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Grazoprevir

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https://www.readbyqxmd.com/read/28625018/no-pharmacokinetic-interaction-between-the-hepatitis-c-virus-inhibitors-elbasvir-grazoprevir-and-famotidine-or-pantoprazole
#1
H-P Feng, P Vaddady, Z Guo, F Liu, D Panebianco, V Levine, L Caro, J R Butterton, M Iwamoto, W W Yeh
Use of agents to suppress gastric acid secretion is common among patients with hepatitis C virus (HCV) infection. The aims of this open-label, three-period, fixed-sequence study were to evaluate the effect of famotidine and pantoprazole on the pharmacokinetics and safety of elbasvir/grazoprevir fixed-dose combination (FDC) in 16 healthy subjects. Elbasvir and grazoprevir each exhibited similar pharmacokinetics following single-dose administration of elbasvir/grazoprevir with or without famotidine or pantoprazole...
June 17, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28615303/favouring-modulation-of-circulating-lipoproteins-and-lipid-loading-capacity-by-direct-antiviral-agents-grazoprevir-elbasvir-or-ledipasvir-sofosbuvir-treatment-against-chronic-hcv-infection
#2
Hung-Yu Sun, Pin-Nan Cheng, Chiung-Ying Tseng, Wei-Jen Tsai, Yen-Cheng Chiu, Kung-Chia Young
OBJECTIVE: Lipid homoeostasis is disturbed in patients with HCV infection. Direct-acting antiviral agent (DAA) treatment eradicates chronic HCV viraemia, but the dynamics of lipid components remain elusive. This study investigates the clinical manifestation and mechanistic relevance of plasma triglyceride (TG), cholesterol (Chol), lipoproteins and apolipoproteins (apos) after DAA treatment. DESIGN: Twenty-four patients with chronic genotype 1 (GT1) HCV treated with elbasvir/grazoprevir or ledipasvir/sofosbuvir for 12 weeks, and followed-up thereafter, were recruited...
June 14, 2017: Gut
https://www.readbyqxmd.com/read/28588311/low-frequency-of-ns5a-relevant-resistance-associated-substitutions-to-elbasvir-among-hepatitis-c-virus-genotype-1a-in-spain-a-cross-sectional-study
#3
Claudia Palladino, Marta Sánchez-Carrillo, Irene Mate-Cano, Sonia Vázquez-Morón, Ma Ángeles Jimenez-Sousa, Mónica Gutiérrez-Rivas, Salvador Resino, Verónica Briz
Relevant resistance-associated substitutions (RASs) to elbasvir, the new HCV NS5A inhibitor, may limit its efficacy and lead to virological failure in HCV-GT1a-infected patients. There are few data outside clinical trials evaluating their prevalence and impact of elbasvir/grazoprevir. A multicenter cross-sectional study of 617 HCV-GT1a-infected individuals attended in 84 Spanish hospitals from the 17 Autonomous Communities and two Autonomous cities was performed. HCV population sequencing was used to identify RASs to elbasvir and the mutational pattern and drug sensitivity were confirmed by geno2pheno[HCV]...
June 6, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28576451/elbasvir-plus-grazoprevir-in-patients-with-hepatitis-c-virus-infection-and-stage-4-5-chronic-kidney-disease-clinical-virological-and-health-related-quality-of-life-outcomes-from-a-phase-3-multicentre-randomised-double-blind-placebo-controlled-trial
#4
Annette Bruchfeld, David Roth, Paul Martin, David R Nelson, Stanislas Pol, Maria-Carlota Londoño, Howard Monsour, Marcelo Silva, Peggy Hwang, Jean-Marie Arduino, Michael Robertson, Bach-Yen Nguyen, Janice Wahl, Eliav Barr, Wayne Greaves
BACKGROUND: In the C-SURFER study, therapy with the all-oral elbasvir plus grazoprevir regimen for 12 weeks in patients with chronic hepatitis C virus (HCV) infection and stage 4-5 chronic kidney disease resulted in a high rate of virological cure compared with placebo. Here, we report sustained virological response (SVR), safety data, health-related quality-of-life (HRQOL), and virological resistance analyses in patients in C-SURFER who received immediate antiviral therapy or who received placebo before therapy...
May 30, 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28566078/-determination-of-drug-resistance-mutations-of-ns3-inhibitors-in-chronic-hepatitis-c-patients-infected-with-genotype-1
#5
Tamer Şanlıdağ, Murat Sayan, Sinem Akçalı, Elmas Kasap, Tahir Buran, Ayşe Arıkan
Direct-acting antiviral agents (DAA) such as NS3 protease inhibitors is the first class of drugs used for chronic hepatitis C (CHC) treatment. NS3 inhibitors (PI) with low genetic barrier have been approved to be used in the CHC genotype 1 infections, and in the treatment of compensated liver disease including cirrhosis together with pegile interferon and ribavirin. Consequently, the development of drug resistance during DAA treatment of CHC is a major problem. NS3 resistant variants can be detected before treatment as they can occurnaturally...
April 2017: Mikrobiyoloji Bülteni
https://www.readbyqxmd.com/read/28521955/prevalence-of-relevant-ns5a-resistance-associated-substitutions-to-elbasvir-in-genotype-1a-hepatitis-c-virus-patients-in-spain
#6
Claudia Palladino, Beatriz Esteban-Cartelle, Irene Mate-Cano, Marta Sánchez-Carrillo, Salvador Resino, Verónica Briz
Resistance-associated substitutions (RASs) to the new HCV NS5A inhibitor elbasvir may limit its efficacy and lead to virological failure in HCV-GT1a-infected patients. There are no data outside clinical trials evaluating their prevalence and impact in grazoprevir/elbasvir in GT1a-infected patients in Spain. A multicentre cross-sectional study of 632 initial patients was conducted. In 13 of these patients, the sample could not be amplified or a consensus sequence by Sanger sequencing could not be performed. Ultimately, 617 HCV-G1a-infected individuals treated at 84 Spanish hospitals from the 17 autonomous communities plus the 2 autonomous cities of Spain were analysed...
May 15, 2017: Enfermedades Infecciosas y Microbiología Clínica
https://www.readbyqxmd.com/read/28497432/resistance-mechanisms-in-hepatitis-c-virus-implications-for-direct-acting-antiviral-use
#7
Sabrina Bagaglio, Caterina Uberti-Foppa, Giulia Morsica
Multiple direct-acting antiviral (DAA)-based regimens are currently approved that provide one or more interferon-free treatment options for hepatitis C virus (HCV) genotypes (G) 1-6. The choice of a DAA regimen, duration of therapy, and use of ribavirin depends on multiple viral and host factors, including HCV genotype, the detection of resistance-associated amino acid (aa) substitutions (RASs), prior treatment experience, and presence of cirrhosis. In regard to viral factors that may guide the treatment choice, the most important is the infecting genotype because a number of DAAs are genotype-designed...
May 12, 2017: Drugs
https://www.readbyqxmd.com/read/28480743/hepatitis-c-virus-resistance-testing-in-genotype-1-the-changing-role-in-clinical-utility
#8
Suzanne Molino, Michelle T Martin
OBJECTIVE: To review the role and utility of baseline resistance testing with currently available and pipeline genotype 1 hepatitis C virus (HCV) treatment. DATA SOURCES: Authors reviewed liver meeting abstracts for data on currently-available and pipeline genotype 1 retreatment regimens from January 1, 2015, to March 23, 2017. Additional trials were identified from a review of clinicaltrials.gov using the pipeline medication names. STUDY SELECTION AND DATA EXTRACTION: Authors identified reports of current and pipeline genotype 1 retreatment regimens...
May 1, 2017: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/28470815/efficacy-of-12-or-18-weeks-of-elbasvir-plus-grazoprevir-with-ribavirin-in-treatment-na%C3%A3-ve-non-cirrhotic-hcv-genotype-3-infected-patients
#9
Edward Gane, Ronald Nahass, Velimir Luketic, Ernest Asante-Appiah, Peggy Hwang, Michael Robertson, Janice Wahl, Eliav Barr, Barbara Haber
Elbasvir (EBR; HCV NS5A inhibitor) and grazoprevir (GZR; HCV NS3/4A protease inhibitor) are approved as a fixed-dose combination to treat patients chronically infected with HCV genotypes 1 and 4. During the development program and supported by in vitro potency, the efficacy of EBR + GZR was assessed in HCV GT3-infected patients. This study's aim was to determine the efficacy and tolerability of 12 or 18 weeks of EBR+GZR with ribavirin (RBV) in treatment-naïve, non-cirrhotic HCV GT3-infected patients. Randomized patients received open-label EBR (50 mg once daily) + GZR (100 mg once daily) + RBV...
May 4, 2017: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/28467997/treating-hepatitis-c-in-patients-with-renal-failure
#10
Sabela Lens, Sergio Rodriguez-Tajes, Laura-Patricia Llovet, Francisco Maduell, Maria-Carlota Londoño
BACKGROUND: There is a strong relationship between hepatitis C virus (HCV) infection and the kidney. Approximately 10-16% of the patients with HCV infection develop renal disease, and the prevalence of HCV infection in patients with renal dysfunction is higher than that of the general population (9.5 vs. 1.6%). Moreover, HCV-positive patients on hemodialysis (HD) have higher mortality rates as compared to HCV-negative patients also on HD, not only due to liver-related complications but also owing to cardiovascular disease...
2017: Digestive Diseases
https://www.readbyqxmd.com/read/28417245/elbasvir-grazoprevir-a-review-in-chronic-hcv-genotypes-1-and-4
#11
REVIEW
Zaina T Al-Salama, Emma D Deeks
A fixed-dose combination tablet comprising the hepatitis C virus (HCV) NS5A inhibitor elbasvir and the HCV NS3/4A protease inhibitor grazoprevir (elbasvir/grazoprevir; Zepatier™) was recently approved for the treatment of chronic HCV genotype 1 and 4 infection in the EU and the USA. In phase III trials, 12 or 16 weeks of treatment with once-daily elbasvir/grazoprevir (fixed-dose tablet or as individual agents), taken with or without ribavirin, generally provided high rates of sustained virological response at 12 weeks (SVR12) in treatment-naive and -experienced adult patients with chronic HCV genotype 1a, 1b or 4 infection, including those with or without compensated cirrhosis, HIV co-infection, inherited blood disorders or chronic kidney disease or patients receiving opioid agonist therapy or of Japanese origin...
May 2017: Drugs
https://www.readbyqxmd.com/read/28416549/antiviral-activity-and-resistance-analysis-of-ns3-4a-protease-inhibitor-grazoprevir-and-ns5a-inhibitor-elbasvir-in-hepatitis-c-virus-gt4-replicons
#12
Ernest Asante-Appiah, Stephanie Curry, Patricia McMonagle, Paul Ingravallo, Robert Chase, David Nickle, Ping Qiu, Anita Howe, Frederick C Lahser
Although genotype (GT) 4-infected patients represent a minor overall percentage of the global hepatitis C virus (HCV)-infected population, the high prevalence of the genotype in specific geographic regions coupled with substantial sequence diversity makes it an important genotype to study for antiviral drug discovery and development. We evaluated two direct-acting antiviral agents: grazoprevir, an HCV NS3/4A protease inhibitor, and elbasvir, an HCV NS5A inhibitor, in GT4 replicons prior to clinical studies in this genotype...
April 17, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28376038/elbasvir-grazoprevir-use-in-postliver-transplantation-patients-on-hemodialysis
#13
Michelle T Martin, Sean Koppe
BACKGROUND: Current national hepatitis C virus (HCV) guidelines do not recommend the use of elbasvir/grazoprevir (EBR/GZR) in postliver transplantation (LT) patients due to drug-drug interactions (DDIs) with immunosuppression agents. However, recommendations do not address the treatment of HCV in renally-impaired post-LT patients. Treatment regimens that are recommended for post-LT patients are not safe in patients with severe renal impairment and patients on dialysis. EBR/GZR is approved for use in patients with renal impairment and patients on dialysis, but not in the post-LT setting...
April 3, 2017: Transplantation
https://www.readbyqxmd.com/read/28334495/elbasvir-grazoprevir-does-not-worsen-renal-function-in-patients-with-hepatitis-c-virus-infection-and-pre-existing-renal-disease
#14
K Rajender Reddy, David Roth, Annette Bruchfeld, Peggy Hwang, Barbara Haber, Michael N Robertson, Eliav Barr, Wayne Greaves
AIM: Treatment options have been limited for patients with hepatitis C virus (HCV) infection and chronic kidney disease stage 4/5 (CKD 4/5). The aim of this analysis was to evaluate the impact of elbasvir/grazoprevir on estimated glomerular filtration rate (eGFR) in patients with CKD stage 3 enrolled in phase II/III clinical trials. METHODS: We conducted a retrospective integrated analysis of patients with CKD 3 enrolled in the EBR/GZR phase II/III clinical trials...
March 23, 2017: Hepatology Research: the Official Journal of the Japan Society of Hepatology
https://www.readbyqxmd.com/read/28318208/elbasvir-grazoprevir-zepatier-for-hepatitis-c-virus-infection
#15
Jessica Early, George Maxted
No abstract text is available yet for this article.
March 15, 2017: American Family Physician
https://www.readbyqxmd.com/read/28286567/grazoprevir-elbasvir-combination-therapy-for-hcv-infection
#16
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/28256747/elbasvir-grazoprevir-for-patients-with-hepatitis-c-virus-infection-and-inherited-blood-disorders-a-phase-iii-study
#17
Christophe Hézode, Massimo Colombo, Marc Bourlière, Ulrich Spengler, Ziv Ben-Ari, Simone I Strasser, William M Lee, Leslie Morgan, Jingjun Qiu, Peggy Hwang, Michael Robertson, Bach-Yen Nguyen, Eliav Barr, Janice Wahl, Barbara Haber, Robert Chase, Rohit Talwani, Vito Di Marco
Direct-acting antiviral agents have not been studied exclusively in patients with inherited blood disorders and hepatitis C virus (HCV) infection. The objective of the randomized, placebo-controlled, phase III C-EDGE IBLD study was to assess the safety and efficacy of elbasvir/grazoprevir (EBR/GZR) in patients with inherited bleeding disorders and HCV infection. One hundred fifty-nine adults with HCV infection and sickle cell anemia, thalassemia, or hemophilia A/B or von Willebrand disease were enrolled at 31 study sites in the United States, Europe, Australia, Canada, Israel, and Thailand...
March 3, 2017: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/28246435/elbasvir-grazoprevir
#18
REVIEW
(no author information available yet)
No abstract text is available yet for this article.
February 2017: Australian Prescriber
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/28217256/interferon-free-regimens-in-patients-with-hepatitis-c-infection-and-renal-dysfunction-or-kidney-transplantation
#20
REVIEW
Evangelos Cholongitas, Chrysoula Pipili, George V Papatheodoridis
Treatment of patients with chronic kidney disease (CKD) and chronic hepatitis C (CHC) differs from that used in the general CHC population mostly when glomerular filtration rate (GFR) is below 30 mL/min, as sofosbuvir, the backbone of several current regimens, is officially contraindicated. Given that ribavirin free regimens are preferable in CKD, elbasvir/grazoprevir is offered in CHC patients with genotype 1 or 4 and ombitasvir/paritaprevir and dasabuvir in genotype 1b for 12 wk. Although regimens containing peginterferon with or without ribavirin are officially recommended for patients with CKD and genotype 2, 3, 5, 6, such regimens are rarely used because of their low efficacy and the poor safety and tolerance profile...
February 8, 2017: World Journal of Hepatology
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