FDA Approves New Hepatitis C Treatment

The FDA approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adults.

Safety and efficacy of elbasvir and grazoprevir with or without ribavirin was evaluated in a clinical trial of 1373 patients with chronic hepatitis C virus (HCV) genotypes 1 and 4. The study aimed to measure whether the hepatitis C virus was detectable in blood 12 weeks after being treated daily with elbasvir and grazoprevir with or without ribavirin.

Overall sustained virologic response rates ranged from 94% to 97% in genotype 1-infected subjects and from 97% to 100% in genotype 4-infected subjects across trials for the approved treatment.

The most common side effects of elbasvir and grazoprevir without ribavirin were headache and nausea, while the most common side effects of elbasvir and grazoprevir with ribavirin were anemia and headache.

In about 1% of clinical trial participants, liver enzymes >5 times the upper limit of normal occurred. Prior to the start of therapy, liver-related blood tests should be performed, as well as at certain time throughout treatment. Elbasvir and grazoprevir should not be given to patients with moderate or severe liver impairment.

Zepatier is marketed by Merck & Co. Inc

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