Drug intelligence / Profile preview

Harvoni

Development stage
Approved
Lead developer
Gilead Sciences
Modality
Inhalation Devices → Device-based Delivery → Drug Delivery Systems, Small Molecules, Implantable Devices → Device-based Delivery → Drug Delivery Systems, Transdermal Patches → Device-based Delivery → Drug Delivery Systems
Administration
Oral
01

Overview

Harvoni is a fixed-dose combination antiviral medication containing ledipasvir and sofosbuvir. Ledipasvir is an NS5A inhibitor, while sofosbuvir is a nucleotide analog NS5B polymerase inhibitor. Together, they inhibit hepatitis C virus (HCV) replication by targeting two distinct steps in the viral life cycle. Harvoni was developed as the first once-daily single-tablet regimen for chronic hepatitis C infection that does not require interferon or ribavirin. It achieves high cure rates (SVR12 of 94–99%) in patients with HCV genotype 1 and is also approved for genotypes 4, 5, and 6[1][2][3][6]. Indications include use in adults and children aged three years or older with chronic HCV infection—specifically genotypes 1, 4, 5, or 6 without cirrhosis or with compensated cirrhosis; genotype 1 with decompensated cirrhosis (in combination with ribavirin); and certain post-liver transplant populations[3][6][8]. The drug comes as oral tablets or pellets in various strengths.

Brand names
HarvoniHepcinat-LP
Other names
ledipasvir/sofosbuvirledipasvir and sofosbuvir
02

Targets

NS5A (Hepatitis C virus nonstructural protein 5A (genotype 1b))NS5B (Hepatitis C virus non-structural protein 5B (NS5B) RNA-dependent RNA polymerase)

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