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Early Week 4 Response Predicts SVR in Genotype 1
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Customizing Treatment with PEGASYS May Improve Chances for Success in Hepatitis C
-- Results point to innovative treatment strategies --
Press announcement from Roche.
BOSTON (October 27, 2006) - Patients with chronic hepatitis C who respond quickly to PEGASYSŪ (peginterferon alfa-2a) and COPEGUSŪ (ribavirin, USP) may have an excellent chance of achieving treatment success with a shortened course of therapy, according to interim results presented at the 57th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). Three-quarters of patients with the difficult-to-treat viral genotypes 1 and 4 who had a rapid viral response (RVR) - defined as undetectable levels of the virus after four weeks of therapy - achieved treatment success after 24 weeks of therapy. (Patients with these genotypes are typically treated for 48 weeks.)
"These results show that within a month of starting therapy with peginterferon alfa-2a and ribavirin, we can give excellent news to some patients with difficult-to-treat genotypes - that they are likely to achieve treatment success with six months of therapy rather than 11 months," said Donald Jensen, M.D., Professor of Medicine and Director of the Center for Liver Diseases at the University of Chicago Hospital in Chicago. "If confirmed in further study, these data are encouraging because they could help motivate more patients to seek treatment and to stay on treatment."
Currently, the best indicator of treatment success is a sustained viral response (SVR), defined by undetectable hepatitis C virus RNA in the blood six months after the end of treatment. Long-term studies show that the virus returns to detectable levels in very few patients who achieve an SVR.
In this study, patients received PEGASYS 180_g/week once weekly plus a 1000-1200mg daily dose of COPEGUS. After four weeks of treatment, virus levels in the blood were measured to identify patients who achieved an RVR. This group of patients was treated for another 20 weeks, receiving a total of 24 weeks of therapy (n=104). All other patients continued on treatment and were reassessed at week 12. Those who had an early virological response (EVR, defined as undetectable viral load or a drop in viral load to less than one percent of pre-treatment viral load) were randomized to receive either 48 weeks (n=105) or 72 weeks (n=108) of therapy. Those who did not have an EVR continued treatment up to 72 weeks (n=56). The study was designed to allow a comparison of 48 vs. 72 weeks of therapy in patients who achieved an EVR.
Results of the study showed:
- 78 percent of patients who achieved an RVR in the study achieved an SVR with 24 total weeks of therapy;
- among those who did not achieve an RVR but had an EVR, SVR rates were similar for 48 or 72 weeks of treatment (57 percent and 59 percent of patients, respectively);
- patients who did not have an EVR were highly unlikely to achieve an SVR (four percent) even after 72 weeks of treatment.
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