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Celgosivir with Peginterferon and Ribavirin in Chronic Hepatitis C
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DDW, May 22, 2007, Wash DC
Celgosivir is a new class of antiviral medicine in clinical development for the treatment of chronic hepatitis C virus (HCV) infection. Researchers tested this new antiviral medicine and measured its potential to offer improved treatment outcomes when combined with other anti-HCV drugs.
The current study evaluated 57 chronic HCV genotype-1 patients, separated by prior treatment status into non-responders or partial responders and randomized to three treatment groups:
1) celgosivir 400 mg once daily in combination with peginterferon alfa-2b and ribavirin (PRC);
2) celgosivir 400 mg once daily in combination with peginterferon alfa-2b (PC); or
3) placebo with peginterferon alfa-2b and ribavirin (PR, active control).
All patients were treated for 12 weeks. The non-responders cohort enrolled 36 patients (PRC: 15; PC: 11; PR: 10) and the partial responder cohort had 21 patients (PRC: 3; PC: 9; PR: 9).
For prior non-responder patients, an Early Viral Response (EVR) was achieved in 42 percent (5/12) of those in which celgosivir was added to the standard peginterferon alfa-2b and ribavirin therapy compared with only 10 percent (1/10) of patients receiving just peginterferon alfa-2b and ribavirin. Non-responder patient study results also demonstrate an improved mean decrease in HCV viral loads when celgosivir is added to peginterferon alfa-2b and ribavirin of 1.63 log10 IU/mL versus 0.92 log10 IU/mL in patients treated with peginterferon alfa-2b and ribavirin alone. Eleven of the 36 non-responder patients were classified as a very difficult-to-treat patient subgroup (null responders) as they were shown to have a prior HCV treatment response of =0.4log10 to optimized therapy. In the present study, the mean decrease in HCV viral loads in these null responder patients was 1.86 log10 IU/mL with celgosivir plus peginterferon alfa-2b and ribavirin while the two null responder patients treated with peginterferon alfa-2b and ribavirin was 0.32 log10 IU/mL. The observed difference in mean viral load between the PRC and PR treatment groups provides evidence that the combined effect of celgosivir with peginterferon alfa-2b and ribavirin provides a clinically significant treatment benefit for difficult-to-treat chronic HCV infected patients.
"This study is the first demonstration that celgosivir in combination with peginterferon alfa-2b and ribavirin results in a clinically significant decrease in HCV viral loads in patients highly resistant to current standard treatment," said Kelly D. Kaita, M.D., of the University of Manitoba in Canada, and lead author of this study. "Further clinical research on the best dosing regimen and combinations is warranted to optimize the potential of this innovative combination for chronic HCV patients."
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