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.
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.1 Achieving
SVR12 is considered a virologic cure.2
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)
Largest real-world analysis of DAA HCV regimens3
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.
aCC patients had a higher risk of not achieving a cure.
aDerived from the HCV-TARGET, HepaC, HELIOS, and Mangia cohorts. Adverse reaction data were not recorded in other cohorts.
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.
in GT 1-4 NC/CC adult patients
(n=97/103; SIMPLIFY study)
in GT 1-4 NC/CC adult patients
(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%].6,7
SVR12 was the primary endpoint (HCV RNA <LLOQ 12 weeks after treatment completion). Achieving SVR12 is considered a virologic cure.1,2
The mITT analysis is not presented in the EPCLUSA full Prescribing Information and the SIMPLIFY publication.
This mITT analysis was not in the original statistical plan and should be considered descriptive only.
Therefore, the results require cautious interpretation and could represent chance findings.
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 patients with both decompensated cirrhosis and severe renal impairment, including ESRD requiring dialysis. Additionally, no safety data are available in pediatric patients with renal impairment.
Trial Safety Data
In a retrospective analysis of 12 EPCLUSA Phase 2 and 3 trials in adults:
with a PPI
(n=84/87)
without a PPI
(n=2445/2517)
Trial Safety Data9
Cure = sustained virologic response (SVR12; HCV RNA <LLOQ 12 weeks after treatment completion).2
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 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 : REACTIVATIONTest all patients for evidence of current or prior hepatitis B virus (HBV)...
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.
AE = adverse event; CC = compensated cirrhosis; DAA = direct-acting antiviral; DDI = drug-drug interaction; ESRD = end-stage renal disease; F0-F2 = stages 0-2 fibrosis; F3 = stage 3 fibrosis; F4 = stage 4 fibrosis; GT = genotype; ITT = intent to treat; LLOQ = lower limit of quantification; NC = non-cirrhotic; PI = protease inhibitor; PP = per protocol; PPI = proton-pump inhibitor; SAE = serious adverse event; 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: