The U.S. Food and Drug Administration (FDA) recently announced it has granted an amended Breakthrough Therapy Designation for an investigational combination of promising drugs to treat hepatitis C virus (HCV) patients with advanced cirrhosis as well as those who had a liver transplant but have had a viral relapse.
The announcement comes after researchers from The University of Texas Health Science Center (UT Health Science Center) at San Antonio, presented the results of the ALLY-1 clinical trial at the 2015 International Liver Congress in April, part of the annual meeting of the European Association for the Study of the Liver. The designation will allow for expedited drug development and further review by the FDA based on these early clinical trial results.
The ALLY-1 clinical trial was a Phase III study that evaluated a 12-week oral regimen of daclatasvir and sofosbuvir in patients with the genotype 1 strain of HCV. This strain of HCV is the most difficult to treat as well as the most common strain occurring in the US.
The results showed that after the 12-week drug regimen:
- There was an overall cure rate of 94 percent for patients with a liver transplant and returning hepatitis C.
- There was an overall cure rate of 83 percent for patients with advanced cirrhosis.
- 95 percent of post-transplant genotype 1 patients were considered cured 12 weeks after treatment.
- 82 percent of genotype 1 patients with advanced cirrhosis were considered cured 12 weeks after treatment.
In a University press release about the announcement, Dr. Fred Poordad, MD, professor of medicine, UT Health Science Center, vice president of academic and clinical affairs, Texas Liver Institute, and senior study author, stated, “I have been researching cures for hepatitis C for 20 years–We have had a lot of success recently with new oral medications for various groups of patients, but it’s exciting to see a cure in sight for patients who have the bleakest outlook. We are refining treatments for different groups and I would say that in the next few years we should be able to treat most genotypes very successfully. This is a very promising time for hepatitis C patients.”
Dr. Poordad’s optimism was shared by his colleague, Dr. Douglas Manion, MD, head of specialty development at Bristol-Myers Squibb, which sponsored the clinical trial, “Our daclatasvir clinical development program focuses on addressing high unmet medical needs still encountered in the treatment of hepatitis C despite the advent of new therapies. This designation recognizes the importance of developing a new treatment option for post-liver transplant and cirrhotic patients who are among the most challenging patient populations to treat with currently available regimens.”