Biotech Values

[dewophile]

addendum to the MRK data:

According to multiple outlets reporting on the presentation today baseline viral load significantly affected outcomes with 100% SVR in the low VL group and 92% high VL group (all patients/genotypes). Note the standard definition for high VL is > 800,000 IU/mL (>2 million copies virus/mL). In the MRK study 70% of patients had high viral load. I went back and checked and in the ABBV/ENTA TN sapphire 1 study 79% of patients had high VL, and there was no meaningful difference in patients with high and low viral loads ( 98% vs 96%). I should also clarify that in this study GT1a naives had 95% SVR (in their separate PEARL IV study the SVR for GT1a was 97%). Now back to MRK's GT1a problem - If you assume the # patients with high and low viral loads in the MRK study were evenly distributed by genotype* you can calculate the SVR for pts with high VL as follows:

144/157 overall, subtracting the 47/47 (30%) 100% SVR pts with low viral loads yields an SVR of 97/110 or 88%. Forget approval for a moment- how is MRK going to negotiate an exclusive contract with any payor if they have an 88% SVR for the single largest subgroup of patients in the US (ie TN GT1a w high baseline VL). I'm not surprised MRK didn't include this in their PR

*the distribution of VL of course may not be equal across genotypes but the 88% figure is likely to be a close approximation. If anyone has the full text paper in annals of internal medicine that might give the exact breakdown