Increased SVR and Decreased Adverse Events Reported in Final Results of Phase 3 Study on Telaprevir

BOSTON, Nov. 1 /PRNewswire/ -- The Phase 3 results from the ADVANCE study confirm the clinical benefits of telaprevir-based combination therapy regimens. The study reports an improvement in treatment discontinuation rates due to adverse events compared to Phase 2 studies, and demonstrates an increase in sustained viral response (SVR) in patients with hepatitis C virus (HCV). The primary endpoint for this study was SVR 24 weeks after last treatment.

The study was conducted on 1088 treatment-naive HCV patients, all of whom had genotype 1. For the three arms of the trial, one group of patients was treated with 750 mg of telaprevir every eight hours in combination with peginterferon alfa-2a 180 ug/week and ribavirin 1000-1200 mg/day for 12 weeks, while the second group was given the same treatment but for only 8 weeks.  Patients in the first group (T12PR) were treated for an additional 12  weeks of peginterferon and ribavirin if HCV RNA was undetectable at weeks 4 and 12, for a total of 24 weeks of treatment, and an additional 36 weeks if HCV RNA was detectable at week 4 or week 12, for a total of 48 weeks' treatment.  Patients in the second group (T8PR) were treated with peginterferon and ribavirin for an additional 16 weeks if HCV RNA was undetectable at weeks 4 and 12, and for an additional 40 weeks if HCV RNA was detectable at either week 4 or 12, for a total of 24 or 48 weeks of treatment, respectively.  Patients in the control group were treated with peginterferon alfa-2a and ribavirin for 48 weeks.

SVR was 75 percent for those receiving telaprevir combination treatment for 12 weeks, 69 percent for those receiving telaprevir combination treatment for 8 weeks, and 44 percent for those receiving standard of care.  Extended rapid virologic response (HCV RNA undetectable at weeks 4 and 12) was attained in  58 percent, 57 percent, and 8 percent, respectively.  During the telaprevir/placebo treatment phase, adverse events leading to treatment discontinuation occurred in 7 percent of patients in the arm receiving telaprevir combination treatment for 12 weeks, 8 percent in telaprevir for 8 weeks, and 4 percent in the peginterferon alfa-2a and ribavirin arm.

Abstract title:

Telaprevir in Combination with Peginterferon and Ribavirin in Genotype 1 HCV Treatment-Naive Patients: Final Results of Phase 3 ADVANCE Study

About the AASLD

AASLD is the leading medical organization for advancing the science and practice of hepatology. Founded by physicians in 1950, AASLD's vision is to prevent and cure liver diseases. This year's Liver Meeting®, held in Boston, Massachusetts, October 29-November 2, will bring together more than 7,500 researchers from 55 countries.

A pressroom will be available from October 30 at the annual meeting. For copies of abstracts and press releases, or to arrange for pre-conference research interviews contact Gregory Bologna at 703-299-9766. To pre-register, call Ann Haran at 703-299-9766.

Press releases and all abstracts are available online at www.aasld.org.

Quote from Dr. Jacobson: "This phase 3 trial confirms previous findings that telaprevir confers  higher rates of viral cure in patients with the highly prevalent genotype 1 when compared with the current standard of care, with the added advantage of a  shorter total duration of treatment  in the majority of patients.  Although rash and anemia were more common with telaprevir, treatment discontinuation due to side effects was very infrequent and side effects attributable to the drug are reversible.  This study, along with others on protease inhibitors at this year's meeting, heralds an  exciting new era in HCV therapy in which increasing numbers of patients will be cured and spared the life-threatening risks of advanced liver disease."

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SOURCE American Association for the Study of Liver Diseases (AASLD)