SATURDAY, SEPTEMBER 24, 2016

FDA approves new chronic hepatitis C genotype 3 infection treatment

FDA approves new chronic hepatitis C genotype 3 infection treatment. | Courtesy of hepatitiscnewdrugresearch.com
The U.S. Food and Drug Administration (FDA) approved Daklinza, or declatasvir, to be used with sofosbuvir as treatments for hepatitis C virus (HCV) genotype 3 infections on Friday.

This is the first drug that has shown efficacy and safety adequate to treating genotype 3 HCV infections. These demonstrations have shown that Daklinza, marketed by Bristol-Myers Squibb, does not require a co-administration of ribavirin or interferon, both of which are drugs that were approved by the FDA to treat HCV infections.

Hepatitis C, a viral disease, inflames the liver and may develop into liver failure or reduced liver function. Many people with HCV infections do not show any symptoms until they develop liver damage, which can take years. People who have chronic HCV infections develop cirrhosis, or scarred livers with poor functioning, over time. This causes many health complications, like fluid accumulation in the abdomen, jaundice, bleeding, liver cancer, or infections.

The Centers for Disease Control and Prevention said approximately 2.7 million Americans have HCV infections. Approximately 10 percent of these people have genotype 3 HCV infections.

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

Organizations in this story

FDA Office of Medical Products and Tobacco 10903 New Hampshire Ave NE Silver Spring, MD 20903

U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD 20903

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