DTG+3TC in GEMINI-1&-2: HIV-1 replication at <50 c/mL and VL blips through 144 weeks


BACKGROUND: The GEMINI-1&-2 studies in treatment-naive adults showed DTG+3TC was non-inferior to DTG+TDF/FTC by FDA Snapshot (HIV-1 RNA <50 c/mL) at Week 144. Abbott's RealTime HIV-1 assay provides viral load (VL) from 40 to 10,000,000 c/mL, and qualitative target detected (TD) or target not detected (TND) for VL <40 c/mL. We assessed low-level viremia and 'blips' through Week 144.
METHODS: The proportion of participants with VL <40 c/mL and TND status throughout Week 144 is presented based on Snapshot analysis. Participant subgroups assessed included ITT-E population and an Observed subpopulation (ITT-E participants with VL <50 c/mL at Week 144). 'Blips' (one VL '¥50 to <200 c/mL bounded by VL <50 c/mL) were assessed from Day 1 after VL suppression to <50 c/mL, and from Weeks 48 through 144.
RESULTS: At Week 144, there were similar proportions of ITT-E participants with TND receiving DTG+3TC vs DTG+TDF/FTC by Snapshot (63% [451/716] vs 65% [465/717]), or for Observed population (77% [451/584] vs 78% [465/599]). Proportions with TND trended upward through ~Week 48 and were similar between arms at all visits (Figure 1a). Participant proportions with '¥1 'blip' through Week 144 were generally similar across arms (Figure 1b), with higher frequency in DTG+TDF/FTC participants from Day 1 to Week 144 with BL VL >100,000 c/mL or CD4+ '¤200 cells/mm3.

CONCLUSIONS: Proportions of participants with TND were similar through Week 144 in the DTG+3TC and DTG+TDF/FTC arms. The frequency of 'blips' through Week 144 was generally similar across arms when assessed early from Day 1 or from Week 48. These data continue to demonstrate the efficacy, potency, and durability of DTG+3TC in treatment-naive adults.