Name Daclatasvir
Classes Antiinfective Agent
Antiviral Agent
Diseases Infectious Disease

Daclatasvir

Daclatasvir is an antiviral drug. It is an inhibitor of NS5A, a nonstructural protein encoded by HCV. NS5A protein is required for the synthesis of viral RNA. Daclatasvir binds to the N-terminus of NS5A and inhibits both viral RNA replication and virion assembly. 

Daclatasvir indicated for use with sofosbuvir, with or without ribavirin, for the treatment of chronic HCV genotype 1 or 3 infection.

  • Daclatasvir should be taken orally, once daily, with or without meals, at doses of 60 mg.
  • Ribavirin should be administered at a starting dose of 600 mg once day for HCV genotype 1 or 3 patients with Child-Pugh B or C cirrhosis or post-transplant patients, and then increased to 1000 mg daily as tolerated. Based on hemoglobin and creatinine clearance, the initial and ongoing doses of ribavirin may be reduced.
  • The recommended ribavirin dosage for HCV genotype 3 patients with compensated cirrhosis (Child-Pugh A) is based on weight (1000 mg for patients weighing less than 75 kg and 1200 mg for those weighing at least 75 kg administered orally in two divided doses with food).

Most common adverse reactions observed with Daclatasvir in combination with sofosbuvir were

  • headache
  • fatigue
  • Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV:  Patients with HCV/HBV coinfection who were undergoing or had finished treatment with HCV direct acting antivirals and who were not getting HBV antiviral medication have had HBV reactivation. In few instances, fulminant hepatitis, liver failure, and death have occurred.
  • Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions: Daclatasvir and other medications used together may have known or potential serious drug interactions.
  • Serious Symptomatic Bradycardia When Co-administered with Sofosbuvir and Amiodarone: When amiodarone is co-administered with sofosbuvir in combination with another HCV direct acting antiviral, such as Daclatasvir, incidences of symptomatic bradycardia and cases needing pacemaker intervention have been documented  post-marketing.
  • Risks Associated with Ribavirin Combination Treatment: The warnings and precautions for ribavirin, in particular the pregnancy avoidance warning, apply to this combination regimen if Daclatasvir and sofosbuvir are used together.

Contraindication

Co-administration with the following drugs are contraindicated-

  • phenytoin
  • carbamazepine
  • rifampin

 

Daclatasvir is contraindicated with-

  • St. John’s wort