Cure in sight for Hep C patients
The outlook for the sickest hepatitis C patients—those with advanced cirrhosis or those who have had a liver transplant but the virus has returned—has historically been bleak.
But researchers say that could change now that the U.S. Food and Drug Administration has cleared the way for expedited drug development and review of an investigational combination of drugs that shows promise for healing these patients.
The FDA has granted amended Breakthrough Therapy Designation for an oral regimen of daclatasvir and sofosbuvir taken with ribavirin for the treatment of patients with the genotype 1 strain of hepatitis C.
The decision was based on early results of the ALLY-1 clinical trial.
Fred Poordad, M.D., the principal investigator of the study, has 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,” said Dr. Poordad, clinical professor of medicine at the Health Science Center and vice president of academic and clinical affairs at the Texas Liver Institute. “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.”
The Phase III study evaluated a 12-week oral regimen of daclatasvir and sofosbuvir taken once a day with ribavirin. Results showed an overall cure rate of 94 percent for patients with a liver transplant and returning hepatitis C, and 83 percent for patients with advanced cirrhosis. The study’s primary endpoints also were reached, with 95 percent of post-transplant genotype 1 patients and 82 percent of genotype 1 patents with advanced cirrhosis being cured 12 weeks after treatment.
Earlier this year, the FDA had planned to withdraw the Breakthrough Therapy Designation for the regimen because of the availability of other medicines that were more successful for other genotypes. But based on the early data from the ALLY-1 trial, the FDA amended its original decision and opted to continue expedited development of this treatment for the subgroup of patients studied in ALLY-1.
The FDA is continuing its new drug application review of the daclatasvir-sofosbuvir regimen for the treatment of genotype 3 hepatitis C.