Replies to post #1291 on Enanta Pharmaceuticals Inc (ENTA)

[NY1972]

Simple screening may not be accurate.


These data suggest that frequent exposure to HCV could contribute significantly to increased viral diversity and cell tropism within an individual and might also result in variants that would not be readily detected should only serum/plasma be evaluated by a clinical HCV genotype assay and not by a robust, multicompartment sequencing approach.


http://jid.oxfordjournals.org/content/195/4/519.full

[NY1972]

Will EMA give MRK a different label? No mention of lower efficacy for GT1a patients who have high VL in FDA label.

EMA nixes “accelerated assessment” of 2-DAA* HCV regimen and will review the application on a standard timetable

above 800,000 IU/mL, the virologic failures were all over the map. one at 948k, 3 between 1-2M iu/ml, 3 between 2-4M, 3 between 4-6M, 3 w VL>6M. So unlike havoni's 8 week trial where they only saw a break point post hoc above 6M baseline VL (constituting the minority of patients), MRK will forever be dogged in the marketplace with a lower efficacy for GT1a, which will be especially pronounced for the majority of GT1a patients who don't have low viral loads. I also think this adds regulatory risk since these pts as i mentioned likely have SVRs below 90%. Recall 8 weeks of Harvoni for pts with VL >6M had 91% SVR and the label only allowed consideration of 8 weeks below this level, so what are they to do with MRK?