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https://www.readbyqxmd.com/read/29344726/the-safety-and-efficacy-of-elbasvir-and-grazoprevir-in-participants-with-hepatitis-c-virus-genotype-1b-infection
#1
Stefan Zeuzem, Lawrence Serfaty, John Vierling, Wendy Cheng, Jacob George, Jan Sperl, Simone Strasser, Hiromitsu Kumada, Peggy Hwang, Michael Robertson, Janice Wahl, Eliav Barr, Rohit Talwani, Heather Platt
BACKGROUND: Genotype 1b (GT1b) is the most common subtype of the hepatitis C virus (HCV). We present an integrated analysis of 1070 participants with HCV GT1b infection from 30 countries who received elbasvir/grazoprevir for 12 weeks. METHODS: This is a retrospective analysis of data from participants with chronic HCV GT1b infection enrolled in 11 phase II/III clinical trials. All participants received elbasvir 50 mg plus grazoprevir 100 mg once daily for 12 weeks...
January 17, 2018: Journal of Gastroenterology
https://www.readbyqxmd.com/read/29329497/pharmacokinetic-interactions-between-elbasvir-grazoprevir-and-immunosuppressant-drugs-in-healthy-volunteers
#2
Hwa-Ping Feng, Luzelena Caro, Christine M Fandozzi, Zifang Guo, Jennifer Talaty, Dennis Wolford, Deborah Panebianco, Marian Iwamoto, Joan R Butterton, Wendy W Yeh
Elbasvir (EBR)/grazoprevir (GZR) may be coadministered with immunosuppressant drugs in posttransplant people who are infected with hepatitis C virus. The aim of the present study was to assess the safety and pharmacokinetic interactions between EBR and GZR and single doses of cyclosporine, tacrolimus, mycophenolate mofetil (MMF), and prednisone. This was a 4-part, open-label study in 58 healthy volunteers. Participants received single doses of cyclosporine 400 mg, tacrolimus 2 mg, MMF 1 g, or prednisone 40 mg alone or in the presence of once-daily EBR 50 mg/GZR 200 mg...
January 12, 2018: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29325996/direct-acting-antiviral-therapy-for-hepatitis-c-virus-infection-in-the-kidney-transplant-recipient
#3
REVIEW
Donald F Chute, Raymond T Chung, Meghan E Sise
Hepatitis C virus infection (HCV) is a common comorbidity in patients who have undergone kidney transplantation and is associated with increased morbidity and mortality compared with recipients who do not have chronic HCV infection. Because interferon-α-based therapies can precipitate acute rejection, they are relatively contraindicated after kidney transplantation. Thus, the majority of kidney transplant recipients with HCV remain untreated. There are now all-oral, interferon-free direct-acting antiviral therapies for HCV infection that are extremely effective and well tolerated in the general population...
January 9, 2018: Kidney International
https://www.readbyqxmd.com/read/29311409/meta-analysis-of-grazoprevir-plus-elbasvir-for-treatment-of-hepatitis-c-virus-genotype-1-infection
#4
Hussien Ahmed, Abdelrahman Ibrahim Abushouk, Amr Menshawy, Attia Attia, Arwa Mohamed, Ahmed Negida, Mohamed M Abdel-Daim
BACKGROUND AND AIM: Grazoprevir is an NS3/4A protease inhibitor (PI), while elbasvir is an NS5A inhibitor. We performed this meta-analysis to directly compare grazoprevir plus elbasvir and ribavirin regimen vs. grazoprevir and elbasvir without ribavirin in the treatment of hepatitis C virus genotype 1 infection and to precisely evaluate the efficacy of the latter regimen in cirrhotic, IL28 CC genotype patients and those coinfected with human immunodeficiency virus. MATERIAL AND METHODS: A computer literature search of PubMed, Scopus, EBSCO, Embase, and Cochrane central was conducted...
December 27, 2017: Annals of Hepatology
https://www.readbyqxmd.com/read/29247332/pharmacokinetics-safety-and-tolerability-of-single-dose-elbasvir-in-participants-with-hepatic-impairment
#5
William L Marshall, Hwa-Ping Feng, Larissa Wenning, Graigory Garrett, Xiaobi Huang, Fang Liu, Deborah Panebianco, Luzelena Caro, Christine Fandozzi, Kenneth C Lasseter, Richard A Preston, Thomas Marbury, Joan R Butterton, Marian Iwamoto, Wendy W Yeh
BACKGROUND: The combination of elbasvir and grazoprevir is approved for the treatment of hepatitis C virus genotype 1 or 4 infection. OBJECTIVE: To evaluate the pharmacokinetics and safety of single-dose elbasvir 50 mg in participants with hepatic impairment. METHODS: Participants with mild, moderate, or severe hepatic impairment and age-, sex-, and weight-matched healthy controls were enrolled in a 3-part, open-label, sequential-panel, single-dose pharmacokinetic study...
December 15, 2017: European Journal of Drug Metabolism and Pharmacokinetics
https://www.readbyqxmd.com/read/29152828/efficacy-and-safety-of-12-weeks-of-elbasvir-%C3%A2-grazoprevir-%C3%A2-ribavirin-in-participants-with-hcv-genotype-2-4-5-or-6-infection-the-c-scape-study
#6
A Brown, C Hézode, E Zuckerman, G R Foster, A Zekry, S K Roberts, F Lahser, C Durkan, C Badshah, B Zhang, M Robertson, J Wahl, E Barr, B Haber
People with hepatitis C virus (HCV) infection other than genotype 1 represent a heterogeneous group. The aim of the phase 2 C-SCAPE study was to evaluate elbasvir/grazoprevir (EBR/GZR), with or without ribavirin (RBV), in participants with HCV genotype 2, 4, 5 or 6 infection. This was a part randomized, open-label, parallel-group study (NCT01932762; PN047-03) of treatment-naive, non-cirrhotic participants. Participants with HCV genotype 2 infection received GZR 100 mg+RBV±EBR 50 mg for 12 weeks and those with genotype 4, 5 or 6 infection were randomized to receive EBR/GZR±RBV for 12 weeks...
November 20, 2017: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/29145802/effectiveness-of-current-and-future-regimens-for-treating-genotype-3-hepatitis-c-virus-infection-a-large-scale-systematic-review
#7
Hosnieh Fathi, Andrew Clark, Nathan R Hill, Geoffrey Dusheiko
BACKGROUND: Six distinct genetic variants (genotypes 1 - 6) of hepatitis C virus (HCV) exist globally. Certain genotypes are more prevalent in particular countries or regions than in others but, globally, genotype 3 (GT3) is the second most common. Patients infected with HCV GT1, 2, 4, 5 or 6 recover to a greater extent, as measured by sustained virological response (SVR), following treatment with regimens based on direct-acting antivirals (DAAs) than after treatment with older regimens based on pegylated interferon (Peg-IFN)...
November 16, 2017: BMC Infectious Diseases
https://www.readbyqxmd.com/read/29077864/retreatment-with-sofosbuvir-plus-grazoprevir-elbasvir-plus-ribavirin-of-patients-with-hepatitis-c-virus-genotype-1-or-4-who-previously-failed-a-ns5a-or-ns3-containing-regimen-anrs-hc34-revenge
#8
Victor de Lédinghen, Claire Laforest, Christophe Hézode, Stanislas Pol, Alain Renault, Laurent Alric, Dominique Larrey, Sophie Métivier, Albert Tran, Caroline Jézéquel, Didier Samuel, Fabien Zoulim, Christelle Tual, Aurélie Pailhé, Séverine Gibowski, Marc Bourlière, Eric Bellissant, Jean-Michel Pawlotsky
Failure to achieve sustained virological response (SVR) with hepatitis C virus (HCV) direct-acting antiviral-based regimens is commonly associated with emergence of resistance-associated substitutions (RAS). Re-treatment of patients who failed prior direct-acting antivirals remain challenging. The aim of this prospective and randomized study was to evaluate the efficacy (SVR12 primary endpoint) and safety of sofosbuvir + grazoprevir/elbasvir + ribavirin for 16 or 24 weeks in patients who had failed to achieve SVR on previous NS5A or NS3-based therapy and with evidence of RAS at failure...
October 25, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/29052413/asymmetric-synthesis-of-functionalized-trans-cyclopropoxy-building-block-for-grazoprevir
#9
Feng Xu, Yong-Li Zhong, Hongming Li, Ji Qi, Richard Desmond, Zhiguo J Song, Jeonghan Park, Tao Wang, Matthew Truppo, Guy R Humphrey, Rebecca T Ruck
A practical and asymmetric synthesis of a functionalized trans-cyclopropoxy building block for the preparation of the HCV NS3/4a protease inhibitor grazoprevir is reported. Intramolecular SN2 displacement-ring closure, followed by a Baeyer-Villiger oxidation, yields the desired trans-cyclopropanol with full control of diastereoselectivity. A terminal alkyne is then effectively installed using LiNH(CH2)2NEt2. Starting from (S)-epichlorohydrin, the cyclopropoxy building block is prepared in 51% overall yield with >99...
October 20, 2017: Organic Letters
https://www.readbyqxmd.com/read/28992878/peginterferon-alfa-2a-for-the-treatment-of-chronic-hepatitis-c-in-the-era-of-direct-acting-antivirals
#10
REVIEW
Yan Huang, Ming-Hui Li, Min Hou, Yao Xie
BACKGROUND: The availability of novel direct-acting antivirals (DAAs) represents a new era of curative hepatitis C virus (HCV) treatment, with over 95% of patients infected with HCV genotype 1 achieving sustained virological response (SVR). Nevertheless, the majority of patients globally are unable to access these treatments because of cost and infrastructure constraints and, thus, remain untreated and uncured. DATA SOURCE: Relevant articles of peginterferon (PegIFN)-based treatments in HCV and sofosbuvir-based treatments, simeprevir, daclatasvir/asunaprevir, ritonavir-boosted paritaprevir/ombitasvir/dasabuvir, and grazoprevir/elbasvir, were searched in PubMed database, including general population and special population...
October 15, 2017: Hepatobiliary & Pancreatic Diseases International: HBPD INT
https://www.readbyqxmd.com/read/28964443/cost-utility-of-elbasvir-grazoprevir-in-patients-with-chronic-hepatitis-c-genotype-1-infection
#11
COMPARATIVE STUDY
Shelby Corman, Elamin H Elbasha, Steven N Michalopoulos, Chizoba Nwankwo
OBJECTIVE: To evaluate the cost-utility of treatment with elbasvir/grazoprevir (EBR/GZR) regimens compared with ledipasvir/sofosbuvir (LDV/SOF), ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin (3D ± RBV), and sofosbuvir/velpatasvir (SOF/VEL) in patients with chronic hepatitis C genotype (GT) 1 infection. METHODS: A Markov cohort state-transition model was constructed to evaluate the cost-utility of EBR/GZR ± RBV over a lifetime time horizon from the payer perspective...
September 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28947524/elbasvir-grazoprevir-a-new-direct-acting-antiviral-combination-for-hepatitis-c
#12
REVIEW
Lamis R Karaoui, Hanine Mansour, Elias B Chahine
PURPOSE: The chemistry, pharmacology, pharmacodynamics, pharmacokinetics, efficacy, safety, dosage, administration, and role of elbasvir-grazoprevir in the treatment of hepatitis C virus (HCV) infection are reviewed. SUMMARY: Elbasvir-grazoprevir was recently approved by the Food and Drug Administration for the treatment of chronic HCV genotype 1 or 4 infections with or without ribavirin in patients with or without compensated cirrhosis. Elbasvir exhibits antiviral activity against HCV genotypes 1a, 1b, 2a, 3a, and 4a...
October 1, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28947470/the-effect-of-hepatic-impairment-on-the-pharmacokinetics-of-grazoprevir-a-hepatitis-c-virus-protease-inhibitor
#13
Luzelena Caro, Larissa Wenning, Zifang Guo, Iain P Fraser, Christine Fandozzi, Jennifer Talaty, Deborah Panebianco, Maureen Ho, Naoto Uemura, Christina Reitmann, Peter Angus, Edward Gane, Thomas Marbury, William B Smith, Marian Iwamoto, Joan R Butterton, Wendy W Yeh
Grazoprevir (GZR) plus elbasvir is an approved treatment for chronic hepatitis C virus (HCV) genotype 1 or 4 infection. HCV infection complications include liver cirrhosis, end-stage liver disease, and hepatocellular carcinoma. The objective of this study was to evaluate the pharmacokinetics and safety of multiple-dose GZR 200, 100, and 50 mg in non-HCV participants with mild, moderate, or severe hepatic impairment (HI), respectively, versus healthy matched controls (Protocol MK-5172_p013). Participants with mild, moderate, or severe HI and race-, age-, sex-, and body mass index--matched controls (aged 18-65 years) were enrolled in a 3-part, open-label, sequential-panel, pharmacokinetic study...
September 25, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28902678/brief-report-high-need-to-switch-cart-or-comedication-with-the-initiation-of-daas-in-elderly-hiv-hcv-coinfected-patients
#14
Elise J Smolders, Colette Smit, Clara T M M de Kanter, Anton S M Dofferiiof, Joop E Arends, Kees Brinkman, Bart Rijnders, Marc van der Valk, Peter Reiss, David M Burger
BACKGROUND: To describe the use of nonantiretroviral comedication and combination antiretroviral therapy (cART) in patients coinfected with HIV/hepatitis C virus (HCV) and to predict the potential for drug-drug interactions (DDIs) with direct-acting antivirals (DAAs) against HCV. METHODS: This is a retrospective, cross-sectional study, using the Dutch, nationwide ATHENA observational HIV cohort database. All patients with a known HIV/HCV coinfection on January 1, 2015, were included...
October 1, 2017: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/28815028/the-majority-of-hepatitis-c-patients-treated-with-direct-acting-antivirals-are-at-risk-for-relevant-drug-drug-interactions
#15
Elise J Smolders, Floor Ac Berden, Clara Tmm de Kanter, Wietske Kievit, Joost Ph Drenth, David M Burger
BACKGROUND: Direct-acting antivirals have improved treatment of chronic hepatitis C virus infection significantly. Direct-acting antivirals inhibit/induce and can also be substrates of drug-metabolising enzymes and transporters. This increases the risk for drug-drug interactions. OBJECTIVE: The purpose of this study was to predict drug-drug interactions with co-medication used by hepatitis C virus-infected patients. METHODS: We assembled a nationwide cohort of hepatitis C patients and collected cross-sectional data on co-medication use...
August 2017: United European Gastroenterology Journal
https://www.readbyqxmd.com/read/28806701/application-of-different-spectrophotometric-methods-for-simultaneous-determination-of-elbasvir-and-grazoprevir-in-pharmaceutical-preparation
#16
Khalid A M Attia, Nasr M El-Abasawi, Ahmed El-Olemy, Ahmed H Abdelazim
The first three UV spectrophotometric methods have been developed of simultaneous determination of two new FDA approved drugs namely; elbasvir and grazoprevir in their combined pharmaceutical dosage form. These methods include simultaneous equation, partial least squares with and without variable selection procedure (genetic algorithm). For simultaneous equation method, the absorbance values at 369 (λmax of elbasvir) and 253nm (λmax of grazoprevir) have been selected for the formation of two simultaneous equations required for the mathematical processing and quantitative analysis of the studied drugs...
August 10, 2017: Spectrochimica Acta. Part A, Molecular and Biomolecular Spectroscopy
https://www.readbyqxmd.com/read/28802816/safety-and-efficacy-of-an-8-week-regimen-of-grazoprevir-plus-ruzasvir-plus-uprifosbuvir-compared-with-grazoprevir-plus-elbasvir-plus-uprifosbuvir-in-participants-without-cirrhosis-infected-with-hepatitis-c-virus-genotypes-1-2-or-3-c-crest-1-and-c-crest-2-part
#17
Edward J Gane, Stephen Pianko, Stuart K Roberts, Alexander J Thompson, Stefan Zeuzem, Eli Zuckerman, Ziv Ben-Ari, Graham R Foster, Kosh Agarwal, Alex L Laursen, Jan Gerstoft, Wei Gao, Hsueh-Cheng Huang, Brian Fitzgerald, Doreen Fernsler, Jerry J Li, Anjana Grandhi, Hong Liu, Feng-Hsiu Su, Shuyan Wan, Zhen Zeng, Huei-Ling Chen, Frank J Dutko, Bach-Yen T Nguyen, Janice Wahl, Michael N Robertson, Eliav Barr, Wendy W Yeh, Rebeca M Plank, Joan R Butterton, Rafael Esteban
BACKGROUND: New hepatitis C virus (HCV) therapies with pan-genotypic efficacy are needed. The goals of part A of C-CREST-1 and C-CREST-2 were to compare the efficacies of two doses (300 mg or 450 mg once daily) of uprifosbuvir (MK-3682; NS5B inhibitor) in an 8-week regimen combined with grazoprevir (NS3/4A inhibitor; 100 mg once daily) and an NS5A inhibitor, either elbasvir (50 mg once daily) or ruzasvir (MK-8408; 60 mg once daily), and to evaluate the safety and tolerability of these combination regimens in individuals infected with genotypes 1, 2, or 3...
November 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28802814/safety-and-efficacy-of-a-fixed-dose-combination-regimen-of-grazoprevir-ruzasvir-and-uprifosbuvir-with-or-without-ribavirin-in-participants-with-and-without-cirrhosis-with-chronic-hepatitis-c-virus-genotype-1-2-or-3-infection-c-crest-1-and-c-crest-2-part-b-two
#18
Eric Lawitz, Maria Buti, John M Vierling, Piero L Almasio, Savino Bruno, Peter J Ruane, Tarek I Hassanein, Beat Muellhaupt, Brian Pearlman, Ligita Jancoriene, Wei Gao, Hsueh-Cheng Huang, Aimee Shepherd, Brynne Tannenbaum, Doreen Fernsler, Jerry J Li, Anjana Grandhi, Hong Liu, Feng-Hsiu Su, Shuyan Wan, Frank J Dutko, Bach-Yen T Nguyen, Janice Wahl, Michael N Robertson, Eliav Barr, Wendy W Yeh, Rebeca M Plank, Joan R Butterton, Eric M Yoshida
BACKGROUND: There is a need for hepatitis C virus (HCV) therapies with excellent efficacy across genotypes and in diverse populations. Part A of the C-CREST-1 and C-CREST-2 trials led to the selection of a three-drug regimen of grazoprevir (MK-5172; an HCV NS3/4A protease inhibitor; 100 mg/day) plus ruzasvir (MK-8408; an NS5A inhibitor; 60 mg/day) plus uprifosbuvir (MK-3682; an HCV NS5B polymerase inhibitor; 450 mg/day). Part B of the studies tested this combination as a single formulation in different treatment durations in a broader population...
November 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28766477/simultaneous-spectrophotometric-determination-of-elbasvir-and-grazoprevir-in-a-pharmaceutical-preparation
#19
Khalid A M Attia, Nasr M El-Abasawi, Ahmed El-Olemy, Ahmed H Abdelazim
Three UV spectrophotometric methods have been developed for the simultaneous determination of two new Food andDrug Administration-approved drugs, elbasvir (EBV) and grazoprevir (GRV), in their combined pharmaceutical dosage form. These methods include dual wavelength (DW), classic least-squares (CLS), and principal component regression (PCR). To achieve the DW method, two wavelengths were chosen for each drug in a way to ensure the difference in absorbance was zero from one drug to the other. GRV revealed equal absorbance at 351 and 315 nm, for which the distinctions in absorbance were measured for the determination of EBV...
August 1, 2017: Journal of AOAC International
https://www.readbyqxmd.com/read/28715911/hepatitis-c-treatment-regimens-are-cost-effective-but-compared-with-what
#20
T Joseph Mattingly, Julia F Slejko, C Daniel Mullins
BACKGROUND: Numerous economic models have been published evaluating treatment of chronic hepatitis C virus (HCV) infection, but none provide a comprehensive comparison among new antiviral agents. OBJECTIVE: Evaluate the cost-effectiveness of all recommended therapies for treatment of genotypes 1 and 4 chronic HCV. METHODS: Using data from clinical trials, observational analyses, and drug pricing databases, Markov decision models were developed for HCV genotypes 1 and 4 to compare all recommended drugs from the perspective of the third-party payer over a 5-, 10-, and 50-year time horizon...
November 2017: Annals of Pharmacotherapy
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