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.
About HCV
Screen and treat to help manage chronic hepatitis C
~2.7 million Americans were living
with CHRONIC HEPATITIS C INFECTION in 20181
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
a
CDC
b
USPSTF
c
EASL
d
ASAM
e
ACOG
f
aUnless they have limited life expectancy that cannot be remediated by HCV therapy.4
bExcept in settings where the prevalence of HCV infection (HCV RNA-positivity) is <0.1%.5
cRecommendations for screening of adults (18-79 years).3
dUnless 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
Reactive HCV antibody test
Positive result or reactive result confirms exposure to the virus. Run an HCV RNA test to verify.
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.
RNA not detected = STOPa-c
RNA detected
Detection confirms presence of virus.
Diagnose current HCV infection.
Follow pre-treatment steps
INITIATE TREATMENT
HCV antibody test with reflex to quantitative HCV RNA test:
CPT code - 86803
Quest DiagnosticsTM code - 8472
LabCorp code - 1440509,10
Reflex Testing: Diagnosis can be facilitated by automatically testing for HCV RNA on the same sample if the HCV antibody test is positive.
aFor 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.
bRepeat 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.
cAnnual testing recommended for active injection drug users.
BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV COINFECTED
PATIENTSTest 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.
BOXED WARNING: RISK OF HEPATITIS B VIRUS
REACTIVATION:IN
HCV/HBV COINFECTED PATIENTSTest 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; 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:
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.
Centers for Disease Control and Prevention. Viral Hepatitis Surveillance: United States, 2019.
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.
AASLD-IDSA. Recommendations for testing, managing, and treating hepatitis C. Updated January 21, 2021. Accessed July 7, 2021. https://www.hcvguidelines.org
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.
European Association for the Study of the Liver. EASL recommendations on treatment of hepatitis C - Final update of the series. J Hepatol. 2020;73(5):1170-1218. doi:10.1016/j.jhep.2020.08.018.
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/public-policy-statements/details/public-policy-statements/2021/08/09/hepatitis-c.
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.
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.
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.
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.