Table 4.
Treatment‐emergent, resistance‐associated substitutions in patients who experienced virologic failure in studies M12‐536 and GIFT‐II
| M12‐536, n/N a | GIFT‐II, n/N a | |||||||
|---|---|---|---|---|---|---|---|---|
| GT | Target | Treatment‐emergent substitution | 25/100/100 mg b | 25/150/100 mg b | 12 wk, TN | 12 wk, TE | 16 wk, TN | 16 wk, TE |
| 2a | NS3 | Any c | 2/2 | NA | 1/3 | 1/3 | 2/2 | 1/1 |
| Y56H, D168V | 1/2 | 1/3 | ||||||
| D168A/E/Y | 1/2 | 1/3 | 2/2 | 1/1 | ||||
| 2a | NS5A | Any c | 0/2 | NA | 2/3 | 0/3 | 2/2 | 1/1 |
| F28S | 1/3 | 2/2 | ||||||
| K30M | 1/3 | |||||||
| T24A, L31I/V | 1/1 | |||||||
| 2a | NS3 + NS5A | Any c | 0/2 | NA | 1/3 | 0/3 | 2/2 | 1/1 |
| 2b | NS3 | Any c | 6/6 | 5/5 | 5/7 | 8/8 | 2/2 | 9/9 |
| D168A/F/H/L/N/P/S/T/V/Y | 6/6 | 5/5 | 5/7 | 8/8 | 2/2 | 9/9 | ||
| 2b | NS5A | Any c | 6/6 | 4/5 | 6/7 | 7/8 | 2/2 | 8/9 |
| L28F | 3/6 | 1/5 | 4/7 | 3/8 | 4/9 | |||
| M31V | 1/5 | 1/8 | ||||||
| C92Y | 1/8 | |||||||
| Y93H | 1/6 | 1/7 | ||||||
| L28F, C92S/Y | 1/6 | 1/5 | 1/8 | |||||
| L28F, M31I | 1/5 | 2/2 | 3/9 | |||||
| L28F, M31V | 1/6 | 1/8 | ||||||
| M31V, C92S | 1/7 | |||||||
| M31V, Y93H | 1/9 | |||||||
| 2b | NS3 + NS5A | Anyc | 6/6 | 4/5 | 4/7 | 7/8 | 2/2 | 8/9 |
GT, genotype; NA, not applicable as there were no GT2a VFs in the study arm; TN, treatment‐naïve; TE, treatment‐experienced to an IFN‐containing regimen (IFN alpha, beta, or pegIFN) with or without RBV.
n = number of patients with the treatment‐emergent substitution, N = total number of patients who experienced VF in the designated study Arm. Patients without cirrhosis or with compensated cirrhosis who experienced VF are included in the analysis.
Patients in study M12‐536 received OBV/PTV/r for 12 weeks, and all patients were treatment‐experienced to pegIFN/RBV.
Number of patients with any treatment‐emergent substitution at signature resistance‐associated amino acid positions in the designated target.