Ledipasvir

in HARVONI

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Pronunciation: le-DIP-as-veer

Ledipasvir ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Ledipasvir ballicule

Ledipasvir IN HARVONI mascot mnemonic cartoon — Visual mnemonic: Ledipasvir mascot
**“Lee dip a sphere”**

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.

Ledipasvir molecular structure (skeletal formula) — Molecular structure: Ledipasvir

FDA-approved for

chronic hepatitis C (2014)

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Risk of hepatitis B virus reactivation in HCV/HBV coinfected patients (some fatal). Test all patients for current/prior HBV before treatment and monitor.

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)

Available strengths

tab 45/200, 90/400 mg
pellet 33.75/150, 45/200 mg
pellets 33.75/150, 45/200 mg/packet

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

Cost

Ledipasvir (IN HARVONI)

Strength		#/mo	generic $/mo	CostPlus
45/200 mg	tab	30 qd		not offered
90/400 mg	tab	30 qd		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Ledipasvir is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

⚠ 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

Therapeutic safety burden1 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk1 / 4

Defining liabilityTransporter interactions and rapid resistance with ineffective regimens

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BCRP inhibitor

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