Canada: Abbvie’s HOLKIRA PAK for chronic genotype 1 Hepatitis C treatment receives Health Canada approval

AbbVie receives Health Canada approval for HOLKIRA PAK (ombitasvir/paritaprevir/ritonavir film-coated tablets; dasabuvir film-coated tablets), an all-oral, short-course (12 weeks for the majority of patients), interferon-free treatment, with or without ribavirin (RBV), for the treatment of patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with cirrhosis. The approval of HOLKIRA PAK is supported by a robust clinical development program that was designed to study the safety and efficacy of the regimen in six pivotal Phase 3 studies, including one trial exclusively in subjects with cirrhosis, with more than 2,300 patients across 25 countries.

"Hepatitis C is a devastating disease that causes more years of life lost than any infectious disease in the country. With the introduction of life-saving therapies that offer high cure rates, we can finally prevent complications of the disease and it actually raises the possibility that we even eliminate the disease from Canada altogether," said Dr. Jordan Feld, a hepatologist at the Francis Family Liver Clinic at Toronto Western Hospital, part of the University Health Network. "As physicians, we are thrilled to have an alternative to interferon. In just 12 to 24 weeks of pills with few or no side effects, we are able to cure people who have been living with this disease for decades. This is history in the making."

According to the Public Health Agency of Canada, an estimated 242,500 Canadians are living with hepatitis C. A significant number of the estimated cases in Canada remain undiagnosed, although the exact proportion is unclear. There are six different genotypes of hepatitis C; two-thirds of Canadians living with hepatitis C have genotype 1 – either subtype 1a or 1b – which are the most difficult to cure.


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