Table 4.
Treatment Regimens/Dosing | Design | Study Population | Virologic Suppression (HIV-RNA ≤50 copies/mL) | Virologic Failure | Treatment- Emergent RAMs |
---|---|---|---|---|---|
DTG 50 mg + 3TC 300 mg QD (n = 94)54 | Prospective, clinical, observational, trial | ART-experienced × ≥6 months duration with baseline HIV-RNA <50
copies/mL PI based: 28.8% NNRTI based: 57.4% INSTI based: 17% |
Week 24: 100% | None | None |
ASPIRE: DTG 50 mg + 3TC 300 mg QD (n = 44) versus continue ART (n = 45)56 | Open label, randomized, multicenter, clinical trial | ART-experienced × ≥ 48 weeks duration with baseline HIV-RNA <50
copies/mL PI based: 33% versus 32% NNRTI based: 33% versus 27% INSTI based: 33 versus 41% |
Week 24: 93.2% versus 91.1% (95% CI: 11.2 to 15.3%, P =
.71) Week 48: 90.9% versus 88.9% (95% CI: −12.6 to 16.5%, P = .76) |
Week 48: 0% versus 3% | None |
ANRS 167: DTG 50 mg + 3TC 300 mg QD55 | Noncomparative, open label, single arm, multicenter study with 2
phases Phase 1: Third agent replaced with DTG 50 mg QD plus current NRTI backbone (n = 110) Phase 2: DTG 50 mg + 3TC 300 mg QD for 48 weeks (n = 104) |
ART-experienced × ≥2 years duration with baseline HIV-RNA <50 copies/mL | Week 48: 97% | 3% | None |
Abbreviations: 3TC, lamivudine; ART, antiretroviral therapy; CI, confidence interval; DTG, dolutegravir; INSTI, integrase strand transfer inhibitor; NRTI, nucleoside/nucleotide reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor; PLWH, people living with HIV; RAM, resistance-associated mutation; QD, once daily.