ROBUST CLINICAL TRIALS
Randomized trials in TN and TE adult chronic HCV patients without cirrhosis or with
compensated cirrhosis
Patients who were active injection drug users (use within 12 months), or those with a
positive urine drug test at screening, were excluded from the ASTRAL pivotal trials.
ASTRAL-1:
Double-blind, placebo-controlled trial in GT 1, 2, 4, 5, or 6 patients (N=740). GT 1, 2, 4, or
6 patients were randomized 5:1 to receive EPCLUSA or placebo for 12 weeks; GT 5 patients
received EPCLUSA for 12 weeks.
ASTRAL-2:
Open-label trial in GT 2 patients (N=266). Patients received EPCLUSA or SOF + RBV for 12
weeks.
ASTRAL-3:
Open-label trial in GT 3 patients (N=552). Patients received EPCLUSA for 12 weeks or SOF + RBV
for 24 weeks.
POLARIS-2:
Open-label comparator trial in GT 1-6 DAA-naïve patients (N=941) who were randomized to
receive EPCLUSA for 12 weeks or sofosbuvir/velpatasvir/voxilaprevir for 8 weeks.
POLARIS-3:
Open-label comparator trial in DAA-naïve GT 3 cirrhosis patients (N=219) who were randomized
to receive EPCLUSA for 12 weeks or sofosbuvir/velpatasvir/voxilaprevir for 8 weeks.
TE patients had failed a Peg-IFN + RBV-based regimen with or without an HCV NS3/4A protease
inhibitor (boceprevir, simeprevir, or telaprevir).
Sustained virologic response (SVR12) was the primary endpoint for all clinical trials and was
defined as HCV RNA <15 IU/mL at 12 weeks after the end of treatment.
