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https://www.readbyqxmd.com/read/27920481/new-real-time-pcr-method-to-identify-single-point-mutations-in-hepatitis-c-virus
#1
Qian Chen, Irene Belmonte, Maria Buti, Leonardo Nieto, Damir Garcia-Cehic, Josep Gregori, Celia Perales, Laura Ordeig, Meritxell Llorens, Maria Eugenia Soria, Rafael Esteban, Juan Ignacio Esteban, Francisco Rodriguez-Frias, Josep Quer
AIM: To develop a fast, low-cost diagnostic strategy to identify single point mutations in highly variable genomes such as hepatitis C virus (HCV). METHODS: In patients with HCV infection, resistance-associated amino acid substitutions within the viral quasispecies prior to therapy can confer decreased susceptibility to direct-acting antiviral agents and lead to treatment failure and virological relapse. One such naturally occurring mutation is the Q80K substitution in the HCV-NS3 protease gene, which confers resistance to PI inhibitors, particularly simeprevir...
November 21, 2016: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/27917405/efficacy-and-safety-of-3-week-response-guided-triple-direct-acting-antiviral-therapy-for-chronic-hepatitis-c-infection-a-phase-2-open-label-proof-of-concept-study
#2
George Lau, Yves Benhamou, Guofeng Chen, Jin Li, Qing Shao, Dong Ji, Fan Li, Bing Li, Jialiang Liu, Jinlin Hou, Jian Sun, Cheng Wang, Jing Chen, Vanessa Wu, April Wong, Chris L P Wong, Stella T Y Tsang, Yudong Wang, Leda Bassit, Sijia Tao, Yong Jiang, Hui-Mien Hsiao, Ruian Ke, Alan S Perelson, Raymond F Schinazi
BACKGROUND: To shorten the course of direct-acting antiviral agents for chronic hepatitis C virus (HCV) infection, we examined the antiviral efficacy and safety of 3 weeks of response-guided therapy with an NS3 protease inhibitor and dual NS5A inhibitor-NS5B nucleotide analogue. METHODS: In this open-label, phase 2a, single centre study, Chinese patients with chronic HCV genotype 1b infection without cirrhosis were randomly allocated by a computer program to one of three treatment groups (sofosbuvir, ledipasvir, and asunaprevir; sofosbuvir, daclatasvir, and simeprevir; or sofosbuvir, daclatasvir, and asunaprevir) until six patients in each group (1:1:1) achieved an ultrarapid virological response (plasma HCV RNA <500 IU/mL by day 2, measured by COBAS TaqMan HCV test, version 2...
October 2016: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/27917084/sofosbuvir-and-simeprevir-combination-therapy-for-hcv-genotype-1-infection-results-of-a-single-center-va-experience
#3
Seth N Sclair, Maria Del Pilar Hernandez, Evan Vance, Dani Gilinski, Helen Youtseff, Maribel Toro, Marie Antoine, Lennox J Jeffers, Adam Peyton
Treatment of chronic hepatitis C virus (HCV) infection remains a priority in the veterans affairs (VA) health care system nationwide, as there is a high burden of liver disease due to HCV infection among US veterans. The combination of sofosbuvir and simeprevir was the first all-oral antiviral regimen used in clinical practice to treat veterans with HCV infection. In this study, we report a single-center experience showing both the feasibility and effectiveness of this all-oral combination to treat HCV genotype 1 infection...
August 2016: Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/27914803/effectiveness-of-direct-acting-antivirals-in-hepatitis-c-virus-infection-in-haemodialysis-patients
#4
Soraya Abad, Almudena Vega, Diego Rincón, Eduardo Hernández, Evangelina Mérida, Nicolás Macías, Raquel Muñoz, Mónica Milla, Jose Luño, Juan Manuel López-Gómez
Hepatitis C virus (HCV) infection is highly prevalent among patients on haemodialysis and leads to a poorer prognosis compared to patients who do not have said infection. Treatment with interferon and ribavirin is poorly tolerated and there are limited data on the experience with new direct-acting antivirals (DAAs). The aim of this study is to retrospectively analyse the current prevalence of HCV infection and efficacy and safety results with different DAA regimens in the haemodialysis population of 2hospital areas...
November 30, 2016: Nefrología: Publicación Oficial de la Sociedad Española Nefrologia
https://www.readbyqxmd.com/read/27898592/the-hepatitis-c-virus-nonstructural-protein-3-q80k-polymorphism-is-frequently-detected-and-transmitted-among-hiv-infected-msm-in-the-netherlands
#5
Astrid M Newsum, Cynthia K Y Ho, Faydra I Lieveld, Thijs J W van de Laar, Sylvie M Koekkoek, Sjoerd P Rebers, Jan T M van der Meer, Anne M J Wensing, Greet J Boland, Joop E Arends, Karel J van Erpecum, Maria Prins, Richard Molenkamp, Janke Schinkel
OBJECTIVES: The Q80K polymorphism is a naturally occurring resistance-associated variant in the hepatitis C virus (HCV) nonstructural protein 3 (NS3) region and is likely transmissible between hosts. This study describes the Q80K origin and prevalence among HCV risk groups in the Netherlands and examines whether Q80K is linked to specific transmission networks. DESIGN AND METHODS: Stored blood samples from HCV genotype 1a-infected patients were used for PCR and sequencing to reconstruct the NS3 maximum likelihood phylogeny...
January 2, 2017: AIDS
https://www.readbyqxmd.com/read/27896858/efficacy-and-safety-of-simeprevir-and-sofosbuvir-with-and-without-ribavirin-in-subjects-with-recurrent-genotype-1-hepatitis-c-post-orthotopic-liver-transplant-the-randomized-galaxy-study
#6
Jacqueline G O'Leary, Robert J Fontana, Kimberly Brown, James R Burton, Roberto Firpi-Morell, Andrew Muir, Christopher O'Brien, Mordechai Rabinovitz, K Rajender Reddy, Robert Ryan, Adam Shprecher, Shirley Villadiego, Avinash Prabhakar, Robert S Brown
This prospective, randomized, phase 2 study in subjects with recurrent hepatitis C virus (HCV) genotype 1 post-orthotopic liver transplant evaluated once-daily simeprevir 150mg+sofosbuvir 400mg, with and without ribavirin 1,000mg. Primary endpoint was proportion of subjects with Week 12 sustained virologic response (SVR12). Thirty-three subjects without cirrhosis were randomized 1:1:1 into three arms (stratified by geno/subtype and Q80K): Arm 1, simeprevir+sofosbuvir+ribavirin, 12 weeks; Arm 2, simeprevir+sofosbuvir, 12 weeks; Arm 3, simeprevir+sofosbuvir, 24 weeks; 13 additional subjects (2 with cirrhosis, 11 without cirrhosis) entered Arm 3...
November 29, 2016: Transplant International: Official Journal of the European Society for Organ Transplantation
https://www.readbyqxmd.com/read/27896822/simeprevir-in-combination-with-sofosbuvir-in-treatment-na%C3%A3-ve-and-experienced-patients-with-hepatitis-c-virus-genotype-4-infection-a-phase-iii-open-label-single-arm-study-pluto
#7
M Buti, J L Calleja, S Lens, M Diago, E Ortega, J Crespo, R Planas, M Romero-Gómez, F G Rodríguez, J M Pascasio, B Fevery, D Kurland, C Corbett, R Kalmeijer, W Jessner
BACKGROUND: Hepatitis C virus (HCV) infection is a leading cause of liver cirrhosis and subsequent hepatocellular carcinoma. HCV genotype 4 is found widely in the Middle East, Egypt and Africa, and has also spread into Europe. There are limited data available regarding the use of direct-acting antiviral agents in HCV genotype 4-infected patients with cirrhosis. AIM: The Phase III, open-label, single-arm PLUTO study evaluated the efficacy and safety of 12 weeks of simeprevir (HCV NS3/4A protease inhibitor) plus sofosbuvir (HCV nucleotide-analogue NS5B polymerase inhibitor) in treatment-naïve and (peg)interferon ± ribavirin-experienced HCV genotype 4-infected patients, with or without compensated cirrhosis...
November 29, 2016: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/27896690/elucidating-the-plasma-and-liver-pharmacokinetics-of-simeprevir-in-special-populations-using-physiologically-based-pharmacokinetic-modelling
#8
Jan Snoeys, Maria Beumont, Mario Monshouwer, Sivi Ouwerkerk-Mahadevan
The disposition of simeprevir (SMV) in humans is characterised by cytochrome P450 3A4 metabolism and hepatic uptake by organic anion transporting polypeptide 1B1/3 (OATP1B1/3). This study was designed to investigate SMV plasma and liver exposure upon oral administration in subjects infected with hepatitis C virus (HCV), in subjects of Japanese or Chinese origin, subjects with organ impairment and subjects with OATP genetic polymorphisms, using physiologically based pharmacokinetic modelling. Simulations showed that compared with healthy Caucasian subjects, SMV plasma exposure was 2...
November 29, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27882839/real-world-drug-costs-of-treating-hepatitis-c-genotypes-1-4-with-direct-acting-antivirals-initiating-treatment-at-fibrosis-0-2-and-3-4
#9
Timothy A Bach, Kathy Zaiken
BACKGROUND: Direct-acting antivirals (DAA) for the treatment of hepatitis C virus (HCV) have drastically improved outcomes but are also very costly. For this reason, priority for treatment is often given to patients with a higher fibrosis score at baseline by payers and providers rather than treating all eligible patients. Simulation studies have suggested that waiting to treat patients until fibrosis 3-4 may be more costly and result in worse outcomes; however, real-world implications are unknown...
December 2016: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/27882706/high-frequency-of-potential-interactions-between-direct-acting-antivirals-and-concomitant-therapy-in-hiv-hepatitis-c-virus-coinfected-patients-in-clinical-practice
#10
J Macías, P Monge, M Mancebo, N Merchante, K Neukam, L M Real, J A Pineda
OBJECTIVES: The aim of the study was to analyse the frequency and degree of potential drug-drug interactions (DDIs) between direct-acting antivirals (DAAs) and concomitant medication used by HIV/hepatitis C virus (HCV)-coinfected patients, including antiretroviral therapy (ART) and other drugs. METHODS: All patients with HIV infection and viraemic HCV genotype 1, 3 or 4 coinfection attending a tertiary care centre in Spain (November 2014 to November 2015) were included in the study...
November 24, 2016: HIV Medicine
https://www.readbyqxmd.com/read/27878906/simeprevir-daclatasvir-and-sofosbuvir-for-hepatitis-c-virus-infected-patients-with-decompensated-liver-disease
#11
E Lawitz, F Poordad, J A Gutierrez, T N Kakuda, G Picchio, G Beets, A Vandevoorde, P Van Remoortere, B Jacquemyn, D Luo, S Ouwerkerk-Mahadevan, L Vijgen, V Van Eygen, M Beumont
Approximately three million individuals in the United States are chronically infected with hepatitis C virus (HCV). Chronic HCV infection may lead to the development of compensated as well as decompensated liver cirrhosis. The Phase II IMPACT study was conducted in HCV genotype 1- or 4-infected cirrhotic patients with portal hypertension or decompensated liver disease and assessed for the first time the combination of the three direct-acting antivirals simeprevir, daclatasvir and sofosbuvir. Treatment-naïve or treatment-experienced adults with Child-Pugh (CP) score <7 (CP A) and evidence of portal hypertension, or CP score 7-9 (CP B), received 12 weeks of simeprevir 150 mg, daclatasvir 60 mg and sofosbuvir 400 mg, once daily...
November 23, 2016: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/27869323/comparative-treatment-effectiveness-of-direct-acting-antiviral-regimens-for-hepatitis-c-data-from-the-veterans-administration
#12
D S Fox, J J McGinnis, I Tonnu-Mihara, J S McCombs
BACKGROUND AND AIMS: Data addressing real world effectiveness of direct acting antiviral agents in hepatitis C infected patients are now emerging. This study compared the sustained virologic response rates achieved 12 weeks post-treatment in patients treated with three such agents by the Veterans Health Administration. METHODS: A retrospective cohort study was conducted using patients who terminated treatment by July 1, 2015. Data were retrieved from the Veterans Health Administration electronic medical records system...
November 21, 2016: Journal of Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/27861593/neutrophil-and-monocyte-function-in-patients-with-chronic-hepatitis-c-undergoing-antiviral-therapy-with-regimens-containing-protease-inhibitors-with-and-without-interferon
#13
Martina Gambato, Noelia Caro-Pérez, Patricia González, Nuria Cañete, Zoe Mariño, Sabela Lens, Martín Bonacci, Concepció Bartres, José-María Sánchez-Tapias, José A Carrión, Xavier Forns, Manel Juan, Sofía Pérez-Del-Pulgar, María-Carlota Londoño
Real-life data showed an increased incidence of bacterial infections in patients with advanced liver disease receiving a protease inhibitor (PI)-containing antiviral regimen against hepatitis C (HCV). However, the causes of this event are unknown. We hypothesized that PIs might impair innate immune responses through the inhibition of proteases participating in the anti-bacterial functions of neutrophils and monocytes. The aims of the study were to assess phagocytic and oxidative burst capacity in neutrophils and monocytes obtained from patients receiving a PI containing-antiviral regimen, and to determine cytokine secretion after neutrophil stimulation with flagellin...
2016: PloS One
https://www.readbyqxmd.com/read/27846791/clinical-experience-with-dolutegravir-abacavir-lamivudine-in-hiv-hcv-co-infected-patients-treated-with-a-sofosbuvir-based-regimen-safety-and-efficacy
#14
Tamara M Johnson, Raymund Sison, James P Fallon, Prerak P Shukla, Sristi Bhattarai, Herbert Galang, Richard Habeeb, Jihad Slim
BACKGROUND: There is no known reason to suspect an adverse drug interaction between dolutegravir-based antiretroviral therapy and sofosbuvir, simeprevir, or ledipasvir. There is a paucity of clinical data for this combination. METHODS: Prospective, open-label study of patients with HIV well controlled on dolutegravir, abacavir, and lamivudine, who were co-infected with HCV genotype 1, and required therapy with simeprevir plus sofosbuvir or sofosbuvir/ledipasvir single-tablet regimen (STR) for 12 weeks...
November 2016: HIV Clinical Trials
https://www.readbyqxmd.com/read/27826322/daclatasvir-based-treatment-regimens-for-hepatitis-c-virus-infection-a-systematic-review-and-meta-analysis
#15
REVIEW
Seyed Moayed Alavian, Mohammad Saeid Rezaee-Zavareh
CONTEXT: Direct acting antivirals (DAAs) have recently emerged as a promising therapeutic regimen for the treatment of hepatitis C virus (HCV) infection, which is a major public health problem. Among the known DAAs, daclatasvir (DCV), an inhibitor of the non-structural 5A protein, has been used in combination with several drugs for treatment of infection with HCV of different genotypes under different conditions. We conducted a systematic review and meta-analysis of combination therapy with DCV...
September 2016: Hepatitis Monthly
https://www.readbyqxmd.com/read/27813162/do-directly-acting-antiviral-agents-for-hcv-increase-the-risk-of-hepatic-decompensation-and-decline-in-renal-function-results-from-erchives
#16
A A Butt, Y Ren, K Marks, O S Shaikh, K E Sherman
BACKGROUND: Directly acting antiviral agents (DAA) have been associated with hepatic decompensation, especially in patients with pre-treatment cirrhosis, but this risk is not well defined. AIM: To determine the incidence of hepatic decompensation, liver transplantation, death and worsening renal function in patients treated with a Paritaprevir/ritonavir, Ombitasvir, Dasabuvir (PrOD), sofosbuvir/simeprevir or sofosbuvir/ledipasvir regimen. METHODS: We followed ERCHIVES participants treated with the above regimens for up to 12 weeks post-treatment...
January 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/27806815/new-direct-acting-antiviral-agents-for-the-treatment-of-hepatitis-c-2016-and-beyond
#17
Muhammad Umar, Tayyab Saeed Akhter
Hepatitis C is one of the commonest public health problems with 130 million people infected worldwide and the burden is increasing. Previously, Interferon along with Ribavirin was the mainstay of treatment but it was associated with toxic side effects. An all-oral regimen with higher rates of sustained viral response (SVR), minimal side effects and no restriction for liver fibrosis staging, was long awaited. Several all-oral interferon-free direct acting antiviral agents (DAAs) have now been approved by FDAfor different genotypes of HCV...
October 2016: Journal of the College of Physicians and Surgeons—Pakistan: JCPSP
https://www.readbyqxmd.com/read/27805527/first-case-in-kazakhstan-of-successful-therapy-with-2-consecutive-direct-acting-antiviral-regimens-in-a-patient-with-hepatitis-c-virus-induced-decompensated-liver-cirrhosis-on-a-liver-transplant-wait-list
#18
Kakharman Yesmembetov, Aiymkul Ashimkhanova, Kulpash Kaliaskarova
A 40-year-old man, diagnosed with decompensated liver cirrhosis because of hepatitis C virus, was on the wait list for a liver transplant when he began treatment with the direct-acting antivirals simeprevir 150 mg and sofosbuvir 400 mg. The patient demonstrated end of treatment virologic response at week 12, normal bilirubin, and alanine aminotransferase levels, resolution of ascites, with downgrading to subcompensated liver cirrhosis, and was removed from the liver transplant wait list. However, the patient did not comply with the recommended duration of the antiviral treatment of at least 16 weeks, which resulted in hepatitis C virus relapse at posttreatment week 12...
November 2016: Experimental and Clinical Transplantation
https://www.readbyqxmd.com/read/27804195/the-value-of-cure-associated-with-treating-treatment-na%C3%A3-ve-chronic-hepatitis-c-genotype-1-are-the-new-all-oral-regimens-good-value-to-society
#19
Zobair M Younossi, Haesuk Park, Douglas Dieterich, Sammy Saab, Aijaz Ahmed, Stuart C Gordon
BACKGROUND & AIMS: All-oral regimens are associated with high cure rates in hepatitis C virus-genotype 1 (HCV-GT1) patients. Our aim was to assess the value of cure to the society for treating HCV infection. METHODS: Markov model for HCV-GT1 projected long-term health outcomes, life years, and quality-adjusted life years (QALYs) gained. The model compared second-generation triple (sofosbuvir+pegylated interferon+ribavirin [PR] and simeprevir+PR) and all-oral (ledipasvir/sofosbuvir and ombitasvir+paritaprevir/ritonavir+dasabuvir±ribavirin) therapies with no treatment...
November 2, 2016: Liver International: Official Journal of the International Association for the Study of the Liver
https://www.readbyqxmd.com/read/27795376/preclinical-characterization-and-human-microdose-pharmacokinetics-of-itmn-8187-a-non-macrocyclic-inhibitor-of-the-hepatitis-c-virus-ns3-protease
#20
Ravi Rajagopalan, Lin Pan, Caralee Schaefer, John Nicholas, Sharlene Lim, Shawn Misialek, Sarah Stevens, Lisa Hooi, Natalia Aleskovski, Donald Ruhrmund, Karl Kossen, Lea Huang, Sophia Yap, Leonid Beigelman, Vladimir Serebryany, Jyanwei Liu, Srikonda Sastry, Scott Seiwert, Brad Buckman
The current paradigm for the treatment of chronic hepatitis C virus (HCV) infection involves combinations of agents which act directly on steps of the HCV lifecycle. Here we report the preclinical characteristics of ITMN-8187, a non-macrocyclic inhibitor of the NS3/4A HCV protease. X-ray crystallographic studies of ITMN-8187 and simeprevir binding to NS3/4A protease demonstrated good agreement between structures. Low nanomolar biochemical potency was maintained against NS3/4A derived from HCV genotypes 1, 2b, 4, 5, and 6...
October 17, 2016: Antimicrobial Agents and Chemotherapy
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