Liver Meeting 2015 Clinical Trial Highlights

The Liver MeetingThe American Association for the Study of Liver Diseases (AASLD) held its 66th annual meeting, The Liver Meeting 2015 (#Liver15), November 13th – November 17th. The meeting drew more than 9,500 international hepatologists and hepatology health professionals to San Francisco to discuss the latest treatments and research for liver diseases.

Some of the meeting’s highlights have been posted in our Liver Meeting 2015 Highlights blog post. In addition, some of the clinical trial results that were part of the meeting are presented below.

Some Clinical Trial Result Highlights that were Presented at the 2015 Liver Meeting

 

Patients
Treatment Regimen
Duration in Weeks
SVR
ASTRAL-1: A Phase 3 Double-Blind Placebo-Controlled Evaluation of Sofosbuvir/Velpatasvir Fixed Dose Combination for
12 Weeks in Naïve and Experienced Genotype 1, 2, 4,
5, 6 HCV Infected Patients with and without cirrhosis (Abstract LB-2)
Genotype 1, 2, 4, 5, 6 Hepatitis C (GT 1, 2, 4, 5, 6 HCV); with and without cirrhosis; 740 patients Sofosbuvir/Velpatasvir 12 SVR12 99% Overall (GT1 98% GT2 100% GT4 100% GT5 97% GT6 100%)
Placebo Similar adverse effects
ASTRAL-2 and ASTRAL-3: Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection
GT 2, 3 HCV; treatment naive and treatment experienced; including patients with compensated cirrhosis GT2 Sofosbuvir/Velpatasvir 12 SVR12 99%
Sofosbuvir + ribavirin (RBV) SVR12 94%
GT3 Sofosbuvir/Velpatasvir 12 SVR12 95%
Sofosbuvir + RBV 24 SVR12 80%
ASTRAL-4: Sofosbuvir/Velpatasvir Fixed Dose Combination for the Treatment Of HCV in Patients with Decompensated Liver Disease
GT 1, 2,
3, 4, 6 HCV; with decompensated liver
disease; 267 patients (Patients with prior liver transplant or
hepatocellular carcinoma were excluded)
Sofosbuvir/Velpatasvir 12 SVR12 83% Overall (GT1 88% GT2 100% GT3 50% GT4 100%)
Sofosbuvir/Velpatasvir + RBV SVR12 94% Overall (GT1 95% GT2 100% GT3 84% GT4 100%)
Sofosbuvir/Velpatasvir 24 SVR24 85% Overall (GT1 91% GT2 75% GT3 50% GT4 100% GT6 100%)
SURVEYOR-I and SURVEYOR-II: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With HCV Genotype 1, 4, 5, and 6 Infection (Ongoing Phase 2 clinical studies. Part 1 results of the SURVEYOR-II were presented at AASLD)
GT 1 HCV; without compensated cirrhosis; treatment naive or did not respond to pegylated interferon + RBV (PR) ABT-493 (200mg) + ABT-530 (120mg) 12 SVR12 100%
ABT-493 (200mg) + ABT-530 (40mg) SVR12 97%
ABT-493 (300mg) + ABT-530 (120mg) 8
GT 2 HCV; without compensated cirrhosis; treatment naive or did not respond to PR ABT-493 (300mg) + ABT-530 (120mg) 12 SVR12 96%
ABT-493 (200mg) + ABT-530 (120mg) SVR12 100%
ABT-493 (200mg) + ABT-530 (120mg) once daily + RBV (weight-based, 1000 or 1200mg) twice daily
GT 3 HCV; without compensated cirrhosis; treatment naive or did not respond to PR ABT-493 (300mg) + ABT-530 (120mg) 12 SVR12 93%
ABT-493 (200mg) + ABT-530 (120mg)
ABT-493 (200mg) + ABT-530 (120mg) once daily + RBV (weight-based, 1000 or 1200mg) twice daily SVR12 94%
ABT-493 (200mg) + ABT-530 (40mg) SVR12 83%
ALLY-3+ Phase 3 Study: All-Oral Treatment With Daclatasvir (DCV) Plus Sofosbuvir (SOF) Plus Ribavirin (RBV) for 12 or 16 Weeks in HCV Genotype (GT) 3-Infected Patients With Advanced Fibrosis or Cirrhosis (Abstract LB-3)
GT 3 HCV; treatment-naive or treatment-experienced with advanced fibrosis or cirrhosis. Patients were randomized 1:1 to receive 12 weeks vs 16 weeks of DCV + SOF + RBV DCV + SOF + RBV 12 SVR4 88% Overall (83% in those with cirrhosis, 100%
in those with advanced fibrosis)
16 SVR4* 96% (94% with cirrhosis, 100% in those with advanced fibrosis)
*The AASLD Abstracts states, “DCV+SOF+RBV for 12 or 16 weeks achieved high SVR4 rates of 88% and 96%, respectively…”.
An Integrated Analysis of 402 Compensated Cirrhotic Patients With HCV Genotype (GT) 1, 4 or 6 Infection Treated With Grazoprevir/Elbasvir (Abstract 42, pg 23)
GT 1, 4, 6 HCV; treatment-naive with compensated liver cirrhosis (Child-Pugh class A) Grazoprevir/Elbasvir 12 SVR12 90%
Grazoprevir/Elbasvir + RBV SVR12 98%
GT 1, 4, 6 HCV; treatment-experienced with compensated liver cirrhosis (Child-Pugh class A) Grazoprevir/Elbasvir SVR12 89%
Grazoprevir/Elbasvir + RBV SVR12 91%
GT 1, 4, 6 HCV; treatment-experienced Grazoprevir/Elbasvir 16 or 18 SVR12 94%
Grazoprevir/Elbasvir + RBV SVR12 100%
C-CREST-1 & 2, Part A: 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 (Abstract LB-15)
Population* G+E + MK-3682 300mg Grazoprevir
+ Elbasvir (G+E)
+ MK-3682
450mg
Grazoprevir
+ MK-8408
+ MK-3682
300mg
Grazoprevir
+ MK-8408
+ MK-3682
450mg
GT 1 HCV 100%** 100% 100% 91%
GT 2 HCV 69% 60% 71% 94%
GT 3 HCV 90% 86% 95% 91%
*Treatment-naive without liver cirrhosis; **SVR12, following 8 weeks of treatment
Osiris: Simeprevir in Combination with Sofosbuvir in Genotype 4 Infected HCV Patients In Egypt
GT 4 HCV, without liver cirrhosis, treatment naïve and treatment experienced Simeprevir + Sofosbuvir 8 SVR12 75%
GT 4 HCV, with liver cirrhosis, treatment naïve and treatment experienced Simeprevir + Sofosbuvir 12 SVR12 100%

The American Association for the Study of Liver Diseases’ Liver Meeting 2016 will be in Boston.

Additional information presented at The Liver Meeting can be found online in easy-to-use versions and in our Liver Meeting 2015 Highlights blog post so that you can find the information that may become the meeting’s highlights for you. Explore on your own or use PHCN’s Hepatitis C Treatment Information Project / email us for direction.