Table 6. Genotypic Resistance at Week 48 by Deep Sequencing.
| Number of Subjects (% of RAP; % of All Subjects) | |||
|---|---|---|---|
| Resistance Substitution Development | Deep Sequencing, 15% Cutoff (n=575) | Deep Sequencing, 2% Cutoff (n=575) | Population Sequencing (n=575) |
| Resistance Analysis Population (RAP) | 39 (6.8%) | ||
|
| |||
| Subjects who resuppressed HIV-1 RNA to <50 copies/mL while on study drugs | 20 (51.3%; 3.5%) | ||
|
| |||
| Subjects who did not resuppress HIV-1 RNA to <50 copies/mL while on study drugs | 19 (48.7%; 3.3%) | ||
|
| |||
| Subjects with data, of those who did not resuppress HIV-1 RNA to <50 copies/mL while on study drugs | 18 | 18 | 19 |
| Developed Resistance Substitutions to Study Drugs | 3 (16.7%; 0.5%) | 3 (16.7%; 0.5%) | 3 (15.8%; 0.5%) |
| No Change from Baseline (Primary Substitutions)a | 15 (83%; 2.6%) | 15 (83%; 2.6%) | 16 (84%; 2.8%) |
|
| |||
| Any Primary INSTI-Rb | 0 | 0 | 0 |
| E92G/Q | 0 | 0 | 0 |
| Q148H/K/R | 0 | 0 | 0 |
| N155H/S | 0 | 0 | 0 |
|
| |||
| Any NRTI-Rc | 3 (16.7%; 0.5%) | 3 (16.7%; 0.5%) | 4 (21%; 0.7%) |
| K65R | 0 | 0 | 0 |
| D67N | 0 | 0 | 1 (5.3%; 0.2%)d |
| M184V/I | 3 (16.7%; 0.5%)e | 3 (16.7%; 0.5%)e | 3 (15.8%; 0.5%)e |
|
| |||
| Any NNRTI-Rf | 1 (5.6%; 0.2%) | 1 (5.6%; 0.2%) | 0 |
| K101E | 1 (5.6%; 0.2%)g | 1 (5.6%; 0.2%)g | 0 |
|
| |||
| Any Primary PI-Rh | 0 | 0 | 0 |
No change from baseline at INSTI-R, NRTI-R, NNRTI-R, or primary PI-R sites.
Primary integrase strand transfer inhibitor resistance substitutions (INSTI-R) are T66A/I/K, E92G/Q, T97A, Y143C/H/R, S147G, Q148H/K/R, N155H/S in IN.
NRTI resistance substitutions (NRTI-R) are M41L, A62V, K65R, D67N, T69 insertions, K70E/R, L74I/V, V75I, F77L, Y115F, F116Y, Q151M, M184V/I, L210W, T215F/Y, K219E/N/Q/R in RT.
One EVG/COBI/FTC/TDF subject developed D67D/N by population sequencing, but there was no additional sample available for confirmation by deep sequencing.
Three ATV+RTV+FTC/TDF subjects developed M184V/I by population sequencing and deep sequencing.
NNRTI resistance substitutions (NNRTI-R) are V90I, A98G, L100I, K101E/H/P, K103N/S, V106A/I/M, V108I, E138A/G/K/Q/R, V179D/F/L/T, Y181C/I/V, Y188C/H/L, G190A/E/Q/S, H221Y, P225H, F227C, M230I/L in RT.
One EVG/COBI/FTC/TDF subject developed K101E by deep sequencing, at 23.1%, but this substitution was not observed by population sequencing and did not confer phenotypic resistance to any approved NNRTIs.
Primary protease inhibitor resistance substitutions (PI-R) are D30N, V32I, L33F, M46I/L, I47A/V, G48V, I50L/V, I54L/M, Q58E, T74P, L76V, V82A/F/L/S/T, I84V, N88S, L90M in protease.