New Treatment Approved for Chronic Hepatitis C Genotype 3 Infections

The US Food and Drug Administration (FDA) today approved daclatasvir (Daklinza/ Bristol-Myers Squibb) for use with sofosbuvir for the treatment of hepatitis C virus (HCV) genotype 3 infections.

To measure whether an individual’s hepatitis C virus could no longer be detected in the bloodstream 12 weeks post-treatment, researchers conducted a clinical trial that evaluated 152 treatment-naïve and treatment-experienced individuals suffering from chronic HCV genotype 3 infection.

Participants were administered Daklinza 60 mg and sofosbuvir 400 mg once daily for 12 weeks and were also monitored for 24 weeks following the end of treatment.

Results indicated 98% of treatment-naïve participants without liver cirrhosis and 58% of the treatment-naïve participants with cirrhosis achieved sustained virologic response at 12 weeks.

For the treatment-experienced group, 92% without liver cirrhosis and 69% with cirrhosis achieved sustained virologic response at 12 weeks.

The most common adverse events reported during testing were fatigue and headache. The Daklinza label will include a warning that some patients may be at risk for symptomatic bradycardia when amiodarone is co-administered with sofosbuvir in combination with another HVC direct-acting antiviral, including Daklinza.

Daklinza is the first drug that can safely and effectively treat genotype 3 HCV without the use of concomitant interferon or ribavirin.

Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA

S Center for Drug Evaluation and Research, remarked, “Today’s approval provides a new option for patients with genotype 3 HCV, including those patients who cannot tolerate ribavirin.”