Looks like BMY's two and half billion dollar purchase of Inhibitex was a disaster. The question is whether the heart failure in a single patient was indeed a reaction this this drug, and if it was due to this nuc, is it a problem unique this nuc or could it be a problem for the entire class?
I suspect the FDA may require stringent monitoring of cardiac function with echocardiograms in all studies involving this class of drug to answer the question. This may cause further delay of studies currently underway and allow Vertex time to 'catch up' since it will not have to redo prior studies using the nucs it is just putting into Phase 2 clinical trials.
If it is a class effect, nucs may cost Gilead $11 billion it paid to Pharmasett. The Alios licensing fees being paid by Vertex are a much more rationale amount given the risks of drug development. In the meantime Vertex may have an easier time marketing Incivek because the 'next generation drugs' are now starting to show their own respective weaknesses such as serious toxicities in this case and treatment failure (higher incidence of hep C relapse occurring six months or later after the treatment course was completed).
It is very concerning the lack of any followup data to Gilds studies. I suspect there is viral breakthrough. Interferons are so important in reducing relapse. That being said, a combination with incivek and ? maybe the best future oral combo. The hep c market isn't as big as analysts think. Its nice Vertex still has the best drug for the next 1-2 years which they can siphon the profits to fund longer lasting and needed therapies.