icon-folder.gif   Conference Reports for NATAP  
  57th Annual Meeting of the American Association
for the Study of Liver Diseases
October 27-31, 2006
Boston, MA
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Roche's Oral Polymerase Inhibitor R1626 Shows Strong Antiviral Activity in Chronic Hepatitis C Patients
  BASEL, Switzerland, October 27 /PRNewswire/ --
- R1626 Demonstrates Greatest Hepatitis C Viral Load Reduction of all Polymerase Inhibitors
Note from Jules Levin: last week Roche announced they licensed the new hepatitis C protease inhibitor ITMN-191, from Intermune. This makes for an interesting situation, since Roche now has 3 oraly administered HCV drugs to develop for themselves. In addition to R1626 they have rights to develop R7128, a HCV polymerase inhibitor from Pharmasset. So, Roche is in a position where they may be able to conduct a study using a regimen with 3 orally administered HCV drugs. No other company at this point can do this.
Roche's new investigational drug for hepatitis C has been shown to have a strong antiviral effect. The drug, which is known as R1626, has achieved clinically significant reductions in viral load in chronic hepatitis C patients infected with the difficult-to-cure genotype 1 virus.[i] Furthermore, the drop in hepatitis C viral load achieved in patients receiving R1626 is the largest seen for this class of antiviral treatments called polymerase inhibitors. These findings were announced today at the annual meeting for the 57th American Association for the Study of the Liver (AASLD) in Boston.
"The results from this phase I study show us that the polymerase inhibitor R1626 is very effective in inhibiting hepatitis C viral replication. In fact, the drop in hepatitis C virus is the best that we have seen with all the polymerase inhibitors studied so far," said Dr. Stuart Roberts, Director of Gastroenterology at Alfred Hospital in Melbourne, Australia and lead investigator of the study. "Adding R1626 to current therapies could potentially improve cure rates in hepatitis C."
As a result of these outstanding virological results, Roche has commenced a phase II trial to evaluate how well R1626 works in combination with the current standard of care, PEGASYS(R) (peginterferon alfa-2a (40KD)) and COPEGUS(R) (ribavirin).
About the study presented at AASLD
In this phase I study, 47 patients with genotype 1 hepatitis C were randomised to receive either oral treatment with R1626 twice daily or placebo for 14 days with 14 days of follow up. The final results presented at AASLD included patients who received the higher doses of R1626 at 3,000 mg or 4,500 mg twice a day.
The study found:
- Clinically significant reductions in serum hepatitis C virus RNA (a measure of how much virus is in the blood) of 1.2, 2.6 and 3.7 log reduction with R1626 at the doses of 1,500 mg, 3,000 mg and 4,500 mg, respectively.
- R1626 at all doses tested had a good safety profile and no patient was prematurely withdrawn. Reversible mild to moderate haematological changes were observed with increasing doses.
Defining treatment for a new generation
"Roche is fully committed to developing the best treatment options so that as many patients as possible have the best chance for a cure," said Dr. Friederike Zahm, Life Cycle Leader for R1626 at Roche in Basel, Switzerland. "The development of R1626, ongoing research with PEGASYS and extensive partnerships with other companies such as InterMune, Pharmasset and Maxygen underscores our long-term commitment to finding effective therapies to benefit patients with chronic hepatitis C."
About the phase IIa R1626 clinical trial
Roche have commenced a multicentre phase II trial that is enrolling patients with genotype 1 chronic hepatitis C who have not previously received treatment. Patients are randomised into four treatment groups assessing R1626 with PEGASYS or PEGASYS plus COPEGUS, versus the standard of care. Following the first 4 weeks of treatment, all patients will receive PEGASYS 180 1/4g subcutaneously every week plus COPEGUS 1,000-1,200 mg daily for another 44 weeks, making the total treatment duration of 48 weeks.
The objectives of the study are to evaluate the 4 week safety and antiviral effect of combining R1626 with PEGASYS and/or COPEGUS. The study is currently enrolling patients in the US. Patients and healthcare providers interested in the trial can find more information at www.roche-trials.com.
[i] Roberts S, Cooksley G, et al. Results of a Phase 1B, Multiple Dose Study of R1626, a Novel Nucleoside Analog Targeting HCV Polymerase in Chronic HCV Genotype 1 Patients. Presented at the American Association for the Study of the Liver (AASLD). Oct 30, 2006.
[ii] Roberts S, Cooksley G, et al. Results of a Phase 1B, Multiple Dose Study of R1626, a Novel Nucleoside Analog Targeting HCV Polymerase in Chronic HCV Genotype 1 Patients. Presented at the American Association for the Study of the Liver (AASLD). Oct 30, 2006.
[iii] Global surveillance and control of hepatitis C. Report of a WHO Consultation organized in collaboration with the Viral Hepatitis Prevention Board, Antwerp, Belgium. J Viral Hepat 1999;6(1):35-47.
Distributed by PR Newswire on behalf of Roche Pharmaceuticals