12:00 AM
Nov 11, 2013
 |  BioCentury  |  Product Development

Cosmic salvation

Why J&J says Q80K mutation shouldn't limit simeprevir in all-oral HCV combos

Simeprevir's commercial potential in HCV would look to be limited after Johnson & Johnson agreed with FDA that genotype 1a patients should be screened for the Q80K polymorphism, a cohort where the pharma's drug did not produce a robust response as part of an interferon regimen.

But J&J also argues the effect is interferon-specific, and that additional data show the company's protease inhibitor still could be used in all-oral, IFN-free combinations.

At an Oct. 24 meeting of FDA's Antiviral Drugs Advisory Committee, the agency presented a subgroup analysis of pooled data from two Phase III trials in treatment-naïve genotype 1 patients. Subjects with the Q80K polymorphism who were treated with simeprevir plus IFN/ribavirin had an SVR12 rate of 58% vs. 55% for patients receiving IFN/ribavirin alone (see "Sorting out HCV," A8).

Patients with genotype 1a infection but without the polymorphism had an 84% SVR12 rate in the simeprevir plus IFN/ribavirin cohort...

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