FDA Approves New Single-Pill Regimen for Hepatitis C Genotypes 1 and 4
The FDA has approved elbasvir/grazoprevir (Zepatier) to treat adults with chronic hepatitis C virus (HCV) genotypes 1 and 4 infection. The oral therapy can be used with or without ribavirin and in patients with chronic kidney disease.
The combination of elbasvir (an NS5A inhibitor) and grazoprevir (an NS3/4a protease inhibitor) was approved after clinical trials of roughly 1400 patients. After 12 or 16 weeks' treatment, sustained virologic response was observed in 94–97% of patients with genotype 1 infection and 97–100% of patients with genotype 4 infection. Clinicians should screen patients with genotype 1a infections for certain NS5A polymorphisms before initiating treatment to establish proper dosage and duration.
Roughly 1% of patients experienced liver enzyme elevations — above five times the upper limit of normal — beginning in the eighth week of treatment. The agency recommends conducting liver-related blood tests before and periodically during treatment. Patients with moderate to severe liver impairment should not be prescribed the pill.
In HIV and ID Observations, physician-blogger Paul Sax explains potential reasons why the list price for 12 weeks of elbasvir/grazoprevir is substantially lower than the other approved single pill option, ledipasvir/sofosbuvir ($54,000 vs. $94,000). Click the link below to see more.
Attribution: Physician's First Watch, Kelly Young.