icon-folder.gif   Conference Reports for NATAP  
 
  AASLD
The Liver Meeting
Boston MA
November 2016
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New HCV Drugs at AASLD
 
 
  Here are key presentations of new HCV DAA regimens - Abbvie' double, Merck's triple, Gilead's triple - these are 3rd generation new drugs with greater potency & higher barriers to resistance. Jules Levin, NATAP.... There were several key presentations highlighting reinfection concerns which i have not reported yet but will soon and several presentations regarding HCC risk after SVR where there are 2 concerns HCC recurrence, and "de novo" HCC; de novo was the subject of study from Romano in Italy which I reported to listserve yesterday but not yet posted on NATAP website & results report no HCC greater risk after SVR but a suggestion that for those who did develop HCC it appeared to be perhaps if you will a little more concerning with & author suggests its perhaps due to DAA affect on immune response to DAAs but this is a theory & has been discussed before without further understanding. Published studies on HCC recurrence have shown mixed results & remains controversial although I think at this point the general feeling is that recurrence may not be a concern. There was a suggestion that cure with peg interferon resulted in less recurrence than with DAA but now this theory may not be as popular, several studies have found there was no difference between whether cured by peg or DAA but I think remains an open question. HCV screening & testing remains a big problem, lots of barriers & no federal or state funding commitment, for a highly curable virus, disgraceful the federal government will not fund this, despite that pricing is very low - $17k in VA & $35 or less to $25 in medicaids, considering its a cure this is really very inexpensive. It costs $500k is provide care & treatment to 1 patient with HIV for 30 years. More to come from NATAP. And there was a study treating patients with HCC with new cancer drug I will report now, from BMS! In phase 2 is J&J with their triple AL335+ACH3102 renamed odalasvir+simeprevir:
 
AASLD: Triple Combination Drug Interaction Studies of the Nucleotide Analog, AL-335, in Combination with Simeprevir and Odalasvir Demonstrate Significant Synergy in the Hepatitis C Virus (HCV) Subgenomic Replicon System - (11/15/16) Cocrystal
 
[http://www.natap.org/2016/HCV/081016_02.htm ]& Trek Pharma
 
[http://natap.org/2016/HCV/090216_04.htm ] also are in early development stages for new DAA regimens
 
HCV Resistance, DAA Failures, and Other difficult situations - Excerpts - (09/02/16)
 

 
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Gilead Triple - Sofosbuvir+valpatasvir+voxilaprevir (GS9857), waiting for FDA Approval
 
AASLD: A Randomized, Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevir for 8 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks for Patients with Genotype 3 HCV Infection and Cirrhosis: The POLARIS-3 Study - (11/15/16)
 
AASLD: A Randomized Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevir for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in DAA-Na´ve Genotype 1-6 HCV Infected Patients: The POLARIS-2 Study - (11/15/16)
 
AASLD: Sofosbuvir/Velpatasvir/Voxilaprevir for 12 Weeks as a Salvage Regimen in NS5A Inhibitor-Experienced Patients With Genotype 1-6 Infection: The Phase 3 POLARIS-1 Study - (11/15/16)
 
AASLD: A Randomized, Controlled, Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevir or Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Experienced Patients With Genotype 1-6 HCV Infection: The POLARIS-4 Study - (11/14/16)
 
AASLD: Integrated Analysis of Sofosbuvir +Ribavirin, Ledipasvir/Sofosbuvir or Sofosbuvir/Velpatasvir for the Treatment of Genotype 4 Chronic HCV Infection - (11/15/16)
 
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Abbvie 2-drug - ABT493+ABT530, waiting for FDA approval
 
AASLD: ENDURANCE-1: A Phase 3 Evaluation of the Efficacy and Safety of 8- versus 12-week Treatment with Glecaprevir/Pibrentasvir (formerly ABT-493/ABT-530) in HCV Genotype 1 Infected Patients with or without HIV-1 Co-infection and without Cirrhosis - (11/15/16)
 
AASLD: ENDURANCE-2: Safety and Efficacy of Glecaprevir/Pibrentasvir in Hepatitis C Virus Genotype 2-infected Patients without Cirrhosis: a Randomized, Double-Blind, Placebo-Controlled Study - (11/14/16)
 
AASLD: EXPEDITION-4: EFFICACY AND SAFETY OF GLECAPREVIR/PIBRENTASVIR (ABT-493/ABT-530) IN PATIENTS WITH RENAL IMPAIRMENT AND CHRONIC HEPATITIS C VIRUS GENOTYPE 1 - 6 INFECTION - (11/15/16)
 
AASLD: SURVEYOR-II, PART 3: EFFICACY AND SAFETY OF GLECAPREVIR/PIBRENTASVIR (ABT-493/ABT-530) IN PATIENTS WITH HEPATITIS C VIRUS GENOTYPE 3 INFECTION WITH PRIOR TREATMENT EXPERIENCE AND/OR CIRRHOSIS - (11/14/16)
 
AASLD: SURVEYOR-II, Part 4: Glecaprevir/Pibrentasvir Demonstrates High SVR Rates in Patients With HCV Genotype 2, 4, 5, or 6 Infection Without Cirrhosis Following an 8-Week Treatment Duration - (11/16/16)
 
AASLD: ENDURANCE-4: Efficacy and Safety of Glecaprevir/Pibrentasvir (Formerly ABT-493/ABT-530) Treatment in Patients with Chronic HCV Genotype 4, 5, or 6 Infection - (11/14/16)
 
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Merck Triple - MK3682+MK8408+Grazoprevir, phase 3 soon
 
AASLD: Safety and Efficacy of the Fixed-Dose Combination Regimen of MK-3682 / Grazoprevir / MK-8408 (Ruzasvir) in Cirrhotic or Non-cirrhotic Patients with Chronic HCV GT1 Infection who Previously Failed a Direct-acting Antiviral Regimen (C-SURGE) - (11/15/16)
 
AASLD: High Sustained Virologic Response Rates in Patients with Chronic HCV GT1, 2 or 3 Infection Following 16 Weeks of MK-3682/Grazoprevir/MK-8408 (Ruzasvir) Plus Ribavirin After Failure of 8 Weeks of Therapy (Part C of C-CREST-1 & 2) - (11/14/16)
 
AASLD: Safety and Efficacy of the Fixed-Dose Combination Regimen of MK-3682/Grazoprevir/MK-8408 (Ruzasvir) With or Without Ribavirin in Non-cirrhotic or Cirrhotic Patients with Chronic HCV GT1, 2 or 3 Infection (Part B of C-CREST-1 & -2) - (11/14/16)
 
AASLD: ELBASVIR/GRAZOPREVIR PLUS SOFOSBUVIR ▒ RIBAVIRIN IN TREATMENT-NAIVE AND TREATMENT-EXPERIENCED PATIENTS WITH HEPATITIS C VIRUS GENOTYPE 3 INFECTION AND COMPENSATED CIRRHOSIS: THE C-ISLE STUDY - (11/14/16)