Hep C Drug Approved for Genotypes 1 and 4

The US Food and Drug Administration (FDA) has approved a combination of elbasvir and grazoprevir (Zepatier/Merck) for treatment of adults with chronic hepatitis C infection, the drug company reported today. The combo works for HCV genotypes 1 and 4.

The drug will cost $54,600 for a 12-week regimen, about two-thirds the cost of sofosbuvir (Sovaldi/Gilead).

It can be given with or without ribavirin. It is a once-daily, fixed dose tablet containing the NS5A inhibitor elbasvir and the NS3/4A protease inhibitor grazoprevir.

The FDA approved the drug under "breakthrough therapy" designations.

In trials therapy goals of sustained virologic response ranged from 90% to 97% in HCV patients with GT1 infections and 97% to 100% in those with GT4 infections at 12 weeks after treatment was stopped.

It is not for use in patients with moderate of severe liver impairment, that is, those rated as having a Child-Pugh score of B or C.

It is also not for use with organic anion transporting polypedtides.

Treatment lass for a duration of 12 or 16 weeks, depending on HC genotype, patient history and other factors.

The drug trials leading to approval included six studies in 1,373 patients with chronic HCV GT1 and GT4.

Those include patients with compensated cirrhosis and HIV-1 co-infection, and GT1 patients with several kidney disesase.