INDICATION
EPCLUSA (sofosbuvir 400 mg/velpatasvir 100 mg, 200 mg/50 mg tablets; 200 mg/50 mg, 150 mg/37.5 mg oral pellets) is indicated for the treatment of patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1-6 infection without cirrhosis or with compensated cirrhosis and in combination with ribavirin for those with decompensated cirrhosis.
Please see below for Important Safety Information for EPCLUSA.
CONFIDENTLY CURE YOUR CHRONIC HCV PATIENTS WITH EPCLUSA OR ITS AUTHORIZED GENERIC1
(sofosbuvir/velpatasvir)
Featured patients compensated by Gilead.
ONLY EPCLUSA HAS
100%
OVERALL CURE RATE (mITT) IN PEOPLE WHO INJECT DRUGS AMONG PANGENOTYPIC REGIMENS2,3
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%].1,3
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.1,4
ONLY EPCLUSA HAS
(n=72/72; 95%
CI: 95%-100%)
(n=26/26; 95%
CI: 87%-100%)
(n=54/54; 95%
CI: 93%-100%)
(n=60/60; 95%
CI: 94%-100%)
(n=22/22; 95%
CI: 85%-100%)
(n=57/57; 95%
CI: 94%-100%)
(n=97; SIMPLIFY study)3
a 95-97% cure rate in GT 3 patients receiving EPCLUSA (n=455/475) in the ASTRAL‑3 and POLARIS‑2 and -3 studies.1,6
ONLY EPCLUSA HAS
100%
CURE RATE (mITT) IN PEOPLE WITH IMPERFECT ADHERENCE IN A PWID-SPECIFIC STUDY2,3,5
(n=31/31; 95% CI: 89%-100%;
SIMPLIFY study)
Imperfect adherence = <90% adherence or >8 doses missed.2,7
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.1,3
91%
CURE RATE (ITT) IN PEOPLE WITH IMPERFECT ADHERENCE IN A PWID-SPECIFIC STUDY1,2
(n=31/34; SIMPLIFY study)
Imperfect adherence = <90% adherence or >8 doses missed.2,7
SVR12 (cure) = HCV RNA <LLOQ 12 weeks after treatment completion.4
Overall median adherence: 94% (IQR 88-98).2
a In SIMPLIFY, “people who inject drugs” was defined as those who had injected drugs within the 6 months prior to study initiation.1
98%
OVERALL CURE RATE1 IN GT 1-6 TN/TE NC/CC ADULT PATIENTS
(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.1,4
99%
OVERALL CURE RATE8 IN EFFECTIVENESS POPULATION IN GT 1-6 TN/TE NC/CC PATIENTS
(n=5141/5196; pooled analysis of 12 clinical cohorts and studies in Canada, Europe, and the USA, PP)
Cure rate for the whole population was 93% (n=5141/5552, ITT).8
The Real-World Integrated Analysis is not presented in the EPCLUSA (sofosbuvir/velpatasvir) 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.
a CC patients had a higher risk of not achieving a cure.
b Derived from the HCV-TARGET, HepaC, HELIOS, and Mangia cohorts. Adverse reaction data were not recorded in other cohorts.9
Cure rates from ASTRAL-1, -2, and -3 and POLARIS-2 and -3 studies
Genotype | F0-F2 | F3 | F4 (CC) |
---|---|---|---|
GT 1-6 |
99%
(n=871/874) |
99%
(n=232/234) |
97%
(n=431/443) |
GT 1 |
100%
(n=303/303) |
99%
(n=91/92) |
98%
(n=152/155) |
GT 2 |
100%
(n=195/195) |
100%
(n=34/34) |
100%
(n=58/58) |
GT 3 |
99%
(n=218/221) |
100%
(n=76/76) |
94%
(n=154/163) |
GT 4-6 |
100%
(n=155/155) |
97%
(n=31/32) |
100%
(n=67/67) |
Cure rates (SVR12) derived from a completer efficacy analysis of the ASTRAL-1, -2, and -3 and POLARIS-2 and -3 studies, which included all patients who were randomized, completed the assigned study treatment, and had HCV RNA data observed at post-treatment Week 12 or thereafter. Individual fibrosis stage efficacy is not presented in the EPCLUSA full Prescribing Information.
95%
CURE RATE1 IN GT 1, 2, 3, 4, AND 6 NC/CC ADULT PATIENTS WITH HCV AND ESRD REQUIRING DIALYSIS
(n=56/59; Trial 4062)
EPCLUSA (sofosbuvir/velpatasvir) can be used with no dosage adjustment in HCV patients with any stage of renal impairment, including those requiring dialysis.
No safety data are available in subjects with both decompensated cirrhosis and severe renal impairment, including ESRD requiring dialysis. Additionally, no safety data are available in pediatric patients with renal impairment.
In a retrospective analysis of 12 EPCLUSA Phase 2 and 3 trials in adults:
97%
CURE RATE11 WITH A PPI
(n=84/87)
97%
CURE RATE11 WITHOUT A PPI
(n=2445/2517)
1% of patients taking a PPI discontinued HCV treatment due to an AE11
Cure = sustained virologic response (SVR12; HCV RNA <LLOQ 12 weeks after treatment completion).4
BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV COINFECTED PATIENTS Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with EPCLUSA. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals (DAAs) and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive, in patients with serologic evidence of resolved HBV, and also in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV DAAs may be increased in patients taking these other agents. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
EPCLUSA (sofosbuvir 400 mg/velpatasvir 100 mg, 200 mg/50 mg tablets; 200 mg/50 mg, 150 mg/37.5 mg oral pellets) is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1-6 infection without cirrhosis or with compensated cirrhosis and in combination with ribavirin for those with decompensated cirrhosis.
Consult the full Prescribing Information for EPCLUSA for more information on potentially significant drug interactions, including clinical comments.
Please see full Prescribing Information for EPCLUSA, including BOXED WARNING.
BOXED WARNING: RISK OF HEPATITIS B
REACTIVATION
IN HCV/HBV COINFECTED PATIENTS
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection
before initiating treatment with EPCLUSA. HBV reactivation has been reported in HCV/HBV
coinfected patients who were undergoing or had completed treatment with HCV
EPCLUSA (sofosbuvir 400 mg/velpatasvir 100 mg, 200 mg/50 mg tablets; 200 mg/50 mg, 150 mg/37.5 mg oral pellets) is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1-6 infection without cirrhosis or with compensated cirrhosis and in combination with ribavirin for those with decompensated cirrhosis.
AE = adverse event; CC = compensated cirrhosis; CI = confidence interval; DAA = direct-acting antiviral; ESRD = end-stage renal disease; F0-F2 = stages 0-2 fibrosis; F3 = stage 3 fibrosis; F4 = stage 4 fibrosis; GT = genotype; IQR = interquartile range; ITT = intent-to-treat; LLOQ = lower limit of quantification; mITT = modified intent-to-treat; NC = non-cirrhotic; PP = per protocol; PPI = proton-pump inhibitor; SAE = serious adverse event; SVR = sustained virologic response; 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: