FDA approves Daklinza for hepatitis C genotype 3

July 27, 2015

On July 24, FDA approved Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections.

On July 24, the FDA approved Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections. Notably, Daklinza, marketed by Bristol-Myers Squibb in Princeton, N.J., is the first drug that has demonstrated safety and efficacy to treat genotype 3 HCV infections without the need for co-administration of interferon or ribavirin for HCV.

Around 2.7 million Americans are infected with HCV, of which approximately 10% are genotype 3, according to the Centers for Disease Control and Prevention (CDC).

“Today’s approval provides a new option for patients with genotype 3 HCV, including those patients who cannot tolerate ribavirin,” said Edward Cox, MD, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research.

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Sustained virologic response (SVR) rates are reduced in HCV genotype 3-infected patients with cirrhosis receiving the combination of Daklinza and sofosbuvir. The recommended dosage of Daklinza is 60 mg in combination with sofosbuvir for 12 weeks.

“The U.S. approval of Daklinza means that chronic HCV genotype 3 patients may now complete treatment in just 12 weeks with an all-oral, once-daily regimen,” said Chris Boerner, head of U.S. Commercial for Bristol-Myers Squibb. “We believe this Daklinza-based regimen may be a solution to improving the standard of care for these patients. This approval is the result of many years of partnership with the HCV community to address the complexities of genotype 3, and an important achievement in our ongoing Daklinza development program, which focuses on patients that are most challenging to treat.”

The safety and efficacy of Daklinza in combination with sofosbuvir were evaluated in a clinical trial of 152 treatment-naive and treatment-experienced participants with chronic HCV genotype 3 infection. Participants received Daklinza 60 mg plus sofosbuvir 400 mg once daily for 12 weeks and were monitored for 24 weeks post-treatment.

Ninety-eight percent of the treatment-naive participants had no cirrhosis of the liver and 58% of the treatment-naive participants with cirrhosis achieved sustained virologic response. Of the participants who were treatment-experienced, 92% demonstrated no cirrhosis of the liver and 69% with cirrhosis achieved sustained virologic response.

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Daklinza carries a warning for patients and health care providers that serious slowing of the heart rate (symptomatic bradycardia) and cases requiring pacemaker intervention have been reported when amiodarone is co-administered with sofosbuvir in combination with another HCV direct-acting antiviral, including Daklinza. Co-administration of amiodarone with Daklinza in combination with sofosbuvir is not recommended.

The most common side effects of Daklinza with sofosbuvir were fatigue and headache.

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