New Data Suggest Vertex's Oral Hepatitis C Virus Protease Inhibitor VX-950 May Reduce Liver Injury
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New data show that patients with genotype 1 hepatitis C virus (HCV) infection treated with VX-950, an investigational oral HCV protease inhibitor being developed by Vertex Pharmaceuticals Incorporated, rapidly achieved substantial reductions in alanine aminotransferase (ALT) levels after 14 days of treatment.
Data from a 14-day clinical study demonstrated that treatment with any one of three doses of VX-950 resulted in median serum ALT declines of 25-32 U/L in all dose groups. In the placebo group, a median 8 U/L increase was observed. Prior to treatment with VX-950, serum ALT levels were elevated in approximately 70 percent of patients in the study. In the VX-950 dose groups, 83 percent (15 of 18) of patients with elevated ALT levels at baseline (prior to treatment) had achieved normalization of ALT levels at day 14, compared to 0 percent (0 of 6) in the placebo group. Elevated ALT levels are common in HCV patients and are considered to be a marker of liver injury due to HCV infection. Mean levels of serum neopterin also were observed to decrease with VX-950 treatment in the study. Decreased neopterin levels may be a further signal of a reduction in inflammation associated with HCV infection.
A study of viral isolates from patients at baseline in a 14-day clinical study found heterogeneity among viral sequences in the HCV protease domain. In vitro analysis indicated that all baseline viral isolates were sensitive to VX-950.
"To date, data from early clinical studies have suggested that VX-950 is well-tolerated and can rapidly reduce HCV viral levels in patients over a short treatment period," said John Alam, M.D., Senior Vice President of Drug Evaluation and Approval at Vertex. "In addition, we now have evidence that treatment with VX-950 appeared to lead to a dramatic decline in markers of liver injury associated with viral infection."
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