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Harvoni (ledipasvir / sofosbuvir)

Indications and Contraindications

Harvoni® is indicated for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6 infection. [Harvoni® PI 2016 p2 Sec1/A]

Contraindications: [Harvoni® PI 2016 p3 Sec4/A]

If Harvoni® is administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen.


Harvoni® is a fixed-dose combination of ledipasvir and sofosbuvir. [Harvoni® PI 2016 p14 Sec12.1/A]

Ledipasvir is an inhibitor of the HCV NS5A protein, which is required for viral replication. Resistance selection in cell culture and cross-resistance studies indicate ledipasvir targets NS5A as its mode of action. [Harvoni® PI 2016 p22 Sec12.4 para1/A] Sofosbuvir is an inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is required for viral replication.

Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator. In a biochemical assay, GS-461203 inhibited the polymerase activity of the recombinant NS5B from HCV genotypes 1b, 2a, 3a and 4a with IC50 values ranging from 0.7 to 2.6 µM. GS-461203 is neither an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase. [Harvoni® PI 2016 p22 sec12.4 para2/B]

Supplied Form/Description

Harvoni® is available as tablets for oral administration:

  • 90 mg ledipasvir and 400 mg sofosbuvir in an orange colored, diamond shaped, film-coated tablet debossed with “GSI” on one side and “7985” on the other [Harvoni® PI 2016 p3 Sec3/E]

Harvoni ® is packaged as follows:

  • Bottle of 28 tablets [Harvoni® PI 2016 p38 sec16 para1/A]