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.
Read more... Labels: Abbvie, Canada, GT1, HOLKIRA PAK