Breakthrough Hep C Development Announced

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

The U.S. Food and Drug Administration on July 24 approved Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus genotype 3 infections. This is the first drug that has demonstrated safety and efficacy to treat these infections without the need for co-administration of interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection, according to the agency.

Hepatitis C is a scourge, a viral disease that causes inflammation of the liver that can cause diminished liver function or liver failure. "Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take several years. Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice, fluid accumulation in the abdomen, infections or liver cancer. According to the Centers for Disease Control and Prevention, approximately 2.7 million Americans are infected with HCV of which, approximately 10 percent are genotype 3," according to the agency.

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

The agency's announcement said 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. The studies were designed to measure whether a participant’s hepatitis C virus was no longer detected in the blood 12 weeks after finishing treatment (sustained virologic response), suggesting a participant's infection had been cured. Results showed that 98 percent of the treatment-naive participants with no cirrhosis of the liver and 58 percent of the treatment-naive participants with cirrhosis achieved sustained virologic response. Of the participants who were treatment-experienced, 92 percent with no cirrhosis of the liver and 69 percent with cirrhosis achieved sustained virologic response. Daklinza labeling carries a Limitations of Use statement to inform prescribers that sustained virologic response rates are reduced in HCV genotype 3 infected patients with cirrhosis."

The drug 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."

Daklinza is marketed by Bristol-Myers Squibb, based in Princeton, N.J.

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