HELP SECURE A CURE FOR YOUR PATIENTS WITH CHRONIC HCV1-3
POWERFUL EFFICACY FOR PEOPLE WHO INJECT DRUGS1
Only EPCLUSA has
100%
Overall cure rate (mITT)
in people who inject drugs
(among pangenotypic regimens)1,3,4
GT 1-4 NC/CC (n=97/97; SIMPLIFY study)
mITT = modified intent-to-treat excludes 1 reinfection and 5 patients who did not meet virologic failure criteria [SVR rate 95% CI: 96%-100%].1,4
This post-hoc mITT analysis of patients from the SIMPLIFY trial was not in the original statistical plan and should be considered descriptive only. The mITT analysis is not presented in the EPCLUSA full Prescribing Information or the SIMPLIFY publication.
94%
Overall cure rate (ITT)
in people who inject drugs
with chronic HCV1
GT 1-4 NC/CC (n=97/103; SIMPLIFY study)
SVR12 was the primary endpoint in the SIMPLIFY study (HCV RNA <LLOQ 12 weeks after treatment completion). Achieving SVR12 is considered a virologic cure.1,2
There were no cases of virologic failure or relapse
SVR12 could not be determined in 6 patients because 4 were lost to follow-up, 1 died of an overdose, and 1 was reinfected with a phylogenetically different virus.1,3
SIMPLIFY Study Safety Data1
The most common adverse reactions overall were fatigue (18%), nausea (13%), and headache (11%). Adverse reactions leading to permanent discontinuation of treatment were not observed in any subject.
CONSISTENT CURE FOR TODAY’S SUB-POPULATIONS5
ONLY EPCLUSA HAS
A 100% cure rate (mITT) across all of the following sub-populations (among pangenotypic regimens)5
100% cure rate
Any injection
drug use in the
past 30 days
(n=72/72; 95% CI:
95%-100%)
100% cure rate
At least daily
injection drug use
in the past 30 days
(n=26/26; 95% CI:
87%-100%)
100% cure rate
Current MOUD
(n=54/54; 95% CI:
93%-100%)
100% cure rate
Alcohol use in
the past 30 days
(n=60/60; 95% CI:
94%-100%)
100% cure rate
Unstably housed
(n=22/22; 95% CI:
85%-100%)
100% cure rate
Genotype 3a
(n=57/57; 95% CI:
94%-100%)
(n=97; SIMPLIFY study)4
a95%-97% cure rate in GT 3 patients receiving EPCLUSA (n=455/475) in the ASTRAL‑3 and POLARIS‑2 and -3 studies.1,6
SIMPLIFY Study Information and Limitations1,4
mITT = modified intent-to-treat excludes 1 reinfection and 5 patients who did not meet virologic failure criteria [SVR rate 95% CI: 96%-100%]. Among the 6 excluded patients, 4 were on current MOUD, 4 had IDU in the last 30 days, 3 had <90% adherence, 3 were unstably housed, 2 had alcohol use in the past 30 days, and 1 had daily IDU in the past 30 days.
The post-hoc mITT analysis of patients from the SIMPLIFY trial was not in the original statistical plan and should be considered descriptive only. The mITT analysis is not presented in the EPCLUSA full Prescribing Information or the SIMPLIFY publication.
ASTRAL-3, POLARIS-2, and POLARIS-3 Study Designs1,6
Open-label trial in GT 3 patients (ASTRAL-3; N=552), evaluating 12-week EPCLUSA or 24-week SOF/RBV. Open-label comparator trials in DAA-naïve, GT 1-6 (POLARIS-2; N=941) and GT 3 CC (POLARIS-3; N=219) patients, evaluating 12-week EPCLUSA or 8-week SOF/VEL/VOX. Primary endpoint for all 3 trials was SVR12 (HCV RNA <15 IU/mL) 12 weeks after treatment completion.
HIGH CURE RATE FOR HEPATITIS C ACROSS PIVOTAL STUDIES1
98%
OVERALL CURE RATE
IN GT 1-6 TN/TE NC/CC ADULT PATIENTS1
(n=1015/1035; ASTRAL-1, -2, -3 studies)
SVR12 was the primary endpoint in EPCLUSA clinical trials and was defined as HCV RNA <15 IU/mL at 12 weeks after the end of treatment. Achieving SVR12 is considered a virologic cure.1,2
ASTRAL Trials Safety Data1
- Adverse reactions reported in ≥5% of subjects in ASTRAL-1 study: headache (22%), fatigue (15%), nausea (9%), asthenia (5%), and insomnia (5%)
- The adverse reactions observed in subjects treated with EPCLUSA in ASTRAL-2 and ASTRAL-3 were consistent with those observed in ASTRAL-1
- Irritability was also observed ≥5% of subjects treated with EPCLUSA in ASTRAL-3
CONSISTENT CURE FOR PEOPLE WITH IMPERFECT ADHERENCE3-5
Only EPCLUSA has
100%
Cure rate (mITT)
in people with
imperfect adherence
(in a PWID‑specific study)3-5
(n=31/31; 95% CI: 89%-100%;
SIMPLIFY study)
Imperfect adherence = <90% adherence or >8 doses missed.3,7
mITT = modified intent-to-treat excludes 1 reinfection and 5 patients who did not meet virologic failure criteria [SVR rate 95% CI: 96%-100%]. Among the 6 excluded patients, 3 had <90% adherence.1,4
The post-hoc mITT analysis of patients from the SIMPLIFY trial was not in the original statistical plan and should be considered descriptive only. The mITT analysis and SIMPLIFY adherence data are not presented in the EPCLUSA full Prescribing Information. The mITT analysis is not presented in the SIMPLIFY publication.
91%
Cure rate (ITT)
in people with
imperfect adherence1,3
(n=31/34; SIMPLIFY study)
Imperfect adherence = <90% adherence or >8 doses missed.3,7
Cure = SVR12 (HCV RNA <LLOQ 12 weeks after treatment completion).1,2
Adherence was a key secondary endpoint in the SIMPLIFY study. Overall median adherence: 94% (IQR 88-98).3
There were no cases of virologic failure or relapse
SVR12 could not be determined in 3 patients with <90% adherence because 2 were lost to follow-up and 1 died of an overdose.1,3,4
Counsel your patients on the importance of following the EPCLUSA dosing regimen—one pill every day for 12 weeks as prescribed1
SIMPLIFY Study Information and Limitations1,3
Adherence was assessed by dividing the total number of doses received by the total doses expected (84). Patients in SIMPLIFY were instructed to use EPCLUSA once daily for 12 weeks as recommended in the EPCLUSA full Prescribing Information. Adherence may have been improved by weekly clinic visits and electronic blister packs, which patients were incentivized to return. Adherence was assumed when a blister pack was damaged in a way that prevented scanning, but no pills were returned.