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.

~2.7 million Americans were living with CHRONIC
HEPATITIS C INFECTION in 20181

In 2018, approximately 2.7 million Americans were estimated to have HCV; 24% of these were diagnosed and only 5% received HCV treatment
In 2018, approximately 2.7 million Americans were estimated to have HCV; 24% of these were diagnosed and only 5% received HCV treatment

leading institutions recommend broad HCV screening to help identifY cases of HCV2-4

  • AASLD/IDSA, CDCa, and USPSTFb all independently recommend a one-time universal HCV screening for all adults as part of hepatitis C guidelines
  • AASLD/IDSA, CDC, and USPSTF also independently recommend HCV screening for at-risk patients
  • Screening can lead to diagnosis before hepatitis C symptoms appear3

aExcept in settings where the prevalence of HCV infection (HCV RNA-positivity) is <0.1%.3
bRecommendations for screening of adults (18-79).4

Help ensure more patients get the hepatitis C treatment they need by screening for HCV today2,5

New cases of hepatitis C infection are on the rise due to the opioid epidemic and injection drug use1

44K estimated new acute HCV cases in 2017

Acute cases increased 280% over the past decade (2010-2017) due to increased injection drug use4

Acute cases increased 280%
Acute cases increased 280%

The most rapid increase in incidence has been in adults4:

aged 20-39 years

who inject drugs

Although curable, HCV was responsible for more deaths than HIV in 20176,7

17,253 HCV deaths vs 16,352 HIV deaths in 2017 17,253 HCV deaths vs 16,352 HIV deaths in 2017

Follow the current hepatitis C treatment guidelines: screen at-risk individuals and treat diagnosed patients with hepatitis C medication

Cure = sustained virologic response (SVR12; HCV RNA <LLOQ 12 weeks after treatment completion).8

See Efficacy Data
See Access and Support

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 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 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.

AASLD = American Association for the Study of Liver Diseases; CDC = Centers for Disease Control and Prevention; HIV = human immunodeficiency virus; IDSA = Infectious Diseases Society of America; LLOQ = lower limit of quantification; SVR12 = sustained virologic response 12 weeks after treatment completion; USPSTF = United States Preventive Services Task Force.

References:

  1. Chhatwal J, Chen Q, Bethea ED, et al. The impact of direct-acting anti-virals on the hepatitis C care cascade: identifying progress and gaps towards hepatitis C elimination in the United States. Aliment Pharmacol Ther. 2019;50:66-74.
  2. Hepatitis C guidance 2018 update: AASLD-IDSA recommendations for testing, managing, and treating hepatitis C virus infection. AASLD-IDSA HCV Guidance Panel. Clin Infect Dis. 2018:67(10):1477-1492.
  3. Centers for Disease Control and Prevention. CDC recommendations for hepatitis C screening among adults - United States. 2020. https://www.cdc.gov/mmwr/volumes/69/rr/rr6902a1.htm?s_cid+rr6902a1_w. Published April 9, 2020. Accessed June 6, 2020.
  4. US Preventive Services Task Force. Screening for hepatitis C virus infection in adolescents and adults: US Preventive Services Task Force recommendation statement. JAMA. 2020;323(10):970-975. doi:10.1001/jama.2020.1123.
  5. Centers for Disease Control and Prevention. Hepatitis C questions and answers for health professionals. https://www.cdc.gov/hepatitis/hcv/hcvfaq.htm. Updated July 2, 2019. Accessed June 3, 2020.
  6. Centers for Disease Control and Prevention. Viral hepatitis surveillance: United States, 2017. https://www.cdc.gov/hepatitis/statistics/2017surveillance/index.htm. Accessed June 3, 2020.
  7. Centers for Disease Control and Prevention. HIV Surveillance Report, 2018 (preliminary); vol. 30. http://www.cdc.gov/hiv/library/reports/hivsurveillance.html. Published November 2019. Accessed June 3, 2020.
  8. 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.