Replies to post #1255 on Enanta Pharmaceuticals Inc (ENTA)

[NY1972]

How negative will FDA view grazoprevir/elbasvir on January 28, 2016?


NS5A RAVs were identified at baseline in 19 of 154 (12%) GT1a-infected patients. SVR12 was achieved in 11 of 19 (58%) of these patients compared with 133 of 135 (99%) patients without baseline NS5A RAVs. SVR12 in patients with baseline GT1a RAVs with a 5-fold or smaller shift to elbasvir was 90% (9 of 10) versus 22% (2 of 9) in patients with baseline GT1a RAVs with a greater than 5-fold shift (Appendix Table 5). An association of GT1a RAVs with virologic failure was observed only in patients with baseline viral loads greater than 800 000 IU/mL (Appendix Table 6). In 18 of 130 (14%) patients with GT1b infection and baseline NS5A RAVs, SVR12 rates were 94% (17 of 18) versus 100% (112 of 112) in those without baseline NS5A RAVs. Among the 6% (16 of 280) of GT1-infected patients with both NS3 and NS5A RAVs at baseline, SVR12 was achieved in 12 of 16 (75%) (Appendix Table 7).