The combination of ledipasvir and sofosbuvir is used to treat adults with chronic hepatitis C (CHC) infection caused by genotype 1 of the virus.

This is a fixed-dose combination tablet containing Ledipasvir and Sofosbuvir for oral use. Ledipasvir is an HCV NS5A inhibitor, and Sofosbuvir is a nucleotide analog inhibitor of HCV NS5B polymerase. After oral administration, median peak concentrations of Ledipasvir are observed 4 to 4.5 hours post-dose.

Recommended dosage: One tablet (90 mg of Ledipasvir and 400 mg of Sofosbuvir) taken orally once daily with or without food.

Recommended treatment duration:

• Treatment-naive with or without cirrhosis: 12 weeks
• Treatment-experienced without cirrhosis: 12 weeks
• Treatment-experienced with cirrhosis: 24 weeks

A dose recommendation cannot be made for patients with severe renal impairment or end stage renal disease.

• Coadministration with Amiodarone may cause serious symptomatic bradycardia. Therefore, Ledipasvir and Sofosbuvir combination should not be used with Amiodarone.
• P-gp inducers such as Rifampin and St. John’s wort may alter the concentrations of Ledipasvir and Sofosbuvir. The use of Ledipasvir and Sofosbuvir combination with P-gp inducers is not recommended.

The Ledipasvir and Sofosbuvir combination is contraindicated in patients with known hypersensitivity to Ledipasvir, Sofosbuvir, or any other ingredient in the product.

The most common side effects observed with Ledipasvir and Sofosbuvir combination therapy for 8, 12, or 24 weeks include fatigue, headache, nausea, diarrhea, and insomnia, occurring in 10% or more of patients.

Pregnancy Category B: There are no adequate and well-controlled studies of Ledipasvir and Sofosbuvir in pregnant women. Because animal reproduction studies do not always predict human response, this combination should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Ledipasvir and Sofosbuvir or their metabolites are present in human breast milk.

Bradycardia with Amiodarone coadministration: Serious symptomatic bradycardia may occur in patients taking Amiodarone, especially those also on beta-blockers or with underlying heart conditions and/or advanced liver disease. Coadministration of Amiodarone with Ledipasvir and Sofosbuvir is not recommended. In patients with no alternative treatment options, cardiac monitoring is advised. Use with other drugs containing Sofosbuvir is not recommended.

Pediatric Use: The safety and effectiveness of Ledipasvir and Sofosbuvir have not been established in pediatric patients.
Geriatric Use: No overall differences in safety or effectiveness were observed between elderly and younger patients, and clinical experience has not identified significant differences in response. No dosage adjustment of Ledipasvir and Sofosbuvir is required for geriatric patients.

Hepatic viral infections (Hepatitis C)

Ledipasvir and Sofosbuvir should be kept out of the reach of children, stored in a cool and dry place, and protected from light.