Gilead nabs two new Harvoni approvals as hep C contest heats up

Gilead Sciences ($GILD) won two new uses for its hepatitis C blockbuster Harvoni, in patients who are in more advanced stages of liver disease. Though the populations are small, the FDA approvals could give the company's hep C franchise yet another boost as it competes with newcomers in the field.

Gilead CSO Norbert Bischofberger

Specifically, one approval applies to genotype 1 and 4 patients who've had liver transplants, except for those with the more serious variety of liver scarring, decompensated cirrhosis. The other, to genotype 1 patients with decompensated cirrhosis, with or without a transplant.

These are difficult-to-treat patients, as Gilead CSO Norbert Bischofberger said in a statement. "Hepatitis C-infected patients who have decompensated cirrhosis and those who have previously received a liver transplant have an urgent need for treatment, but historically their options have been limited," Bischofberger said.

They're also likely to be at the front of the line when it comes to payer reimbursements, even in state Medicaid programs that have tried to clamp down on hep C spending as much as possible. Some private and public payers continue to constrain their hep C spending even after new competition yielded big discounts.

Some analysts say the new approvals are also another edge for Harvoni compared with AbbVie's ($ABBV) newer Viekira Pak. Last year, the FDA slapped a warning on that med, cautioning against its use in patients with advanced liver disease.

Gilead has dominated the new age of hepatitis C treatment since its first drug in the field, Sovaldi, made its debut in 2014. The Harvoni combo followed, and between the two, they own the lion's share of the hep C market. The advent of AbbVie's Viekira Pak in late 2014 forced prices down, as both companies fought for exclusive reimbursement deals in exchange for discounts, but Gilead remains on top, even if growth has slowed.

But both players are facing new competition, from Merck & Co.'s ($MRK) brand-new Zepatier and Bristol-Myers Squibb's ($BMY) Daklinza. Some analysts see those meds as niche products, but Merck priced Zepatier quite a bit lower than other meds at $54,600 per year. Some payers see the Merck cocktail gaining strength as the company strikes new exclusive contracts for 2017.

- read the Gilead release

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