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Optimal Timing of Hepatitis C Treatment for Patients on the Liver Transplant Waiting List
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Jagpreet Chhatwal, PhD
J Chhatwal, S Samur, B Kues, T Ayer, MS Roberts, F Kanwal, C Hur, DMS Donnell, RT Chung
Massachusetts General Hospital
Harvard Medical School
Boston, USA
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FDA Harvoni Updated Label Feb 12 2016....http://www.natap.org/2016/HCV/021616_03.htm......On February 12, 2016, the FDA approved changes to the Harvoni (ledipasvir and sofosbuvir) fixed-dose combination label to expand the patient population to include those with chronic hepatitis C virus genotype 1, infection who are liver transplant recipients, genotype 4 infection who are liver transplant recipients without cirrhosis, or with compensated cirrhosis, and genotype 1 infection with decompensated cirrhosis. The major changes to the label are the following
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)
Early Viral Kinetics in Patients With Varying Degrees of Fibrosis and Cirrhosis in the SOLAR-1 Trial....http://www.natap.org/2015/EASL/EASL_102.htm
Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis (ASTRAL-4).....http://www.natap.org/2015/AASLD/AASLD_65.htm
Resistance Analyses for Ledipasvir/Sofosbuvir-Containing Regimens in Patients Infected With Chronic HCV Who Have Advanced Liver Disease Or Are Post Liver Transplant (SOLAR-1 and -2 Studies).....http://www.natap.org/2016/EASL/EASL_42.htm
Ledipasvir/Sofosbuvir With Ribavirin Is Safe in >600 Decompensated and Post-Liver Transplantation Patients With HCV Infection: An Integrated Safety Analysis of the SOLAR-1 and SOLAR-2 Trials.....http://www.natap.org/2015/EASL/EASL_88.htm
High Efficacy of Ledipasvir/Sofosbuvir Plus Ribavirin Among Patients With Decompensated Cirrhosis Who Underwent Liver Transplant During Participation in the SOLAR-1 and -2 Studies......http://www.natap.org/2016/EASL/EASL_71.htm
SOLAR-2: the sun also rises for cirrhotics
http://www.natap.org/2016/HCV/060816_02.htm
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