- Earlier this year, the FDA granted Merck breakthrough status for its combined grazoprevir/elbasvir combination medication for treatment of hepattis C (HCV). Merck is also targeting patients with severe kidney impairment or those with severe renal insufficiency. Despite numerous advances in treatment of hepatitis C, there remains a lack of treatment options for patients with HCV and chronic kidney disease (CKD).
- Merck is seeking approval for treatment of HCV genotypes 1, 4, and 6. It would also like to target patients with severe kidney impairment or those with severe renal insufficiency.
- Results from a phase 3 trial, which were published in the Lancet, showed that treatment with grazoprevir/elbasvir resulted in sustained virologic response in 99% of patients twelve weeks (SVR12) after treatment was completed. Results included difficult-to-treat populations.
Although Merck will most likely be third to market with its next-generation HCV drug, following Gilead and AbbVie, it's aiming to democratize treatment options even further.
Merck's clinical trial program for its grazoprevir/elbagavir submission is extensive. During the recent International Liver Congress in April 2015, there were 14 individual abstracts highlighting the data from these trials. One of these abstracts has been published in the latest issue of the Lancet and highlights the use of Merck's combo in traditionally difficult-to-treat patient populations, including African-Americans, patients with chronic kidney disease (CKD) and others.
CKD is particularly challenging in patients with HCV. In fact, CKD is both a cause of HCV, as well as a complication, which makes achieving a strong SVR12 difficult in these patients. A 99% SVR12 rate in thse patients is a major accomplishment and greatly enhances Merck's application. Although the market may seem crowded, HCV patients are diverse with a broad set of anti-virologic needs. Merck's goal is to position grazoprevir/elbagavir to address some of these needs.
A regulatory decision is expected in January 2016.