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https://www.readbyqxmd.com/read/27910116/the-cost-effectiveness-of-testing-for-ns5a-resistance-associated-polymorphisms-at-baseline-in-genotype-1a-infected-treatment-na%C3%A3-ve-and-treatment-experienced-subjects-treated-with-all-oral-elbasvir-grazoprevir-regimens-in-the-united-states
#1
E H Elbasha, M N Robertson, C Nwankwo
BACKGROUND: The presence of baseline NS5A resistance-associated variants (RAVs) impacted treatment response in HCV genotype 1a (GT1a)-infected patients treated with elbasvir/grazoprevir (EBR/GZR) for 12 weeks, but not patients treated with EBR/GZR and ribavirin (RBV) for 16 weeks. AIM: We assessed the cost-effectiveness of baseline testing for NS5A RAVs in EBR/GZR-treated patients compared without testing and with current treatments for GT1a patients. METHODS: We simulated the course of treatment with EBR/GZR, ledipasvir/sofosbuvir (LDV/SOF) and ombitasvir/paritaprevir/ritonavir+dasabuvir (3D) with or without RBV and natural history of disease of GT1a patients...
December 1, 2016: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/27873094/the-combination-of-elbasvir-and-grazoprevir-for-the-treatment-of-chronic-hcv-infection-in-japanese-patients-a-randomized-phase-ii-iii-study
#2
Hiromitsu Kumada, Yoshiyuki Suzuki, Yoshiyasu Karino, Kazuaki Chayama, Norifumi Kawada, Takeshi Okanoue, Yoshito Itoh, Satoshi Mochida, Hidenori Toyoda, Hitoshi Yoshiji, Shintaro Takaki, Naoyoshi Yatsuzuka, Etsuo Yodoya, Takashi Iwasa, Go Fujimoto, Michael N Robertson, Stuart Black, Luzelena Caro, Janice Wahl
BACKGROUND: Elbasvir (EBR) in combination with grazoprevir (GZR) has demonstrated efficacy in patients with hepatitis C virus (HCV) infections in trials primarily conducted in the USA and Europe. We investigated the safety and efficacy of EBR in combination with GZR in Japanese patients with chronic HCV infection, with or without cirrhosis. METHODS: The study was conducted in two parts. In part 1, noncirrhotic patients were randomized 1:1 to receive EBR (50 mg) in combination with GZR (50 or 100 mg) once daily for 12 weeks...
November 21, 2016: Journal of Gastroenterology
https://www.readbyqxmd.com/read/27867981/grazoprevir-plus-elbasvir-and-other-treatment-options-in-hepatitis-c-infected-patients-with-stage-4-5-chronic-kidney-disease
#3
EDITORIAL
Kalyan Ram Bhamidimarri
No abstract text is available yet for this article.
October 2016: Annals of Translational Medicine
https://www.readbyqxmd.com/read/27867980/c-worthy-the-beginning-of-the-rise-of-elbasvir-and-grazoprevir-for-the-treatment-of-hepatitis-c-genotype-1-mono-and-hiv-co-infected-patients
#4
EDITORIAL
Dost Sarpel, Douglas T Dieterich
No abstract text is available yet for this article.
October 2016: Annals of Translational Medicine
https://www.readbyqxmd.com/read/27861265/drug-updates-and-approvals-2016-in-review
#5
Lindsy Meadowcraft, Geoffrey Mospan, Taylor Morrisette, Katie Smart, Melissa Janis
In 2016, the FDA approved several new drugs for use in primary care. These drugs include amphetamine extended-release orally disintegrating tablets (Adzenys XR-ODT), elbasvir and grazoprevir (Zepatier), emtricitabine and tenofovir alafenamide (Descovy), glycopyrrolate and formoterol (Bevespi Aerosphere), insulin degludec injection (Tresiba), and ixekizumab (Taltz).
December 16, 2016: Nurse Practitioner
https://www.readbyqxmd.com/read/27807768/process-chemistry-in-antiviral-research
#6
REVIEW
Yong-Li Zhong, Nobuyoshi Yasuda, Hongming Li, Mark McLaughlin, David Tschaen
This article reviews antiviral therapies that have been approved for human use during the last decade, with a focus on the process chemistry that enabled access to these important drugs. In particular, process chemistry highlights from the practical syntheses of the HCV drugs sofosbuvir (Gilead), grazoprevir (Merck), and elbasvir (Merck), the HIV therapy darunavir (Tibotec) and the influenza treatment peramivir (BioCryst) are presented.
December 2016: Topics in Current Chemistry (Journal)
https://www.readbyqxmd.com/read/27803742/direct-acting-antivirals-for-the-treatment-of-chronic-hepatitis-c-in-patients-with-chronic-kidney-disease
#7
REVIEW
Anita Kohli, Ali Alshati, Fawaz Georgie, Richard Manch, Robert G Gish
All-oral, direct-acting antivirals (DAAs) have significantly improved the efficacy and safety of chronic hepatitis C (CHC) treatment but their effectiveness and safety among patients with chronic kidney disease (CKD) remains poorly understood. Our aim was to assess the efficacy and safety of DAAs for treatment of CKD patients. The National Library of Medicine through PubMed was searched for studies evaluating the efficacy of DAAs for the treatment of patients with CKD stages 4 or 5, as defined by the Kidney Disease Outcomes Quality Initiative guidelines [i...
November 2016: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/27773808/regulatory-analysis-of-effects-of-hepatitis-c-virus-ns5a-polymorphisms-on-efficacy-of-elbasvir-and-grazoprevir
#8
Takashi E Komatsu, Sarita Boyd, Adam Sherwat, LaRee Tracy, Lisa K Naeger, Julian J O'Rear, Patrick R Harrington
BACKGROUND & AIMS: Elbasvir (an NS5A inhibitor) and grazoprevir (an NS3/4A protease inhibitor) are direct-acting antiviral agents recently approved in the US for treatment of chronic hepatitis C virus (HCV) genotype 1 and 4 infections, as a fixed-dose combination. Trials of elbasvir and grazoprevir, with or without ribavirin, demonstrated high rates of sustained virologic response 12 weeks after treatment ended (SVR12). However, 12 weeks of treatment with elbasvir and grazoprevir failed in a small proportion of patients with HCV genotype 1 infection...
October 20, 2016: Gastroenterology
https://www.readbyqxmd.com/read/27770561/short-duration-treatment-with-elbasvir-grazoprevir-and-sofosbuvir-for-hepatitis-c-a-randomized-trial
#9
Eric Lawitz, Fred Poordad, Julio A Gutierrez, Jennifer T Wells, Carmen E Landaverde, Barbara Evans, Anita Howe, Hsueh-Cheng Huang, Jerry Jing Li, Peggy Hwang, Frank J Dutko, Michael Robertson, Janice Wahl, Eliav Barr, Barbara Haber
Direct-acting antiviral agents (DAAs) represent the standard of care for patients with hepatitis C virus (HCV) infection. Combining DAAs with different mechanisms may allow for shorter treatment durations that are effective across multiple genotypes. The aim of the C-SWIFT study was to identify the minimum effective treatment duration across multiple genotypes. C-SWIFT was an open-label, single-center trial in treatment-naïve patients with chronic HCV genotype (GT)1 or 3 infection. All patients received elbasvir (EBR) 100 mg/grazoprevir (GZR) 50 mg with sofosbuvir (SOF) 400 mg for 4-12 weeks...
October 22, 2016: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/27757504/network-meta-analysis-of-first-and-second-generation-protease-inhibitors-for-chronic-hepatitis-c-genotype-1-efficacy-based-on-rvr-and-svr-24
#10
Helena H Borba, Astrid Wiens, Laiza M Steimbach, Cassio M Perlin, Fernanda S Tonin, Maria L A Pedroso, Fernando Fernandez-Llimos, Roberto Pontarolo
PURPOSE: This study aimed to compare the efficacy among direct-acting antiviral agents (first and second-generation direct-acting antiviral agents (DAAs)) with placebo and with standard dual therapy (pegylated interferon + ribavirin (Peg-IFN + RBV)) in terms of rapid virologic response (RVR) and sustained virologic response (SVR) in chronic hepatitis C genotype 1 treatment. METHODS: We performed a systematic review of randomized controlled trials (RCTs) in MEDLINE, International Pharmaceutical Abstracts, Cochrane Library, SCIELO, and Scopus and conducted a network meta-analysis to compare the efficacy of boceprevir (BOC), daclatasvir (DCV), grazoprevir, simeprevir (SMV) and telaprevir (TVR), in treatment-naive and treatment-experienced patients...
October 19, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27720838/effectiveness-of-elbasvir-and-grazoprevir-combination-with-or-without-ribavirin-for-treatment-experienced-patients-with-chronic-hepatitis-c-infection
#11
Paul Kwo, Edward Gane, Cheng-Yuan Peng, Brian Pearlman, John M Vierling, Lawrence Serfaty, Maria Buti, Stephen Shafran, Paul Stryszak, Li Lin, Jacqueline Gress, Stuart Black, Frank J Dutko, Michael Robertson, Janice Wahl, Lisa Lupinacci, Eliav Barr, Barbara Haber
BACKGROUND & AIMS: Patients infected with hepatitis C virus (HCV) genotype 1, 4, or 6, with or without cirrhosis, previously treated with peg-interferon and ribavirin, are a challenge to treat. We performed a phase 3 randomized controlled open-label trial to assess the effects of 12 or 16 weeks of treatment with once-daily elbasvir (an HCV NS5A inhibitor, 50 mg) and grazoprevir (an HCV NS3/4A protease inhibitor, 100 mg), in a fixed-dose combination tablet, with or without twice-daily ribavirin, in this patient population...
October 5, 2016: Gastroenterology
https://www.readbyqxmd.com/read/27717014/use-of-direct-acting-agents-for-hcv-positive-kidney-transplant-candidates-and-kidney-transplant-recipients
#12
L Rostaing, L Alric, N Kamar
In some parts of the world, hepatitis C virus (HCV) infection remains a huge problem for kidney-transplant candidates and kidney-transplant (KT) recipients. Until 2 years ago, anti-HCV treatment for the general population relied on pegylated-alpha-interferon plus ribavirin, but led to a sustained viral response (SVR) in <50% of cases. This treatment was contraindicated in KT patients because of acute-rejection issues and was poorly tolerated in patients with end-stage renal disease. Over the last year, direct-acting antiviral agents (DAAs) have entered the market and are associated in the general population with a SVR of >90%, whatever the patient's HCV genotype...
October 7, 2016: Transplant International: Official Journal of the European Society for Organ Transplantation
https://www.readbyqxmd.com/read/27698508/elbasvir-grazoprevir
#13
Dennis J Cada, Anne P Kim, Danial E Baker
Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers...
September 2016: Hospital Pharmacy
https://www.readbyqxmd.com/read/27641990/hepatitis-c-virus-infection-and-chronic-kidney-disease-time-for-reappraisal
#14
REVIEW
Patrice Cacoub, Anne Claire Desbois, Corinne Isnard-Bagnis, Dario Rocatello, Clodoveo Ferri
Hepatitis C virus (HCV) infection is associated with tremendous morbidity and mortality due to liver complications. HCV infection is also associated with many extrahepatic manifestations including cardiovascular diseases, glucose metabolism impairment, cryoglobulinemia vasculitis, B cell non-Hodgkin lymphoma and chronic kidney disease (CKD). Many studies have shown a strong association between HCV and CKD, by reporting (i) an increased prevalence of HCV infection in patients on haemodialysis, (ii) an increased incidence of CKD and proteinuria in HCV-infected patients, and (iii) the development of membranoproliferative glomerulonephritis secondary to HCV-induced cryoglobulinemia vasculitis...
October 2016: Journal of Hepatology
https://www.readbyqxmd.com/read/27624503/elbasvir-grazoprevir-for-treatment-of-chronic-hepatitis-c-virus-infection
#15
Chandana Papudesu, Shyamasundaran Kottilil, Shashwatee Bagchi
Hepatitis C is the leading cause of progressive liver fibrosis worldwide and results in cirrhosis, liver cancer, liver failure and death. Successful treatment for hepatitis C virus (HCV) has rapidly evolved in recent years to a well-tolerated, highly efficacious all-oral therapy. Elbasvir/grazoprevir (Zepatier) is the newest of the oral combinations of HCV direct-acting agents that was approved by the US Federal Drug Administration. This review focuses on the pharmacology, mechanism of action and clinical trial data that support the use of this new combination treatment for HCV infection...
September 13, 2016: Hepatology International
https://www.readbyqxmd.com/read/27621510/sacubitril-valsartan
#16
EDITORIAL
Dennis J Cada, Danial E Baker, James Leonard
Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are sent in print and are also available on-line...
November 2015: Hospital Pharmacy
https://www.readbyqxmd.com/read/27618896/detection-of-natural-resistance-associated-substitutions-by-ion-semiconductor-technology-in-hcv1b-positive-direct-acting-antiviral-agents-na%C3%A3-ve-patients
#17
Nadia Marascio, Grazia Pavia, Alessio Strazzulla, Tim Dierckx, Lize Cuypers, Bram Vrancken, Giorgio Settimo Barreca, Teresa Mirante, Donatella Malanga, Duarte Mendes Oliveira, Anne-Mieke Vandamme, Carlo Torti, Maria Carla Liberto, Alfredo Focà, The Sinergie-Umg Study Group
Naturally occurring resistance-associated substitutions (RASs) can negatively impact the response to direct-acting antivirals (DAAs) agents-based therapies for hepatitis C virus (HCV) infection. Herein, we set out to characterize the RASs in the HCV1b genome from serum samples of DAA-naïve patients in the context of the SINERGIE (South Italian Network for Rational Guidelines and International Epidemiology, 2014) project. We deep-sequenced the NS3/4A protease region of the viral population using the Ion Torrent Personal Genome Machine, and patient-specific majority rule consensus sequence summaries were constructed with a combination of freely available next generation sequencing data analysis software...
2016: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/27603877/elbasvir-and-grazoprevir-for-chronic-hepatitis-c-genotypes-1-and-4
#18
Mohamed El Kassas, Tamer Elbaz, Yasmeen Abd El Latif, Gamal Esmat
INTRODUCTION: During the last few years, treatment of hepatitis C virus (HCV) revolutionized with the appearance of direct antiviral agents especially for patients with HCV genotypes 1 and 4 infections. Elbasvir (NS5A inhibitor) and grazoprevir (NS3/4A protease inhibitor) are newly developed drugs that are presented in fixed dose combination tablets. AREAS COVERED: This review covers the mechanism of action, pharmacokinetic and pharmacodynamics properties, clinical uses, safety and efficacy of elbasvir/grazoprevir in managing a wide variety of easy and difficult to treat populations (such as presence of cirrhosis, treatment experienced, co-infection with HIV and patients with inherited blood disorders)...
September 7, 2016: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/27545640/-novel-treatments-for-hepatitis-c-virus-infection-in-chronic-kidney-disease
#19
Fabrizio Fabrizi, Piergiorgio Messa
Recent evidence has been accumulated showing a negative impact of chronic hepatitis C virus infection on survival in patients with chronic kidney disease. Moreover, it appears that anti-HCV positive status has been associated with an increased risk of developing chronic kidney disease in the adult general population. These reports have emphasized the need for safe and effective therapies for hepatitis C virus infection in the chronic kidney disease population. Treatment of HCV has made considerable progress with the approval of interferon-free, direct-acting antiviral drug-based combination therapies among patients with intact kidneys; but a paucity of information exists regarding chronic kidney disease patients...
July 2016: Giornale Italiano di Nefrologia: Organo Ufficiale Della Società Italiana di Nefrologia
https://www.readbyqxmd.com/read/27544488/hepatitis-c-virus-ns3-4a-protease-inhibitors
#20
John A McCauley, Michael T Rudd
Hepatitis C virus (HCV) infection is a major health issue around the world and HCV NS3/4a protease inhibitors have been the focus of intensive research for the past 20 years. From the first identification of substrate-derived peptide inhibitors to the complex, macrocyclic compounds, including paritaprevir and grazoprevir, that are currently available, the field has used structure-based design to confront the issues of potency, resistance and pharmacokinetics. Numerous breakthrough structures from a multitude of companies have led to compounds that are now key components of combination therapies with cure rates of >90%...
August 18, 2016: Current Opinion in Pharmacology
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