Viekira Pak received approval from the US Food and Drug Administration (FDA) for the treatment of adult patients with genotype 1 chronic hepatitis C virus infection late last month, becoming the fourth oral hepatitis C compound available on the market within thirteen months.
Gilead’s Sovaldi (sofosbuvir) is a nucleotide analog that inhibits the polymerase enzyme that the hepatitis C virus uses to replicate its RNA.
Harvoni – which was approved in October – is a combination of sofosbuvir and the inhibitor drug ledipasvir.
In contrast, AbbVie’s offering contains three active pharmaceutical ingredients (API) with distinct mechanisms: an NS5A inhibitor, ombitasvir; NS3/4A protease inhibitor, paritaprevir; and non-nucleoside NS5B polymerase inhibitor, ritonavir, which work together to inhibit the virus from reproducing by attacking the virus at three separate stages of the disease lifecycle.
Another difference between Abbvie's product and Gilead's drugs is cost
While there is now a plethora of options for a patient with HCV, Gilead has been hit by criticism regarding its $84,000 pricetag for a 12-week course of Sovaldi – equating to $1,000 a pill – with Harvoni costing even more, and AbbVie’s initial pricing was in a similar vein.
However, a deal struck days after approval will see Viekira Pak be the exclusive option with US payer Express Scripts for patients with Genotype 1 Hepatitis C, with Sovaldi, Harvoni and J&J’s Olysio – approved in November 2013 to treat HCV in combination with peginterferon-alfa and ribavirin – being excluded from Express Scripts’ National Preferred Formulary.
According to ISI analyst Mark Schoenebaum, the advent of private payers along with a number of “basically interchangeable” drugs in an “intensively competitive” sector could put the pricing of such drugs at risk.
However, he told this publication AbbVie did not offer an outsized discount (more than 30%) to gain access with Express Scripts and the deal would only have a “modest” impact on Gilead’s US business.