Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that abstracts from its hepatitis C program, including two late-breaking posters from studies of INCIVEK™ (telaprevir) tablets and VX-222, were accepted for presentation at The Liver Meeting®, the 62nd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, November 4-8, 2011.
New data, including sustained viral response (SVR, or viral cure) results, from a Phase 2 study evaluating short durations of 12- and 24-week regimens of VX-222 in combination with INCIVEK (in-SEE-veck), pegylated-interferon and ribavirin in people with genotype 1 chronic hepatitis C who were new to treatment will be presented for the first time. Additionally, new data from a Phase 2 study evaluating INCIVEK combination treatment in people co-infected with genotype 1 chronic hepatitis C and human immunodeficiency virus (HIV) will be presented at the meeting. All people in this study were new to hepatitis C treatment.
"INCIVEK combination therapy has successfully increased viral cure rates and shortened total treatment time for the majority of people with hepatitis C who are being treated for the first time, but we have more to do," said Peter Mueller, Ph.D., Chief Scientific Officer and Executive Vice President of Global Research and Development at Vertex. "Our ongoing research is aimed at further improving treatment for hepatitis C by exploring the use of INCIVEK among those in critical need of more effective medicines and evaluating combinations, including some without interferon, that may offer higher cure rates and shorter treatment times."
INCIVEK Oral Presentations
1. #31: "Efficacy and safety of telaprevir-based regimens in cirrhotic patients with HCV genotype 1 and prior peginterferon/ribavirin treatment failure: subanalysis of the REALIZE Phase III study." November 6, 2011, 3:00 p.m. PDT.
2. #32: "Predictors of virologic response with telaprevir-based combination treatment in HCV genotype 1-infected patients with prior peginterferon/ribavirin treatment failure: post-hoc analysis of the Phase III REALIZE study." November 6, 2011, 3:15 p.m. PDT.
3. #35: "Retreatment with telaprevir/Peg-IFN/RBV after a short exposure to telaprevir in Phase I studies: interim results from a Phase IIIb rollover trial (C219)." November 6, 2011, 4:00 p.m. PDT.
4. #248: "Follow-up of SVR Durability and Viral Resistance in Patients with Chronic Hepatitis C Treated with Telaprevir-Based Regimens: Interim Analysis of the EXTEND Study." November 8, 2011, 11:00 a.m. PDT.
Vertex Late-Breaking Poster Presentations
1. #LB-8: "Telaprevir Combination with Peginterferon Alfa-2a/Ribavirin in HCV/HIV Coinfected Patients: 24-Week Treatment Interim Analysis." November 7, 2011.
2. #LB-14: "VX-222/telaprevir in Combination with Peginterferon Alfa-2a and Ribavirin in Treatment-naïve Genotype 1 HCV Patients Treated for 12 Weeks: ZENITH Study, SVR12 Interim Analysis." November 7, 2011.
Vertex Poster Presentations
1. #943: "Projections Using Decision-Analytic Modeling of Long-Term Clinical Value of Telaprevir for the Treatment of HCV Patients who had Failed Prior Peginterferon/Ribavirin Treatment." November 6, 2011.
2. #1328: "Summary of Clinical Virology Findings from Clinical Trials of Telaprevir." November 7, 2011.
3. #1331: "Different likelihood of achieving SVR on a telaprevir-containing regimen among null responders, partial responders and relapsers irrespective of similar responses after a peginterferon/ribavirin 4-week lead-in phase: REALIZE study subanalysis." November 7, 2011.
4. #1368: "Impact of anemia and ribavirin dose reduction on SVR to a telaprevir-based regimen in patients with HCV genotype 1 and prior peginterferon/ribavirin treatment failure in the Phase III REALIZE study." November 7, 2011.
5. #1369: "Impact of insulin resistance on virologic response to a telaprevir-based regimen in patients with HCV genotype 1 and prior peginterferon/ribavirin treatment failure: post-hoc analysis of the REALIZE Phase III study." November 7, 2011.
6. #2105: "Sustained Virologic Response Rates and Viral Resistance Profiles Were Similar in Patients Treated with a Telaprevir-Based Regimen Regardless of Liver Fibrosis Stage." November 8, 2011.
Exploring mouse models for studying liver fibrosis regression