HCV protease R7227+HCV nucleoside R7128; Twice Daily Oral Medication Shows Promise

NFORM Study: HCV protease R7227+HCV nucleoside R7128; Twice Daily Oral Medication Shows Promise in Treating Patients with Hepatitis C

Mon Nov 2, 2009 11:44am EST

Presented: Tuesday, November 3, 2009, 8:00 am Eastern Time in Boston, MA




ALEXANDRIA, Va. and BOSTON, Nov. 2 /PRNewswire/ -- All approved therapy
regimens to treat patients with hepatitis C are based on interferon, which
must be injected. In this clinical trial to be presented at the annual meeting
of the American Association for the Study of Liver Diseases, researchers
treated patients - both treatment naive and experienced patients - with a
twice daily oral combination therapy of a nucleoside polymerase and protease
inhibitor. The results were significant antiviral potency and sustained viral
reductions. In addition, the therapy appeared safe and well-tolerated. "The
expected better tolerability of these IFN-free combination DAA regimens may
make treatment easier for patients and also allow for patients to be treated
who are unable to take interferon based therapy," said Edward Gane, MD, lead
investigator on this study. "The greater numbers treated and better success
rates should eventually help reduce the future projected burden of end-stage
liver disease for chronic HCV."

The INFORM-1 trial is randomized, double-blind, and placebo controlled. The
oral therapy was administered over a 14-day period, and the antiviral
responses were impressive among all groups. It was reported that the
combination is undergoing further development for treatment of chronic
hepatitis C. "This is the first study to demonstrate that an IFN-free, twice
daily, combination DAA regimen produces similar antiviral activity compared to
triple therapy (SOC plus protease) over 2 weeks of treatment," said Dr. Gane.
"This combination may represent the first IFN-free treatment regimen for both
treatment-naive and previously treated patients with HCV Genotype 1
infection."

These results are very promising in regards of antiviral potency and lack of
resistance development. "From here we will need to explore in a stepwise
fashion if longer treatment will result in persistent viral suppression, clear
all HCV-infected hepatocytes and ultimately lead to a sustained virologic
response (SVR)," said Dr. Gane. He concluded by saying, "as we explore this
new treatment paradigm, we hope to gain a better understanding of the virus
host interaction in HCV, as DAA induced viral suppression in the absence of
extrinsic interferon allows us to study intrinsic interferon responses and
associated biomarkers."

Abstract title:
Combination therapy with a nucleoside polymerase (R7128) and protease
(R7227/ITMN-191) inhibitor in HCV: Safety, pharmacokinetics, and virologic
results from INFORM-1

About the AASLD

AASLD is the leading medical society focused solely on advancing the science
and practice of hepatology and represents more than 3,300 practitioners,
researchers, and allied health professionals worldwide. Founded by physicians
in 1950, AASLD has upheld the standards of the profession and fostered
research that generates treatment options for the millions of patients with
liver diseases.

This year's Liver Meeting, held in Boston, Massachusetts, October 30 -
November 3, will bring together more than 7,000 researchers from 55 countries.
A pressroom will be available from October 31 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 Tracy at 703-299-9766.

Press releases, additional information for the media, and all abstracts are
available online at www.aasld.org.


Media Contact: Gregory Bologna
703-299-9766
gbologna@aasld.org

Press Room: October 31 - November 3, 2009
Hynes Convention Center, Room 209
Telephone: (617) 954-2827

Researcher: Edward Gane, MD
Email: edgane@adhb.govt.nz
Phone: 64 9529 4001


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