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EPCLUSA
Viral infections
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Drug Name:

EPCLUSA Rx

Generic Name and Formulations:
Sofosbuvir, velpatasvir 400mg/100mg; tabs.

Company:
Gilead Sciences, Inc.

Therapeutic Use:

Indications for EPCLUSA:

Chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection in adults without cirrhosis or with compensated cirrhosis; or with decompensated cirrhosis for use in combination with ribavirin (RBV).

Adult:

Test for HBV infection prior to initiation. 1 tab once daily. Without cirrhosis or with compensated cirrhosis (Child-Pugh A): treat for 12 weeks. With decompensated cirrhosis (Child-Pugh B or C): treat with RBV for 12 weeks. HCV/HIV-1 co-infection: follow same dosage schedule.

Children:

<18yrs: not established.

Contraindications:

When co-administered with ribavirin, its contraindications also apply to this combination regimen (eg, Pregnancy Cat.X).

Warnings/Precautions:

Risk of HBV reactivation in patients coinfected with HCV/HBV. Test all patients for HBV infection by measuring HBsAg and anti-HBc; if positive serologic evidence, monitor for hepatitis flare or HBV reactivation during and at post-treatment follow-up; treat if clinically indicated. Increased risk of symptomatic bradycardia when concomitant amiodarone esp. patients also taking beta-blockers or with cardiac comorbidities and/or advanced liver disease. Severe renal impairment (eGFR <30mL/min/1.73m2) or ESRD requiring hemodialysis. Pregnancy. Nursing mothers.

Interactions:

Concomitant amiodarone: not recommended; if no alternatives, monitor cardiac function (see full labeling). Concomitant certain immunosuppressants or chemotherapeutic agents: may increase risk of HBV reactivation. May potentiate P-gp, BCRP, OATP1B1, OATP1B3, or OATP2B1 substrates. Concomitant P-gp and/or moderate to potent CYP2B6, CYP2C8, CYP3A4 inducers (eg, rifampin, St. John’s wort, carbamazepine), anticonvulsants (eg, phenytoin, phenobarbital, oxcarbazepine), rifabutin, rifapentine, tipranavir/ritonavir, topotecan, efavirenz-containing regimens: not recommended. Separate dosing of antacids by 4hrs. May give H2-antagonists simultaneously or 12hrs apart (comparable to max famotidine 40mg twice daily). Concomitant omeprazole or other PPIs: not recommended; if necessary, take Epclusa with food 4hrs before omeprazole 20mg. May potentiate digoxin; monitor. Concomitant tenofovir DF regimens; monitor. May potentiate rosuvastatin (do not exceed 10mg dose) and atorvastatin (monitor).

Pharmacological Class:

HCV NS5B polymerase inhibitor + HCV NS5A inhibitor.

Adverse Reactions:

Headache, fatigue, nausea, asthenia, insomnia; with ribavirin: anemia, diarrhea.

Note:

For ribavirin specific dosing and safety information, refer to the full prescribing information.

Generic Availability:

NO

How Supplied:

Tabs—28

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