Hepatitis C Patients Benefit From Combination Of VX-950 And Pegylated Interferon

Main Category: Liver Disease / Hepatitis
Also Included In: Clinical Trials / Drug Trials
Article Date: 02 May 2006 - 0:00 PDT

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The experimental oral protease inhibitor VX-950, dosed in combination with pegylated interferon alfa-2a (PegasysR; peg-IFN), is potent and well tolerated in patients with chronic genotype 1 hepatitis C virus (HCV) infection, researchers announced at the 41st Annual Meeting of the European Association for the Study of the Liver (EASL).

Henk W. Reesink, MD, with the Academic Medical Center in Amsterdam, the Netherlands, reported phase 1b results in 20 patients who were treated with a tablet formulation of VX-950 at a dose of 750 mg every eight hours in combination with a standard dose of peg-IFN, the same dose of VX-950 administered alone, or a standard dose of peg-IFN alone. Patients had not undergone prior treatment with interferon and/or ribavirin.

In a 14-day study reported previously, VX-950 was well tolerated and had substantial antiviral effects. All patients had at least a 2-log decrease in viral load in two days and a decrease in median HCV RNA of 4.4-log10 at the end of dosing in the best dose group

In the present trial, the median baseline viral load for the entire cohort was 6.65 log10 IU/mL HCV RNA, or about 4.4 million IU/mL.

Results showed that the combination treatment yielded an initial median reduction in plasma HCV RNA that exceeded 3 log10 in the first two days.

Antiviral results after 14 days of dosing showed a median 5.5 log10 reduction in HCV RNA in patients receiving VX-950 and peg-IFN; six of eight patients had viral levels below the limit of quantitation (30 IU/mL) at 14 days, and four of eight also achieved viral levels below the limit of detection (10 IU/mL).

A median 4.0 log10 reduction in HCV RNA was observed in patients receiving VX-950 alone; one of eight patients had viral levels below the limit of detection (10 IU/mL).

A median 1.0 log10 reduction in HCV RNA was documented in patients receiving peg-IFN alone; no patient had viral levels below the limit of quantitation (30 IU/mL) at 14 days.

All patients completed dosing, and no serious adverse events were reported. All adverse events in the group who received VX-950 were mild.

Following the completion of this study, patients were offered a full course of treatment with peg-IFN and ribavirin.

All eight patients in the combination group opted to receive treatment with peg-IFN and ribavirin. After three months, all eight patients were shown to have undetectable levels of HCV RNA.

"The continued viral suppression during follow-on therapy points to the robustness of the viral response to VX-950 and peg-IFN and is encouraging for the design of future VX-950 studies that assess the potential for short-course, curative therapy," Dr. Reesink said.

"With a growing number of HCV patients seeking treatment as their disease progresses, there is an urgent need for improved therapies," he added.

Finally, he said that future studies will assess whether VX-950 combined with peg-IFN will permit HCV eradication with significantly shorter length of treatment.

The study was funded by Vertex Pharmaceuticals Incorporated in Cambridge, Massachusetts.

By Jill Stein
Jill Stein is a Paris-based freelance medical writer.

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