AbbVie ($ABBV) is heralding positive new data on its hepatitis C cocktail, touting the treatment's benefit in some tough-to-treat patients as it prepares for a head-to-head competition with market leader Gilead Sciences ($GILD).
In a Phase II study on liver transplant patients with the difficult genotype 1 variety of hep C, AbbVie's three-drug combination cured 97.1% of participants in 12 weeks, the company said. In a separate mid-stage study, AbbVie's cocktail notched a 12-week cure rate of 93.5% in genotype 1 patients who also have HIV, a population the company said is particularly resistant to antiviral therapy.
The studies, presented at the American Association for the Study of Liver Diseases conference in Boston, are part of AbbVie's plan to contend with Gilead on the fledgling market for injection-free hep C treatments. Gilead won FDA approval last month for Harvoni, an all-oral combination of the blockbuster Sovaldi with the NS5A inhibitor ledipasvir, while AbbVie expects final word from the agency on its similar combination by year's end.
Analysts expect Gilead's pill to bring in about $10 billion a year, but AbbVie, depending on how well it makes its case to payers and providers, could stand in the way. The company is drilling down on hep C subpopulations in hopes of differentiating itself from Gilead's standard-bearer, but it remains to be seen whether AbbVie will try to compete on price with Harvoni, which carries a sticker price of $94,500 for a 12-week regimen.
AbbVie's candidate is a fixed-dose combination of three antiviral agents: ombitasvir, dasabuvir, and ABT-450/ritonavir, which was developed alongside partner Enanta Pharmaceuticals ($ENTA). And while the cocktail's overlapping mechanisms of action are exactly what disrupt hep C's replication process, the drug requires patients to handle multiple pills each day, possibly putting it at a disadvantage on the market.
Meanwhile, the next phase of the hep C arms race is focused less on pan-genotypic efficacy and more on speed, as drug developers set sights on 8- and even four-week cures.
Achillion's ($ACHN) shares popped this week after the biotech disclosed Phase II results in which a combination of its ACH-3102 and Sovaldi notched a 100% cure rate on an 8-week regimen. Gilead is studying Sovaldi alongside a new NS5A inhibitor called GS-5816, reporting Phase II results in which the combo cured 96% of patients in 8 weeks.
- read more on AbbVie's trials