Switching to Dolutegravir/Lamivudine Two-Drug Regimen: Durability and Virologic Outcomes by Age, Sex, and Race in Routine US Clinical Care

Figures & data

Table 1 Study Population Characteristics at the Time of Switch to DTG/3TC 2DR in the OPERA Cohort (N = 787)

	n (%) or Median (IQR)
Prior ART regimen
DTG/ABC/3TC	421 (54)
BIC/TAF/FTC	240 (30)
DTG + TAF/FTC	126 (16)
Age (years)
<50	490 (62)
≥50 to <65	261 (33)
≥65	36 (5)
Female	128 (16)
Race
Asian	20 (2)
Black	250 (32)
White	447 (57)
Other	34 (4)
Unknown	36 (5)
CD4 cell count (cells/µL)	738 (569, 932)
History of AIDS	149 (19)
Years since HIV diagnosis	5.8 (2.5, 14.3)
HBV co-infection	19 (2)
Any comorbidity^a actively managed in past 12 months	422 (54)
Ryan White/ADAP program^b beneficiary	252 (32)

Notes: ^aAutoimmune disease, cardiovascular disease, invasive cancers, endocrine disorders, mental health disorders, liver disease, bone disorders, peripheral neuropathy, renal disease, hypertension, substance abuse, COVID-19. ^bThe Ryan White HIV/AIDS Program helps low-income people with HIV receive medical care, medications and essential support services to help them stay in care. ADAP provides FDA-approved medications to low-income people with HIV who have limited or no health insurance. ADAP funds can also be used to buy health insurance for eligible clients and provide services that improve drug treatments.

Abbreviations: 3TC, lamivudine; ABC, abacavir; ADAP, AIDS Drug Assistance Program; BIC, bictegravir; DTG, dolutegravir; FTC, emtricitabine; IQR, interquartile range; TAF, tenofovir alafenamide.

Table 2 Incidence of Virologic Outcomes Among Individuals Who Switched to DTG/3TC 2DR and Have ≥1 Follow-Up Viral Load, Compared Across Strata of Age, Sex, and Race

	Loss of Virologic Control^a			Confirmed Virologic Failure^b
	n (%)	IR per 100 Person-Years (95% CI)	IRR (95% CI)	n (%)	IR per 100 Person-Years (95% CI)	IRR (95% CI)
Overall, N=696	118 (17)	14.0 (11.7, 16.8)	NA	≤5^c	0.4 (0.2, 1.1)	NA
Age <50 years, N=432	72 (17)	13.8 (11.0, 17.4)	Reference	≤5^c	0.5 (0.2, 1.6)	Reference
Age ≥50 years, N=264	46 (17)	14.4 (10.8, 19.2)	1.04 (0.72, 1.51)	≤5^c	0.3 (0.0, 2.0)	0.55 (0.06, 5.31)
Male sex, N=582	94 (16)	13.3 (10.9, 16.3)	Reference	≤5^c	0.5 (0.2, 1.4)	Reference
Female sex, N=114	24 (21)	17.7 (11.9, 26.4)	1.33 (0.85, 2.08)	0	0	NA
Non-Black race, N=481	77 (16)	13.0 (10.4, 16.3)	Reference	≤5^c	0.2 (0.0, 1.1)	Reference
Black race, N=215	41 (19)	16.4 (12.1, 22.3)	1.26 (0.86, 1.84)	≤5^c	1.1 (0.3, 3.3)	7.00 (0.73, 67.30)

Notes: Incidence rates and incidence rate ratios were estimated using univariate Poisson regression. ^aFirst viral load ≥50 copies/mL. ^b2 consecutive viral loads ≥200 copies/mL, or regimen discontinuation after 1 VL ≥ 200 copies/mL. ^cHIPAA regulations require the masking of cells with 1 to 5 individuals.

Abbreviations: CI, confidence interval; IQR, interquartile range; IR, incidence rate; IRR, incidence rate ratio; N, number; NA, not applicable.

Table 3 Duration of Follow-Up and Incidence of Regimen Discontinuation Among Individuals Who Switched to DTG/3TC 2DR, Compared Across Strata of Age, Sex, and Race

	Months of Follow-Up	DTG/3TC Discontinuation
	Median (IQR)	n (%)	IR per 100 Person-Years (95% CI)	IRR (95% CI)
Overall, N=787	13.6 (8.2, 22.3)	170 (22)	17.5 (15.0, 20.3)	NA
Age <50 years, N=490	13.7 (8.8, 22.2)	104 (21)	17.0 (14.0, 20.6)	Reference
Age ≥50 years, N=297	13.5 (7.5, 22.3)	66 (22)	18.2 (14.3, 23.2)	1.07 (0.79, 1.46)
Male sex, N=659	13.6 (8.3, 22.4)	146 (22)	17.9 (15.2, 21.0)	Reference
Female sex, N=128	13.6 (7.6, 21.3)	24 (19)	15.3 (10.2, 22.8)	0.85 (0.55, 1.31)
Non-Black race, N=537	13.3 (7.9, 21.3)	118 (22)	17.4 (14.6, 20.9)	Reference
Black race, N=250	13.3 (7.9, 21.3)	52 (21)	17.5 (13.4, 23.0)	1.00 (0.72, 1.39)

Note: Incidence rates and incidence rate ratios were estimated using univariate Poisson regression.

Abbreviations: 3TC, lamivudine; CI, confidence interval; DTG, dolutegravir; IQR, interquartile range; IR, incidence rate; IRR, incidence rate ratio; N, number; NA, not applicable.