Ledipasvir

Ledipasvir is a direct-acting antiviral medication used in combination with sofosbuvir for the treatment of chronic hepatitis C virus (HCV) infection. It is an NS5A inhibitor that interferes with viral RNA replication and assembly, and is typically given as part of a single-tablet regimen taken once daily.

Indications and regimen: Ledipasvir/sofosbuvir (90 mg/400 mg) is approved for adults with chronic HCV infection due to genotypes 1, 4, 5, and 6, and for certain pediatric patients aged 12 years and older. Treatment duration is generally 8 to 12 weeks, depending on factors such as genotype, prior treatment history, cirrhosis, and early virologic response. In many noncirrhotic, treatment-naive genotype 1 patients, 8 weeks may be sufficient; otherwise, 12 weeks is common. The goal is sustained virologic response (SVR), a virologic cure assessed about 12 weeks after completing therapy.

Administration and interactions: The tablet can be taken with or without food. Acid-reducing agents can lower ledipasvir exposure; antacids should be separated from dosing by at least 4 hours, and proton pump inhibitors may require adjustments. Avoid concurrent use with strong inducers of P-glycoprotein or UGT1A1, such as rifampin and St. John’s wort. Coadministration with amiodarone has been associated with bradycardia in rare cases; monitor if used together.

Adverse effects and considerations: Common adverse effects include fatigue, headache, nausea, and diarrhea. Serious liver-related or cardiovascular events are uncommon but can occur in patients with advanced liver disease. The safety and efficacy in pregnancy are not established, and use during pregnancy should be discussed with a clinician. Ledipasvir/sofosbuvir has largely replaced older regimens for many genotype 1–6 infections.