The NDA for telaprevir was granted Priority Review by the
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.i Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.i Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.i
Unlike HIV and hepatitis B virus, chronic hepatitis C is curable.ii However, approximately 60 percent of people who undergo treatment with an initial 48-week regimen of pegylated-interferon and ribavirin, the currently approved medicines for genotype 1 hepatitis C, do not achieve SVR,iii,iv,v or viral cure.vi If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.vii,viii
More than 170 million people worldwide are chronically infected with
hepatitis C.vi In
Telaprevir is an investigational, oral inhibitor that acts directly on the hepatitis C virus protease, an enzyme essential for viral replication. More than 2,800 people with hepatitis C have received telaprevir-based combination therapy as part of Phase 2 and Phase 3 studies. The Phase 3 registration studies, ADVANCE, ILLUMINATE and REALIZE, evaluated telaprevir (750 mg, taken three times daily) in combination with Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin) in people with hepatitis C who had not been treated before as well as those who were treated before but not cured with a prior treatment course of pegylated-interferon and ribavirin.
Vertex is developing telaprevir in collaboration with Tibotec BVBA and
Vertex creates new possibilities in medicine. Our team aims to discover, develop and commercialize innovative therapies so people with serious diseases can lead better lives.
Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases.
Founded more than 20 years ago in
Special Note About Forward-looking Statements
This press release contains forward-looking statements, including a
statement regarding the expectation that the
PEGASYS® and COPEGUS® are registered trademarks of Hoffmann-La Roche.
ii Pearlman BL and Traub N. Sustained Virologic Response to Antiviral Therapy for Chronic Hepatitis C Virus Infection: A Cure and So Much More. Clin Infect Dis. 2011 Apr;52(7):889-900.
iii 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.
iv 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.
v 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.
vi Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.
vii 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).
viii 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.
x Pyenson B, Fitch K, Iwasaki K. Consequences of hepatitis C virus (HCV): Costs of a baby boomer epidemic of liver disease. Available at: http://www.natap.org/2009/HCV/051809_01.htm. Updated
xi Volk MI, Tocco R, Saini S, Lok, ASF. Public health impact of antiviral therapy for hepatitis C in
xii Davis GL, Alter MJ, El-Serag H, Poynard T, Jennings LW. Aging of hepatitis C virus (HCV)-infected persons in
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