April 8, 2015
By Krystle Vermes, BioSpace.com Breaking News Staff
Merck & Co. , the global healthcare company known as MSD outside of the U.S., announced on April 8 that the U.S. Food and Drug Administration (FDA) had granted two Breakthrough Therapy designations for grazoprevir/elbasvir for the treatment of chronic HCV genotype 1 (GT1).
In October 2013, the FDA granted Breakthrough Therapy designation for grazoprevir/elbasvir for the treatment of chronic HCV genotype 1 (GT1). However, it told Merck that it would be rescinding its designation in January 2015. This recent news indicates a change in position for the FDA.
The single tablet regimen has been designated for the treatment of chronic HCV genotype 4 (GT4) infection, as well as chronic HCV genotype 1 (GT1) infection in patients with end stage renal disease on hemodialysis.
“HCV remains a global public health epidemic,” said Eliav Barr, vice president of infectious diseases at Merck Research Laboratories. “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.”
Advancements in Hepatitis C Treatment
Merck is not the only company that has made strides in hepatitis C treatment as of late. Bristol-Myers Squibb Company announced on March 12 that it had resubmitted its New Drug Application for daclatasvir to the FDA. This drug is designed to be used in combination with sofosbuvir for the treatment of chronic hepatitis C genotype 3.
In October 2014, Gilead Sciences, Inc. revealed that the FDA had approved Harvoni, a combination treatment consisting of ledipasvir and sofosbuvir, for the treatment of chronic hepatitis C genotype 1.
However, these hepatitis C treatments are not always economical for patients. A study recently led by the Boston Medical Center found that the drugs may be effective, but they are only financially suitable for specific groups of HCV-infected patients.
Researchers compiled their data after focusing on the combination of sofosbuvir and ribavirin for treatment of HCV genotypes 2 and 3. While the treatment cured more than 90 percent of patients, the wholesale cost of sofosbuvir was $85,000 per treatment course.
“These new oral treatments provide better clinical results with fewer side effects for all patients, but at the current price, are only good value for those who need treatment the most - patients with advanced liver disease or those who failed prior therapy,” said Benjamin Linas, a lead author of the study.
Patients without liver disease who have never been treated for HCV could spend $100,000 on therapies for each quality-adjusted life year gained.
BioSpace Temperature Poll
After last week’s news that Gilead had issued a health advisory to doctors, concern is growing after nine patients taking Harvoni or Sovaldi along with another drug, amiodarone, were treated for abnormally slow heartbeats. One of the patients died of cardiac arrest. Three of the nine patients required a pacemaker. That has BioSpace asking, what next?
