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.
HOLKIRA PAK is the only hepatitis C treatment to combine three direct-acting antivirals to attack the virus at three separate stages of its replication process. In Phase 3 clinical trials, HOLKIRA PAK (with or without ribavirin) cured an overall 97 percent of GT1 HCV patients, and 98 percent of patients completed treatment. In Phase 2 and 3 clinical trials, the overall rates of discontinuation due to adverse reactions were low (0.2 percent).
"When I was first diagnosed with hepatitis C, I was hopeless and afraid because I didn't know what the future held for me, but AbbVie gave me hope," says Stéphanie Léger who was diagnosed with hepatitis C in 2010. "I am grateful to have been given the opportunity to participate in AbbVie's clinical trial. Today, now that I am cured, I can live my life to the fullest."
The recommended treatment regimens and durations for HOLKIRA PAK are:
"HOLKIRA PAK's approval underlines AbbVie's ongoing commitment to providing solutions for unmet medical needs and to solving some of today's most complex health challenges," said Stéphane Lassignardie, General Manager, AbbVie Canada. "By delivering high cure rates, our all-oral, interferon-free regimen provides adults living with genotype 1 chronic hepatitis C with a breakthrough solution."
Canadians prescribed HOLKIRA PAK will have the opportunity to be enrolled in AbbVie Care, AbbVie's signature care program designed to provide a wide range of services including reimbursement assistance, education and ongoing disease management support. AbbVie Care will support health care professionals and people living with genotype 1 hepatitis C throughout their treatment journey to achieve high cure rates in the real world.
AbbVie's chronic HCV treatment known as VIEKIRA PAK™ in the United States was approved by the Food and Drug Administration (FDA) on December 19. On November 21, the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted positive opinions for AbbVie's VIEKIRAX + EXVIERA. The European Commission will review the opinions and make a final decision sometime in the first quarter of 2015.