April 24, 2015 / 5:01 AM / 4 years ago

Merck oral hepatitis C regimen shows 95 pct cure rate

April 24 (Reuters) - Merck and Co Inc presented trial results on Friday showing that a once-daily combination of two experimental pills cured 95 percent of previously untreated hepatitis C patients after 12 weeks.

The trial included patients infected with the most common form of the liver-destroying virus, genotype 1, along with less common genotypes 4 and 6. It also involved patients with and without liver cirrhosis.

Cure rates, defined as sustained virologic response 12 weeks after treatment, were 92 percent for patients with genotype 1a; 99 percent for genotype 1b; 100 percent for genotype 4; and 80 percent for genotype 6. Cures were achieved in 97 percent of cirrhotic patients and 94 percent of non-cirrhotic patients.

Gilead Sciences Inc’s Harvoni, currently the only hepatitis C drug that does not need to be taken with antiviral pill ribavirin, is approved only for genotype 1 patients, which account for about 70 percent of U.S. infections.

“We have a really high efficacy regimen in a single tablet without ribavirin,” said Eliav Barr, Merck’s vice president, infectious diseases. “Current data that have been out there have really focused on a standard population for HCV.”

Merck said it still aims to submit an application for the grazoprevir/elbasvir regimen to the U.S. Food and Drug Administration in the first half of this year. The agency has granted Merck “breakthrough therapy” designation for the treatment in genotype 1 HCV patients with end stage renal disease who are on hemodialysis and for genotype 4 HCV patients.

Results from the 412-patient trial were presented at a meeting of the European Association for the Study of the Liver in Vienna and published in Annals of Internal Medicine.

Gilead secured an early lead in the lucrative market for oral hepatitis C drugs - first with Sovaldi, and now Harvoni, which has a list price of $94,500 for 12 weeks. AbbVie Inc entered the market last year with a multi-pill regimen. Nevertheless, AbbVie secured exclusive contracts with payers such as pharmacy benefit manager Express Scripts Holding Co , forcing Gilead to discount its own contract prices.

Hepatitis C infects an estimated 3.2 million Americans.

“HCV is a huge population. There is going to be a need for a lot of players here to make sure we eliminate the disease,” Barr said. “We will have a really strong offering for patients, payers, and physicians.”

Reporting By Deena Beasley

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