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HCV Highlights: HepDart/AASLD - Current HCV Treatments -
New HCV Treatments in Development
Sofosbuvir/GS5816 (Velpatasvir)
Abbvie 3D
Ledipasvir+Sofosbuvir+Vedroprevir 8 weeks

HEPDART 2015: Frontiers in Drug Development for Viral Hepatitis
December 6-10 2015 Wailea, HI
66th Annual Meeting of the American Association for the Study of Liver Diseases Boston, MA Nov 13-17 2015
AASLD: Summary from AASLD 2015 for Hepatitis C Beyond 95% SVR cure rates: still room for improvement? Jurgen K. Rockstroh M.D., Professor of Medicine University of Bonn, Germany - (12/29/15)
AASLD: Regression of Advanced Fibrosis or Cirrhosis Measured by Elastography in Patients with Chronic Hepatitis C who Achieve Sustained Virologic Response after Treatment for HCV - (12/01/15)...... Cirrhosis May Persists Despite SVR - (12/21/15)........ AASLD: Hepatitis C Cure Leads to a Durable Decrease in Liver Stiffness..... "cirrhosis persisted in 58%" - (12/18/15)
Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir/Velpatasvir for Treatment of All Genotypes of Chronic Hepatitis C Infection - (01/05/15).....Prescription Drug User Fee Act (PDUFA) of June 28, 2016
Merck Announces U.S. Food and Drug Administration Acceptance of New Drug Application for Grazoprevir/Elbasvir, an Investigational Therapy for Treatment of Chronic Hepatitis C Genotypes 1, 4 and 6 Infection - (07/31/15) .....Prescription Drug User Fee Act (PDUFA) action date of January 28, 2016
AASLD: SVR12 results from the Phase II, open-label IMPACT study of simeprevir (SMV) in combination with daclatasvir (DCV) and sofosbuvir (SOF) in treatment-naïve and -experienced patients with chronic HCV genotype 1/4 infection and decompensated liver disease - (11/16/15)
AASLD: QUARTZ-I: Retreatment of HCV Genotype 1 DAA-failures With Ombitasvir/Paritaprevir/r, Dasabuvir, and Sofosbuvir - (11/17/15)
AASLD: C-SWIFT Retreatment (Part B): 12 Weeks of Elbasvir/Grazoprevir with Sofosbuvir and Ribavirin Successfully Treated G1-Infected Subjects who Failed Short-Duration All-Oral Therapy - (11/23/15)
hepDART: Retreatment of Patients Who Failed Sofosbuvir-Based Regimens with Ledipasvir/Sofosbuvir Regimens (12/22/15)
AASLD: Short-Duration Therapy With Daclatasvir/Asunaprevir/Beclabuvir Fixed-Dose Combination Plus Sofosbuvir in Patients With Chronic Hepatitis C Genotype 1 (FOURward Study) - (12/04/15)
hepDART: Risk of cardiomyopathy and cardiac failure among patients with evidence of hepatitis C virus infection: an administrative claims database analysis (12/14/15)
hepDART: High Efficacy of Sofosbuvir/Velpatasvir In HCV Genotypes 1-6 Infected Patients With Cirrhosis: Pooled Data From the ASTRAL 1, 2 and 3 Trials (12/14/15)
hepDART: High Efficacy of Sofosbuvir/Velpatasvir Across 7 HCV Genotypes and 46 Subtypes: Pooled Data From the ASTRAL1, 2 and 3 Trials (12/14/15)
AASLD: Sofosbuvir/Velpatasvir Fixed-Dose Combination for the Treatment of HCV in Patients With Decompensated Liver Disease: the Phase 3 ASTRAL-4 Study / ASTRAL 1, 2 and 3 - (11/30/15)
AASLD: Sofosbuvir Plus Velpatasvir (GS-5816) Combination Therapy for Treatment-Experienced Patients With Genotype 1 or 3 Hepatitis C Virus Infection: A Randomized Trial - (11/17/15)
hepDART: (HepDart) Ledipasvir/Sofosbuvir Is Safe and Effective for the Treatment of Patients with Genotype 1 Chronic HCV Infection in Both HCV Mono- and HIV/HCV Coinfected Patients (12/22/15)
AASLD: Pharmacokinetic Analyses of Ledipasvir/Sofosbuvir and HIV Antiretroviral Regimens in Subjects With HCV/HIV Coinfection - (11/16/15)
AASLD: Preliminary Safety and Efficacy Results From TOPAZ-II: A Phase 3b Study Evaluating Long-Term Clinical Outcomes in HCV Genotype 1-Infected Patients Receiving Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir ± Ribavirin - (12/18/15)
AASLD: Long-Term Efficacy of Ombitasvir/Paritaprevir/r and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Patients With or Without Cirrhosis - (12/18/15)
AASLD: The Combination of Elbasvir and Grazoprevir ± RBV Is Highly Effective for the Treatment of GT1a-Infected Patients - (11/17/15)
hepDART: 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 Infection (Part A of C-CREST 1 & 2) - (12/14/15)
hepDART: (HepDart) SURVEYOR-II: High SVR4 Rates Achieved With the Next Generation NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530 In Non-Cirrhotic Treatment-Naïve and Treatment-Experienced Patients With HCV Genotype 3 Infection (12/22/15)
AASLD: Sofosbuvir/Velpatasvir + GS-9857 for 6 or 8 Weeks in Genotype 1 or 3 HCV-Infected Patients - (11/16/15)
AASLD: Characterization of HCV Resistance From a 3-Day Monotherapy Study of GS-9857, a Novel Pangenotypic NS3/4A Protease Inhibitor - (12/18/15)
AASLD: Failure with All-oral DAA Regimens: Real-world experience from the TRIO Network. Academic and community treatment of a real-world, heterogeneous population - (12/03/15)
AASLD: (HCV-TARGET) - Treatment Outcomes With 8, 12 and 24 Week Regimens of Ledipasvir/Sofosbuvir for the Treatment of Hepatitis C Infection: Analysis of a Multicenter Prospective, Observational Study - (12/03/15)
AASLD: Effectiveness of 8 or 12 week LDV-SOF in Treatment-Naïve Patients with Non-Cirrhotic, Genotype 1 Hepatitis C: Real-World Experience from the TRIO Network - (12/16/15)
AASLD: High Rates of SVR in Treatment-Experienced Patients With Genotype 1 HCV Infection and Cirrhosis After Treatment With Ledipasvir/Sofosbuvir and Vedroprevir With or Without Ribavirin for 8 Weeks - (12/01/15)
hepDART: (HepDart) Ledipasvir/Sofosbuvir (LDV/SOF) for 8 Weeks in Genotype 1 (GT1) Treatment-Naïve (TN) Non-Cirrhotic (NC) Patients with HCV Viral load (VL) <6 million IU/ml (6M); A Comparative Analysis of the Phase-3 ION-3 Efficacy Data to Real World Effectiveness (RWE) (12/14/15)
EACS: Sofosbuvir plus ledipasvir for 8 weeks in HCV-mono- and HIV-HCV-coinfected patients - Results from the German hepatitis C cohort (GECCO) (10/27/15)
hepDART: (HepDart) Ledipasvir/Sofosbuvir Is Safe and Effective for the Treatment of Patients with Genotype 1 Chronic HCV Infection in Both HCV Mono- and HIV/HCV Coinfected Patients (12/22/15)
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: Effect of Chronic Kidney Disease on the Pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir and Dasabuvir in Subjects with HCV Genotype 1 Infection - (12/22/15)
AASLD: TURQUOISE-III: 12-Week Ribavirin-Free Regimen of Ombitasvir/Paritaprevir/r and Dasabuvir for Patients With HCV Genotype 1b and Cirrhosis - (12/22/15)
AASLD: RUBY-I: Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir ± Ribavirin in Non-Cirrhotic HCV Genotype 1-Infected Patients With Severe Renal Impairment or End-Stage Renal Disease - (12/16/15)
AASLD: Projected Long-term Impact of Grazoprevir (GZR, MK-5172)/Elbasvir (EBR, MK-8742) in Treatment-naïve and Treatment-experienced Patients With Hepatitis C Virus Genotype 1 Infection and Chronic Kidney Disease - (12/16/15)
AASLD: C-EDGE Co-Infected: final results from Phase 3 Study of elbasvir / grazoprevir in Patients with HCV/HIV - (11/30/15)
AASLD: 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: Prevalence and Impact of Baseline NSA Resistance Associated Variants (RAVs) on the Efficacy of Elbasvir/Grazoprevir (EBR/GZR) Against GT1a Infection - (11/19/15)
AASLD: Efficacy of Elbasvir (EBR) and Grazoprevir (GZR) in Black HCV-Infected Patients: Results of a Pooled Analysis of Phase 2/3 Studies - (12/03/15)
AASLD: High Efficacy of the Combination HCV Regimen Elbasvir and Grazoprevir for 8 or 12 Weeks With or Without Ribavirin in Treatment-Naive, Non-Cirrhotic HCV GT1b-Infected Patients: An Integrated Analysis - (01/04/16)
AASLD: Safety and Tolerability of Elbasvir/Grazoprevir in Patients With Chronic Hepatitis C: An Integrated Analysis of Phase 2-3 Trials - (01/04/16)
AASLD: Predictors of Response to Elbasvir/Grazoprevir Among HCV Genotype 1 (GT1)-Infected Patients: Integrated Analysis of phase 2-3 Trials - (01/04/16)
hepDART: Optimizing Outcomes in HCV Patients: Elbasvir/Grazoprevir: kidney disease/IDUs/resistance (01/04/16)
AASLD: High Virologic Response Rate in Egyptian HCV-Genotype 4 Patients Treated with Ravidasvir (PPI-668) and Sofosbuvir: Results of a Large Multicenter Phase 3 Registrational Trial - (11/23/15)
Achillion Announces That Janssen Has Initiated a Phase I Study to Evaluate the Effect of Simeprevir and Odalasvir (ACH-3102) on AL-335 Pharmacokinetics - (08/03/15)

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