Indications: Daclatasvir (Daklinza) is a hepatitis C virus (HCV) NS5A inhibitor indicated for use with sofosbuvir for the treatment of chronic HCV genotype 3 infection.

Dosing: The recommended starting dosage is 60 mg taken orally once daily with or without food in combination with sofosbuvir. Recommended treatment duration is 12 weeks. Reduce dosage to 30 mg once daily with strong CYP3A inhibitors and increase dosage to 90 mg once daily with moderate CYP3A inducers.

Pharmacokinetics: The pharmacokinetic properties of daclatasvir were evaluated in healthy adult subjects and in subjects with chronic HCV. Administration of daclatasvir tablets in HCV-infected subjects resulted in approximately dose-proportional increases in C_max, AUC, and C_min up to 60 mg once daily. Steady state is anticipated after approximately 4 days of once-daily daclatasvir administration. Exposure of daclatasvir was similar between healthy and HCV-infected subjects.

Efficacy: In phase-III ALLY-3 clinical trial involving a total of 152 treatment-naïve and treatment-experienced subjects with chronic HCV genotype 3 infection and compensated liver disease, results showed that 98% of the treatment-naïve participants with no cirrhosis of the liver and 58% of the treatment-naïve participants with cirrhosis achieved sustained virolgic response (SVR) while 92% of treatment-experienced patients with no cirrhosis of the liver and 69% with cirrhosis achieved SVR.

Side Effects/Risks: Serious symptomatic bradycardia may occur in patients taking amiodarone with sofosbuvir in combination with another HCV direct-acting agent, including Daklinza. The most common adverse reactions with sofosbuvir are headache and fatigue.

Source: Highlights of Prescribing Information: Daklinza (daclatasvir). FDA website. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206843Orig1s000lbl.pdf. Revised July 2015. Accessed August 3, 2015.