Hepatitis C Therapy Candidate Granted Priority Review from Health Canada

Hepatitis C Therapy Candidate Granted Priority Review from Health Canada

A potential new drug being developed for the treatment of chronic hepatitis C received priority review from Health Canada. This means the compound may be reviewed in advance of non-priority submissions, and if approved, may become available to patients faster.

The compound called glecaprevir/pibrentasvir, or G/P, which is being developed by the pharmaceutical company AbbVie, targets all major types of hepatitis C viruses (HCV, genotypes 1 to 6). If approved, it could provide a shorter treatment time for many patients with hepatitis C, including those without cirrhosis (who make up a large portion of HCV patients in Canada) and those with compensated cirrhosis.

The potential drug could also meet the medical needs of patients with specific treatment challenges, such as those with severe chronic kidney disease (CKD) and those not cured with previous direct-acting antiviral treatments. 

“HCV patients with severe chronic kidney disease present a complex challenge for physicians to treat. This is particularly true in those with genotype 2 and 3 infection, and those with cirrhosis,” Dr. Curtis Cooper, director of the Regional Hepatitis Program at Ottawa Hospital, said in a press release. “Recent clinical trial results are a positive development in AbbVie’s investigation of the G/P regimen for patients with chronic kidney disease, who currently have limited HCV treatment options.”

Stéphane Lassignardie, general manager at AbbVie Canada, said this is the first time in history the goal of eliminating hepatitis C in Canada has been within reach.

“We are firmly committed to seeing this goal accomplished. As such, we have invested significantly in recent years in clinical trials in Canada for our investigational, pan-genotypic G/P regimen and will continue collaborating with Health Canada to help provide a cure for as many Canadians as possible living with HCV,” Lassignardie said.

The company has also applied to U.S. and European regulators, who are currently assessing the drug candidate.

Although the safety and effectiveness of G/P have not yet been fully established, the drug has been investigated in eight studies in 27 countries and on more than 2,300 patients. The studies were conducted on patients who were infected with all major types of HCV, and also included special patient populations, such as those with compensated cirrhosis, CKD, and those not cured with a prior direct-acting antiviral treatment.

The investigational G/P drug combines two different antiviral agents: glecaprevir (300 mg), which blocks the activity of certain viral enzymes, and pibrentasvir (120 mg), an agent that blocks NS5A, a protein that plays a crucial role in HCV replication. The drug is designed to be taken as three oral tablets once a day.

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Özge has a MSc. in Molecular Genetics from the University of Leicester and a PhD in Developmental Biology from Queen Mary University of London. She worked as a Post-doctoral Research Associate at the University of Leicester for six years in the field of Behavioural Neurology before moving into science communication. She worked as the Research Communication Officer at a London based charity for almost two years.

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