Tuesday, May 24, 2016

Health Canada Approves DAKLINZA™ (daclatasvir) for Difficult-to-Treat Hepatitis C Patient Populations

Health Canada Approves DAKLINZA™ (daclatasvir) for Difficult-to-Treat Hepatitis C Patient Populations

SOURCE Bristol-Myers Squibb Canada

DAKLINZA™ is approved in Canada in combination with other agents for the treatment of chronic hepatitis C Patients with HIV co-infection, advanced cirrhosis and post-liver transplant HCV recurrence

MONTREAL, May 24, 2016 /CNW/ - Bristol-Myers Squibb Canada today announced Health Canada's approval of DAKLINZA™ (daclatasvir), in combination with sofosbuvir (with or without ribavirin) for 12 weeks in the treatment of chronic hepatitis C (CHC) in adult patients with hepatitis C virus (HCV) genotypes 1, 2 or 3 in three difficult-to-treat populations, including patients with HIV-1 co-infection, patients with compensated or decompensated cirrhosis and patients with HCV recurrence after liver transplantation.1

Both co-infected and post-transplant patient populations, historically, have been difficult to treat, in large part due to potential drug-to-drug interactions between the antiviral therapy regimens for HIV or anti-rejection drugs for post-transplant.2,3

"Chronic hepatitis C patients who have advanced disease, are co-infected with HIV or who have a recurrence of HCV after receiving a new liver pose complex treatment challenges to physicians," said Dr. Curtis Cooper, Director, The Ottawa Hospital and Regional Hepatitis Program. "These new indications for DAKLINZA™ give physicians more treatment options. We can now offer safe and highly curative HCV treatment to even the most complex and medically challenging of patients."

HCV and HIV co-infection is not rare. Approximately 20 per cent of Canadians with HIV have both infections.4 HCV progresses more rapidly to liver damage in people who are co-infected than in those who only have HCV.2 Currently, liver disease related to HCV is the leading cause of death among people with co-infection.2

"As part of our commitment to the HCV community, we have strived to make new treatment options available for patients with different genotypes, including those who are amongst the most difficult-to-treat," said Dr. Nawal Peacock, President and General Manager, Bristol-Myers Squibb Canada. "With this expanded label for DAKLINZA™, we are proud to provide an option that helps bridge what has been a challenging treatment gap for these patients."

The new indications are based on data from the ALLY-1 clinical trial (in post-transplant patients and patients with advanced cirrhosis) and the ALLY-2 clinical trial (in HIV-1 co-infected patients). In ALLY-1, DAKLINZA in combination with sofosbuvir and ribavirin achieved a cure rate of 94 per cent in patients with post-liver transplant and 92 to 94 per cent in patients with advanced cirrhosis.3 In ALLY-2, the DAKLINZA™ plus sofosbuvir combination achieved a 97 per cent cure rate in treatment naive co-infected patients and 98 per cent in treatment experienced co-infected patients.2

"As people in the advanced stages of the disease can attest, HCV can be a devastating illness," Dr. Morris Sherman, hepatologist and chair of the Canadian Liver Foundation, who has treated patients with hepatitis C for more than 20 years. "These patients are in great need of a cure so they can recover and enjoy their life again. The HCV community welcomes each new treatment option that can help to cure this illness, and bring us closer to seeing a day when HCV is gone for good."

DAKLINZA™, a potent, pan-genotypic NS5A replication complex was approved by Health Canada in August 2015 for use in combination with other agents for the treatment of adult patients with HCV genotypes 1, 2, or 3 and compensated liver disease, including cirrhosis.1 In Canada, genotypes 1, 2 and 3 account for 65 per cent, 14 per cent and 20 per cent of HCV infections respectively.5

About Bristol-Myers Squibb Canada Co.
Bristol-Myers Squibb Canada is an indirect wholly-owned subsidiary of Bristol-Myers Squibb Company, a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb global operations, visit www.bms.com. Bristol-Myers Squibb Canada has been delivering innovative medicines for serious diseases to Canadian patients in the areas of cardiovascular health, oncology, neuroscience, immunoscience and virology for over 80 years. Bristol-Myers Squibb Canada employs over 300 people across the country. For more information, please visit www.bmscanada.ca.

Additional Information:

About ALLY-1 Clinical Trial1
In the trial, the DAKLINZA™ plus sofosbuvir and ribavirin regimen demonstrated overall SVR12 in 94 per cent of post-liver transplant patients and 83 per cent of patients in the advanced cirrhosis cohort, including 92 to 94 per cent of patients with compensated cirrhosis (Child-Pugh A or B). In the cirrhosis cohort, four subjects with hepatocellular carcinoma underwent liver transplantation after 1 to 71 days of treatment; three of the four subjects received 12 weeks of post-liver transplant treatment extension and one subject, treated for 23 days before transplantation, did not receive treatment extension. All four subjects achieved SVR12.

In the ALLY 1 trial, the most common adverse reactions (frequency of 10% or greater) among the 113 subjects were headache, anemia, fatigue and nausea. Most adverse reactions were mild to moderate in severity. Fifteen (13%) subjects experienced an SAE; all SAEs were considered unrelated to treatment. Of the 15 (13%) subjects who discontinued study drug for adverse events, 13 (12%) subjects discontinued ribavirin only and 2 (2%) subjects discontinued all study drugs.

About ALLY-2 Clinical Trial1
In ALLY-2, the DAKLINZA™ plus sofosbuvir regimen demonstrated overall SVR12 in 97 per cent in treatment-naive patients and 98 per cent in treatment-experienced patients, including 100 per cent in genotype 3 (n=10). SVR12 rates were high regardless of combination antiretroviral therapy (cART) regimens, including boosted-protease inhibitor-, NNRTI-, and integrase inhibitor-based therapies. In the trial, 2 per cent of subjects experienced SAEs and no discontinuations due to AEs. The most common adverse reaction (=10% or greater) was fatigue (14%).

1 Bristol-Myers Squibb Canada DAKLINZA™ Product Monograph. Revised: May 13, 2016.
2 Wyles DL, et al. Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1. N Engl J Med. 2015;373:714-25.
3 Poordad, F., Schiff, E.R., Vierling, J.M., et al, Daclatasvir, sofosbuvir, and ribavirin combination for HCV patients with advanced cirrhosis or posttransplant recurrence: phase 3 ALLY-1 study. J Hepatol. 2015;62:261.
4 Centre for Communicable Diseases and Infection Control Infectious Disease Prevention and Control Branch Public Health Agency of Canada. Hepatitis C in Canada: 2005-2010 Surveillance Report. 2012. Page 25.
5 RP Myers, RP, Shah KW, Cooper, C, et al. An update on the management of chronic hepatitis C: 2015 consensus guidelines from the Canadian Association for the Study of the Liver. Can J Gastroenterol Hepatol 2015.

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