Wednesday, October 21, 2015

AbbVie's HOLKIRA PAK Now Reimbursed in all Four Atlantic Provinces

AbbVie's HOLKIRA PAK Now Reimbursed in all Four Atlantic Provinces

HOLKIRA PAK now reimbursed in Nova Scotia, New Brunswick and Newfoundland and Labrador for patients with genotype 1 hepatitis C virus infection

Prince Edward Island was the first province in Canada to reimburse HOLKIRA PAK

In Phase 3 clinical trials, HOLKIRA PAK (with or without ribavirin) cured an overall 97 percent of genotype 1 HCV patients; additionally, 98 percent of patients completed treatment

MONTREAL, Oct. 21, 2015 /CNW/ - AbbVie's HOLKIRA PAK (ombitasvir/paritaprevir/ritonavir film-coated tablets; dasabuvir film-coated tablets) will now be reimbursed in Nova Scotia, New Brunswick and Newfoundland and Labrador. HOLKIRA PAK is 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 compensated cirrhosis.

"With the hepatitis C treatment revolution over the last few years, there is an amazing shift in how we approach our patients. We can now offer them options and hope," explains Dr. Lisa Barrett, Clinician Scientist, Division of Infectious Diseases, Nova Scotia Health Authority and Dalhousie Medical School. "Now, we want to eliminate HCV by treating and curing everyone, in order to prevent the devastating long-term effects the disease has on the liver. I am excited that providers have another tool to treat hepatitis C. In the long-term, this benefits not only people living with this disease, but also our health care system as a whole."

In the Atlantic Provinces, HOLKIRA PAK will be reimbursed for treatment-naïve and treatment-experienced adult patients with chronic hepatitis C genotype 1 infection, with compensated liver disease, (including compensated cirrhosis) according to specific criteria. Prince Edward Island's HCV strategy, including access to HOLKIRA PAK, was announced on February 121. HOLKIRA PAK was listed on theNewfoundland and Labrador Prescription Drug Program2, effective August 1. The listing by Nova Scotia Pharmacare3 was announced on August 13 but became effective on Tuesday, September 1.

"It is wonderful to see the new hepatitis C treatments, such as HOLKIRA PAK, become available in Nova Scotia. This treatment, that has an extremely high cure rate, manageable side effects, and short treatment course, offers hope to many Nova Scotians who have been living with hepatitis for years as well as those who are newly diagnosed. This is what we have been waiting for; it's a life saver," says Carla Densmore MS, executive director, Hepatitis Outreach Society of Nova Scotia.

In New Brunswick4, the listing on the Drug Plans Formulary became effective onOctober 14. "It is a truly exciting time to have well tolerated and curative treatments for a disease that is a leading cause of liver failure and liver cancer in New Brunswick. With these drugs New Brunswick physicians are dramatically improving models of care for patients living with this disease," states Dr. Daniel Smyth, assistant professor, Dalhousie University, Division of Infectious Diseases. "Research programs initiated in New Brunswick will show that using these drugs correctly saves money in the long term by preventing new infections and preventing costly complications of untreated disease. I recommend that all persons born between the years 1945 and 1975 be screened for hepatitis C infection, as well as others who may have been exposed through high risk activities including injecting drugs and self-tattooing. Please ask your family physician about hepatitis C testing, and referral if needed."

HOLKIRA PAK combines 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.

"Since the launch of HOLKIRA PAK in December 2014, we committed to a collaborative approach with governments, medical and patient organizations to bring our best-in-class treatment to Canadians living with genotype 1 hepatitis C. Today, we are proud to say that we made good on our promise because HOLKIRA PAK is now reimbursed across Canada," says Stéphane Lassignardie, general manager, AbbVie Canada. "And with HOLKIRA PAK, AbbVie is offering its support program AbbVie Care, designed to provide a wide range of customized services throughout the treatment and beyond."

HOLKIRA PAK was approved by Health Canada on December 22, 2014. The approval of HOLKIRA PAK was 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 with more than 2,300 patients across 25 countries, including one trial exclusively in subjects with cirrhosis.

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