(USA) FDA Grants Breakthrough Therapy Designation

A treatment combination which may be possible if the government approves the PBAC recommendations from March has recently been granted Breakthrough Therapy Status in the United States of America.

Source: hepatitisnewstoday.com - 26 May 2015

The daclatasvir-sofosbuvir regimen for the treatment of genotype 1 hepatitis C patients was granted amended Breakthrough Therapy Designation by U.S. Food and Drug Administration (FDA). In the beginning of 2015, the FDA had planned to remove Breakthrough-Therapy Designation for the daclatasvir-sofosbuvir treatment since other therapies were available and had higher success for other genotypes. However, the FDA revised its first decision and decided to continue the development of this therapy for the genotype 1 hepatitis C patients addressed in ALLY-1 Trial due to its promising results.

Genotypes are strains of a disease, such as hepatitis C. There are many subtypes of the hepatitis C virus according to geographic regions where the strain is most predominant. With time, each strain develops differently so that therapies are chosen dependent on the genotype of the disease. In the United States, Genotype 1 is the most frequent hepatitis C strain and most difficult to treat.

The Phase III Daclatasvir, Sofosbuvir, and Ribavirin in Cirrhotic Subjects and Subjects Post-liver Transplant (ALLY 1) was a study involving 12-week oral treatment of daclatasvir and sofosbuvir once a day with ribavirin for the therapy of patients with the genotype 1 strain of hepatitis C. In this study, the enrolled individuals either had advanced cirrhosis (scarring of the liver) or have had a liver transplant but hepatitis C has reappeared. The study findings demonstrated 94% and 83% of cure, respectively, for patients with a liver transplant and returning hepatitis C, and patients with advanced cirrhosis.

Dr. Fred Poordad, from The University of Texas Health Science Center at San Antonio and principal investigator of the study, presented the findings of the ALLY-1 clinical trial at The International Liver CongressTM 2015 last April.

“I have been researching cures for hepatitis C for 20 years,” said Dr. Poordad in the news release.

“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. He added that they are improving therapies and in the near future there will be new drugs able to treat with high success most genotypes.

Dr. Poordad highlighted that researchers are in a very promising period for hepatitis C patients.

Dr. Douglas Manion, head of specialty development at Bristol-Myers Squibb, which financially supported the clinical trial, said, “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.

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