There’s a new option in the treatment of hepatitis C, with the U.S. Food and Drug Administration (FDA) approving Merck’s Zepatier™ (elbasvir and grazoprevir) just a few days ago on January 28, 2016. This medication’s entry to the treatment field came on an accelerated track with the FDA granting it a breakthrough therapy designation last year, based in part on Zepatier’s strong results at the Phase 2 and Phase 3 clinical trial level, curing 95% of some patient sub-groups.
This news brings an additional therapy choice for two hepatitis C genotypes: genotype 1, which is the most common form of hepatitis C, and genotype 4, which is the least common type in the U.S. For both groups of patients, Zepatier is used as a once-daily pill for 12 weeks (or 16 weeks in some situations). This medication has shown success in studies including patients with failed prior treatment and those with cirrhosis. Zepatier is also appropriate for those with chronic kidney disease.
Zepatier will include a label warning that liver enzyme elevations (of five times normal) can occur with a 1% incidence; for this reason the FDA recommends liver enzyme tests before embarking on treatment, as well as periodically during treatment. The FDA also recommends, but does not require, that patients with genotype 1a of the hepatitis C virus (HCV) be tested for resistance-associated variants (RAVs) of the virus since clinical trials showed such patients to have lower response rates.
BioPlus keeps prescribers up-to-date with all the ongoing additions and changes to hepatitis C treatment with an app called HCV Treatment Path. For example, in our latest version of the app, we ask prescribers if NS5A polymorphisms are present. In some situations this could extend the treatment to 16 weeks for Zepatier, which serves as an example of how this app keeps prescribers current as they plan for individualized treatment of their patients to aim for the best possible outcomes.
Stephen C. Vogt, Pharm.D.
President and CEO
BioPlus Specialty Pharmacy
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