Monday, March 20, 2017

Quebec Broadens Access - Listing of EPCLUSA™ tablets effective on March 22 , 2017

EPCLUSA™, to treat all six genotypes of chronic hepatitis C infection, added to the Liste des médicaments de la RAMQ

-- Quebec Broadens Access for Patients with Less Advanced Disease Who Have Other Health Conditions --

MISSISSAUGA, ON , March 20, 2017 /CNW/ - Gilead Sciences Canada, Inc. ( Gilead Canada ) commends the continued leadership of Quebec in the treatment of hepatitis C with the listing of EPCLUSA™ (sofosbuvir/velpatasvir) tablets effective on March 22 , 2017. 

EPCLUSA is the first once-daily, pan-genotypic single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. 

This listing will support patients to access curative therapy in Quebec , and is a significant contribution to advancing Canada's efforts to achieving its World Health Organization commitment to eliminate hepatitis C by 2030.

EPCLUSA, one tablet taken daily for 12 weeks, is for use in adult patients without cirrhosis or with compensated cirrhosis, and in combination with ribavirin (RBV) for those with decompensated cirrhosis.  It is also the first single tablet regimen approved for the treatment of patients with genotypes 2 and 3, without the need for RBV. 

The approval of EPCLUSA was supported by data from four international Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4.  Of the 1,035 patients without cirrhosis or with compensated cirrhosis treated with EPCLUSA for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 per cent) achieved SVR12 (sustained virologic response 12 weeks after the end of treatment).  In ASTRAL-4, patients with decompensated cirrhosis who received EPCLUSA with RBV for 12 weeks achieved a high SVR12 rate (94 per cent) compared to those who received EPCLUSA for 12 weeks or 24 weeks without RBV (83 per cent and 86 per cent, respectively).  The most common adverse events in the four ASTRAL studies were headache and fatigue, and were comparable in incidence to the placebo group included in ASTRAL-1.

New médicament d'exception criteria for SOVALDI® (sofosbuvir), HARVONI® (ledipasvir/sofosbuvir) and EPCLUSA will increase access to patients with a lower stage of disease and poor prognosis.  These new criteria are available on the RAMQ website.

"We now have the ability to cure almost all patients with chronic HCV with a simple, safe and effective 12-week treatment, regardless of genotype or patient history," said Dr. Peter Ghali , Hepatologist, and Program Director, Hepatology training, McGill University Health Centre.  "Broader access to EPCLUSA, particularly at the earlier stage of the disease, means that we can move more quickly to help patients achieve a cure and improve their quality of life, while saving valuable funds associated with the significant long-term burden of illness and costs to the healthcare system."

The Institut national de la santé publique du Québec (INSPQ) estimates that between 40,000 to 75,000 people in the province could have chronic hepatitis C infection.  Between 1990 and 2014, 39,700 individuals were identified with hepatitis C.  In 2015, an additional 1,073 cases were identified, thus supporting the importance of access to treatment to prevent the future complications of the disease.1   There are six genotypes of hepatitis C.  Genotype 1 infection is the most prevalent genotype representing 62 per cent of infected individuals.  Genotypes 2 and 3 account for approximately 6.9 per cent and 25 per cent of infections, whereas genotypes 4, 5, and 6 are less prevalent in Québec at 6.1 per cent.2

"We are very pleased that access to treatments is now expanded to a broader population of hepatitis C patients in our province," said Laurence Mersilian, Executive Director, The Centre and Association for People Living with Hepatitis C (CAPAHC).  "We wish to thank and congratulate the Government of Quebec for its continued leadership and commitment to care for those living with hepatitis C."

" Gilead Canada is pleased that INESSS (Institut national d'excellence en santé et services sociaux) and the Ministry of Health and Social Services are recognizing the innovation and clinical value of EPCLUSA for the treatment of all genotypes of hepatitis C in a single tablet regimen," said Kennet Brysting, General Manager, Gilead Canada .  "Broader treatment access for patients will potentially have a profound impact on disease elimination efforts in Canada , and supporting such efforts is a key priority for our company.  We will continue to work closely with all jurisdictions to bring this simple and cost-effective curative treatment to all eligible patients, regardless of their genotype or stage of fibrosis."

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