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Gilead at AASLD / HepDart - Harvoni, Sofosbuvir/Velpatasvir, Sofosbuvir/Velpatasvir+GS9857 (6-8 weeks), Harvoni + Vedroprevir
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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 -
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hepDART: Risk of cardiomyopathy and cardiac failure among patients with evidence of hepatitis C virus infection: an administrative claims database analysis (12/14/15)
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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).......
Treat HCV Early, Deferral to Cirrhosis Increases Risk for NOT Regression & Developing HCC, Death - (11/13/15)
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Harvoni FDA Label Update- HIV/GT-4/5/6 PK/DDIs - (12/22/15)
U.S. FDA Approves New Indications for Harvoni®, Gilead's Once-Daily Single Tablet Regimen for Chronic Hepatitis C - (11/13/15)
Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir/Velpatasvir for Treatment of All Genotypes of Chronic Hepatitis C Infection - (01/05/15)
European Medicines Agency Validates Gilead's Marketing Application for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for the Treatment of Hepatitis C - (12/04/15)
AASLD: Gilead Presents New Data at The Liver Meeting 2015 - (11/16/15)
AASLD: Multiple Scientific Presentations at The Liver Meeting 2015 Further Highlight the Utility of Sofosbuvir-Based Hepatitis C Therapies - (11/16/15)
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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)
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AASLD: Pharmacokinetic Analyses of Ledipasvir/Sofosbuvir and HIV Antiretroviral Regimens in Subjects With HCV/HIV Coinfection - (11/16/15)
AASLD: Sofosbuvir/Velpatasvir + GS-9857 for 6 or 8 Weeks in Genotype 1 or 3 HCV-Infected Patients - (11/16/15)
AASLD: Resistance Analysis of Treatment-Naïve and DAA-Experienced Genotype 1 Patients With and Without Cirrhosis Who Received Short-Duration Treatment With Sofosbuvir/Velpatasvir + GS-9857 - (12/18/15)
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)
AASLD: Drug-Drug Interaction Studies Between Hepatitis C Virus Antivirals Sofosbuvir and Velpatasvir (GS-5816) and HIV Antiretoviral Therapies - (12/07/15)
AASLD: Characterization of HCV Resistance From a 3-Day Monotherapy Study of GS-9857, a Novel Pangenotypic NS3/4A Protease Inhibitor - (12/18/15)
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)
Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection - (12/11/15)
AASLD: Sofosbuvir+GS-5816 GT 1-6: ASTRAL-1, ASTRAL-2, ASTRAL-3, ASTRAL-4 - (12/09/15)
AASLD: Sofosbuvir/Velpatasvir + GS-9857 for 6 or 8 Weeks in Genotype 1 or 3 HCV-Infected Patients - (11/16/15)
AASLD: A Phase 3 Double-Blind Placebo-Controlled Evaluation of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Genotype 1, 2, 4, 5, 6 HCV-Infected Patients: Results of the ASTRAL-1 Study - (11/17/15)
AASLD: A Randomized Controlled Trial of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks Compared to Sofosbuvir with Ribavirin for 12 Weeks in Genotype 2 HCV-Infected Patients: The Phase 3 ASTRAL-2 Study - (11/30/15)
AASLD: Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks Compared to Sofosbuvir with Ribavirin for 24 Weeks in Genotype 3 HCV-Infected Patients: The Randomized Controlled Phase 3 ASTRAL-3 Study - (11/30/15)
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 and Velpatasvir for HCV Genotype 2 and 3 Infection - (11/30/15) published
AASLD: Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection - (11/30/15) published
AASLD: Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis (ASTRAL-4) - (11/30/15) published
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) published
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AASLD: Sofosbuvir and Ledipasvir/Sofosbuvir for the Treatment of Patients With Chronic Genotype 6 Hepatitis C Virus Infection: Integrated Analysis of Phase 2 and Phase 3 Studies - (12/08/15)
AASLD: Drug-Drug Interaction Studies Between Hepatitis C Virus Antivirals Sofosbuvir and Velpatasvir (GS-5816) and HIV Antiretoviral Therapies 2 - (12/02/15)
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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)
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)
hepDART: High Efficacy of Ledipasvir/Sofosbuvir With Ribavirin In HCV Genotype-1 Infected Patients with Decompensated Liver Disease: Analysis by MELD Score from the SOLAR-1 and SOLAR-2 Trials (12/22/15)
AASLD: Ledipasvir/Sofosbuvir With Ribavirin in Patients With Decompensated Cirrhosis or Liver Transplantation and HCV Infection: SOLAR-1 and -2 Trials - (12/08/15)
AASLD: Detecting Drug-Induced Liver Injury in Patients With Decompensated Chronic Hepatitis C: A Review of the SOLAR-1 and SOLAR-2 Studies - (11/23/15)
hepDART: Retreatment of Patients Who Failed Sofosbuvir-Based Regimens with Ledipasvir/Sofosbuvir Regimens (12/22/15)
AASLD: Highly Successful Retreatment With LDV/SOF in HCV Gt-1 Patients Who Failed Short Course LDV/SOF-Based Therapy: The NIH SYNERGY Trial - (12/01/15)
AASLD: Evolution Of Resistance Associated Variants During Initial Treatment, Viral Failure, And Re-Treatment With Directly Acting Antiviral Therapy NIH SYNERGY Trial - (12/04/15)
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AASLD: The Antiviral Response to the Toll-Like Receptor 7 Agonist GS-9620 in Preclinical Models of Chronic Hepatitis B Is Associated With an Intrahepatic Cytotoxic T Cell Transcriptional Signature - (12/22/15)
AASLD: Dual-Combination Therapy (NASH) Directed Against Lysyl Oxidase-Like-2 and Apoptosis Signal-Regulating Kinase 1 Potently Inhibits Fibrosis and Portal Hypertension in a New Mouse Model of PSC-Like Liver Disease/NASH - (12/22/15)
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8 weeks / TARGET / TRIO
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)
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)
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)
AASLD: (VA) Effectiveness of Ledipasvir/Sofosbuvir in Treatment Naïve Genotype 1 Patients Treated in Routine Medical Practice - (11/16/15)
AASLD: Effectiveness of 12 or 24 week LDV-SOF and 12 week LDV-SOF + RBV in Treatment-Experienced Patients with Cirrhotic, Genotype 1 Hepatitis C: Real-world Experience from the TRIO Network - (12/16/15)
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)
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EASL: The Pharmacokinetics of GS-5816, a Pangenotypic HCV-Specific NS5A Inhibitor, in HCV-Uninfected Subjects With Severe Renal Impairment - (12/21/15)
AASLD: Population Pharmacokinetics of Sofosbuvir and Its Major Metabolite (GS-331007) in Healthy and HCV-Infected Adult Subjects - (12/21/15)
AASLD: Safety and Efficacy of Treatment With Daily Sofosbuvir 400 mg + Ribavirin 200 mg for 24 Weeks in Genotype 1 or 3 HCV-Infected Patients With Severe Renal Impairment - (12/09/15)
AASLD: Safety, Antiviral Efficacy, and Pharmacokinetics of Sofosbuvir in Patients With Severe Renal Impairment - (12/09/15)
AASLD: The Pharmacokinetics of Ledipasvir, an HCV-Specific NS5A Inhibitor, in HCV-Uninfected Subjects With Severe Renal Impairment - (12/09/15)
AASLD: Safety, efficacy & Tolerability in the Treatment of Patients with Chronic HCV & Severe Renal Impairment - Hepatitis C Cure Could Avoid Liver Transplant In Some Cirrhotic Patients On Dialysis Listed for Simultaneous Liver Kidney Transplantation - (12/07/15)
AASLD: Impact of Sofosbuvir-Based Regimens on Renal Function in Liver Transplant Recipients: Results of a Multicenter Study - (12/07/15)
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Acute HCV
AASLD: Sofosbuvir and Ledipasvir versus Sofosbuvir and Simeprevir combination therapy in the management of acute hepatitis C: A randomized open label prospective clinical pilot study. SLAM C study - (12/04/15)
AASLD: Sofosbuvir Plus Ribavirin Without Interferon for Treatment of Acute HCV in HIV-1 Infected Individuals: SWIFT-C....Harvoni 8 weeks enrolling - (12/04/15)
AASLD: SOFOSBUVIR IN THE TREATMENT OF ACUTE HCV INFECTION IN HIV-INFECTED MEN - (12/04/15)
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AASLD: Improving liver function and delisting of patients awaiting liver transplantation for HCV cirrhosis: do we ask too much to DAAs? - (12/01/15)
Ledipasvir and sofosbuvir for hepatitis C genotype 4: a proof-of-concept, single-centre, open-label phase 2a cohort study - (09/04/15)
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