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https://www.readbyqxmd.com/read/29765256/grazoprevir-elbasvir-for-the-treatment-of-adults-with-chronic-hepatitis-c-a-short-review-on-the-clinical-evidence-and-place-in-therapy
#1
REVIEW
Nimisha Sulejmani, Syed-Mohammed Jafri
Chronic hepatitis C virus (HCV) infection impacts approximately 71 million people and approximately 400,000 deaths are attributed to HCV-related liver disease annually worldwide. Mainstay of treatment for over 25 years has been pegylated interferon until the advent of protease inhibitors, which has led to all-oral HCV treatment regimens that have changed the outlook of hepatitis C treatment. Grazoprevir/elbasvir provides high rates of efficacy and tolerability and is an all-oral once daily treatment option for HCV infection...
2018: Hepatic Medicine: Evidence and Research
https://www.readbyqxmd.com/read/29761174/elbasvir-grazoprevir-in-asia-pacific-russian-participants-with-chronic-hepatitis-c-virus-genotype-1-4-or-6-infection
#2
Jacob George, Eduard Burnevich, I-Shyan Sheen, Jeong Heo, Nguyen Van Kinh, Tawesak Tanwandee, Pin-Nan Cheng, Do Young Kim, Won Young Tak, Svetlana Kizhlo, Konstantin Zhdanov, Vasily Isakov, Liwen Liang, Pauline Lindore, Joy Ginanni, Bach-Yen Nguyen, Janice Wahl, Eliav Barr, Michael Robertson, Paul Ingravallo, Rohit Talwani
The prevalence of hepatitis C virus (HCV) infection in Asian countries is high. This study assessed the efficacy and safety of elbasvir/grazoprevir (EBR/GZR) in participants with HCV infection from Asia-Pacific countries and Russia. In this phase 3, randomized, placebo-controlled, double-blind study, treatment-naive participants with HCV genotype (GT) 1, 4, or 6 infection were randomized to EBR 50 mg/GZR 100 mg (immediate-treatment group [ITG]) or placebo (deferred-treatment group [DTG]) once daily for 12 weeks (Protocol PN-5172-067, NCT02251990)...
May 2018: Hepatology Communications
https://www.readbyqxmd.com/read/29746724/efficacy-and-safety-of-elbasvir-grazoprevir-fixed-dose-in-the-management-of-polytreated-hcv-patients-evidence-from-real-life-clinical-practice
#3
Benedetto Caroleo, Lidia Colangelo, Maria Perticone, Giovambattista De Sarro, Luca Gallelli
Chronic hepatitis C virus (HCV) infection represents a global public health challenge, and new drugs have been authorized for its treatment. In this study, we evaluated both the clinical efficacy and safety of elbasvir-grazoprevir fixed-dose combination in HCV patients. We performed a prospective single-blind study on patients admitted to the Regional Center for HCV Treatment of the University of Catanzaro from March 1, 2017, to December 31, 2017, in patients >30 years old with a history of chronic HCV infection...
May 10, 2018: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29740665/real-world-virological-efficacy-and-safety-of-elbasvir-and-grazoprevir-in-patients-with-chronic-hepatitis-c-virus-genotype-1-infection-in-japan
#4
Hidenori Toyoda, Masanori Atsukawa, Koichi Takaguchi, Tomonori Senoh, Kojiro Michitaka, Atsushi Hiraoka, Shinichi Fujioka, Chisa Kondo, Tomomi Okubo, Haruki Uojima, Toshifumi Tada, Hirohito Yoneyama, Tsunamasa Watanabe, Toru Asano, Toru Ishikawa, Hideyuki Tamai, Hiroshi Abe, Keizo Kato, Kunihiko Tsuji, Chikara Ogawa, Noritomo Shimada, Etsuko Iio, Akihiro Deguchi, Ei Itobayashi, Shigeru Mikami, Akio Moriya, Hironao Okubo, Joji Tani, Akihito Tsubota, Yasuhito Tanaka, Tsutomu Masaki, Katsuhiko Iwakiri, Takashi Kumada
BACKGROUND: The real-world virological efficacy and safety of an interferon (IFN)-free direct-acting antiviral (DAA) therapy with elbasvir (EBR) and grazoprevir (GZR) were evaluated in Japanese patients chronically infected with hepatitis C virus (HCV) genotype 1. METHODS: The rate of sustained virologic response (SVR) and safety were analyzed in patients who started the EBR/GZR regimen between November 2016 and July 2017. SVR rates were compared based on patient baseline characteristics...
May 8, 2018: Journal of Gastroenterology
https://www.readbyqxmd.com/read/29735308/grazoprevir-plus-elbasvir-in-hcv-genotype-1-or-4-infected-patients-with-stage-4-5-severe-chronic-kidney-disease-is-safe-and-effective
#5
Laurent Alric, Isabelle Ollivier-Hourmand, Emilie Bérard, Sophie Hillaire, Maeva Guillaume, Anais Vallet-Pichard, Brigitte Bernard-Chabert, Veronique Loustaud-Ratti, Marc Bourlière, Victor de Ledinghen, Isabelle Fouchard-Hubert, Valerie Canva, Anne Minello, Eric Nguyen-Khac, Vincent Leroy, David Saadoun, Dominique Trias, Stanislas Pol, Nassim Kamar
Patients with advanced chronic kidney disease who receive direct-acting antiviral drugs require special consideration regarding comorbid conditions. Here we assessed the efficacy and safety of grazoprevir plus elbasvir in 93 patients infected with HCV genotype 1 or 4 and with advanced chronic kidney disease in a non-randomized, multicenter, nationwide observational survey. Twenty patients with HCV genotype 1a, 51 patients with 1b, four unclassified genotype 1, 17 with genotype 4 and one with genotype 6 received grazoprevir plus elbasvir (100/50 mg) once daily...
May 5, 2018: Kidney International
https://www.readbyqxmd.com/read/29724498/a-phase-i-single-and-multiple-dose-study-to-evaluate-the-pharmacokinetics-of-elbasvir-and-grazoprevir-in-healthy-chinese-participants
#6
Tommy Tsang Cheung, Joanne Wing Yan Chiu, Man Fung Yuen, Karen Siu Ling Lam, Bernard Man Yung Cheung, Hwa-Ping Feng, Wendy W Yeh, Jiangdian Wang, Wenting Li, Xu Min Zhao, Zaiqi Wang, Shengmei Mu
PURPOSE: This study evaluated the single- and multiple-dose pharmacokinetic (PK) variables of elbasvir and grazoprevir in healthy Chinese individuals. METHODS: This study was a 2-part, parallel-arm, open-label trial. In part 1, single-dose PK variables of elbasvir 10/50/100 mg and grazoprevir 50/100/200 mg were evaluated in 10 participants per drug. In part 2, 10-day multiple-dose PK variables of elbasvir 50 mg and grazoprevir 100 mg administered once daily alone and in combination were evaluated in 12 participants...
May 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29703432/antiviral-activity-safety-and-tolerability-of-multiple-ascending-doses-of-elbasvir-or-grazoprevir-in-participants-infected-with-hepatitis-c-virus-genotype-1-or-3
#7
Wendy W Yeh, Iain P Fraser, Patricia Jumes, Amelia Petry, Inge De Lepeleire, Martine Robberechts, Christina Reitmann, Kristien Van Dyck, Xiaobi Huang, Zifang Guo, Deborah Panebianco, Robert B Nachbar, Edward O'Mara, John A Wagner, Joan R Butterton, Frank J Dutko, Valentin Moiseev, Zhanna Kobalava, Andreas Hüser, Sorin Visan, Christian Schwabe, Edward Gane, Serghei Popa, Nelea Ghicavii, Markus Uhle, Frank Wagner
PURPOSE: Elbasvir (MK-8742) and grazoprevir (MK-5172; Merck & Co, Inc, Kenilworth, New Jersey) are hepatitis C virus (HCV)-specific inhibitors of the nonstructural protein 5A phosphoprotein and the nonstructural protein 3/4A protease, respectively. The aims of these studies were to evaluate the antiviral activity and safety of different doses of elbasvir or grazoprevir each administered as monotherapy to participants infected with either HCV genotype (GT) 1 or GT3. METHODS: These 2 double-blind, randomized, placebo-controlled, sequential-panel, multiple ascending dose studies were conducted to assess the safety and pharmacodynamics of 5 days of once-daily elbasvir or 7 days of once-daily grazoprevir in adult male participants chronically infected with either HCV GT1 or GT3...
April 24, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29696459/economic-evaluation-of-zepatier-for-the-management-of-hcv-in-the-italian-scenario
#8
F R Rolli, M Ruggeri, F Kheiraoui, C Drago, M Basile, C Favaretti, A Cicchetti
BACKGROUND: Hepatitis C virus (HCV) is a major health issue worldwide. New generation of direct-active antiviral medications is an epoch-making turning point in the management of HCV infections. OBJECTIVE: Conducing a cost-effectiveness analysis comparing the combination of elbasvir/grazoprevir and sofosbuvir + pegylated interferon/ribavirin for the management of all HCV patients (even those in the initial stages of fibrosis). METHODS: A Markov model was built on the natural history of the disease to assess the efficacy of the alternatives...
April 25, 2018: European Journal of Health Economics: HEPAC: Health Economics in Prevention and Care
https://www.readbyqxmd.com/read/29695828/elbasvir-grazoprevir-in-black-adults-with-hepatitis-c-virus-infection-a-pooled-analysis-of-phase-2-3-clinical-trials
#9
Philippe J Zamor, John Vierling, Reem Ghalib, Velimir Luketic, Natarajan Ravendhran, Luis Balart, Michael Robertson, Peggy Hwang, George J Hanna, Bach-Yen Nguyen, Eliav Barr, Rohit Talwani, Brian Pearlman
OBJECTIVES: Although direct-acting antiviral regimens have dramatically improved the treatment of hepatitis C virus (HCV) infection, there is some evidence that black race may be an independent predictor of treatment failure. We report a retrospective analysis of black participants receiving elbasvir/grazoprevir (EBR/GZR) in nine phase 2/3 clinical trials. METHODS: Black participants with chronic HCV genotype 1 or 4 (GT1 or GT4) infection who received EBR 50 mg/GZR 100 mg once daily for 12 weeks, or in combination with ribavirin for 16 weeks, were included...
April 26, 2018: American Journal of Gastroenterology
https://www.readbyqxmd.com/read/29695614/the-drug-drug-interaction-potential-of-antiviral-agents-for-the-treatment-of-chronic-hepatitis-c-infection
#10
Kimberly L Garrison, Polina German, Erik Mogalian, Anita Mathias
Several safe and highly-effective directly-acting antiviral drugs for chronic hepatitis C virus (HCV) have been developed and greatly increase the number of treatment options available to successfully treat HCV infection. However, as treatment regimens contain at least two drugs (e.g., sofosbuvir with daclatasvir, simeprevir, ledipasvir, or velpatasvir; elbasvir and grazoprevir) and up to five drugs (ombitasvir/paritaprevir/ritonavir+dasabuvir+ribavirin), the potential for drug-drug interactions (DDI) becomes an important consideration for HCV-infected individuals with comorbidities that require concomitant medications, such as HIV/HCV co-infection or immunosuppression following liver transplantation...
April 25, 2018: Drug Metabolism and Disposition: the Biological Fate of Chemicals
https://www.readbyqxmd.com/read/29694728/rationale-for-treatment-of-hepatitis-c-virus-infection-in-end-stage-renal-disease-patients-who-are-not-kidney-transplant-candidates
#11
REVIEW
Laith Al-Rabadi, Terry Box, Girish Singhania, Catreena Al-Marji, Adhish Agarwal, Isaac Hall, Craig E Gordon, Huy Tran
Hepatitis C virus (HCV) infection is a common problem in patients treated with maintenance hemodialysis (HD) and is associated with an increased morbidity and mortality and lower quality of life. The major causes of HCV-associated mortality are liver and cardiovascular-related death. HCV-infected HD patients have a higher prevalence of inflammation-related metabolic and vascular diseases, leading to high rates of cardiovascular mortality in patients with end-stage renal disease. In the current era of highly effective direct-acting antiviral regimens, HCV treatment may also confer hepatic, cardiovascular and other morbidity and mortality benefits even to dialysis-dependent patients who do not qualify for kidney transplantation...
April 2018: Hemodialysis International
https://www.readbyqxmd.com/read/29681166/direct-acting-antivirals-to-prevent-vertical-transmission-of-viral-hepatitis-c-when-is-the-optimal-time-to-treat
#12
Leigh Cervino, Lauren M Hynicka
OBJECTIVE: To describe the most current evidence for the use of direct-acting antivirals (DAAs) to treat hepatitis C along the pregnancy-pediatric continuum in the United States. DATA SOURCES: The MEDLINE/PubMed databases were searched (January 1995 to February 2018) for articles in English using the terms: hepatitis C, vertical transmission, pregnancy, pediatrics, ribavirin, interferon, direct acting antivirals, daclatasvir, dasabuvir, elbasvir, glecaprevir, grazoprevir, ledipasvir, ombitasvir, paritaprevir, pibrentasvir, simeprevir, sofosbuvir, and velpatasvir...
April 1, 2018: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/29665097/real-world-use-of-elbasvir-grazoprevir-in-patients-with-chronic-hepatitis-c-retrospective-analyses-from-the-trio-network
#13
S L Flamm, B Bacon, M P Curry, S Milligan, C U Nwankwo, N Tsai, Z Younossi, N Afdhal
BACKGROUND: Elbasvir-grazoprevir is indicated for chronic hepatitis C virus (HCV) genotypes 1 and 4. AIMS: To evaluate the utilization and outcomes of chronic HCV patients treated with elbasvir-grazoprevir in the United States. METHODS: We conducted a retrospective cohort study of adults treated with elbasvir-grazoprevir with or without ribavirin for chronic HCV genotypes 1 or 4 infection. Data were collected from healthcare providers and specialty pharmacies through Innervation Platform, a proprietary, cloud-based disease management program from Trio Health...
April 17, 2018: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29662642/successful-retreatment-with-grazoprevir-and-elbasvir-for-patients-infected-with-hepatitis-c-virus-genotype-1b-who-discontinued-prior-treatment-with-ns5a-inhibitor-including-regimens-due-to-adverse-events
#14
Tatsuo Kanda, Shin Yasui, Masato Nakamura, Shingo Nakamoto, Koji Takahashi, Shuang Wu, Reina Sasaki, Yuki Haga, Sadahisa Ogasawara, Tomoko Saito, Kazufumi Kobayashi, Soichiro Kiyono, Yoshihiko Ooka, Eiichiro Suzuki, Tetsuhiro Chiba, Hitoshi Maruyama, Mitsuhiko Moriyama, Naoya Kato
Background: Sustained virologic response (SVR) by interferon and interferon-free treatment can results in the reduction of advanced liver fibrosis and the occurrence of hepatocellular carcinoma in patients infected with hepatitis C virus (HCV). Recent interferon-free treatment for HCV shortens the duration of treatment and leads to higher SVR rates, without any serious adverse events. However, it is important to retreat patients who have had treatment-failure with HCV non-structural protein 5A (NS5A) inhibitor-including regimens...
March 23, 2018: Oncotarget
https://www.readbyqxmd.com/read/29661883/unexpected-replication-boost-by-simeprevir-for-simeprevir-resistant-variants-in-genotype-1a-hepatitis-c-virus
#15
Kazuhisa Murai, Tetsuro Shimakami, Christoph Welsch, Takayoshi Shirasaki, Fanwei Liu, Juria Kitabayashi, Shiho Tanaka, Masaya Funaki, Hitoshi Omura, Tomoki Nishikawa, Ariunaa Suminyadorj, Masao Honda, Shuichi Kaneko
Simeprevir is a novel NS3/4A protease inhibitor (PI) of hepatitis C virus (HCV). The baseline polymorphism NS3-Q80K is frequently observed in genotype (gt) 1a HCV and often associated with treatment failure in simeprevir-containing regimens. We aimed to elucidate mechanisms of treatment failure due to NS3-Q80K. We included a Q80R mutation in our study and generated a series of Huh-7.5 cells, each of which harbored either wild-type gt 1a H77S.3 or one of the variants, Q80K or Q80R. The cells were cultured with increasing concentrations of simeprevir, and NS3 domain sequences were determined...
April 16, 2018: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29661427/hepatitis-c-virus-eradication-in-kidney-transplant-recipients-a-single-center-experience-in-portugal
#16
A Weigert, S Querido, L Carvalho, L Lebre, C Chagas, P Matias, R Birne, C Nascimento, C Jorge, T Adragão, M Bruges, D Machado
INTRODUCTION: Hepatitis C (HCV) is a major cause of liver impairment post-kidney transplantation (KT). Anti-HCV direct-acting antivirals (DAA) made viral eradication possible. METHODS: We performed a retrospective review of KT patients (n = 23) who received DAA at our hospital. Sustained viral response (SVR) was defined as absence of viral detection 12 weeks after cessation of therapy. RESULTS: From 1985 to September 2017, 1440 patients underwent transplantation at Hospital Santa Cruz...
April 2018: Transplantation Proceedings
https://www.readbyqxmd.com/read/29606942/elbasvir-grazoprevir-an-alternative-in-antiviral-hepatitis-c-therapy-in-patients-under-amiodarone-treatment
#17
Lina Weiss, Kerstin Wustmann, Mariam Semmo, Markus Schwerzmann, Nasser Semmo
A sofosbuvir/ledipasvir combination is part of a first-line treatment of hepatitis C. However, in patients concurrently treated with amiodarone, cardiac side effects have been described, resulting in an official warning in 2015 by the American Food and Drug Administration and the European Medicines Agency when combining those substances. This deprived numerous hepatitis C patients with concurrent cardiovascular problems of receiving this highly effective treatment. Here we present a treatment alternative with an elbasvir/grazoprevir regimen, based on our successful treatment of a patient under concurrent amiodarone therapy...
January 2018: Case Reports in Gastroenterology
https://www.readbyqxmd.com/read/29582685/-real-life-experience-with-direct-acting-antiviral-agents-for-hepatitis-c-virus-in-end-stage-renal-disease
#18
Rebeca García-Agudo, Sami Aoufi-Rabih, Mercedes Salgueira-Lazo, Carmen González-Corvillo, Fabrizio Fabrizi
BACKGROUND AND AIMS: The advent of direct-acting antiviral agents promises to change the management of hepatitis C in patients with end-stage renal disease, a patient group where the treatment of hepatitis C was historically challenging. We investigated the safety and efficacy of all-oral, interferon-free direct-acting antiviral agents for the treatment of hepatitis C in a 'real-world' group of patients with end-stage renal disease. METHODS: We performed a single-arm, multi-centre study in a cohort (n=30) of patients with advanced chronic kidney disease (mostly on dialysis) who underwent antiviral therapy with direct-acting antiviral agents...
March 1, 2018: International Journal of Artificial Organs
https://www.readbyqxmd.com/read/29572333/risk-of-clinically-relevant-pharmacokinetic-based-drug-drug-interactions-with-drugs-approved-by-the-u-s-food-and-drug-administration-between-2013-and-2016
#19
Jingjing Yu, Zhu Zhou, Jessica Tay-Sontheimer, Rene H Levy, Isabelle Ragueneau-Majlessi
A total of 103 drugs (including 14 combination drugs) were approved by the U.S. Food and Drug Administration from 2013 to 2016. Pharmacokinetic-based drug interaction profiles were analyzed using the University of Washington Drug Interaction Database and the clinical relevance of these observations was characterized based on information from New Drug Application reviews. CYP3A was identified as a major contributor to clinical drug-drug interactions (DDIs), involved in approximately 2/3 of all interactions. Transporters (alone or with enzymes) were found to participate in about half of all interactions, although most of these were weak-to-moderate interactions...
March 23, 2018: Drug Metabolism and Disposition: the Biological Fate of Chemicals
https://www.readbyqxmd.com/read/29557529/clinical-pharmacokinetics-and-drug-drug-interactions-of-elbasvir-grazoprevir
#20
Tony K L Kiang
Elbasvir and grazoprevir, in a fixed-dose combination of 50 and 100 mg, respectively, have received approval to be administered orally once daily, with or without ribavirin, for the treatment of chronic hepatitis C virus (HCV) infections. The absorption characteristics of elbasvir and grazoprevir have been adequately summarized, although differences were observed for grazoprevir (e.g., increased exposure at steady state in patients), but not elbasvir, between healthy and HCV-infected subjects. Inconsistencies with respect to absorption were also reported on the effects of food or acid reducers (famotidine or pantoprazole) in the literature...
March 20, 2018: European Journal of Drug Metabolism and Pharmacokinetics
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