Vertex Drug Shows Quick Results in Tough Hepatitis C Patients

Vertex Drug Shows Quick Results in Tough Hepatitis C Patients

Posted by Jacob Goldstein

The experimental drug telaprevir for hepatitis c looks promising for patients who have failed existing treatments, researchers are reporting.

The data are from an early analysis of a rather small study (72 patients) with no control group. So it’s way too soon to say whether the drug, which inhibits an enzyme needed for the virus to reproduce, will work for patients over the long haul.

Still, the early results, being presented today at a liver conference in Milan, do look pretty good: 83% of patients showed a response to the drug after four weeks, and the benefit appeared to persist for those patients who have reached the eight- and 12-week milestones.

But the true test won’t come for a while yet, when researchers see whether patients get a “sustained viral response” from the drug, which is defined as having viral levels below a set threshold 24 weeks after going off of treatment.

If the data do hold up, it will be a big deal, because about half of all hep c patients fail the standard treatment, and no existing treatments have shown much success for those patients.

At the end of March, the market got excited when the company released the four-week data that formed the core of today’s presentation. Vertex’s share price jumped by more than 20% in a single day, and it’s stayed high (as the chart at right shows).

“It’s the first time we’re seeing promising antiviral data in the treatment-failure population,” Vertex’s chief commercial officer Kurt Graves told the Health Blog.

Graves said interim data will soon be a available from a separate, larger study of similar patients, but he wouldn’t give a timetable for possible FDA approval. “It’s too early for us to speculate about what happens at the FDA level,” he said. “Until we have all the data in our hands, we don’t want to set that expectation