Vertex’s “Prove 3″ Study “Goes Yard!” — Teleprevir Likely to Be God-Send for “Non-Responder” Hep C Patients

The top-line, here: Vertex keeps rollin’ toward an FDA approvable letter. . . .

Now, while it is true that Schering released some interesting interim data, in the SPRINT series of studies on its candidate, Boceprivir — all of that data centered on “new” Hep C patients — so-called “treatment naive” patients. That is not the bulk of the market — nor is it the bulk of the current problem. That will likely belong to Vertex’s Teleprevir (as we much earlier noted — see that link).

You see, the current problem is that a significant portion of Hep C patients are “non-responders” to all forms of current treatment (including a current FDA-approved Schering drug-products-cocktail — think canibalization, here). That is, there seemed (until Vertex’s Teleprevir) to be no drug to help them.

And so, while this is a moment of “dueling pharma-spun press releases” — with the American Association for the Study of Liver Diseases Conference in session, in San Francisco — it still seems clear that Vertex retains the lead on both efficacy, and length of remission, in the largest segment of the market — patients already living with Hep C, with prior failed treatment attempts. Per Reuters, now:

. . . .telaprevir, when combined with standard treatments, showed the potential to cut in half the 48 weeks of treatment needed with the current standard of care and with greater efficacy.

In a study known as Prove 3 with 453 patients who had failed previous treatment with pegylated-interferon and ribavirin, 52 percent of those who received telaprevir saw the virus fall to undetectable levels and remain there 12 weeks after stopping treatment, according to interim analysis of data to be presented at the American Association for the Study of Liver Diseases meeting in San Francisco next week.

The percentage with undetectable virus 24 weeks after stopping treatment will yield the critical measure known as sustained viral response (SVR).

Within the 52 percent result, the virus was undetectable in 41 percent of patients who had not responded to previous treatment and 73 percent of those who had relapsed after previous treatment.

“Efficacy in non-responders is huge. No one should have any doubt about whether this drug works,” said Jason Kolbert, an analyst with Susquehanna Financial Group. . . .