FDA OKs Zepatier (Elbasvir/Grazoprevir) for Hepatitis C


January 28, 2016

The US Food and Drug Administration (FDA) today approved the combination drug elbasvir/grazoprevir (Zepatier, Merck) for chronic hepatitis C virus (HCV) genotypes 1 and 4 infections, another cure that does not require concomitant use of interferon with all its harsh adverse events, the agency announced.

Elbasvir/grazoprevir is indicated with or without ribavirin for adults with either genotype of HCV. Genotype 1 is the most common, while genotype 4 is one of the least common.

The new drug now will compete head to head with two other combination treatments for HCV genotype 1 that dispense with interferon — ledipasvir plus sofosbuvir (Harvoni, Gilead Sciences), and ombitasvir, paritaprevir, ritonavir, plus dasabuvir (Viekira Pak, AbbVie).

In clinical trials that established the new drug's safety and efficacy, the virus was no longer detected in the blood 12 weeks after the end of treatment in 94% to 97% of patients infected with genotype 1. This sustained virologic response (SVR) was 97% to 100% in patients with genotype 4. SVR is considered a proxy for cure rate. The participants, some of whom had cirrhosis, received elbasvir/grazoprevir once a day with or without ribavirin for 12 to 16 weeks.

Fatigue, headache, and nausea were the most common adverse events reported for patients taking the new drug without ribavirin. For those on ribavirin, the most common adverse events were anemia and headache.

The label for elbasvir/grazoprevir warns that in 1% of clinical trial participants, liver enzymes exceeded five times the upper limit of normal, generally at or after 8 weeks of treatment. Accordingly, clinicians should conduct liver-related blood tests prior to starting therapy, and afterward as well. The drug is contraindicated for patients with moderate or severe liver impairment.

More information on today's announcement is available on the FDA website.


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