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
The real challenges of chronic HCV require a real focus on screening and Treatment
~2.7 million Americans were living
with CHRONIC HEPATITIS C INFECTION in 20181
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
Acute cases increased 280% over the
past
decade
(2010-2017) due to
increased injection
drug use4
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
Follow the current hepatitis C treatment guidelines: screen at-risk individuals and treat diagnosed patients with hepatitis C medication
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; 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:
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.
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.
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.
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.
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.
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.
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.
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.