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Health Canada Approves INCIVEK™ (telaprevir) for People With Hepatitis C
- Nearly 4 out of 5 people treated for the first time cleared the virus with INCIVEK combination treatment -
"Early diagnosis and the effective treatment of hepatitis C are critical to the prevention of long-term consequences of the disease, which may include end-stage cirrhosis, liver cancer and the need for a transplant," said
"Health Canada's rapid approval of INCIVEK underscores the urgent need for new medicines to treat hepatitis C, which affects about a quarter of a million Canadians," said
INCIVEK is given as two 375-mg tablets, three times daily. It is given for 12 weeks in combination with pegylated-interferon and ribavirin. After the first 12 weeks, all patients stop receiving INCIVEK and continue treatment with pegylated-interferon and ribavirin alone for an additional 12 weeks or 36 weeks of treatment. With INCIVEK combination treatment, more than 60 percent of people treated for the first time, as well as those who relapsed after previous therapy, are expected to complete all treatment in 24 weeks — half the time needed if they were to take pegylated-interferon and ribavirin alone. All other patients will receive a total of 48 weeks of treatment. 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 approval of INCIVEK was based on data from three Phase 3 studies of more than 2,500 people with hepatitis C, which showed that people who received INCIVEK combination treatment achieved significantly higher rates of viral cure (sustained viral response, or SVR) compared to those who received pegylated-interferon and ribavirin alone, regardless of their prior treatment experience:
People new to treatment:
|79 percent vs. 46 percent|
People who were treated previously but did not achieve a viral cure:
|86 percent vs. 22 percent|
-- Partial responders:
|59 percent vs. 15 percent|
-- Null responders:
|32 percent vs. 5 percent|
Data from the Phase 3 REALIZE and ADVANCE studies were published on
"As the world's first organization dedicated to providing support for research and education into the causes, diagnoses, prevention and treatment of all liver disease, we are all too familiar with the devastating consequences of hepatitis C," said
INCIVEK™ (telaprevir) is a prescription medicine that treats a disease in adults called chronic hepatitis C (chronic means lasting a long time). INCIVEK does not work by itself. It is always used in combination with peginterferon alfa and ribavirin.
Important Safety Information
INCIVEK must always be used in combination with peginterferon alfa and ribavirin to treat chronic hepatitis C. A female patient should not take INCIVEK combination treatment if she is or plans to become pregnant, and until six months after treatment ends. A male patient should not take INCIVEK combination treatment if he has a sexual partner who is pregnant or may become pregnant any time during treatment, and until six months after treatment ends.
INCIVEK combination treatment may cause a rash that can become severe. It may also cause a serious skin reaction, a rare side effect. Patients will have their blood checked for anemia and other possible blood problems. Drugs that cause an effect on the electrical conduction of the heart known as QTc prolongation should be taken with caution in patients taking INCIVEK.
Certain medicines can cause serious or life threatening reactions with INCIVEK. Patients should tell their health care provider about all the medicines they take, including over-the-counter medicines, vitamins and herbal medicines.
The most common side effects of INCIVEK include rash, itching, anal or rectal problems, anemia, nausea, diarrhea, vomiting, and taste alteration. This is not a complete list of side effects. Patients should tell their health professional about any unexpected effects or any side effect that bothers them or does not go away.
For more information or questions about INCIVEK please call 1-877-634-VRTX (8789).
About Hepatitis C
Hepatitis C is a serious liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver.1 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.1 Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.1
Unlike HIV and hepatitis B virus, chronic hepatitis C can be cured.2 However, approximately 60 percent of people do not achieve SVR,3,4,5 or viral cure,6 after treatment with 48 weeks of pegylated-interferon and ribavirin alone. If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.7,8
More than 170 million people worldwide are chronically infected with hepatitis C.6,9
Hepatitis C in
Approximately 250,000 people in
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2 Pearlman BL and
3 Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001;358:958-965.
4 Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-982.
5 McHutchison JG, Lawitz EJ, Shiffman ML, et al; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009;361:580-593.
6 Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.
7 Morgan TR, Ghany MG, Kim HY, Snow KK, Lindsay K, Lok AS. Outcome of sustained virological responders and non-responders in the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) trial. Hepatology. 2008;50(Suppl 4):357A (Abstract 115).
8 Veldt BJ, Heathcote J, Wedmeyer H. Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Annals of Internal Medicine. 2007; 147: 677-684.
12 Sherman M, Sharfran S, Burak K, et al. Management of chronic hepatitis C consensus guidelines. Can J Gastroenterol. 2007;21 (Suppl C):25C-34C.
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