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  • FDA approves new drug for treatment of chronic hepatitis C genotypes 1 and 4

    February 2, 2016

    The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

    The U.S. Food and Drug Administration approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients.

    The safety and efficacy of Zepatier with or without ribavirin was evaluated in clinical trials of 1,373 participants with chronic HCV genotype 1 or 4 infections with and without cirrhosis. The participants received Zepatier with or without ribavirin once daily for 12 or 16 weeks. 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 or SVR), suggesting a participant’s infection had been cured.

    The overall SVR rates ranged from 94-97 percent in genotype 1-infected subjects and from 97-100 percent in genotype 4-infected subjects across trials for the approved treatment regimens. In order to maximize SVR rates for patients, the product label provides recommendations regarding length of treatment with or without ribavirin specifically tailored to the characteristics of the patient and their virus. It is recommended that healthcare professionals screen genotype 1a-infected patients for certain viral genetic variations prior to starting treatment with Zepatier to determine dosage regimen and duration.

    The most common side effects of Zepatier without ribavirin were fatigue, headache and nausea. The most common side effects of Zepatier with ribavirin were anemia and headache.

    Zepatier carries a warning alerting patients and health care providers that elevations of liver enzymes to greater than five times the upper limit of normal occurred in approximately 1 percent of clinical trial participants, generally at or after treatment week eight. Liver-related blood tests should be performed prior to starting therapy and at certain times during treatment. Zepatier should not be given to patients with moderate or severe liver impairment.

    For more information, please visit: Zepatier.
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