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. 2019 Aug 20;74(12):3555–3564. doi: 10.1093/jac/dkz347

Table 4.

Genotypic and phenotypic profiles of participants in the RAP

No. Treatment group Visit name Visit type HIV-1 RNA (copies/mL) Resistance substitutionsa
 Drug susceptibility (fold change from WT)b
IN RT INSTI
 NRTI
 PI
BIC DTG ABC 3TC FTC TFV ATV DRV
1 BIC/FTC/TAF baseline first <50 M50I none – – – – – – – –
week 12 lastc 928 AF AF AF AF AF AF AF AF AF AF
2 BIC/FTC/TAF baseline first 28 none K70K/R, M184M/V – – – – – – – –
week 12d lastc 2860 none M184V 0.78 0.99 3.51 >141 >95 0.54 1.01 0.79
3 BIC/FTC/TAF baseline first <50 S119T none – – – – – – – –
week 24 lastc 499 AF AF AF AF AF AF AF AF AF AF
4 BIC/FTC/TAF baseline first 159 none V106V/I – – – – – – – –
week 4 cVF 206 AF V106I AF AF 0.75 1.09 0.98 0.75 0.83 0.80
week 8 cVF 117 AF V106I AF AF 0.94 1.22 0.96 0.84 0.94 0.55
week 48 last <50 ND ND – – – – – – – –
5 BIC/FTC/TAF baseline first <50 S119P K103N – – – – – – – –
week 36 cVF 1500 AF AF AF AF AF AF AF AF AF AF
week 48 last <50 ND ND – – – – – – – –
6 Boosted PI (DRV + RTV + ABC/3TC) baseline first 6980 none V118I AF AF 0.94 1.02 1.09 0.92 0.97 0.64
week 4 lastc 874 AF L74L/V, V118I AF AF 1.22 1.17 1.35 0.85 0.86 0.80
7 Boosted PI (DRV/COBI + FTC/TDF) baseline first 99900 none V90I, M184I 0.89 0.98 2.17 >141 >95 0.50 0.64 0.47
week 8 cVF 1060 none V90I, M184I 0.84 0.88 2.31 >127 >94 0.50 0.69 0.43
week 36 lastc 171 ND ND – – – – – – – –
8 Boosted PI (ATV + RTV + FTC/TDF) baseline first <50 S119S/A/G/T K103N – – – – – – – –
week 36 cVF 1580 none K103N, E138E/Ke 0.84 0.78 1.01 1.05 1.23 0.85 0.51 0.33
week 48 cVF 982 S119S/A/G/T K103N, E138E/Ke 0.98 1.01 0.81 1.06 0.98 0.85 0.54 0.41
week 48 last 621 ND ND – – – – – – – –
9 Boosted PI (DRV/COBI + FTC/TDF) baseline first <50 none V106V/I – – – – – – – –
week 8 cVF 384 AF none AF AF 0.79 1.14 1.03 0.86 0.97 0.49
week 48 last 40 ND ND – – – – – – – –
10 Boosted PI (DRV/COBI + FTC/TDF) baseline first <50 M50M/I none – – – – – – – –
week 12 cVF 357 AF none AF AF 1.00 1.30 1.26 0.82 0.72 0.56
week 48 last 47 ND ND – – – – – – – –
11 DTG/ABC/3TC baseline first <50 AF AF AF AF AF AF AF AF AF AF
week 8 lastc 12600 none none 0.80 0.97 0.88 1.09 1.09 0.81 0.77 0.74
12 DTG/ABC/3TC baseline first <50 M50I S119R E157Q none – – – – – – – –
week 12 cVF 1200 M50I S119R E157Q none 0.54 0.64 0.68 0.84 0.96 0.62 0.73 0.40
week 48 last <50 ND ND – – – – – – – –

AF, assay failure; ATV, atazanavir; cVF, confirmed virological failure; COBI, cobicistat; ND, not determined; RTV, ritonavir; TFV, tenofovir; –, phenotypic testing not performed.

a

Resistance substitutions that emerged on study drugs are shown in bold.

b

Phenotypic fold change represents the half-maximal inhibitory concentration compared with that of the intra-assay WT control. Fold change values greater than or equal to the assay cut-off indicate resistance. Phenotypic cut-offs are 2.5 for bictegravir, 4.0 for dolutegravir, 4.5 for abacavir, 3.5 for lamivudine, 3.5 for emtricitabine, 1.4 for tenofovir (parent compound of tenofovir alafenamide), 5.2 for boosted atazanavir and 10 for boosted darunavir.

c

Early study drug discontinuation due to participant decision (1, 2, 7 and 11), adverse event (3) or non-compliance (6).

d

Bictegravir plasma concentrations were undetectable at this study visit and BIC/FTC/TAF adherence was 76% by pill count up to week 12.

e

The NNRTI resistance substitution E138K emerged at week 36, but was not associated with resistance to the current regimen.