Table 2.

PWH with M184V treated with DTG + 3TC in real-world studies

Cohort or study	Study type	Study population	PWH on DTG + 3TC, N	M184V					Definition of VF
				PWH with M184V/I, n	M184V detection method	Time point	PWH maintaining/achieving virologic effectiveness, n or %a	PWH with VF, n
DOLULAMb (France) [33, 55]	Single-center, observational, prospective	Virologically suppressed; heavily treatment experienced	27	17	Historical RNA, 8; Sanger DNA, 2; NGS, 7	2 years	17	0	2 confirmed VL > 50 c/ml
DOLAMAb (Spain) [52]	Multicenter, observational, retrospective	Virologically suppressed	177	4c	BL genotypic test	48 week	3	1	2 confirmed VL > 50 c/ml
ODOACREd (Italy) [30]	Multicenter, observational, retrospective	Virologically suppressed	556	45	NR	48 week	NR	2	2 confirmed VL ≥ 50 c/ml or single VL ≥ 1000 c/ml
ARCA (Italy) [66]	Retrospective, observational	Virologically suppressed	126	21	Historical RNA	1 years	NR for M184V; 95% and 96% estimated probability of remaining free of VF in PWH with M184V (n = 349) and without M184V (n = 87)e	0	2 confirmed VL > 50 c/ml or single VL ≥ 200 c/ml
Galizzi (2020) [48]	Single-center, retrospective	Virologically suppressed	307	60f	Historical RNA	1.74 years (median follow-up)	NR for M184V; 97% and 97% estimated probability of remaining free of VF in PWH with M184V and without M184V	2g	Confirmed VL > 50 c/ml or single VL > 1000 c/ml
Battagin (2020) [45]	Retrospective	Virologically suppressed	61	7	Genotypic resistance test	Week 24	NR for M184V, but no PWH with M184V had VF	0	From undetectable to HIV-1 RNA > 20 c/ml

Duplicate studies have been removed

BL baseline, bPI boosted protease inhibitor, c/ml copies/ml, DTG dolutegravir, INSTI integrase strand transfer inhibitor, NGS next-generation sequencing, NR not reported, PWH people with HIV, PYFU person-years of follow-up, RPV rilpivirine, 3TC lamivudine, VF virologic failure, VL viral load

^aDefined as VL < 50 c/ml

^bStudies included in the total number of PWH treated with DTG + 3TC in studies reporting M184V data

^cOf 90 tested

^dOnly one publication from the ODOACRE cohort is presented to minimize the potential duplication of headcount from this cohort; this is not the publication used to establish the ODOACRE headcount of PWH receiving DTG + 3TC in the total number of PWH treated with DTG + 3TC in studies

^eFor the overall study population in which PWH were treated with 3TC + bPI or 3TC + INSTI

^fOf 220 tested from the population receiving DTG + 3TC or DTG + RPV

^gThree additional PWH had VF while receiving DTG + 3TC but did not have baseline resistance data available