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In addition, people who had severe liver disease also achieved significantly higher rates of viral cure with INCIVEK combination treatment compared to treatment with pegylated-interferon and ribavirin alone: 62 percent versus 33 percent for those new to treatment with advanced fibrosis or cirrhosis (F3/F4 Metavir) and 87 percent versus 13 percent for people with cirrhosis (F4 Metavir) who relapsed after prior therapy. The Canadian Product Monograph also includes Phase 3 clinical data that showed 68 percent of people new to treatment achieved a rapid virologic response (RVR; had no detectable virus after 4 weeks of treatment) with INCIVEK combination therapy, versus 9 percent for those who received pegylated-interferon and ribavirin alone. RVR is a strong predictor of a person's likelihood of achieving a viral cure.

Rash and anemia are the most serious side effects associated with INCIVEK. The most common side effects reported with INCIVEK combination treatment include fatigue, itching, nausea, diarrhea, vomiting, anal or rectal problems, and taste changes.

"The Canadian availability of INCIVEK is an important milestone in the fight against hepatitis C, with many people now expected to be able to complete treatment in half the time previously needed with pegylated-interferon and ribavirin alone," said Robert Myers, MD, Associate Professor and Director of the Viral Hepatitis Clinic at the University of Calgary and an INCIVEK investigator. "This is an encouraging advancement for people with hepatitis C, and we hope that Canadians who need treatment will have access to this important new medication."

Vertex has initiated the process to make INCIVEK accessible to people in Canada through private health insurers and through the provincial and federal drug plans in Canada. The company will implement a comprehensive patient support program to provide financial assistance for costs associated with INCIVEK for people who meet certain program criteria and to provide other support services related to treatment with INCIVEK. Additionally, patients will have access to nurses through a 24-7 hotline where they can receive support, guidance and educational materials about hepatitis C and its treatment. Vertex will also provide nurses and doctors with educational tools and resources so they can offer support and care to their patients with hepatitis C before, during and after the treatment process.

Source Vertex Pharmaceuticals Incorporated