Vertex is hoping that one of those all-oral drug combinations will still include Incivek, even if it has to develop the cocktail itself. Last week the company announced phase 2 data for a combination of Incivek, ribavirin -- an oral medication currently taken with Incivek and Pegasys/Pegintron -- and a new medication, VX-222.
A respectable 83% of patients had undetectable virus levels after taking the three-drug combination for 12 weeks. Some of those patients are going to rebound -- two of 11 patients who reached four weeks post-treatment have relapsed -- but the data is solid enough to justify moving into a larger phase 2b trial, which will help guide the design of a phase 3 trial. If that's positive, Vertex hopes for approval by early 2015.
The worry here is that Vertex might be throwing good money into useless clinical trials if Incivek becomes obsolete. The blockbuster is a protease inhibitor, but there are plenty of next-generation protease inhibitors in development: Bristol-Myers Squibb's
Going forward, though, drugs' efficacies won't be measured individually, but as part of a cocktail. For an all-Vertex cocktail to work, the company needs VX-222 and other drugs in its pipeline to make up for any shortcomings Incivek might have versus other protease inhibitors in other cocktails.
It could happen, for sure -- I wouldn't count Vertex out just yet -- but the company might be better off ditching Incivek and partnering up with others to help get its pipeline drugs into whatever standard-of-care cocktail is eventually developed.
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