Table 3.
Treatment-emergent Drug Resistance, Week 48
| DOR/3TC/TDF (N = 364) | EFV/FTC/TDF (N = 364) | |||||
|---|---|---|---|---|---|---|
| PDVFa | Discontinued Without PDVF | Total | PDVFa | Discontinued Without PDVF | Total | |
| Number (%) of participants, n (%) | 22 (6.0) | 35 (9.6) | 57 (15.7) | 14 (3.8) | 50 (13.7) | 64 (17.6) |
| Genotype test reported, n (%) | 13 (3.4) | 9 (2.5) | 22 (6.0) | 10 (2.5) | 13 (3.4) | 23 (6.3) |
| Phenotype test reported, n (%) | 13 (3.4) | 9 (2.5) | 22 (6.0) | 9 (2.5) | 12 (3.3) | 21 (5.8) |
| Genotypic NNRTI resistance, n (%) | 7 (1.9) | 0 | 7 (1.9) | 9 (2.5) | 3 (0.8) | 12 (3.3) |
| Phenotypic NNRTI resistance, n (%) | 6 (1.6) | 0 | 6 (1.6) | 8 (2.2) | 3 (0.8) | 11 (3.0) |
| Genotypic NRTI resistance, n (%) | 5 (1.4) | 0 | 5 (1.4) | 5 (1.4) | 0 | 5 (1.4) |
| Phenotypic NRTI resistance, n (%) | 5 (1.4) | 0 | 5 (1.4) | 4 (1.1) | 0 | 4 (1.1) |
| Specific NNRTI resistance mutations detected | Y188L; Y318Y/F; V106I, F227C; V106V/I, H221H/Y, F227C; F227C; V106A, P225H, Y318Y/F; V106M/T, F227C/R | K103N; K103N, E138E/G; K103N; K103N; G190E; K103N; K103N, M230L; G190E; K103N, V108V/I, T369T/A/I/V; K103N; K103N; K101K/N, K103N, P225P/H | ||||
| Specific NRTI resistance mutations detected | M41L, M184V; M184V; M184V; K65R; K65K/R, M184V | V118I, M184V; M184V; M184V; M184V, K219K/E; K65K/R, M184M/I | ||||
Abbreviations: DOR/3TC/TDF, doravirine at 100 mg, lamivudine at 300 mg, and tenofovir disoproxil fumarate at 300 mg; EFV/FTC/TDF, efavirenz at 600 mg, emtricitabine at 200 mg, and tenofovir disoproxil fumarate at 300 mg; NNRTI, non-nucleoside reverse-transcriptase inhibitor; NRTI, nucleoside reverse-transcriptase inhibitor; PDVF, protocol-defined virologic failure.
aPDVF was defined as either confirmed HIV-1 RNA of ≥50 copies/mL after initial response of HIV-1 RNA of <50 copies/mL at any time during the study; confirmed HIV-1 RNA of ≥200 copies/mL at week 24 or week 36; or confirmed HIV-1 RNA of ≥50 copies/mL at week 48.