Table 5.
Real-life experiences of switch to dolutegravir/lamivudine two-drug regimens in virologically suppressed HIV-1 patients.
| Study | Design | SubjectsN | Previous Failures Allowed | Latest Follow-up (Weeks) | HIV-RNA <50 copies/mL (%) | No. of VF e | Emerging RAMs g | Baseline M184V/I Role in Failure |
|---|---|---|---|---|---|---|---|---|
| MAGGIOLO, 2017 [73] | Prospective, multicenter, cohort study | 94 | Yes a | 24W | 100% (ITTe) | 0 | No role | |
| BORGETTI, 2018 [74] | Retrospective, single-centre, cohort study | 206 | Yes | 96W | 80.5% b | 4 f | - | - |
| BALDIN, 2019 [75,76] | Retrospective, single-centre, cohort study | 221 | Yes | 144W | 95.3% b | 5 f | No | - |
| BORGHETTI, 2019 [62] | Retrospective, single-centre, cohort study | 183 | Yes | 96W | 92.6% b | 3 f | - | - |
| CICCULLO, 2019 [77] | Retrospective, multicenter, cohort study | 229 | Yes | 96W | 95.3% b | 6 f | No | - |
| DOLAMA [78] | Retrospective, multicenter, cohort study | 177 | No | 48W | 83.6% (ITTe), 97% (PP) | 5 | No | Yes h |
| LOMBARDI, 2019 [79] | Retrospective, multicenter, cohort study | 67 | Yes | 48W | 100% (PP) | 0 | No role | |
| ART-PRO [80] | Non-randomized, single-arm, pilot phase IIa clinical trial | 41 | Yes | 48W | 92.7% (ITTe), 100% (PP) | 0 | No role | |
| BALDIN, 2020 [81] | Retrospective, multicenter, cohort study | 350 | Yes | 24W | 95.5% c | 1 | - | - |
| BATTAGIN, 2020 [82] | Retrospective, single-centre, cohort study | 61 | Yes | 24W | 96.7% (ITTe) | 2 | - | No role |
| GAGLIARDINI, 2020 [83] | Retrospective, multicenter, cohort study | 966 | Yes | 96W | 76.8% b | 18f | - | No role |
| GALIZZI, 2020 [23] | Retrospective, single-centre, cohort study | 307 | Yes | 96W | 92.9% b | 17 f | NRTI: M41L (N = 1) | No role |
| MAGGIOLO, 2020 [84] | Prospective, multicenter, cohort study | 218 | No a | 192W | 100% b | 0 | No role | |
| URBAN [15] | Prospective, multicenter cohort study | 282 | Yes | 24W | 94% d | 2 | No | - |
a Patients were not included if they had a viral failure following their last genotypic test. b Proportion of patients free from virological failure. c Probability of maintaining the study regimen. d effectiveness set (missing = excluded). e Leading to dual-therapy discontinuation. f Calculated on overall person-years of follow-up. g Only patients with available baseline and failure genotypic resistance tests. h Reduced efficacy only in patients with prior viral suppression <96 months. “-” = information not available; ITTe = intention-to-treat exposed analysis; NRTI = nucleoside analog reverse-transcriptase inhibitor; PP = per-protocol analysis; RAMs = resistance-associated mutations; VF = virological failure.