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Re: ciotera post# 163898

Friday, 07/12/2013 8:31:17 AM

Friday, July 12, 2013 8:31:17 AM

Post# of 257273

There may be rational explanations for this beyond inferring that something is wrong with Ledispavir





Just to be clear I see nothing wrong with Ledispavir use in GT1. My position is it's a safe and tolerable drug that works well in this genotype.




For instance, GILD may want to position SOF+RBV as a pan-genotypic "good-enough" regimen - why bother with tailored therapy if you can just prescribe SOF+RBV to anyone without even bothering with genotype testing?





GILD did early testing of Sofo/Riba in GT1. The combo isn't potent enough to be approved within this genotype. Even if there was a slight uptick in efficacy using longer durations of therapy this wouldn't be apparent in larger studies. The bottom line is GILD has an NS5A within their pipeline that works very well in GT1 when combined with Sofosbuvir. The Sofo/Riba study in GT1 is nothing more than a ploy. Why not test longer durations in GT2? Sofo/Riba is the choice combo within this genotype. Does GILD expect 100% 12-week SVR rates in GT2 within the real world setting?



More importantly, this may be driven by pricing considerations, especially with respect to emerging markets - there is more room for premium pricing SOF if there is no additional cost of LED or Peg-IFN.






GILD isn't planning on pushing into emerging markets with Sofosbuvir at this point in time. It's hard to defend GT1 Sofo/Riba use anywhere in the world. By adding interferon SVR rates could be boosted well over 90% in all genotypes.

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