PROVEN HIGH BARRIER TO
RESISTANCE IN THE LONG-
TERM^[1–3]

3DR, 3-drug regimen; 3TC, lamivudine; ABC, abacavir; BID, twice daily; CVW, confirmed virologic withdrawal; DNA, deoxyribonucleic acid; DTG, dolutegravir; FDA, United States Food and Drug Administration; FTC, emtricitabine; ITT-E, intention-to-treat exposed; NRTI, nucleoside/nucleotide reverse transcriptase inhibitor; PA-IC90, protein-adjusted 90% inhibitory concentration; PK, pharmacokinetic; QD, once daily; RNA, ribonucleic acid; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate; TP, triphosphate; XTC, emtricitabine or lamivudine. 
^* Data extracted from a systematic literature review of DTG+3TC real-world evidence. Overlap between cohorts cannot be fully excluded.^[4] 
† The reported rate reflects the sum-total of resistance cases calculated from GEMINI I and II (n=1/716, through 144 Weeks), STAT (n=0/131, through 52 Weeks), and D2ARLING (n=0/106, through 24 Weeks). ^[5–7]
‡ GEMINI I and II are two identical 148-Week, phase III, randomised, double-blind, multicentre, parallel-group, non-inferiority, controlled clinical trials testing the efficacy of DOVATO in treatment-naïve patients. Participants with screening HIV-1 RNA ≤500,000 copies/mL were randomised 1:1 to once-daily DOVATO (n=716, pooled) or DTG + TDF/FTC (n=717, pooled). The primary endpoint of each GEMINI study was the proportion of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 (ITT-E population, snapshot algorithm). In GEMINI, 0 cases of resistance were reported among participants who met protocol-defined confirmed virologic withdrawal (CVW). Participants met CVW criteria if a second and consecutive HIV-1 RNA value met any of the following: decrease from baseline in plasma HIV-1 RNA <1 log10 copies/mL, unless HIV-1 RNA <200 copies/mL, by Week 12; confirmed plasma HIV-1 RNA ≥200 copies/mL at or after Week 24; or plasma HIV-1 RNA ≥200 copies/mL after previous confirmed viral suppression to HIV-1 RNA <200 copies/mL.DTG 50 mg + 3TC 300 mg was used in the GEMINI studies.^[5,13]
§ STAT is a phase IIIb, open-label, 48-week, single-arm pilot study evaluating the feasibility, efficacy, and safety of DTG/3TC in 131 newly diagnosed HIV-1 infected adults as a first-line regimen. The primary endpoint was the proportion of participants with plasma HIV-1 RNA <50 copies/mL at Week 24.^[6]
|| D2ARLING is a randomised, open-label, phase IV study designed to assess the efficacy and safety of DTG/3TC in treatment-naïve people with HIV with no available baseline HIV-1 resistance testing. Participants were randomised in a 1:1 ratio to receive DTG/3TC (n=106) or DTG + TDF/XTC (n=108). The primary endpoint was the proportion of participants with plasma HIV-1 RNA <50 copies/mL at Week 48.^[7]
¶ The reported rate reflects the sum-total of resistance cases calculated from TANGO (n=0/369, through 196 Weeks) and SALSA (n=0/246, through 48 Weeks).^[8,9]
# TANGO is a randomised, open-label, trial testing the efficacy of DOVATO in virologically suppressed patients. Participants were randomised in a 1:1 ratio to receive DOVATO (n=369) or continue with TAF-containing regimens (n=372) for up to 200 weeks. At Week 148, 298 of those on TAF-based regimens switched to DOVATO. The primary efficacy endpoint was the proportion of subjects with plasma HIV-1 RNA ≥50 copies/mL (virologic non-response) as per the FDA Snapshot category at Week 48 (adjusted for randomisation stratification factor).^{[8,13]
††}SALSA is a phase III, randomised, open-label, non-inferiority clinical trial evaluating the efficacy and safety of switching to DTG/3TC compared with continuing current antiretroviral regimens in virologically suppressed adults with HIV. Eligible participants were randomised 1:1 to switch to once-daily DTG/3TC (n=246) or continue current antiretroviral regimens (n=247). The primary endpoint was the proportion of subjects with plasma HIV-1 RNA ≥50 copies/mL at Week 48 (ITT-E population, snapshot algorithm).^[9] 
‡‡Most NRTI-based 3DRs.^[14–16]