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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
#1
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...
January 19, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28075146/five-near-full-length-hepatitis-c-virus-sequences-were-isolated-from-hiv-coinfected-idus-of-china
#2
Fan Li, Yi Feng, Na Ni, Jing Hu, Yuhua Ruan, Yiming Shao, Liying Ma
HIV and 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 (NFLGs) of HCV isolated from five HIV-1 coinfected IDUs in Sichuan and Xinjiang province, China. By conducting reconstruction of neighbor-joining (NJ) phylogenetic tree, our results revealed that the five isolates are different genotypes (1b, 3a, 6a and 6n). The amino acid substitutions(170I) in XJN0021 related to resistant to protease inhibitors (Grazoprevir) were also identified...
January 11, 2017: AIDS Research and Human Retroviruses
https://www.readbyqxmd.com/read/28040878/erratum-to-elbasvir-grazoprevir-for-treatment-of-chronic-hepatitis-c-virus-infection
#3
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
#4
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
#5
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
#6
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
https://www.readbyqxmd.com/read/27970791/cost-effectiveness-of-grazoprevir-elbasvir-in-patients-with-chronic-hepatitis-c-virus
#7
T J Mattingly, J F Slejko, C D Mullins
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27966249/cost-effectiveness-of-elbasvir-grazoprevir-use-in-treatment-naive-and-treatment-experienced-patients-with-hepatitis-c%C3%A2-virus-genotype-1-infection-and-chronic-kidney-disease-in-the-united-states
#8
E Elbasha, W Greaves, D Roth, C Nwankwo
Among patients with chronic kidney disease (CKD) in the United States, HCV infection causes significant morbidity and mortality and results in substantial healthcare costs. A once-daily oral regimen of elbasvir/grazoprevir (EBR/GZR) for 12 weeks was found to be a safe and efficacious treatment for HCV in patients with CKD. We evaluated the cost-effectiveness of EBR/GZR in treatment-naïve and treatment-experienced CKD patients compared with no treatment (NoTx) and pegylated interferon plus ribavirin (peg-IFN/RBV) using a computer-based model of the natural history of chronic HCV genotype 1 infection, CKD and liver disease...
December 13, 2016: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/27943605/efficacy-and-safety-of-direct-acting-antivirals-based-antiviral-therapies-for-hepatitis-c-virus-patients-with-stage-4-5-chronic-kidney-disease-a-meta-analysis
#9
Tao Li, Yundong Qu, Ying Guo, Yan Wang, Lei Wang
BACKGROUND & AIMS: The aim of this study was to assess the efficacy and safety of direct-acting antivirals (DAA)-based antiviral therapies for HCV patients with stage 4-5 chronic kidney disease. METHODS: We conducted a systematic literature search in PubMed, EMBASE, Web of Science, and CENTRAL on the Cochrane Library without time and language limitations. The search strategy used was "(End stage renal disease OR chronic kidney failure OR severe renal impairment OR chronic kidney disease OR dialysis) AND (sofosbuvir OR simeprevir OR grazoprevir OR elbasvir OR ombitasvir OR paritaprevir OR ritonavir OR dasabuvir OR daclatasvir OR asuparevir OR direct-acting antiviral OR DAA)"...
December 10, 2016: Liver International: Official Journal of the International Association for the Study of the Liver
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
#10
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. AIMS: To assess 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...
February 2017: 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
#11
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
#12
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
#13
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
#14
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
#15
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
#16
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
#17
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 United States 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
#18
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...
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
#19
REVIEW
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...
January 2017: 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
#20
Paul Kwo, Edward J 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...
January 2017: Gastroenterology
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