TABLE 5.
Dose QD (mg) and patient | Visit day | EC50 (pM) | Fold resistancea | Treatment-emergent variants at signature resistance-conferring amino acid positions in NS5A (% frequency)b |
||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Multiple variants | M28 |
Q30 |
Y93 |
|||||||||
T | V | E | R | C | H | N | S | |||||
5 | ||||||||||||
1 | 3 | 19.4 | 41 | 100 | ||||||||
6 | 46.2 | 98 | 26 | 31 | 30 | |||||||
2 | 3 | 1.7 | 2.7 | 21 | 8 | |||||||
6 | 2.3 | 3.7 | 15 | 6 | ||||||||
25 | ||||||||||||
3 | 3 | 12.2 | 18 | 16 | 24 | 37 | 15 | |||||
6 | 24.5 | 36 | 16 | 52 | 14 | |||||||
50 | ||||||||||||
4 | 3 | 75.8 | 105 | 46 | 22 | 5 | 16 | |||||
6 | 254 | 353 | 49 | 13 | 25 | 5 | ||||||
5 | 3 | 180 | 219 | 62c | 10 | 22 | ||||||
6 | 333 | 406 | 44c | 11 | 39 | |||||||
200 | ||||||||||||
6 | 6 | 1,477 | 2,238 | 65 | 22 | 8 | ||||||
7 | 3 | 103 | 198 | 18 | 21 | 17 | 19 | |||||
6 | 482 | 927 | 40 | 35 | 6 | 6 | ||||||
8 | 3 | 963 | 2,006 | 34 | 55 | 5 | ||||||
6 | 892 | 1,858 | 40 | 50 | 5 |
Fold change in EC50 of ombitasvir in samples from day 3 or day 6 relative to the EC50 in the respective baseline sample.
Variants observed in ≥5% of the clones are shown.
Q30L + Y93H was the major double variant, and Q30L + Y93S was the minor variant.