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https://www.readbyqxmd.com/read/28417245/elbasvir-grazoprevir-a-review-in-chronic-hcv-genotypes-1-and-4
#1
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...
April 17, 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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
#10
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
https://www.readbyqxmd.com/read/28193518/safety-and-efficacy-of-elbasvir-grazoprevir-in-patients-with%C3%A2-hepatitis-c-virus-infection-and-compensated-cirrhosis-an%C3%A2-integrated-analysis
#11
Ira M Jacobson, Eric Lawitz, Paul Y Kwo, Christophe Hézode, Cheng-Yuan Peng, Anita Y M Howe, Peggy Hwang, Janice Wahl, Michael Robertson, Eliav Barr, Barbara A Haber
BACKGROUND & AIMS: Persons with hepatitis C virus (HCV) infection are at risk of progressive liver disease, cirrhosis, and decompensation. We analyzed the effects of the direct-acting antiviral agents elbasvir and grazoprevir in patients with HCV infection and compensated cirrhosis, combining data from 6 clinical trials. METHODS: We performed an integrated analysis of 402 patients with HCV genotype 1, 4, or 6 infection and Child-Pugh A compensated cirrhosis enrolled in 6 clinical trials...
February 11, 2017: Gastroenterology
https://www.readbyqxmd.com/read/28164081/grazoprevir-and-elbasvir-in-patients-with-genotype-1-hepatitis-c-virus-infection-a-comprehensive-efficacy-and-safety-analysis
#12
Yinan Yao, Ming Yue, Jie Wang, Hongbo Chen, Mei Liu, Feng Zang, Jun Li, Yun Zhang, Peng Huang, Rongbin Yu
Background. It is urgent for patients with hepatitis C virus (HCV) infection to find a safe, effective, and interferon-free regimen to optimize therapy. A comprehensive analysis was performed to evaluate the efficacy and safety of the grazoprevir combined with elbasvir, with or without ribavirin (RBV), in 777 treatment-naive and treatment-experienced patients with HCV genotype 1 infection from 3 randomized controlled trials (RCTs). Method. We collected data from the following trials: C-WORTHY (NCT01717326), C-SALVAGE (NCT02105454), and C-EDGE (NCT02105467)...
2017: Canadian Journal of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28124463/hepatitis-c-treatment-from-response-guided-to-resource-guided-therapy-in-the-transition-era-from-ifn-containing-to-ifn-free-regimens
#13
REVIEW
Ming-Lung Yu
Peginterferon/ribavirin has been the standard-of-care for chronic hepatitis C virus (HCV) infections: 48-week for genotype 1 or 4 (HCV-1/4) and 24-week for HCV-2/3. Response-guided therapy recommended shorter 24-week and 16-week regimens for HCV-1 with lower baseline viral loads (LVL, <400,000-800,000 IU/ml) and rapid virological response (RVR, undetectable HCV RNA at week 4) and HCV-2/3 with RVR, respectively; and extending to 72 and 48 weeks for HCV-1 slower responders and HCV-2 non-RVR patients, respectively, to improve the efficacy...
January 26, 2017: Journal of Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/28114144/hepatitis-c-treatment-in-chronic-kidney-disease-patients-the-kidney-disease-improving-global-outcomes-perspective
#14
REVIEW
Michel Jadoul, Paul Martin
BACKGROUND: Hepatitis C virus (HCV) infection is a very common infection found among hemodialysis (HD) and kidney transplant patients. It is associated with substantial morbidity and mortality. Direct-acting antiviral agents (DAAs) have much better efficacy (sustained viral response (SVR)) and tolerance than interferon-based regimens. Very recent studies extend this breakthrough finding to chronic kidney disease (CKD) populations. SUMMARY: CKD patients with an estimated glomerular filtration rate (eGFR) >30 ml/min/1...
2017: Blood Purification
https://www.readbyqxmd.com/read/28102520/us-fda-perspective-on-elbasvir-grazoprevir-treatment-for-patients-with-chronic-hepatitis-c-virus-genotype-1-or-4-infection
#15
Sarita D Boyd, LaRee Tracy, Takashi E Komatsu, Patrick R Harrington, Prabha Viswanathan, Jeff Murray, Adam Sherwat
Elbasvir/grazoprevir demonstrated high sustained virologic response rates 12 weeks after the end of treatment (SVR12) across five clinical trials in subjects infected with chronic hepatitis C virus (HCV) genotype 1, including those with advanced chronic kidney disease (CKD), and GT4. Despite favorable results overall, the US Food and Drug Administration (FDA) encountered challenging regulatory issues due to the limitations of clinical trial data in certain subpopulations. In GT1a-infected subjects, baseline NS5A resistance-associated polymorphisms emerged as the strongest baseline characteristic associated with diminished SVR12 rates following 12 weeks of elbasvir/grazoprevir treatment...
April 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28075146/five-near-full-length-hepatitis-c-virus-sequences-were-identified-from-hiv-coinfected-injection-drug-users-of-china
#16
Fan Li, Yi Feng, Na Ni, Jing Hu, Yuhua Ruan, Yiming Shao, Liying Ma
HIV and hepatitis C virus (HCV) share transmission routes, including contaminated blood transfusion, sexual intercourse, and needle-sharing in injection drug users (IDUs). We obtained five near full-length genome sequences of HCV isolated from five HIV-1-coinfected IDUs in Sichuan and Xinjiang provinces, China. By conducting reconstruction of neighbor-joining phylogenetic tree, our results revealed that the five isolates are of four different genotypes (1b, 3a, 6a, and 6n). The amino acid substitutions (170I) in XJN0021 related to resistant to protease inhibitors (grazoprevir) were also identified...
February 23, 2017: AIDS Research and Human Retroviruses
https://www.readbyqxmd.com/read/28040878/erratum-to-elbasvir-grazoprevir-for-treatment-of-chronic-hepatitis-c-virus-infection
#17
Chandana Papudesu, Shyamasundaran Kottilil, Shashwatee Bagchi
No abstract text is available yet for this article.
December 31, 2016: Hepatology International
https://www.readbyqxmd.com/read/28038699/elbasvir-grazoprevir-velpatasvir-sofosbuvir-and-eteplirsen
#18
Daniel A Hussar, William P Tidwell
No abstract text is available yet for this article.
January 2017: Journal of the American Pharmacists Association: JAPhA
https://www.readbyqxmd.com/read/28025084/a-profiling-study-of-a-newly-developed-hcvcc-strain-pr63cc-s-sensitivity-to-direct-acting-antivirals
#19
Wanyin Tao, Tianyu Gan, Jie Lu, Jin Zhong
The development of direct-acting antivirals (DAAs) has significantly improved hepatitis C virus (HCV) treatment. However, drug resistance remains a potential concern in the real-world DAA-based therapies. We previously developed a novel full-length genotype 2a HCVcc clone PR63cc directly from clinical isolates. Here in this study, we compared the sensitivity of PR63cc and JFH1 to 12 different DAAs most of which are either already in clinical use or in the late clinical development phase. For NS5B inhibitors, PR63cc and JFH1 displayed comparable sensitivity to nucleoside/nucleotide analogues sofosbuvir and 2'-C-methyladenosine, while PR63cc was 4-fold more sensitive than JFH1 to nesbuvir, a non-nucleoside inhibitor...
December 23, 2016: Antiviral Research
https://www.readbyqxmd.com/read/27994759/design-and-synthesis-of-p2-p4-macrocycles-containing-a-unique-spirocyclic-proline-a-new-class-of-hcv-ns3-4a-inhibitors
#20
Francisco Velázquez, Mariappan Chelliah, Martin Clasby, Zhuyan Guo, John Howe, Randy Miller, Santhosh Neelamkavil, Unmesh Shah, Aileen Soriano, Yan Xia, Srikanth Venkatraman, Samuel Chackalamannil, Ian W Davies
A new class of hepatitis C NS3/4A inhibitors was identified by introducing a novel spirocyclic proline-P2 surrogate onto the P2-P4 macrocyclic core of MK-5172 (grazoprevir). The potency profile of new analogues showed excellent pan-genotypic activity for most compounds. The potency evaluation included the most difficult genotype 3a (EC50 values ≤10 nM) and other key genotype 1b mutants. Molecular modeling was used to design new target compounds and rationalize our results. A synthetic approach based on the Julia-Kocienski olefination and macrolactamization to assemble the P2-P4 macrocyclic core containing the novel spirocyclic proline-P2 moiety is presented as well...
December 8, 2016: ACS Medicinal Chemistry Letters
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