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https://www.readbyqxmd.com/read/28217256/interferon-free-regimens-in-patients-with-hepatitis-c-infection-and-renal-dysfunction-or-kidney-transplantation
#1
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-hepatitis-c-virus-infection-and-compensated-cirrhosis-an-integrated-analysis
#2
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 10, 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
#3
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
#4
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
#5
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...
January 24, 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
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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
#12
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
#13
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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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)
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