TABLE 5.
Impact of baseline Y93H alone or in combination with other variants in NS5A on treatment outcome
| Variant(s)a | SVR24 rate (%; n/N)b by study group |
|||
|---|---|---|---|---|
| M12-536 | GIFT-I |
Total | ||
| Noncirrhotic | Cirrhotic | |||
| Y93H | 100 (4/4) | 73 (8/11) | 80 (4/5) | 80 (16/20) |
| R30Q, Y93H | 100 (1/1) | |||
| L31M, Y93H | (0/1) | |||
| Q54C/H/L/R/Y, Y93H | 91 (10/11) | 100 (1/1) | ||
| P58L/S, Y93H | 100 (2/2) | |||
| Q62D/H, Y93H | 100 (2/2) | |||
| A92V, Y93H | 100 (1/1) | |||
| L28M, R30Q, Y93H | (0/1) | |||
| R30Q, Q54H/Y, Y93H | 100 (1/1) | |||
| Q54H, P58Q, Y93H | 100 (1/1) | |||
| Q54H/Y, Q62A/E/L, Y93H | 67 (2/3) | |||
| Q54H/Y, A92E/M/T/V, Y93H | 50 (1/2) | |||
| L28M, R30Q, P58S, Q62H, Y93H | 100 (1/1) | |||
| L28M, R30L, Q54H, P58L, A92V, Y93H | 100 (1/1) | |||
| Y93H/S in combination with other variants | 83 (24/29) | |||
a
List includes variants detected from patient isolates; variants may not all be linked. Variants detected by population sequencing in study M12-536 and those detected by deep sequencing (detection threshold of >15%) in the GIFT-I study are reported.
b
Patients not achieving SVR due to nonvirologic reasons, e.g., early discontinuations, missing SVR time point, etc., are excluded from the analysis. Only patients with available sequences (N) are included in the analysis. Therefore, N is less than the number of patients enrolled in the study and differs by target.