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.

FOR YOUR CHRONIC HCV PATIENTS, INCLUDING PEOPLE WHO INJECT DRUGS1

DISCOVER WHY EPCLUSA

Featured patients
compensated by Gilead.

HIGH CURE RATES

Scroll to see adherence data below

In patients who inject drugs,
POWERFUL EFFICACY AND PROVEN RESULTS

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

SIMPLIFY STUDY SAFETY DATA1

  • The most common adverse reactions in SIMPLIFY were fatigue (18%), nausea (13%), and headache (11%)
  • Adverse reactions leading to permanent discontinuation of treatment were not observed in any subjects

THERE WERE NO CASES OF
VIROLOGIC FAILURE OR RELAPSE1,2

No virologic failure or relapse patient silhouette

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

THERE WERE NO CASES OF
VIROLOGIC FAILURE OR RELAPSE1,2

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

No virologic failure or relapse patient silhouette
Pivotal Studies
EPCLUSA Safety

CURE RATES WITH
IMPERFECT ADHERENCE

In a study focused on people who injected drugs,a
CONSISTENT CURE FOR PEOPLE WITH IMPERFECT ADHERENCE2,5

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.2,6

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.2,6

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

SIMPLIFY STUDY INFORMATION AND LIMITATIONS2

  • Patients in SIMPLIFY were instructed to use EPCLUSA once daily for 12 weeks as recommended in the EPCLUSA full Prescribing Information
  • Adherence was assessed by dividing the number of total doses received during therapy by the total expected number (84) of doses
  • 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
  • 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

DRUG INTERACTIONS

AN ESTABLISHED DDI PROFILE IN PEOPLE WITH CHRONIC HCV

INFORMATION ON EPCLUSA DRUG INTERACTIONS1

  • Coadministration of EPCLUSA is not recommended with:
    • Amiodarone, due to the risk of symptomatic bradycardia
    • P-gp inducers and/or moderate to strong inducers of CYP2B6, CYP2C8, or CYP3A4, as they may significantly decrease sofosbuvir and/or velpatasvir plasma concentrations
    • Omeprazole or other PPIs, phenobarbital, phenytoin, rifabutin, rifapentine, efavirenz, and tipranavir/ritonavir, due to decreased concentration of sofosbuvir and/or velpatasvir
      • If medically necessary, EPCLUSA should be administered with food and taken 4 hours before omeprazole 20 mg. Use with other PPIs has not been studied
  • Additional monitoring or dosing adjustments may be required with rosuvastatin or atorvastatin, as they may be associated with increased risk of myopathy, including rhabdomyolysis
  • Clearance of HCV infection with DAAs may lead to changes in hepatic function, which may impact safe and effective use of concomitant medications. Frequent monitoring of relevant laboratory parameters and dose adjustments of certain concomitant medications may be necessary

ONLY EPCLUSA HAS

NO CLINICALLY SIGNIFICANT DRUG INTERACTIONS WITH1 :

  • Ethinyl estradiol/norgestimate-based birth controlb

    b Among first-line pangenotypic regimens.

EPCLUSA HAS NO INTERACTIONS EXPECTED WITH7 :

  • ABILIFY (aripiprazole)
  • SEROQUEL (quetiapine)
  • Fentanyl
  • Oxycodone
See additional DDI information
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Important Safety Information

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.

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 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.

Contraindications

  • If EPCLUSA is used in combination with ribavirin (RBV), all contraindications, warnings and precautions, in particular pregnancy avoidance, and adverse reactions to RBV also apply. Refer to RBV prescribing information.

Warnings and Precautions

  • Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with EPCLUSA due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. A fatal cardiac arrest was reported in a patient taking amiodarone who was coadministered a sofosbuvir-containing regimen. In patients without alternative viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia.
  • Risk of Reduced Therapeutic Effect Due to Concomitant Use of EPCLUSA with P-gp Inducers and/or Moderate to Strong Inducers of CYP2B6, CYP2C8 or CYP3A4: Rifampin, St. John’s wort, and carbamazepine are not recommended for use with EPCLUSA as they may significantly decrease sofosbuvir and/or velpatasvir plasma concentrations.

Adverse Reactions

  • The most common adverse reactions (≥10%, all grades) with EPCLUSA in adults and pediatric patients 6 years of age and older were headache and fatigue; and when used with RBV in adults with decompensated cirrhosis were fatigue, anemia, nausea, headache, insomnia, and diarrhea. The most common adverse reactions (≥10%, grade 1 or 2) in pediatric patients less than 6 years of age were vomiting and spitting up the drug.

Drug Interactions

  • Coadministration of EPCLUSA is not recommended with topotecan due to increased concentrations of topotecan.
  • Coadministration of EPCLUSA is not recommended with proton-pump inhibitors, phenobarbital, phenytoin, rifabutin, rifapentine, efavirenz, and tipranavir/ritonavir due to decreased concentrations of sofosbuvir and/or velpatasvir.

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.

VIEW ALL

Important Safety Information

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.

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 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.

CC = compensated cirrhosis; CI = confidence interval; DAA = direct-acting antiviral; DDI = drug-drug interaction; GT = genotype; IQR = interquartile range; ITT = intent-to-treat; LLOQ = lower limit of quantification; mITT = modified intent-to-treat; NC = non-cirrhotic; SVR = sustained virologic response; SVR12 = sustained virologic response 12 weeks after treatment completion.

References:

  1. EPCLUSA [prescribing information]. Foster City, CA: Gilead Sciences, Inc; April 2022.
  2. Grebely J, Dalgard O, Conway B, et al. Sofosbuvir and velpatasvir for hepatitis C virus infection in people with recent injection drug use (SIMPLIFY): an open-label, single-arm, phase 4, multicentre trial. Lancet Gastroenterol Hepatol. 2018;3(3):153-161.
  3. Data on file. Gilead Sciences. April 2022.
  4. US Department of Health and Human Services, Center for Drug Evaluation and Research. Guidance for industry. Chronic hepatitis C virus infection: developing direct-acting antiviral drugs for treatment. November 2017.
  5. Data on file. Gilead Subgroup Statistical Analysis. December 2022.
  6. AASLD-IDSA. Recommendations for testing, managing, and treating hepatitis C. https://www.hcvguidelines.org. Updated October 24, 2022. Accessed September 15, 2023.
  7. University of Liverpool. Drug Interaction Checker. Liverpool HEP Interactions website. https://www.hep-druginteractions.org/checker. Updated June 2, 2022. Accessed September 20, 2023.