A Dose Escalation Study of Merimepodib (VX-497) Plus Interferon Alfa among Treatment-naïve HCV Patients
Inhibition of inosine monophosphate dehydrogenase (IMPDH) is one of several proposed mechanisms of action for ribavirin (RBV), which is a critical component of the current standard of care for treatment of chronic hepatitis C (CHC). The current report was a double-blind, placebo-controlled dose escalation study of an orally active small molecule inhibitor of IMPDH, merimepodib (MMPD), aka VX-497.
Fifty-four treatment-naive patients with genotype1 CHC were randomized to receive standard IFN-alfa 3 MIU subcutaneously three times a week, alone or in combination with 100 mg or 300 mg (every 8 h) of MMPD for 4 weeks.
At the end of 4 weeks, all patients were offered 48 weeks of treatment with IFN-alfa/RBV.
The objectives of the study were to evaluate the tolerability of the IFN-alfa/MMPD combination and to evaluate whether MMPD had an on-treatment effect on HCV RNA, similar to RBV when added to IFN-alfa.
The addition of a selective IMPDH inhibitor to IFN-alfa was well tolerated, write the authors in their conclusion. Further, they state, In a low-dose range, the addition of MMPD may have the potential to add to the antiviral efficacy of IFN-alfa.
Larger, longer duration trials incorporating pegylated IFN would be required to determine whether this combination, alone or with RBV, would increase either early or sustained virological response (SVR) rates.
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