HCV Genotype 1: Anti-viral HCV Drug Advances to Phase II
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BASEL, Switzerland, October 13
FDA Grants Fast Track Status to R1626
excerpt taken from Earthtimes.org
Roche announced today the start of the first phase II development studyto evaluate R1626, their promising new polymerase inhibitor, for the treatment of hepatitis C. The investigational drug has also been granted FastTrack status by the US Food and Drug Administration (FDA), a program designed to facilitate the development and to expedite the review of new drugs withthe potential to help treat serious or life-threatening conditions.
R1626 has been shown in an earlier study to have a strong antiviraleffect against the hepatitis C virus. In the phase I study[1] , the drug achieved significant reductions in viral load in chronic hepatitis C patients infected with the difficult-to-cure genotype 1 virus. By moving R1626 intophase II trials, Roche signifies its commitment to finding more therapeutic solutions for patients with hepatitis C. This trial will evaluate the safety and antiviral effects of R1626 in combination with the current standard of care for hepatitis C, Roche’s PEGASYS (peginterferon alfa-2a (40KD)) and COPEGUS (ribavirin).
About the phase II trial
This on-going multicenter 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. These treatment groups are:
- Group A: R1626 1500mg twice a day + Pegasys 180mcg as a subcutaneous injection every week for 4 weeks
- Group B: R1626 3000mg twice a day + Pegasys 180mcg as a subcutaneous injection every week for 4 weeks
- Group C: R1626 1500mg twice a day + Pegasys 180mcg as a subcutaneous injection every week + Copegus 1000-1200mg daily for 4 weeks
- Group D: Pegasys 180mcg as a subcutaneous injection every week + Copegus 1000-1200mg daily (standard of care group) for 4 weeks
Following the first 4 weeks of treatment, all patients will receive Pegasys 180mcg subcutaneously every week + Copegus 1000-1200mg 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 alone or R1626 with Pegasys plus 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.
