Table 5.
Treatment-Emergent Integrase Inhibitor (INI) Resistance Mutations at the Time of Protocol-Defined Virologic Failure (PDVF)
| Subject | Integrase Mutational Group | VF Visit | PSS | RAL Resistance–Associated Mutationsa |
DTG FC |
||
|---|---|---|---|---|---|---|---|
| Day 1 | Time of PDVF | Day 1 | Time of PDVF | ||||
| Cohort I | |||||||
| S2 | Mixture | Day 11 | 1 | G140S, Y143H, Q148H | L74I/M, E138E/A, G140S, Q148H | 6.49 | 38 |
| S6 | Other | Week 8 | 0 | Noneb | L74L/M/I, T97A, G140S, Q148H | 0.87 | 68 |
| S7 | Y143 | Week 24 | 0 | L74M, T97A, E138A, Y143R | L74M, T97A, E138A, Y143R, N155H | 0.77 | 6.58 |
| S8 | Y143 | Week 24 | 0 | L74M, T97A, Y143R | L74M, T97A, Y143R, N155H | 0.91 | 8.44 |
| Cohort II | |||||||
| S4 | Q148 + 1 | Week 16 | 2 | G140S, Q148H | T97T/A, E138E/K, G140S, Q148H, N155H | 6.23 | 93 |
| S5 | Q148 + 2 | Week 8 | 1 | E138A, G140S, Q148H | E92E/Q, T97T/A, G140S, Q148H | 6.04 | 42.32 |
| S9 | Q148 + 1 | Week 8 | 4 | G140S, Q148H | E138E/K, G140S, Q148H, N155H | 4.11 | 63 |
Abbreviations: DTG, dolutegravir; FC, fold-change in 50% inhibitory concentration; PSS, phenotypic susceptibility score; RAL, raltegravir; VF, virologic failure.
a Differences in integrase genotype between day 1 and time to PDVF are bold.
b Subject harbored virus with G140G/S and Q148Q/H at screening.