Merck ($MRK), angling to compete with dominant hepatitis C treatments from Gilead Sciences ($GILD) and AbbVie ($ABBV), posted positive results for its in-development combos as it works to demonstrate their ability to cure more patients faster.
The company's one-pill combination of elbasvir and grazoprevir, up for FDA approval by Jan. 28, cured 95% of patients in a Phase III trial on hep C sufferers who inject illegal drugs or otherwise take opiates, Merck said. The positive data add to Phase III results in which the two-drug cocktail charted similar 12-week cure rates in patients with hep C genotypes 1, 4 and 6 who were previously treated, treatment-naive or had cirrhosis, the company said.
Behind elbasvir and grazoprevir, Merck is at work on three-drug combos that promise to eradicate hep C infection even faster. In Phase II results disclosed this week, a mixture of grazoprevir, the investigational MK-3682 and an upgraded version of elbasvir called MK-8408 charted 8-week cure rates of at least 91% in patients with hep C types 1, 2 and 3.
The open-label study mixed and matched Merck's in-development therapies in search of a winning combination, and the company believes it has just that in grazoprevir/MK-3682/MK-8408. Now Merck is embarking on a second stage of the Phase II study, testing the three-drug combination in a variety of hep C types to see if it can replicate its 8-week efficacy.
As for the elbasvir-grazoprevir combo, the latest results in intravenous drug users could eventually alter the hep C treatment landscape. As Bloomberg notes, many states require patients to pass drug tests before clearing them for costly hep C therapy. But Merck's latest data could force Medicaid programs to change their policies, ending a practice health advocates have said is discriminatory.
Meanwhile, Gilead and its top-selling Harvoni are in pole position in hep C, trailed by AbbVie and its competing Viekira Pak. Each is working to widen the indications for its combo therapy to include more viral genotypes while developing next-generation combinations that can quicken the cure process.
Merck, now making its way to the market, is hoping to play spoiler in what has been a two-horse race since last year, at the same time running studies on early-stage assets that might someday star in future combination therapies.
- read the elbasvir/grazoprevir statement
- get more on grazoprevir/MK-3682/MK-8408
- read the Bloomberg story on intravenous drug use