TABLE 2.
Treatment-emergent NS3 substitutions in patients who did not achieve SVR in phase 2 and phase 3 studiesa
| Frequency of NS3 amino acid variants in non-SVR patientsb | Amino acid variant (%) after treatment with FDV plus PRc |
|
|---|---|---|
| HCV GT-1a (507 patients) | HCV GT-1b (349 patients) | |
| ≥10% | R155K (88.0) | D168V (67.3) |
| D168V (10.3) | R155Qd (14.6) | |
| 1% to <10% | D168E (3.4) | R155K (8.6) |
| D168A/T (7.4) | ||
| D168Ne (7.2) | ||
| S61Lf (6.9) | ||
| D168I (5.7) | ||
| D168E (4.9) | ||
| D168H (2.6) | ||
| D168Y (1.4) | ||
| <1% | D168A/Ne/Y/Ig/T | |
| R155T/S | R155C/Rh or G/Rh | |
| D168 ambiguous mixtures with F | D168 ambiguous mixtures with L/F/K or P | |
Pooled data for the SVR24 endpoint were from phase 2 studies (SILEN-C1 to -3) and those for the SVR12 endpoint were from phase 3 studies (STARTVerso1 to -4). SVR, sustained virologic response.
Amino acids reported are those at positions associated with resistance to faldaprevir (NS3 155 or 168), detected alone or in combination with other substitutions (includes mixtures) among any post-baseline virology sample that was sequenced per patient including, but not limited to, the first virologic failure sample. Substitutions are listed in the order of their prevalence.
FDV, faldaprevir; PR, pegylated interferon/ribavirin; GT, genotype.
R155Q was detected only as a predominant variant with D168V/N/T/I substitutions and otherwise detected in R155K/Q/R or Q/R mixtures.
D168N was detected only as a predominant variant with R155Q and otherwise in D168D/N or complex D168 mixtures.
Only detected as a mixture with D168V variants.
Only detected in complex mixtures of D/I/N/V or A/I/T/V.
Only detected as a mixture with wild-type amino acid in one patient.