Robust Clinical Trials1-3
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 Study4
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.
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.
CC = compensated cirrhosis; DAA = direct-acting antiviral; DC = decompensated cirrhosis; GT =
genotype;
IFN =
interferon; NC = non-cirrhotic; Peg-IFN = peginterferon alfa;
RBV =
ribavirin; SOF = sofosbuvir; SVR12 = sustained virologic response 12 weeks after treatment completion;
SVR12/24 =
sustained
virologic response 12 or 24 weeks after treatment completion; TE = treatment-experienced; TN =
treatment-naïve.
References:
- EPCLUSA [prescribing information]. Foster City, CA: Gilead Sciences, Inc; April 2022.
-
Feld JJ, Jacobson IM, Hézode C, et al. Sofosbuvir and velpatasvir for HCV genotype 1, 2, 4, 5, and
6
infection. N Eng J Med. 2015;373:2599-2607.
-
Foster GR, Afdhal N, Roberts SK, et al. Sofosbuvir and velpatasvir for HCV genotype 2 and 3
infection.
N Eng J Med. 2015;373:2608-2617.
- Mangia A, Milligan S, Khalili M,
et al. Global real-world
evidence of sofosbuvir/velpatasvir
as simple, effective
HCV treatment: analysis of
5552 patients from 12 cohorts.
Liver Int. 2020;40(8):1841-1852.
