, 2017: Gastroenterology
https://www.readbyqxmd.com/read/28271521/transformation-of-hepatitis-c-antiviral-treatment-in-a-national-healthcare-system-following-the-introduction-of-direct-antiviral-agents
#14
A M Moon, P K Green, K Berry, G N Ioannou
BACKGROUND: Highly effective direct antiviral agents (DAAs) for hepatitis C virus (HCV) were introduced recently. Their utilisation has been limited by high cost and low access to care. AIM: To describe the effect of DAAs on HCV treatment and cure rates in the United States Veterans Affairs (VA) national healthcare system. METHODS: We identified all HCV antiviral treatment regimens initiated from 1 January 1999 to 31 December 2015 (n = 105 369) in the VA national healthcare system, and determined if they resulted in sustained virological response (SVR)...
May 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28270091/implications-of-hepatitis-c-virus-subtype-1a-migration-patterns-for-virus-genetic-sequencing-policies-in-italy
#15
Lize Cuypers, Bram Vrancken, Lavinia Fabeni, Nadia Marascio, Valeria Cento, Velia Chiara Di Maio, Marianna Aragri, Andrea Clemencia Pineda-Peña, Yoeri Schrooten, Kristel Van Laethem, Daniel Balog, Alfredo Focà, Carlo Torti, Frederik Nevens, Carlo Federico Perno, Anne-Mieke Vandamme, Francesca Ceccherini-Silberstein
BACKGROUND: In-depth phylogeographic analysis can reveal migration patterns relevant for public health planning. Here, as a model, we focused on the provenance, in the current Italian HCV subtype 1a epidemic, of the NS3 resistance-associated variant (RAV) Q80K, known to interfere with the action of NS3/4A protease inhibitor simeprevir. HCV1a migration patterns were analysed using Bayesian phylodynamic tools, capitalising on newly generated and publicly available time and geo-referenced NS3 encoding virus genetic sequence data...
March 7, 2017: BMC Evolutionary Biology
https://www.readbyqxmd.com/read/28270038/inf-free-sofosbuvir-based-treatment-of-post-transplant-hepatitis-c-relapse-a-swedish-real-life-experience
#16
Castedal Maria, Segenmark Michael, Cederberg Susanne, Skoglund Catarina, Weiland Ola
BACKGROUND: Relapse of hepatitis C virus (HCV) infection after liver transplantation has been universal, and the fibrosis progression faster than in non-transplanted patients. Interferon (IFN)-free treatment with direct antiviral agents (DAA) has improved the treatment outcome dramatically. We here report on the outcome of IFN-free treatment for HCV relapse after liver transplantation in a real life setting in Sweden. MATERIAL: In total, 93 patients with a mean age of 60 years (range 32-80) with HCV relapse after liver transplantation were given sofosbuvir-based treatment in combination with a protease inhibitor (simeprevir) or a NS5A inhibitor (daclatasvir or ledipasvir) with or without addition of ribavirin (RBV), or sofosbuvir and RBV only...
May 2017: Scandinavian Journal of Gastroenterology
https://www.readbyqxmd.com/read/28261822/systematic-review-interferon-free-regimens-for-patients-with-hcv-related-child-c-cirrhosis
#17
REVIEW
M Guarino, F Morisco, M R Valvano, A M Ippolito, M Librandi, N Andriulli, M Greco, A Amoruso, A Iacobellis, G Niro, N Caporaso, A Andriulli
BACKGROUND: It is unclear whether the efficacy and long-term outcome of treating patients with hepatitis C virus (HCV)-positive cirrhosis with the new protease inhibitors will extend to those with Child C cirrhosis. AIM: To assess the effectiveness of the interferon-free regimens in Child C cirrhotic patients with HCV infection. METHODS: A systematic Medline search was conducted to retrieve studies describing the treatment of Child C patients with direct-acting agents...
May 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28261382/efficacy-and-safety-of-telaprevir-and-simeprevir-based-triple-therapies-for-older-patients-with-chronic-hepatitis-c
#18
Satoshi Yamagiwa, Toru Ishikawa, Nobuo Waguri, Soichi Sugitani, Hiroto Wakabayashi, Shogo Ohkoshi, Takashi Tsukishiro, Toru Takahashi, Toshiaki Watanabe, Shuji Terai
AIM: To evaluate and compare the efficacy and safety of telaprevir (TVR)-and simeprevir (SMV)-based triple therapies in elderly patients, specifically patients aged 66 years or older. METHODS: The present study enrolled 112 and 76 Japanese patients with chronic hepatitis C virus genotype 1b infection who were treated with a 12-wk TVR-based or SMV-based triple therapy, respectively, followed by a dual therapy that included pegylated interferon α and ribavirin (RBV) for 12 wk...
February 18, 2017: World Journal of Hepatology
https://www.readbyqxmd.com/read/28228479/unraveling-the-structural-basis-of-grazoprevir-potency-against-clinically-relevant-substitutions-in-hepatitis-c-virus-ns3-4a-protease-from-genotype-1a
#19
Zhuyan Guo, Stuart Black, Yuan Hu, Patricia McMonagle, Paul Ingravallo, Robert Chase, Stephanie Curry, Ernest Asante-Appiah
Grazoprevir is a potent pan-genotype and macrocyclic inhibitor of hepatitis C virus (HCV) NS3/4A protease and was developed for treating chronic HCV infection. In HCV genotype (GT) 1a, grazoprevir maintains potent activity against a majority of NS3 resistance-associated amino acid substitutions, including the highly prevalent and naturally occurring Q80K polymorphism that impacts simeprevir, another NS3/4A protease inhibitor. The basis for an unexpected difference in the clinical impact of some NS3 substitutions was investigated...
April 14, 2017: Journal of Biological Chemistry
https://www.readbyqxmd.com/read/28187751/efficacy-safety-and-pharmacokinetics-of-simeprevir-and-tmc647055-ritonavir-with-or-without-ribavirin-and-jnj-56914845-in-hcv-genotype-1-infection
#20
RANDOMIZED CONTROLLED TRIAL
Stefan Bourgeois, Hans Van Vlierberghe, Christophe Moreno, Hans Orlent, Frederik Nevens, Keikawus Arastéh, Yves Horsmans, Jörn M Schattenberg, Peter Buggisch, Sven Francque, Leen Vijgen, Thomas N Kakuda, Eva Hoeben, Donghan Luo, An Vandebosch, Bert Jacquemyn, Pieter Van Remoortere, René Verloes
BACKGROUND: A Phase 2a, open-label study (NCT01724086) was conducted to assess the efficacy and safety of a once-daily, 2-direct-acting-antiviral-agent (2-DAA) combination of simeprevir + TMC647055/ritonavir ± ribavirin and of the 3-DAA combination of simeprevir + TMC647055/ritonavir + JNJ-56914845 in chronic hepatitis C virus genotype (GT)1-infected treatment-naïve and prior-relapse patients. METHODS: The study comprised four 12-week treatment panels: Panel 1 (n = 10; GT1a) and Panel 2-Arm 1 (n = 12; GT1b): simeprevir 75 mg once daily + TMC647055 450 mg once daily/ritonavir 30 mg once daily + ribavirin 1000-1200 mg/day; Panel 2-Arm 2 (n = 9; GT1b): simeprevir 75 mg + TMC647055 450 mg/ritonavir 30 mg without ribavirin; Panel 3: simeprevir 75 mg + TMC647055 600 mg/ritonavir 50 mg with (Arm 1: GT1a; n = 7) or without (Arm 2: GT1b; n = 8) ribavirin; Panel 4: simeprevir 75 mg + TMC647055 450 mg/ritonavir 30 mg + JNJ-56914845 30 mg once daily (Arm 1: n = 22; GT1a/GT1b) or 60 mg once daily (Arm 2: n = 22; GT1a/GT1b)...
February 10, 2017: BMC Gastroenterology
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