Results from multiple Phase 1 studies evaluating the interaction between telaprevir and ritonavir-boosted protease inhibitors, NNRTIs and NRTIs (Abstract #119)
— Telaprevir slightly increased the exposure to ritonavir-boosted
atazanavir. Ritonavir-boosted atazanavir slightly reduced the exposure
to telaprevir. This interaction was not considered to be clinically
significant. a HIV regimen that includes ritonavir-boosted atazanavir is
being evaluated in an ongoing Phase 2 study of telaprevir-based therapy
in people infected with both hepatitis C and HIV.
— an interaction between efavirenz and telaprevir (750 mg, every eight
hours) was observed, but a higher dose of telaprevir (1,125 mg, every
eight hours) could largely offset the interaction. This higher dose of
telaprevir is being evaluated as part of an ongoing Phase 2 study in
people co-infected with hepatitis C and HIV who are also receiving
efavirenz as part of their HIV treatment.
— Significant interactions were observed between telaprevir and
boosted-lopinavir, darunavir and fosamprenavir, such that
telaprevir-based combination therapy is not currently being evaluated
for people taking these HIV medicines.
Telaprevir is an investigational, oral inhibitor that acts directly on the HCV protease, an enzyme essential for viral replication. to date, more than 2,500 people with genotype 1 hepatitis C have received telaprevir in Phase 2 and Phase 3 studies.
Vertex is developing telaprevir in collaboration with Tibotec BVBA and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir in North America. Through its affiliate, Janssen, Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries.
Telaprevir has been granted priority review by the U.S. Food and Drug Administration (FDA) and by Health Canada and accelerated assessment by the European Medicines Agency for the treatment of people chronically infected with genotype 1 hepatitis C virus (HCV). the applications include data from three registrational studies, ADVANCE, ILLUMINATE and REALIZE, which evaluated telaprevir in people with hepatitis C who were new to treatment as well as those who did not achieve a viral cure after treatment with currently available medicines. for complete information on the clinical trials or a fact sheet on the trial designs visit: vrtx.com/press.cfm.
About Hepatitis C and HIV Co-Infection
there are 1 million people living with HIV in the United States.(2) It’s estimated that up to 30 percent of people living with HIV/AIDS are also infected with hepatitis C.(3) there have been dramatic improvements in the treatment of HIV and the prognosis for people living with HIV. However, liver disease progresses more rapidly in people co-infected with hepatitis C and HIV, with an increased rate of progression to cirrhosis, decompensated liver disease, hepatocellular carcinoma and death.(3,4,5)
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.(6) Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.(6) though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.(6) Approximately 60 percent of genotype 1 hepatitis C patients who undergo treatment with an initial 48-week regimen with pegylated-interferon and ribavirin, the currently approved medicines, do not achieve SVR,(7,8,9) or viral cure.(10) if treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.(11,12,13,14,15)
more than 170 million people worldwide are chronically infected with hepatitis C. In the United States, nearly 4 million people have chronic hepatitis C and 75 percent of them are unaware of their infection.(16) the majority of people with hepatitis C in the United States were born between 1946 and 1964, accounting for two of every three people with chronic hepatitis C.(15) Hepatitis C is the leading cause of liver transplantations in the United States and is reported to contribute to 4,600 to 12,000 deaths annually.(12) by 2029, total annual medical costs in the United States for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion.(15)
PEGASYS(R) and COPEGUS(R) are registered trademarks of Hoffman-LA Roche.
Reyataz(R) is a registered trademark of Bristol-Myers Squibb.
Atripla(R) is a registered trademark of Bristol-Myers Squibb and Gilead Sciences, LLC.
Special Note regarding Forward-looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including statements regarding (i) the interim results being encouraging because they showed a high proportion of people in the study had a rapid response to telaprevir; (ii) Vertex’s plan to use what it is learning from the study to inform a Phase 3 co-infection study of telaprevir planned for the end of 2011; (iii) expectations that final SVR results from the study will be available in 2012 and (iv) the possibility that a higher dose of telaprevir could largely offset the interaction observed between efavirenz and telaprevir. While Vertex believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. those risks and uncertainties include, among other things, the risks that efforts to develop telaprevir as a treatment for patients co-infected with genotype 1 HCV and HIV may not proceed due to technical, scientific, commercial, financial or other reasons; that final outcomes, including SVR rates, from this clinical trial and any future clinical trials of telaprevir in patients with HCV-HIV co-infection may not be favorable; that RVR and cEVR may not be predictive of SVR in patients with HCV-HIV co-infection and the other risks listed under Risk Factors in Vertex’s annual report and quarterly reports filed with the Securities and Exchange Commission and available through Vertex’s website at vrtx.com. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.
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 Cambridge, MA, we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada.
for more information and to view Vertex’s press releases, please visit vrtx.com.
References: (1) 2010 Guidelines for Antiretroviral Treatment of HIV From the International AIDS Society-USA Panel JAMA. 2010;304(17):1897. (2) Centers for Disease Control and Prevention. HIV/AIDS and Viral Hepatitis. available at cdc.gov/hepatitis/Populations/hiv.htm. Accessed February 17, 2011. (3) Health Resources and Services Administration. Care and Treatment for Hepatitis C and HIV Co-infection. available at hab.hrsa.gov/tools/coinfection/coinfectionsub.html and hab.hrsa.gov/tools/coinfection/index.html Accessed February 28, 2011. (4) Benhamou Y, Bochet M, Di Martino V, Charlotte F, Azria F, Coutellier a, et al. Liver fibrosis progression in human immunodeficiency virus and hepatitis C virus coinfected patients. Hepatology 1999;30(4):1054-58. (5) Martin-Carbonero L, Benhamou Y, Puoti M, Berenguer J, Mallolas J, Quereda C, et al. Incidence and predictors of severe liver fibrosis in human immunodeficiency virus-infected patients with chronic hepatitis C: a European collaborative study. CID 2004;38:128-33. (6) Martinez-Sierra C, Arizcorreta a, Diaz F, Roldan R, Martin-Herrera M, Perez- Guzman E, et al. Progression of chronic hepatitis C to liver fibrosis and cirrhosis in patients coinfected with hepatitis C virus and human immunodeficiency virus. CID 2003;36:491-8. (7) Centers for Disease Control and Prevention. Hepatitis C Fact Sheet: CDC Viral Hepatitis. available at: cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf. Accessed May 25, 2010. (8) 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. (9) 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. (10) 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. (11) Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; an update. Hepatology. 2009;49 (4):1-40. (12) 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.
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