Table 1.
Characteristics of Studies That Met All Systematic or Targeted Literature Review Criteria and Were Included in the Meta-analysis
| VF Outcomes, no./No. (%) | ||||||
|---|---|---|---|---|---|---|
| Lead Study (Cohort) | M184V/I Identification Method | PWH With Pre-Switch M184V/I, no./No. (%) | VF Time Point, Week | With M184V/I | Without M184V/I | VF Definition |
| RWE studies | ||||||
| Hocqueloux 2021 (Dat’AIDS) [13] | RNA and proviral DNA genotypes (pooling both) | 105/695 (15.11) | 24 | 1/105 (0.95) | 0/590 | 2 consecutive confirmed VL >50 copies/mL or 1 VL >200 copies/mL |
| 48 | 2/105 (1.90) | 1/590 (0.17) | ||||
| 96 | 2/105 (1.90) | 3/590 (0.51) | ||||
| Santoro 2022 (LAMRES) [14, 15] | RNA and proviral DNA genotypes | 60/712 (8.43) | 24 | 2/60 (3.33) | 10/652 (1.53) | 2 consecutive confirmed VL >50 copies/mL or 1 VL ≥200 copies/mL |
| 48 | 3/60 (5.00) | 18/652 (2.76) | ||||
| 96 | 4/60 (6.67) | 28/652 (4.29) | ||||
| Borghetti 2021 (ODOACRE) [16, 17] | Historical genotypes; does not specify RNA or proviral DNA | 48/669 (7.17)a | 24 | 0/45 | 2/406 (0.49) | 2 consecutive VL ≥50 copies/mL or 1 VL ≥200 copies/mL |
| 48 | 1/45 (2.22) | 5/406 (1.23) | ||||
| 96 | 2/45 (4.44) | 8/406 (1.97) | ||||
| Galizzi 2020 (NR) [18] | Either RNA or proviral DNA genotypes at baseline (before switch) | 47/174 (27.01)b | 24 | … | … | 2 consecutive confirmed VL >50 copies/mL or 1 VL >50 copies/mL followed by ART modification or 1 VL >1000 copies/mL |
| 48 | 2/47 (4.26) | 7/127 (5.51) | ||||
| 96 | … | … | ||||
| Hidalgo-Tenorio 2019 (DOLAMA) [19] | Baseline RNA genotype | 4/178 (2.25) | 24 | … | … | 2 consecutive VL >50 copies/mL |
| 48 | 1/4 (25.00)c | 4/147 (2.72)c | ||||
| 96 | … | … | ||||
| RWE study total VF outcomes | 24 | 3/210 (1.43) | 12/1648 (0.73) | |||
| 48 | 9/261 (3.45) | 35/1922 (1.82) | ||||
| 96 | 8/210 (3.81) | 39/1648 (2.37) | ||||
| Lead Study (Cohort) | M184V/I Identification Method | PWH With Pre-Switch M184V/I, no./No. (%) | VF Time Point, Week | VF Outcomes, no./No. (%) | VF Definition |
|---|---|---|---|---|---|
| Interventional studies | |||||
| DOLULAM [20] | RNA and proviral DNA genotypes | 17/27 (62.96) | 24 | 0/17 | VL >50 copies/mL |
| 48 | 0/17 | ||||
| 96 | 0/17 | ||||
| TANGO [10] | Proviral DNA genotype | 4/322 (1.24) | 24 | 0/4d | VL ≥50 copies/mL followed by consecutive VL ≥200 copies/mL |
| 48 | 0/4d | ||||
| 96 | … | ||||
| ART PRO [21] | Historical RNA genotype | 21/41 (51.22)e | 24 | 0/21f | VL ≥50 copies/mL |
| 48 | 0/21 | ||||
| 96 | 0/21 | ||||
| SALSA [11] | Proviral DNA genotype | 5/192 (2.60) | 24 | … | VL ≥40 copies/mL |
| 48 | 0/5 | ||||
| 96 | … | ||||
| SOLAR 3D [22] | Historical genotypes; does not specify RNA or proviral DNA | 50/100 (50.00) | 24 | … | VL ≥50 copies/mL followed by consecutive VL >200 copies/mL |
| 48 | 0/50 | ||||
| 96 | … | ||||
| Interventional study total VF outcomes | 24 | 0/42 | |||
| 48 | 0/97 | ||||
| 96 | 0/38 | ||||
Abbreviations: ART, antiretroviral therapy; NR, not reported; PWH, people with human immunodeficiency virus type 1; RWE, real-world evidence; VF, virologic failure; VL, viral load.
aCohort reference reporting the proportion with VF for individuals with M184V/I was used for analysis (n = 45 individuals with M184V/I) [17].
bAssumption: n = 60 PWH with M184V/I were reported out of N = 220 total PWH with available pre-switch genotype resistance data across 2 groups but not reported for dolutegravir plus lamivudine (DTG + 3TC) specifically. Table no. with M184V/I was calculated according to the proportion of PWH in the DTG + 3TC (n = 174) vs other group (n = 46).
cN = 151 total PWH remained on study at week 48.
dAssumption: Week 24 was not reported, but reports described no VF to week 48.
eOf the 20 PWH without known M184V/I at baseline, next-generation sequencing identified n = 7, n = 3, and n = 1 with M184I at 1%, 5%, and 20% thresholds, respectively.
fRefers to the number of PWH with historical 3TC resistance (M184V/I and/or K65R/E/N); 3 PWH with historical 3TC resistance discontinued before week 24 but had VL <50 copies/mL at time of discontinuation (2 protocol violations and 1 adverse event–related discontinuation).