— 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.

For more information on the expanded access criteria:
http://www.ramq.gouv.qc.ca/SiteCollectionDocuments/liste_med/liste_med_2017_03_22_fr.pdf

Note from CD: Here is an extract from the Quebec Formulary Annexe IV page 89 which details the criteria for Epclusa. I have translated it to English with Google’s help:

SOFOSBUVIR / VELPATASVIR :

In combination with ribavirin, for the treatment of people with chronic hepatitis C who have decompensated cirrhosis.

Authorization is granted for a maximum period of 12 weeks.

Monotherapy for the treatment of people with chronic hepatitis C who have:

  • No liver fibrosis (Metavir score of F0 or equivalent) and at least one bad factor prognosis;

Or

  • A mild hepatic fibrosis (Metavir score of F1 or equivalent) and at least one bad factor prognosis;

Or

  • Moderate hepatic fibrosis (Metavir score of F2 or equivalent);

Or

  • Severe hepatic fibrosis (Metavir score of F3 or equivalent);

Or

  • A compensated cirrhosis (Metavir score of F4 or equivalent).

Authorization is granted for a maximum period of 12 weeks.

The factors of poor prognosis are defined as follows:

  • Co-infection with HIV or HBV;
  • Organ transplantation (pre or post-transplant);
  • Severe hepatic manifestations of hepatitis C;
  • Chronic stage 3, 4 or 5 disease according to the National Kidney Foundation classification,Kidney Disease Outcomes Quality Initiative (K / DOQI);
  • Use of antidiabetic medication;
  • Woman of childbearing age who plans a pregnancy in the next year.

Read the complete press release here: http://www.newswire.ca/news-releases/epclusa-to-treat-all-six-genotypes-of-chronic-hepatitis-c-infection-added-to-the-liste-des-medicaments-de-la-ramq-616628064.html