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Optimizing Outcomes in HCV Patients: Elbasvir/Grazoprevir: kidney disease/IDUs/resistance
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Reported by Jules Levin
HepDART, Wailea, HI. Dec 6-10, 2015
Eliav Barr M.D. Head, Infectious Diseases Late Stage Development Merck Research Laboratories
In July 2015, the U.S. Food and Drug Administration (FDA) granted Priority Review for the New Drug Application for elbasvir/grazoprevir, with a Prescription Drug User Fee Act (PDUFA) action date of Jan. 28, 2016.
EASL/2015: C-SURFER: GRAZOPREVIR PLUS ELBASVIR IN TREATMENT-NAIVE AND TREATMENT-EXPERIENCED PATIENTS WITH HEPATITIS C VIRUS GENOTYPE 1 INFECTION AND CHRONIC KIDNEY DISEASE - (04/23/15)
AASLD: Prevalence and Impact of Baseline NS5A Resistance-Associated Variants (RAVs) on the Efficacy of Elbasvir/Grazoprevir (EBR/GZR) Against GT1a Infection - 16 Weeks vs 12 weeks - (11/23/15)
AASLD: AN INTEGRATED ANALYSIS OF 402 COMPENSATED CIRRHOTIC PATIENTS WITH HCV GENOTYPE (GT) 1, 4 or 6 INFECTION TREATED WITH Elbasvir/GRAZOPREVIR - (11/19/15)
AASLD: Prevalence of Pre-Treatment NS5A Resistance Associated Variants in Genotype 1 Patients Across Different Regions Using Deep Sequencing and Effect on Treatment Outcome with LDV/SOF - (11/16/15)
AASLD: C-EDGE Co-Infected: final results from Phase 3 Study of elbasvir / grazoprevir in Patients with HCV/HIV - (11/30/15)
AASLD: C-EDGE CO-STAR: efficacy of grazoprevir / elbasvir Fixed Dose Combination for 12 Weeks in HCV-infected Persons Who Inject Drugs on Opioid Agonist Therapy - (11/16/15)
AASLD: Eliminate Restrictions to Substance Users/Injection Drug Users - SVR Rates the Same in New Study as in Non-IDUs 96% - Routine HCV Testing is needed - (11/18/15)
AASLD: Phase 2, Randomized, Open-Label Clinical Trials of the Efficacy and Safety of Grazoprevir and MK-3682 (NS5B Polymerase Inhibitor) with Either Elbasvir or MK-8408 (NS5A Inhibitor) in Patients with Chronic HCV GT1, 2 or 3 1nfection (Part A of C-CREST-1 & 2) - (11/23/15)
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