Ledipasvir
in HARVONI
What it isHCV NS5A inhibitor given with sofosbuvir; chronic hepatitis C.
Why this oneA single daily tablet cures most genotype 1 infection in eight to twelve weeks.
What limits itHepatitis B reactivation, so B status must be known. Amiodarone with sofosbuvir causes severe bradycardia; acid suppressants reduce absorption.
FDA-approved for
- chronic hepatitis C (2014)
FDA label
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| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Chronic HCV (genotype 1, 4, 5, 6) | Adults | 1 tablet (90 mg ledipasvir/400 mg sofosbuvir) QD | 1 tablet QD | 1 tablet QD |
| Chronic HCV (genotype 1, 4, 5, 6) | Pediatric ≥12 yr or ≥35 kg | 1 tablet (90/400 mg) QD | 1 tablet QD | 1 tablet QD |
Renal No dosage adjustment for any degree of renal impairment, including ESRD on dialysis
Hepatic No dose adjustment; add ribavirin for decompensated cirrhosis (Child-Pugh B or C)
Duration (12 vs 24 weeks) and use of ribavirin depend on genotype, cirrhosis, and treatment history
Instructions
- One tablet once daily with or without food
- Test all patients for HBV (HBsAg and anti-HBc) before starting
- If given with ribavirin, follow ribavirin dosing and contraindications
- Amiodarone coadministration not recommended (bradycardia risk)
Contraindications
- If used with ribavirin, all ribavirin contraindications apply
Cautions
- Hepatitis B virus reactivation
- Serious symptomatic bradycardia with amiodarone coadministration
Adverse reactions
- Fatigue
- Headache
- Asthenia
Pregnancy No adequate human data; if used with ribavirin, contraindicated in pregnancy (ribavirin risk)
Lactation Unknown whether present in human milk
⚠ BOXED WARNING
- Hepatitis B virus reactivation in patients coinfected with HCV and HBV
Principal riskHepatitis B reactivation; bradycardia with amiodarone
Classes and tags
Clinical profile
Mechanism of action: Ledipasvir ballicule
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Memory aids: mascots and interaction avatars
