The U.S. Food and Drug Administration today approved Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections.
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Technivie is the first drug to be sanctioned to treat genotype 4 hepatitis C infection without requiring co-use of the drug interferon, the agency said Friday in a news release.
Bristol-Myers says the list price for Daklinza, also known as daclatascir, will be $63,000 for a course of treatment, though insurers likely will seek big discounts to cover it.
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most infected people don’t develop symptoms until liver damage has already occurred, the FDA said.
The FDA approval was based on results form the PEARL-I study, a Phase 2b, open-label study that evaluated the efficacy and safety of Technivie in GT4 chronic HCV patients without cirrhosis. Ninety-one participants received Technivie with ribavirin once daily for 12 weeks. All sufferers who acquired Technivie with ribavirin achieved SVR12, in comparison with 91 % of sufferers handled with Technivie with out ribavirin.
Safety information was available for approximately 1,900 patients with HCV treated with the recommended dose of Daklinza in combination with other anti-HCV drugs in clinical trials. The mostly reported unwanted side effects included fatigue, weak spot, nausea, insomnia, itching and different pores and skin reactions. The elevations occurred more frequently in females taking contraceptives containing ethinyl estradiol. Such contraceptives should be discontinued before these women take Technivie, the FDA advised. Hepatic laboratory testing should be performed during the first four weeks of starting treatment, and as clinically indicated thereafter.
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Paritaprevir is Enanta’s lead protease inhibitor identified within the ongoing Enanta-AbbVie collaboration and is one of the two direct-acting antivirals (2-DAA) in AbbVie’s TECHNIVIE.
