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.
Screen and treat to help manage chronic hepatitis C
Featured patient
compensated by Gilead.
Test all adult patients at least once3-5 |
Test
all at-risk patients3-8 |
Begin treating
all patients4,6 |
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AASLD/ |
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a |
CDC |
b |
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USPSTF |
c |
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EASL |
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d |
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ASAM |
e |
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ACOG |
f |
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
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.
No virus detected
Positive result or reactive result confirms exposure to the virus. Run an HCV RNA test to verify.
Run either a qualitative or quantitative RNA test. This will confirm the presence of the virus. Choose “reflex testing” option to automate this step.
Detection confirms presence of virus.
Diagnose current HCV infection.
HCV antibody test with reflex to quantitative HCV RNA test:
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
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.
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.
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.
BOXED WARNING: RISK OF HEPATITIS B
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
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: