HARVONI is a fixed-dose combination of ledipasvir and sofosbuvir which are directacting antiviral agents against the hepatitis C virus.

HARVONI is a fixed-dose combination of ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, and is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1, 4, 5 or 6 infection.

• Recommended dosage: One tablet (90 mg of ledipasvir and 400 mg of sofosbuvir) taken orally once daily with or without food See package insert for complete information.

The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with HARVONI were fatigue, headache, and asthenia.

If used in combination with ribavirin, all contraindications to ribavirin also apply to HARVONI combination therapy.

• Bradycardia with amiodarone coadministration: Serious symptomatic bradycardia may occur in patients taking amiodarone, particularly in patients also receiving beta-blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Coadministration of amiodarone with HARVONI is not recommended. In patients without alternative, viable treatment options, cardiac monitoring is recommended.
• Use with other drugs containing sofosbuvir is not recommended.