HCV Drug Receives Breakthrough Therapy Designation
AbbVie’s experimental drug can treat hepatitis C virus genotypes 1 through 6.
AbbVie recently announced that the FDA has granted their experimental hepatitis C virus drug Breakthrough Therapy Designation.
More availability of hepatitis C virus drugs will increase competition in the market, and could even save money by avoiding the associated healthcare costs.
The drug is an investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for patients with chronic hepatitis C virus (HCV) who failed previous treatment with direct-acting antivirals, according to AbbVie. The drug is a combination of an NS3/4A protease inhibitor (glecaprevir) and an NS5A inhibitor (pibrentasvir).
The medication is a once daily dose of 3 oral tablets. G/P is currently in clinical development, and results from a collaboration between AbbVie and Enanta Pharmaceuticals. G/P is used for HCV protease inhibitors and regimens that include the drugs.
The Breakthrough Therapy Designation is based on positive findings from the phase 2 MAGELLAN-1 clinical trial. The company previously announced the results of the study. In the first phase of the study, 50 patients with HCV genotype 1 without cirrhosis, who previously experienced treatment failure with direct-acting antivirals, were randomized to receive glecaprevir and pibrentasvir for 12 weeks, AbbVie reported.
The primary endpoint was a sustained virologic response by week 12. Researchers discovered that 91% of patients with HCV genotype 1 achieved the primary endpoint. In the second phase of the study, researchers investigated the drug without ribavirin in a larger group of patients, including patients with genotypes 4, 5, and 6, and those with cirrhosis.
Common adverse events included headache, fatigue, and nausea. No patients stopped treatment due to adverse events, according to AbbVie.
“AbbVie is committed to advancing HCV care and addressing areas of continued unmet need for people living with chronic HCV,” said Michael Severino, MD, executive vice president, research and development and chief scientific officer, AbbVie. “The FDA's Breakthrough Therapy Designation is an important step in our effort to bring our pan-genotypic regimen to market, which we are also investigating as an 8-week path to virologic cure for the majority of patients.”