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. 2024 Mar 4;16(3):399. doi: 10.3390/v16030399

Table 3.

Virological failure (VF) and prevalence of emergent INSTI DRMs in clinical trials of ART-experienced PLWH with active virus replication receiving DTG plus 2 NRTIs.

Trial Regions Population 1 DTG-Containing Regimen 2 #
PLWH
Weeks # (%)
VF 3
# (%) Undergoing GRT # (%)
with INSTI
DRMs 4
SAILING
2013, 2015 [51,52]
Europe, North America, South America, Asia, Oceania, Africa Adults; VL ≥ 400; INSTI-naïve, ≥2-class resistance DTG + OBR 354 48 21
(5.9%)
9
(2.5%)
2
(0.6%)
DAWNING
2019, 2022 [53,54]
Europe, South America, Asia, Africa Adults; VL ≥ 400 on a first-line NNRTI-containing regimen DTG + 2 NRTIs (≥1 fully active) 312 48 11
(3.5%)
11
(3.5%)
3
(1.0%)
NADIA
2021, 2022 [55,56] 5
Uganda, Kenya, Zimbabwe Adults/Adolescents; VL ≥ 1000 on a first-line NNRTI-containing regimen DTG +
TDF/3TC or AZT/3TC
235 96 24
(10.2%)
21
(8.9%)
9
(3.8%)
ARTIST
2021, 2023 [57,58,59]
South Africa Adults; VL ≥ 400 while on a first-line NNRTI-containing regimen DTG +
TDF/3TC
135 24 21
(15.6%)
4
(3.0%)
0
(0%)
DTG BID + TDF/3TC 64 24 9
(14.1%)
3
(4.7%)
0
(0%)
IMPAACT P1093
2015, 2020, 2022
[60,61,62]
North America, South America, Asia, Africa Infants/children/adolescents with VL ≥ 1000; most ART-experienced DTG +
2 NRTIs
142 48 36
(25.3%)
36
(25.3%)
5
(3.5%)
ODYSSEY
2021, 2022
[63,64]
Europe, Asia, Africa Children and adolescents with V ≥ 500 on a 1st- or 2nd-line ART regimen DTG +
2 NRTIs
196 96 31
(15.8%)
29
(14.7%)
4
(2.0%)

1 The ODYSSEY trial enrolled 350 participants of whom 154 were ART-naïve and 196 were ART-experienced. For IMPACT P1093, the number shown includes those who were ART-experienced. 2 In NADIA, individuals were randomized 1:1 to receive TDF/3TC or AZT/3TC but the numbers undergoing GRT in each arm were not available. For ODYSSEY and IMPACT P1093, the dose of DTG was based on participant weight. 3 For SAILING, DAWNING, NADIA, IMPACT P1093, and ODYSSEY, VF was defined as a confirmed VL ≥ 400 copies/mL. For ARTIST, VF was defined as a VL ≥ 50 copies/mL. 4 Complete sequences were available only for participants in the DAWNING and IMPACT P1093 trials. For the remaining trials, the table indicates only those DRMs reported by the authors. In the SAILING trial, one individual developed the polymorphic accessory INSTI DRM V151I. After week 48, three additional persons developed DRMs including N155H, N155H + T97A, and R263K + S230R. In the DAWNING trial, four additional individuals developed INSTI DRMs during 100 additional weeks of follow-up including G118R, G118GR + E138EK + Q148QR + R263RK, G118R + T66TI, and Q148H + N155H + E138K + G140S. In IMPACT P1093, the individual with R263RK at week 48 later developed A49G, E138T, and S147G by week 136, while another developed G118R + L74M by week 168. 5 For NADIA the cumulative proportion with VF and those undergoing GRT at week 96 is shown. Among those with INSTI DRMs by week 96, 3 received TDF/3TC and 6 received AZT/3TC. Abbreviations: 3TC—lamivudine; AZT—zidovudine; ART—antiretroviral therapy; DTG—dolutegravir; DRMs—drug-resistance mutations; GRT—genotypic resistance testing; INSTI—integrase strand transfer inhibitor; NRTIs—nucleoside/nucleotide reverse transcriptase inhibitors; OBR—optimized background regimen; PLWH—people living with HIV; TDF—tenofovir disoproxil fumarate; VF—virological failure; VL—plasma virus load measured in copies/mL.