April 24, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Merck & Co., Inc. , announced yesterday the first data from the company’s Phase II/III clinical trial dubbed C-SURFER for a once-daily treatment for patients with advanced chronic kidney disease (CKD) that are also infected with chronic hepatitis C virus (HCV) genotype 1 (GT1).
The C-SURFER trial demonstrated that a 12-week regimen of NS3/4A protease inhibitor grazoprevir and NS5A replication complex inhibitor elbasvir had essentially a clinical cure in 99 percent of patients. This is very promising news for Merck, who will be entering a market currently dominated by Gilead Sciences, Inc. ’s Sovaldi and Harvoni and AbbVie ’s Viekira Pak.
Despite Gilead and AbbVie’s lead, as well as their ongoing price war for HCV treatment, Thomson Reuters analysts predict that if Merck could get their drug onto the market early next year the company could hit sales of more than $2 billion by 2019.
“There is an unmet medical need to treat chronic hepatitis C virus infection in patients with advanced chronic kidney disease,” said Howard Monsour, Jr., chief of hepatology at the Houston Methodist Hospital, in a statement. “In this trial, the first to investigate an all-oral ribavirin-free treatment regimen in treatment-naïve and treatment-experienced CKD patients, treatment with grazoprevir and elbasvir for 12 weeks was effective in this study population with HCV genotype 1 infection.”
Earlier this month, the U.S. Food and Drug Administration (FDA) granted Merck Breakthrough Therapy designation for grazoprevir/elbasvir to treat patients infected with chronic HCV GT1 with end-stage renal disease on hemodialysis and patients that were infected with chronic HCV GT4.
“HCV remains a global public health epidemic,” said Eliav Barr, vice president, infectious diseases at Merck Research Laboratories in a statement. “At Merck, we are focused on the development of an efficacious, well-tolerated, once-daily therapy that can be used to treat multiple genotypes and a diverse population of chronic HCV patients.”
This announcement closely follows Gilead’s news yesterday that it will be giving away for free hepatitis C drugs in the country of Georgia. Gilead will be giving away 5,000 doses of its HCV drugs, Solvaldi and Harvoni, to 7 percent of the adults with HCV in Georgia this year. It expects plans to expand a Phase II program to reach 20,000 patients yearly
Sovaldi treatment runs around $84,000, or about $1,000 per pill. Harvoni’s 12-week treatment regimen runs around $94,500. AbbVie’s Viekira Pak costs about $83,310 for a 12-week course of treatment.
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