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https://www.readbyqxmd.com/read/28715911/hepatitis-c-treatment-regimens-are-cost-effective-but-compared-with-what
#1
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...
July 1, 2017: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/28708211/direct-acting-antivirals-for-hepatitis-c-virus-in-patients-on-maintenance-dialysis
#2
Fabrizio Fabrizi, Francesca M Donato, Piergiorgio Messa
The frequency of hepatitis C virus (HCV) infection remains high in patients with chronic kidney disease (CKD) and plays a detrimental role in mortality in this population. According to the latest survey, the adjusted hazard ratio for HCV-positive versus HCV-negative patients on long-term dialysis was 1.12 (95% CI, 1.05 to 1.20) and 1.10 (95% CI, 0.98 to 1.22) for all-cause and cardiovascular mortality, respectively. An impairment on quality of life has also been documented in HCV-infected patients undergoing regular dialysis...
July 8, 2017: International Journal of Artificial Organs
https://www.readbyqxmd.com/read/28690275/preclinical-and-clinical-properties-of-elbasvir-erelsa-%C3%A2-tablets-50%C3%A2-mg-and-grazoprevir-grazyna-%C3%A2-tablets-50%C3%A2-mg-novel-therapeutic-agents-for-hepatitis-c
#3
Kiyoshi Kinoshita, Takashi Iwasa, Ernest Asante-Appiah, Keisuke Nakamura
No abstract text is available yet for this article.
2017: Nihon Yakurigaku Zasshi. Folia Pharmacologica Japonica
https://www.readbyqxmd.com/read/28688129/grazoprevir-ruzasvir-and-uprifosbuvir-for-hcv-after-ns5a-treatment-failure
#4
David Wyles, Heiner Wedemeyer, Ziv Ben-Ari, Edward J Gane, Jesper Bach Hansen, Ira M Jacobson, Alex L Laursen, Annie Luetkemeyer, Ronald Nahass, Stephen Pianko, Stefan Zeuzem, Patricia Jumes, Hsueh-Cheng Huang, Joan Butterton, Michael Robertson, Janice Wahl, Eliav Barr, Hee-Koung Joeng, Elizabeth Martin, Lawrence Serfaty
People with hepatitis C virus (HCV) infection who have failed treatment with an all-oral regimen represent a challenging treatment population. The present studies evaluated the safety and efficacy of grazoprevir, ruzasvir, and uprifosbuvir, with or without ribavirin, in participants who had failed an NS5A inhibitor-containing regimen. C-SURGE (PN-3682-021) and C-CREST Part C (PN-3682-011 and -012) were open-label, multicenter studies. Participants who had previously relapsed following an NS5A inhibitor-containing all-oral regimen were retreated with grazoprevir 100 mg, ruzasvir 60 mg, and uprifosbuvir 450 mg alone for 24 weeks or with ribavirin for 16 weeks...
July 7, 2017: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/28680834/direct-acting-anti-hepatitis-c-virus-drugs-clinical-pharmacology-and-future-direction
#5
Ayman Geddawy, Yasmine F Ibrahim, Nabil M Elbahie, Mohammad A Ibrahim
Chronic hepatitis C virus (HCV) infection is a leading cause of chronic liver disease. The introduction of direct acting antiviral agents (DAAs) for its treatment represents a major advance in terms of sustained virologic response (SVR) rates and adverse effect profiles. Mechanistically, DAAs inhibit specific HCV non-structural proteins (NS) that are vital for its replication. Boceprevir, telaprevir, simeprevir, asunaprevir, grazoprevir and paritaprevir are NS3/4A inhibitors. Ombitasvir, ledipasvir, daclatasvir, elbasvir and velpatasvir are NS5A inhibitors...
March 2017: Journal of Translational Internal Medicine
https://www.readbyqxmd.com/read/28650400/high-need-to-switch-cart-or-co-medication-with-the-initiation-of-daas-in-elderly-hiv-hcv-co-infected-patients
#6
Elise J Smolders, Colette Smit, Clara Tmm De Kanter, Anton Dofferhoff, Joop E Arends, Kees Brinkman, Bart Rijnders, Marc Van Der Valk, Peter Reiss, David M Burger
BACKGROUD: To describe the use of non-antiretroviral co-medication and combination antiretroviral therapy (cART) in HIV/hepatitis C virus (HCV) co-infected patients, 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 co-infection on 1 January 2015 were included...
June 22, 2017: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/28647541/response-tailored-protocol-versus-the-fixed-12weeks-course-of-dual-sofosbuvir-daclatasvir-treatment-in-egyptian-patients-with-chronic-hepatitis-c-genotype-4-infection-a-randomized-open-label-non-inferiority-trial
#7
Mostafa Yakoot, Alaa M Abdo, Siham Abdel-Rehim, Sherine Helmy
BACKGROUND: The most recent European Association for the Study of the Liver (EASL) 2016 Guidelines on treatment of hepatitis C (HCV), allowed for shortening the course of treatment for some subsets of patients with sofosbuvir/ledipasvir and with grazoprevir/elbasvir based on cutoff baseline HCV RNA values. We hypothesized that it would be prudent to also consider an objectively assuring very rapid, on-treatment, virologic response to therapy at week 2 (vRVR) before taking the decision of shortening the treatment duration...
May 17, 2017: EBioMedicine
https://www.readbyqxmd.com/read/28625018/no-pharmacokinetic-interaction-between-the-hepatitis-c-virus-inhibitors-elbasvir-grazoprevir-and-famotidine-or-pantoprazole
#8
H-P Feng, P Vaddady, Z Guo, F Liu, D Panebianco, V Levine, L Caro, J R Butterton, M Iwamoto, W W Yeh
Use of agents to suppress gastric acid secretion is common among patients with hepatitis C virus (HCV) infection. The aims of this open-label, three-period, fixed-sequence study were to evaluate the effect of famotidine and pantoprazole on the pharmacokinetics and safety of elbasvir/grazoprevir fixed-dose combination (FDC) in 16 healthy subjects. Elbasvir and grazoprevir each exhibited similar pharmacokinetics following single-dose administration of elbasvir/grazoprevir with or without famotidine or pantoprazole...
June 17, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28615303/favouring-modulation-of-circulating-lipoproteins-and-lipid-loading-capacity-by-direct-antiviral-agents-grazoprevir-elbasvir-or-ledipasvir-sofosbuvir-treatment-against-chronic-hcv-infection
#9
Hung-Yu Sun, Pin-Nan Cheng, Chiung-Ying Tseng, Wei-Jen Tsai, Yen-Cheng Chiu, Kung-Chia Young
OBJECTIVE: Lipid homoeostasis is disturbed in patients with HCV infection. Direct-acting antiviral agent (DAA) treatment eradicates chronic HCV viraemia, but the dynamics of lipid components remain elusive. This study investigates the clinical manifestation and mechanistic relevance of plasma triglyceride (TG), cholesterol (Chol), lipoproteins and apolipoproteins (apos) after DAA treatment. DESIGN: Twenty-four patients with chronic genotype 1 (GT1) HCV treated with elbasvir/grazoprevir or ledipasvir/sofosbuvir for 12 weeks, and followed-up thereafter, were recruited...
June 14, 2017: Gut
https://www.readbyqxmd.com/read/28588311/low-frequency-of-ns5a-relevant-resistance-associated-substitutions-to-elbasvir-among-hepatitis-c-virus-genotype-1a-in-spain-a-cross-sectional-study
#10
Claudia Palladino, Marta Sánchez-Carrillo, Irene Mate-Cano, Sonia Vázquez-Morón, Ma Ángeles Jimenez-Sousa, Mónica Gutiérrez-Rivas, Salvador Resino, Verónica Briz
Relevant resistance-associated substitutions (RASs) to elbasvir, the new HCV NS5A inhibitor, may limit its efficacy and lead to virological failure in HCV-GT1a-infected patients. There are few data outside clinical trials evaluating their prevalence and impact of elbasvir/grazoprevir. A multicenter cross-sectional study of 617 HCV-GT1a-infected individuals attended in 84 Spanish hospitals from the 17 Autonomous Communities and two Autonomous cities was performed. HCV population sequencing was used to identify RASs to elbasvir and the mutational pattern and drug sensitivity were confirmed by geno2pheno[HCV]...
June 6, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28576451/elbasvir-plus-grazoprevir-in-patients-with-hepatitis-c-virus-infection-and-stage-4-5-chronic-kidney-disease-clinical-virological-and-health-related-quality-of-life-outcomes-from-a-phase-3-multicentre-randomised-double-blind-placebo-controlled-trial
#11
Annette Bruchfeld, David Roth, Paul Martin, David R Nelson, Stanislas Pol, Maria-Carlota Londoño, Howard Monsour, Marcelo Silva, Peggy Hwang, Jean-Marie Arduino, Michael Robertson, Bach-Yen Nguyen, Janice Wahl, Eliav Barr, Wayne Greaves
BACKGROUND: In the C-SURFER study, therapy with the all-oral elbasvir plus grazoprevir regimen for 12 weeks in patients with chronic hepatitis C virus (HCV) infection and stage 4-5 chronic kidney disease resulted in a high rate of virological cure compared with placebo. Here, we report sustained virological response (SVR), safety data, health-related quality-of-life (HRQOL), and virological resistance analyses in patients in C-SURFER who received immediate antiviral therapy or who received placebo before therapy...
May 30, 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28566078/-determination-of-drug-resistance-mutations-of-ns3-inhibitors-in-chronic-hepatitis-c-patients-infected-with-genotype-1
#12
Tamer Şanlıdağ, Murat Sayan, Sinem Akçalı, Elmas Kasap, Tahir Buran, Ayşe Arıkan
Direct-acting antiviral agents (DAA) such as NS3 protease inhibitors is the first class of drugs used for chronic hepatitis C (CHC) treatment. NS3 inhibitors (PI) with low genetic barrier have been approved to be used in the CHC genotype 1 infections, and in the treatment of compensated liver disease including cirrhosis together with pegile interferon and ribavirin. Consequently, the development of drug resistance during DAA treatment of CHC is a major problem. NS3 resistant variants can be detected before treatment as they can occurnaturally...
April 2017: Mikrobiyoloji Bülteni
https://www.readbyqxmd.com/read/28521955/prevalence-of-relevant-ns5a-resistance-associated-substitutions-to-elbasvir-in-genotype-1a-hepatitis-c-virus-patients-in-spain
#13
Claudia Palladino, Beatriz Esteban-Cartelle, Irene Mate-Cano, Marta Sánchez-Carrillo, Salvador Resino, Verónica Briz
Resistance-associated substitutions (RASs) to the new HCV NS5A inhibitor elbasvir may limit its efficacy and lead to virological failure in HCV-GT1a-infected patients. There are no data outside clinical trials evaluating their prevalence and impact in grazoprevir/elbasvir in GT1a-infected patients in Spain. A multicentre cross-sectional study of 632 initial patients was conducted. In 13 of these patients, the sample could not be amplified or a consensus sequence by Sanger sequencing could not be performed. Ultimately, 617 HCV-G1a-infected individuals treated at 84 Spanish hospitals from the 17 autonomous communities plus the 2 autonomous cities of Spain were analysed...
May 15, 2017: Enfermedades Infecciosas y Microbiología Clínica
https://www.readbyqxmd.com/read/28497432/resistance-mechanisms-in-hepatitis-c-virus-implications-for-direct-acting-antiviral-use
#14
REVIEW
Sabrina Bagaglio, Caterina Uberti-Foppa, Giulia Morsica
Multiple direct-acting antiviral (DAA)-based regimens are currently approved that provide one or more interferon-free treatment options for hepatitis C virus (HCV) genotypes (G) 1-6. The choice of a DAA regimen, duration of therapy, and use of ribavirin depends on multiple viral and host factors, including HCV genotype, the detection of resistance-associated amino acid (aa) substitutions (RASs), prior treatment experience, and presence of cirrhosis. In regard to viral factors that may guide the treatment choice, the most important is the infecting genotype because a number of DAAs are genotype-designed...
July 2017: Drugs
https://www.readbyqxmd.com/read/28480743/hepatitis-c-virus-resistance-testing-in-genotype-1-the-changing-role-in-clinical-utility
#15
Suzanne Molino, Michelle T Martin
OBJECTIVE: To review the role and utility of baseline resistance testing with currently available and pipeline genotype 1 hepatitis C virus (HCV) treatment. DATA SOURCES: Authors reviewed liver meeting abstracts for data on currently-available and pipeline genotype 1 retreatment regimens from January 1, 2015, to March 23, 2017. Additional trials were identified from a review of clinicaltrials.gov using the pipeline medication names. STUDY SELECTION AND DATA EXTRACTION: Authors identified reports of current and pipeline genotype 1 retreatment regimens...
May 1, 2017: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/28470815/efficacy-of-12-or-18-weeks-of-elbasvir-plus-grazoprevir-with-ribavirin-in-treatment-na%C3%A3-ve-non-cirrhotic-hcv-genotype-3-infected-patients
#16
Edward Gane, Ronald Nahass, Velimir Luketic, Ernest Asante-Appiah, Peggy Hwang, Michael Robertson, Janice Wahl, Eliav Barr, Barbara Haber
Elbasvir (EBR; HCV NS5A inhibitor) and grazoprevir (GZR; HCV NS3/4A protease inhibitor) are approved as a fixed-dose combination to treat patients chronically infected with HCV genotypes 1 and 4. During the development program and supported by in vitro potency, the efficacy of EBR + GZR was assessed in HCV GT3-infected patients. This study's aim was to determine the efficacy and tolerability of 12 or 18 weeks of EBR+GZR with ribavirin (RBV) in treatment-naïve, non-cirrhotic HCV GT3-infected patients. Randomized patients received open-label EBR (50 mg once daily) + GZR (100 mg once daily) + RBV...
May 4, 2017: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/28467997/treating-hepatitis-c-in-patients-with-renal-failure
#17
Sabela Lens, Sergio Rodriguez-Tajes, Laura-Patricia Llovet, Francisco Maduell, Maria-Carlota Londoño
BACKGROUND: There is a strong relationship between hepatitis C virus (HCV) infection and the kidney. Approximately 10-16% of the patients with HCV infection develop renal disease, and the prevalence of HCV infection in patients with renal dysfunction is higher than that of the general population (9.5 vs. 1.6%). Moreover, HCV-positive patients on hemodialysis (HD) have higher mortality rates as compared to HCV-negative patients also on HD, not only due to liver-related complications but also owing to cardiovascular disease...
2017: Digestive Diseases
https://www.readbyqxmd.com/read/28417245/elbasvir-grazoprevir-a-review-in-chronic-hcv-genotypes-1-and-4
#18
REVIEW
Zaina T Al-Salama, Emma D Deeks
A fixed-dose combination tablet comprising the hepatitis C virus (HCV) NS5A inhibitor elbasvir and the HCV NS3/4A protease inhibitor grazoprevir (elbasvir/grazoprevir; Zepatier™) was recently approved for the treatment of chronic HCV genotype 1 and 4 infection in the EU and the USA. In phase III trials, 12 or 16 weeks of treatment with once-daily elbasvir/grazoprevir (fixed-dose tablet or as individual agents), taken with or without ribavirin, generally provided high rates of sustained virological response at 12 weeks (SVR12) in treatment-naive and -experienced adult patients with chronic HCV genotype 1a, 1b or 4 infection, including those with or without compensated cirrhosis, HIV co-infection, inherited blood disorders or chronic kidney disease or patients receiving opioid agonist therapy or of Japanese origin...
May 2017: Drugs
https://www.readbyqxmd.com/read/28416549/antiviral-activity-and-resistance-analysis-of-ns3-4a-protease-inhibitor-grazoprevir-and-ns5a-inhibitor-elbasvir-in-hepatitis-c-virus-gt4-replicons
#19
Ernest Asante-Appiah, Stephanie Curry, Patricia McMonagle, Paul Ingravallo, Robert Chase, David Nickle, Ping Qiu, Anita Howe, Frederick C Lahser
Although genotype 4 (GT4)-infected patients represent a minor overall percentage of the global hepatitis C virus (HCV)-infected population, the high prevalence of the genotype in specific geographic regions coupled with substantial sequence diversity makes it an important genotype to study for antiviral drug discovery and development. We evaluated two direct-acting antiviral agents-grazoprevir, an HCV NS3/4A protease inhibitor, and elbasvir, an HCV NS5A inhibitor-in GT4 replicons prior to clinical studies in this genotype...
July 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28376038/elbasvir-grazoprevir-use-in-postliver-transplantation-patients-on-hemodialysis
#20
Michelle T Martin, Sean Koppe
BACKGROUND: Current national hepatitis C virus (HCV) guidelines do not recommend the use of elbasvir/grazoprevir (EBR/GZR) in postliver transplantation (LT) patients due to drug-drug interactions (DDIs) with immunosuppression agents. However, recommendations do not address the treatment of HCV in renally-impaired post-LT patients. Treatment regimens that are recommended for post-LT patients are not safe in patients with severe renal impairment and patients on dialysis. EBR/GZR is approved for use in patients with renal impairment and patients on dialysis, but not in the post-LT setting...
April 3, 2017: Transplantation
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