Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that 15 abstracts on the company's medicines in development for hepatitis C, including its protease inhibitor, telaprevir, and polymerase inhibitor, VX-222, were accepted for presentation at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL) in Berlin, Germany, March 30 to April 3, 2011.
Highlights of data presentations include:
- Complete results from the pivotal Phase 3 REALIZE study will be presented for the first time. Topline results from this study, which evaluated telaprevir in combination with pegylated-interferon and ribavirin in people who had not achieved a viral cure (SVR) with currently available medicines, were announced in September 2010.
- The first data from an ongoing Phase 2 study evaluating 12- and 24-week response-guided regimens of telaprevir and VX-222 in combination with pegylated-interferon and ribavirin will be presented during a late-breaker session (Abstract #1363).
- Retrospective analyses of the relationship between IL28B genotype status and rates of viral cure with telaprevir-based combination therapy from the pivotal Phase 3 studies of REALIZE and ADVANCE will also be presented.
"This is an exciting time for the treatment of hepatitis C and for Vertex," said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer for Vertex. "At EASL, we will present, for the first time, complete results from the Phase 3 REALIZE study and early findings of a new study evaluating both of our oral medicines in development for hepatitis C, telaprevir and VX-222 in combination with available medicines."
The regulatory applications for the approval of telaprevir have been granted Priority Review by the U.S. Food and Drug Administration (FDA) and 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.
- "REALIZE Trial Final Results: Telaprevir-based Regimen in Genotype 1 Hepatitis C Virus infection in Patients with Prior Null Response, Partial Response or Relapse to Peginterferon/Ribavirin"; March 31, 2011, 4:15 - 4:30 p.m. CET.
- "Subanalyses of the telaprevir lead-in arm in the REALIZE study: response at week 4 is not a substitute for prior null response categorization"; March 31, 2011, 5:00 - 5:15 p.m. CET.
- "Evolution of Treatment-Emergent Resistant Variants in Telaprevir Phase 3 Clinical Trials (ADVANCE, ILLUMINATE, REALIZE)"; March 31, 2011, 5:30 - 5:45 p.m. CET.
- "Similar SVR Rates in IL28B CC, CT or TT Prior Relapsers, Partial- or Null-Responders Patients Treated with Telaprevir/Peginterferon/ Ribavirin: Retrospective Analysis of the REALIZE Study"; March 31, 2011, 6:45 - 7:00 p.m. CET.
- Late Breaker #1363: "VX-222 with TVR Alone or in Combination with Peginterferon ALFA-2A and Ribavirin in Treatment-Naïve Patients With Chronic Hepatitis C: ZENITH Study Interim Results"; March 31 - April 2, 2011.
- Late Breaker #1369: "Telaprevir Substantially Improved SVR Rates Across All IL28B Genotypes in ADVANCE Trial"; March 31 - April 2, 2011.
- #451: "Telaprevir in Combination with Peginterferon Alfa-2a and Ribavirin: Analyses of Pre-Defined Subpopulations in the Phase 3 ADVANCE Trial"; March 31, 2011, 1:30 - 2:30 p.m. CET.
- #415: "Telaprevir in Combination with Peginterferon Alfa-2a and Ribavirin Increased Sustained Virologic Response Rates in Treatment-Naïve Patients Regardless of Race or Ethnicity"; March 31, 2011, 1:30 - 2:30 p.m. CET.
- #477: "Anemia Had no Effect on Efficacy Outcomes in Treatment-Naïve Patients who Received Telaprevir-Based Regimen in the ADVANCE and ILLUMINATE Phase 3 Studies"; March 31, 2011, 1:30 - 2:30 p.m. CET.
- #400: "Modeling, Clinical and Virology Data From Phase 2 and 3 Studies Support 12-week Telaprevir Duration In Combination with 24- or 48-week Peginterferon/Ribavirin Duration"; March 31, 2011, 1:30 - 2:30 p.m. CET.
- #1202: "Characterization of HCV Variants in Non-SVR Patients in the REALIZE Study Suggests that Telaprevir Exhibits a Consistent resistance profile Irrespective of a Lead-in", April 2, 2011, 12:30 - 1:30 p.m. CET.
- #1244: "The Pharmacokinetic Interaction between Methadone and the Investigational HCV Protease Inhibitor Telaprevir"; April 2, 2011, 12:30 - 1:30 p.m. CET.
- #1245: "The Effect of Severe Renal Impairment on the Pharmacokinetics of the Investigational HCV Protease Inhibitor Telaprevir"; April 2, 2011, 12:30 - 1:30 p.m. CET.
- #1208: "Impact of Telaprevir-based Treatment Regimens on Fatigue in Genotype 1 HCV Treatment-naïve Patients: Results from ADVANCE and ILLUMINATE Studies"; April 2, 2011, 12:30 - 1:30 p.m. CET.
- #1242: "Long-term Follow-up of Chronic Hepatitis C Infected Patients Treated with Telaprevir: Evaluation of Persistence of Resistant Variants by Ultra-deep Sequencing"; April 2, 2011, 12:30 - 1:30 p.m. CET.
Vertex Pharmaceuticals Incorporated