EPCLUSA
Combination product
Pronunciation: soe-FOS-byoo-veer and vel-PAT-as-veer (ep-KLOO-sa)
What it isNucleotide NS5B polymerase inhibitor plus NS5A inhibitor; chronic hepatitis C, all genotypes.
Why this onePangenotypic 12-week tablet; with ribavirin, the choice in decompensated cirrhosis, where protease inhibitors are avoided.
What limits itAcid suppressants reduce velpatasvir absorption, and amiodarone can cause severe bradycardia.
Pearls
- 8-week glecaprevir/pibrentasvir is the shorter pangenotypic alternative.
- Option after solid-organ transplant.
- Approved from age 3.
Components (2)
FDA-approved for
- chronic hepatitis C, genotypes 1–6 (adults and ≥3 y) (2016)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Chronic HCV genotype 1-6, no cirrhosis or compensated cirrhosis (Child-Pugh A) | Adults | 400 mg/100 mg (1 tablet) once daily | 400 mg/100 mg QD x12 weeks | 400 mg/100 mg QD |
| Chronic HCV genotype 1-6, decompensated cirrhosis (Child-Pugh B or C) | Adults | 400 mg/100 mg QD + ribavirin | Epclusa + ribavirin x12 weeks | 400 mg/100 mg QD |
| Chronic HCV genotype 1-6 | Pediatric ≥3 y | ≥30 kg: 400 mg/100 mg QD; 17 to <30 kg: 200 mg/50 mg QD; <17 kg: 150 mg/37.5 mg QD (oral pellets) | weight-based QD x12 weeks (+ ribavirin if decompensated) | 400 mg/100 mg QD |
Renal No adjustment needed (any degree, including dialysis)
Hepatic No adjustment needed (mild, moderate, or severe; Child-Pugh A, B, or C)
Instructions
- Take one tablet once daily with or without food
- Test all patients for HBV (HBsAg and anti-HBc) before initiating
- If used with ribavirin, follow ribavirin dosing/modifications
- Coadministration of amiodarone is not recommended
Available strengths
- tab 200/50, 400/100 mg
- pellet 150/37.5, 200/50 mg
- pellets 150/37.5, 200/50 mg/packet
Contraindications
- When used with ribavirin: contraindications to ribavirin apply (Epclusa + ribavirin regimen is contraindicated in patients for whom ribavirin is contraindicated)
Cautions
- Hepatitis B virus reactivation in HCV/HBV coinfected patients
- Serious symptomatic bradycardia with amiodarone coadministration
- Reduced therapeutic effect with P-gp inducers and/or moderate-to-strong CYP inducers
- Ribavirin-associated risks when used in combination
Adverse reactions
- Headache
- Fatigue
- Nausea (with ribavirin: fatigue, anemia, nausea, headache, insomnia, diarrhea)
Pregnancy No adequate human data for Epclusa; when given with ribavirin the combination is contraindicated in pregnancy and in men whose partners are pregnant
Lactation Unknown whether components present in human milk; consider benefits vs risk
Cost
| Strength | #/mo | generic $/mo | CostPlus | |
|---|---|---|---|---|
| 200/50 mg | tab | 30 qd | not offered | |
| 400/100 mg | tab | 30 qd | $8,340.77 | not offered |
Other forms: Velpatasvir (in EPCLUSA)
Clinical profile
Defining liabilityHBV reactivation and serious interacting-drug bradycardia
Part D rank #672.
Self-check
- Which HCV genotypes are included in EPCLUSA’s supplied indication?
1–6. - What boxed risk matters in HCV/HBV coinfection with EPCLUSA?
HBV reactivation.