"ZURICH, Nov 2 (Reuters) - Swiss drugmaker Roche Holding AG (ROG.VX: Quote, Profile, Research) says it has moved its investigational hepatitis C drug R1626 into a new mid-stage trial after it showed promising results in combination with two of its other medicines.
Roche said on Friday the hepatitis C virus could no longer be detected in up to 81 percent of patients after four weeks of treatment with R1626, in combination with Pegasys and Copegus.
Based on the results of the Phase IIa study, Roche will move R1626 into a Phase IIb trial.
In a separate statement on Friday Roche also said a Pegasus and Copegus combination had shown benefits in patients who did not respond to initial treatment with Schering Plough Corp's (SGP.N: Quote, Profile, Research) Pegintron."
"Roche Issues Hepatits Drug Data
By Elizabeth Trotta
11/2/2007 6:00 PM E
"Roche said Friday that in a phase IIa study a triple-drug combination for treatment of hepatitis C showed a robust virological response and subsequently will proceed to a phase IIb study.
Presenting results at the American Association of the Study of Liver Diseases (AASLD) meeting in Boston, the Swiss drugmaker said its investigational hepatitis C drug R1626 showed promising antiviral activity in the phase IIa trial when given with Pegasys (peginterferon alfa-2a) and Copegus. The aforementioned Roche drugs are used together to treat adults with chronic hepatitis C whose liver still works normally and who haven't been previously treated with an interferon alpha.
After four weeks of treatment with the three-drug combination, the virus couldn't be detected in 81% of patients with a mean decrease in viral load of 5.2 log10 from the baseline, and Roche said most adverse events were mild to moderate.
((((((((Also, no resistance to R1626 was identified following intensive testing for either two weeks of treatment with R1626 as monotherapy or in patients treated with R1626 for four weeks in combination with the standard of care. +++thought this was important)))))))))
The phase IIb study, called POLI 1, which will further investigate R1626 in ((((((((combination with standard or lower dose of Pegasys and standard dose of Copegus++++doesn't look like their interested in the lowering of riba dose)))))))), is now open and enrolling patients in eight countries, including the U.S.
Pharmasset , which partners with Roche to develop chronic hepatitis C drug R7128, presented data Friday on a phase I 14-day monotherapy study of patients who failed to respond to standard therapy. Pharmassest said there was a 99% mean decrease in HCV (((((((with no serious adverse events. ++++++important))))))))(Pharmasset divulged positive preliminary results for the study in September.) The companies are hoping those results will translate when the drug is used in combination with other therapies for a longer duration in a previously untreated population
alagirl, no Alinia in this trial. I believe peg/riba dosing was standard for the Roche SOC products.
Merrybe, I seem to cross paths with you every morning (4:30 am my time) you must be a late owl, or early owl like me (lol)
The only 4 week RVr data from Vertex I have seen was from EASL and showed 88% success measured at less than 30 and 79% at less than 10. The Roche study doesn't show what measurement they were using. But their 81% is either 7% worse or 2% better, unless you have some different Vertex data.
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