“Regimens including two or more direct antiviral agents will not be part of the SoC until 2011 because it will be difficult for companies to run clinical trials on combinations of unapproved drugs.”
The above was meant to express the opinion of the graphic creators rather than my own opinion. However, I do think it will be hard to run such combination trials despite the FDA’s nominal interest in helping them along.
Companies will be reluctant to take a chance on having their own drug tainted by a safety problem with another drug. For instance, say VRTX agreed to test VX-950 with the polymerase inhibitor from VPHM/WYE and there was some serious adverse event. Even if VX-950 were not at fault, it would set back the VX-950 development program while the FDA investigated, and VRTX’s stock price would probably take a beating.
Bottom line: many companies give lip service to running trials with combinations of unapproved drugs, but few of them are actually inclined to do so.
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