Replies to post #157180 on Biotech Values

[mcbio]

GILD—Although extending treatment from 12w to 16w clearly helped, the SVR gap between genotype-2 and genotype-3 remained as wide as ever in the FUSION study: 94% (16w) and 86% (12w) for genotype 2 vs. 62% (16w) and 30% (12w) for genotype-3. Thus, even with 16w of treatment, genotype-2 patients did 3,200 basis points better than genotype-3 patients.

So, what's the answer for better response rates moving forward in GT3? I know this was just sofosbuvir plus ribavirin. Is it simply a matter of combining sofosbuvir with the GILD 2nd gen NS5A? Do we just need a better 2nd gen NS5A? Or do we need both a better 2nd gen nuke and a better 2nd gen NS5A?

As we know, there's a huge opportunity for anyone that can add meaningfully to GT3 treatment. This is why I think a bit more of IDIX than I did before given the prospects for their 2nd gen NS5A. Also, if there is room for a nuke to improve upon sofosbuvir in the 2nd gen HCV nuke space against GT3, that could be good news for IDIX or Medivir given their follow-on uridine nukes at the pre-clinical stage.

[oc631]

Thus, even with 16w of treatment, genotype-2 patients did 3,200 basis points better than genotype-3 patients.

This Phase 2 study of GT3 patients using an interferon-based combo is over two years old and, according to the CT website, it's still recruiting as of 12/2012.



http://www.clinicaltrials.gov/ct2/show/NCT01260350?term=sofosbuvir&rank=6




GILD denied GT2/GT3 treatment-naive and treatment-experienced patients a new interferon-based option by not advancing them into NEUTRINO.

The kind way of looking at this is GILD thought Sofo/Riba would show 100% SVR rates in all GT2/GT3 patients within the U.S. once the combo hit the market so what's the point?

Now we have sub-optimal oral results in GT3 compared to what's being seen in other genotypes. Should the FDA approve an oral combo that works in slightly more than half of GT3 patients? Would the FDA's decision be different if GT3 patients were showing 90%+ SVR rates in NEUTRINO using sofosbuvir/interferon-based therapy?