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.

~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
  • Cases in the US more than doubled from 2012-2019 due to injection drug use2
  • The most rapid increase was in adults aged 20-39 years who inject drugs3

Guidelines recommend universal testing and immediate treatment

Test all adult patients at
least once3-5 		Test all at-risk
patients3-8 		Begin treating all
patients4,6
AASLD/IDSA

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CDC

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USPSTF

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EASL

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ASAM

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ACOG

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a Unless they have limited life expectancy that cannot be remediated by HCV therapy.4

b Except in settings where the prevalence of HCV infection (HCV RNA-positivity) is <0.1%.5

c Recommendations for screening of adults (18-79 years).3

d Unless they have limited life expectancy due to non-liver-related comorbidities.6

e “At-risk” refers to patients with a history of drug use (current and past) and all persons living with HIV infection.7

f “At-risk” refers to pregnant individuals. ACOG recommends screening during each pregnancy and to begin HCV treatment postpartum and/or after completion of breastfeeding.8

Key Steps To Testing And Diagnosing HCV4

Run an HCV antibody test

Choose the lab's "reflex-testing" option at the testing step so that an HCV RNA test will be run automatically if the antibody test is positive.

Nonreactive HCV antibody test = STOPa

No virus detected

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Reactive HCV antibody test

Positive result or reactive result confirms exposure to the virus. Run an HCV RNA test to verify.

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Run an HCV RNA test

Run either a qualitative or quantitative RNA test. This will confirm the presence of the virus. Choose “reflex testing” option to automate this step.

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RNA not detected = STOPa-c

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RNA detected

Detection confirms presence of virus.

Diagnose current HCV infection.

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Follow pre-treatment steps

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INITIATE TREATMENT

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HCV antibody test with reflex to quantitative HCV RNA test:

  • CPT code - 86803
  • Quest DiagnosticsTM code - 8472
  • LabCorp code - 1441279,10

Reflex Testing: Diagnosis can be facilitated by automatically testing for HCV RNA on the same sample if the HCV antibody test is positive.

a For persons who might have been exposed to HCV within the previous 6 months, consider retesting for HCV antibodies or ordering an HCV RNA test. For persons who are immunocompromised, testing for HCV RNA can be considered.

b Repeat HCV RNA testing if the person tested is suspected to have had HCV exposure within the previous 6 months or has clinical evidence of HCV disease.

c Annual testing recommended for active injection drug users.

Cure = sustained virologic response (SVR12; HCV RNA <LLOQ 12 weeks after treatment completion).11

Promptly identify patients with HCV, start their treatment, and get them on the path to cure.

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 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.

AASLD = American Association for the Study of Liver Diseases; ACOG = American College of Obstetricians and Gynecologists; ASAM = American Society of Addiction Medicine; CDC = Centers for Disease Control and Prevention; CPT = Current Procedural Terminology; EASL = European Association for the Study of the Liver; 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. Centers for Disease Control and Prevention. Viral Hepatitis Surveillance: United States, 2019.
  3. United States 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.
  4. AASLD-IDSA. Recommendations for testing, managing, and treating hepatitis C. Updated January 21, 2021. Accessed July 7, 2021. https://www.hcvguidelines.org.
  5. Schillie S, Wester C, Osbourne M, et al. CDC recommendations for hepatitis C infection among adults—United States, 2020. MMWR Recomm Rep. 2020;69(2):1-18.
  6. European Association for the Study of the Liver. EASL recommendations on treatment of hepatitis C – Final update on the series. J Hepatol. 2020;73(5):1170-1218.
  7. American Society of Addiction Medicine. Public policy statement on hepatitis C infection. Published April 5, 2017. Accessed May 27, 2021. https://www.asam.org/advocacy/find-a-policy-statement/view-policy-statement/public-policy-statements/2017/04/11/hepatitis-c.
  8. American College of Obstetricians and Gynecologists. Routine hepatitis C virus screening in pregnant individuals: ACOG practice advisory. Published May 2021. Accessed May 27, 2021. https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2021/05/routine-hepatitis-c-virus-screening-in-pregnant-individuals.
  9. Quest Diagnostics. Hepatitis C antibody with reflex to HCV, RNA, quantitative, real-time PCR. Accessed March 25, 2022. https://testdirectory .questdiagnostics.com/test/test-detail/8472/hepatitis-c-antibody-with-reflex-to-hcv-rna-quantitative-real-time-pcr?p=r&q=8472&cc=MASTER.
  10. Labcorp. Hepatitis C virus (HCV) antibody with reflex to quantitative real-time PCR. Accessed March 25, 2022. https://www.labcorp.com/tests/144050/ hepatitis-c-virus-hcv-antibody-with-reflex-to-quantitative-real-time-pcr.
  11. 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.