Velpatasvir
in EPCLUSA
What it isHCV NS5A inhibitor, given with sofosbuvir; chronic hepatitis C.
Why this onePangenotypic, so genotyping is unnecessary, with cure rates above 95%.
What limits itHepatitis B reactivation, so B status must be known first. Amiodarone with sofosbuvir causes severe bradycardia; acid suppressants reduce absorption.
FDA-approved for
- chronic hepatitis C (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 & peds ≥6 y or ≥17 kg | EPCLUSA (sofosbuvir 400 mg / velpatasvir 100 mg) QD ×12 weeks | 1 tablet QD ×12 weeks | |
| Chronic HCV, decompensated cirrhosis (Child-Pugh B or C) | Adults | EPCLUSA + ribavirin QD ×12 weeks | 1 tablet QD + ribavirin ×12 weeks | |
| Chronic HCV genotype 1–6 | Peds ≥6 y or ≥17 kg | Weight-based (per label Table 2) QD ×12 weeks | Weight-based QD |
Renal No dosage adjustment needed, including ESRD on dialysis.
Hepatic Decompensated cirrhosis (Child-Pugh B/C): add ribavirin.
Instructions
- Test all patients for HBV (HBsAg and anti-HBc) before starting
- With or without food
- Coadministration with amiodarone is not recommended (bradycardia risk)
Contraindications
- EPCLUSA + ribavirin regimen is contraindicated where ribavirin is contraindicated (see ribavirin labeling)
Cautions
- HBV reactivation in HCV/HBV coinfection (monitor during and after treatment)
- Serious symptomatic bradycardia with amiodarone coadministration
Adverse reactions
- Headache
- Fatigue
- With ribavirin: anemia, nausea, insomnia, diarrhea
Pregnancy With ribavirin: contraindicated in pregnancy; EPCLUSA alone — no adequate human data.
Lactation Unknown whether present in human milk.
⚠ BOXED WARNING
- Hepatitis B virus reactivation in patients coinfected with HCV and HBV
Principal riskHepatitis B reactivation; amiodarone causes severe bradycardia
Classes and tags
Clinical profile
Mechanism of action: Velpatasvir ballicule
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