What is Ledipasvir?


Ledipasvir is an antiviral medication used in the treatment of hepatitis C virus (HCV) infection. It is part of a class of drugs known as direct-acting antivirals (DAAs) and is specifically an HCV NS5A inhibitor. Ledipasvir is used in combination with sofosbuvir, another antiviral medication, in a fixed-dose combination pill marketed under the brand name Harvoni. This combination has significantly improved the cure rates and reduced the treatment duration for hepatitis C.

Mechanism of Action

Ledipasvir works by inhibiting the NS5A protein, which is essential for HCV RNA replication and assembly. By blocking NS5A, ledipasvir disrupts the replication process of the hepatitis C virus, thereby reducing the viral load in the body. When used in combination with sofosbuvir, which inhibits the HCV RNA polymerase, the two drugs provide a potent and synergistic effect against HCV.


Ledipasvir, in combination with sofosbuvir, is used to treat chronic hepatitis C infection in adults and certain pediatric patients. It is effective against HCV genotypes 1, 4, 5, and 6. The combination therapy is particularly notable for its high cure rates, often achieving sustained virologic response (SVR) in a large majority of patients. Harvoni is also used in patients with cirrhosis and in those who have previously been treated with other HCV medications.

Approval and Availability

Ledipasvir/sofosbuvir (Harvoni) was approved by the US Food and Drug Administration (FDA) in October 2014. Since then, it has received approval in many other countries worldwide. Harvoni has become a cornerstone in the treatment of chronic hepatitis C due to its efficacy, safety profile, and convenience as an oral once-daily medication.

Side Effects of Ledipasvir

The most common side effects of ledipasvir/sofosbuvir include fatigue, headache, nausea, diarrhea, and insomnia. While generally well-tolerated, some patients may experience more severe side effects, such as bradycardia (slow heart rate) when taken with certain heart medications like amiodarone. It is important for patients to discuss their medical history and current medications with their healthcare provider before starting treatment.