Merck Touts 35% SVR In Non-Responders (Small Study), But Incivek® Reaches 65% In Analogous Non-Responders (Larger Study)


Whitehouse Station is hoping to make a splash at the 62nd Annual Meeting of the American Association for the Study of Liver Diseases, in San Francisco, this coming week — with some putative Victrelis® (boceprevir) Hep C news.

The difficulty — for Merck’s marketing mavens — is that in essentially analogous/head to head interim trial outcomes, Vertex’s Incivek® (telaprevir) comes out WAY ahead, in treating Hep C non-responders. And the IMS data shows that prescribing physicians are now well-aware of the vastly differential efficacy, betwen the two competitors — thus:

. . . .Vertex — Incivek — Study 111 (ILLUMINATE)

This randomized, open-label trial was designed to compare SVR rates in 540 subjects achieving eRVR who were treated with Incivek for 12 weeks in combination with Peg-IFN-alfa-2a/RBV for either 24 weeks (T12/PR24 regimen) or 48 weeks (T12/PR48 regimen). The SVR rate for all subjects enrolled in the trial was 74%. A total of 352 (65%) subjects achieved eRVR and of those 322 (60%) were randomized to 24 weeks (T12/PR24, n=162) or 48 weeks (T12/PR48, n=160) of treatment. The SVR rates were similar at 92% (T12/PR24) and 90% (T12/PR48), respectively. Sixty-one (11%) of subjects had cirrhosis at baseline. Among these subjects, 30 (49%) achieved an eRVR: 18 were randomized to T12/PR24 and 12 to T12/PR48. The SVR rates were 67% (12/18) for the T12/PR24 group and 92% (11/12) for the T12/PR48 group. African Americans comprised 14% of study subjects. . . .

[And, the roughly-analogous Merck Victrelis interim results, trumpeted Friday:]

In the interim results of the PROVIDE study, approximately one-third of the patients who had a null response to prior peginterferon alfa and ribavirin therapy and failed treatment were able to achieve a sustained virologic response when retreated with VICTRELIS in combination therapy,” said John M. Vierling, M.D., F.A.C.P, professor of Medicine and Surgery at the Baylor College of Medicine in Houston, Texas, director of Baylor Liver Health and Chief of Hepatology, who presented the PROVIDE data. . . .

Vertex’s therapy (according to both companies, and IMS data to date) is outselling Merck’s, at about a 9-to-1 rate, thus far in 2011 — making Incivek the most successful launch in the history of pharma. Wow. Thanks, again, Fred. [Fred Hassan, the Ex-CEO of Schering-Plough (which he sold to Merck), touted boceprevir as one of his “five stars” — for the future of Merck/Schering-Plough. Not. So. Much, eh?]

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