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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.

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.

REAL-WORLD STUDY

Real-World Integrated Analysis: A retrospective, pooled analysis of SVR12/24 in adult NC/CC chronic HCV patients treated for 12 weeks with EPCLUSA (400 mg/100 mg) once-daily without RBV in 12 real-world cohorts in Canada, Europe, and the US (N=5552) (ANRS-Hepather, Borgia, DHC-R, Greek Cohort, HCV-TARGET, HepaC, HELIOS, Mangia, NAVIGATORE-II, Ramji, Shafran, TRIO Health). TN patients and patients who had previously received IFN-based therapy (Peg-IFN + RBV with or without telaprevir, boceprevir, or simeprevir) were included. DC patients and patients who had previously failed other DAA treatments were excluded. Patients were treated in different clinical settings, including university hospitals, academic centers, community centers, outpatient clinics and private practices. Treatment and patient monitoring were based on local clinical practice and standard of care, at the discretion of the treating physician.

SVR12/24 (HCV RNA <LLOQ 12 or 24 weeks after treatment completion) was calculated in the overall and effectiveness populations and stratified by fibrosis stage, previous or current intravenous drug use, PPI use at baseline and treatment history.

Patients who did not achieve SVR 12/24 due to non-virological (n=332) or unknown (n=24) reasons were excluded from the effectiveness population.

The Real-World Integrated Analysis is not presented in the EPCLUSA full Prescribing Information.

Real-world data are observational in nature and are not based on controlled clinical studies. Results from the Real-World Integrated Analysis may differ from those observed in clinical practice.

The Real-World Integrated Analysis was supported by Gilead Sciences, Inc.

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.

ESRD Clinical Trial

Single-arm trial of TN and TE adults with ESRD without cirrhosis or with compensated cirrhosis

Trial 4062: Open-label clinical trial in NC/CC adult subjects with GT 1, 2, 3, 4, 6 or indeterminate HCV infection with ESRD requiring dialysis (N=59). Subjects received EPCLUSA for 12 weeks.

TE patients had failed a Peg-IFN + RBV or IFN + RBV-based regimen.

Sustained virologic response (SVR12) was the primary endpoint and was defined as HCV RNA <LLOQ at 12 weeks after the end of treatment.

The PPI analysis was a retrospective evaluation of the safety and efficacy of EPCLUSA with or without concomitant PPI use in GT 1-6 adults treated for 12 weeks in 12 previously completed Phase 2 or 3 clinical trials. This integrated analysis included TN and TE patients with or without cirrhosis (N=2604). PPI use was captured as part of the standard concomitant medication reporting, and specific details regarding PPI dosing were not collected. Eighty-seven patients (3.3%) were treated with PPIs. Of the patients taking PPIs, 60 were subjects in Phase 2 studies, including 20 GT 3 cirrhotic patients in Spain and 40 post-liver-transplant adult patients. PPIs included in the analysis were: omeprazole (68%), pantoprazole (13%), esomeprazole (13%), lansoprazole (5%), dexlansoprazole (2%), and rabeprazole (1%).

Results from the PPI analysis are not presented in the EPCLUSA full Prescribing Information.