Switching to a NRTI-free 2 drug regimen (2DR) –a sub-analysis of the 48 weeks DUALIS study on metabolic and renal changes

Figures & data

Table 1: Baseline characteristics.

	Total	2DR: dolutegravir + boosted darunavir group	3DR: 2 nucleoside reverse transcriptase inhibitors + boosted darunavir group
Subjects total	263	131	132
Male sex	237 (90%)	115 (88%)	122 (92%)
Caucasian ethnicity	236 (90%)	118 (90%)	118 (89%)
Age, median (IQR)	48 (39–54)	47 (39–55)	48 (40–53)
MSM	182 (69%)	90 (69%)	92 (70%)
CDC stage C at time of HIV-diagnosis	70/246 (28%)	31/121 (26%)	39/125 (31%)
CD4^+-nadir < 200/ μl	102/217 (47%)	50/107 (47%)	52/110 (47%)
Time since HIV-diagnosis, median (IQR), years	7.2 (4.3–12.3)	7.0 (4.4–12.0)	7.6 (3.8–12.8)
HBsAg-negative with prior HBV-seroconversion	65/243 (27%)	31/122 (25%)	34/121 (28%)
HBsAb-positive	127 (52%)	65 (53%)	62 (50%)
HCV seropositive	13/260 (5%)	5/129 (4%)	8/131 (6%)
Baseline values
Cholesterol [mg/dl]	200.7 (93.0 to 382.0)	198.4 (107.0 to 382.0)	203.0 (93.0 to 314.0)
LDL[mg/dl]	129.3 (30.0 to 284.0)	126.8 (46.4 to 284.0)	131.9 (30.0 to 254.0)
HDL [md/dl]	48.9 (16.0 to 131.0)	48.8 (16.0 to 112.0)	49.1 (23.0 to 131.0)
Body weight [kg]	79.9 (46.0 to 155.0)	80.0 (46.0 to 155.0)	79.8 (50.0 to 127.0)
BMI [kg/m^2]	25.1 (17.9 to 55.6)	25.5 (17.9 to 55.6)	24.8 (18.1 to 35.6)
Serum creatinine [mg/dl]	0.9 (0.6 to 1.5)	0.9 (0.6 to 1.4)	0.9 (0.6 to 1.5)
Cystatin C [mg/l]	0.9 (0.6 to 1.6)	1.0 (0.6 to 1.6)	0.9 (0.6 to 1.4)
MDRD-eGFR [ml/min/1.73 m^2]	93.1 (54.6 to 157.8)	92.3 (54.5 to 141.9)	93.9 (55.2 to 157.8)
CKD-EPI Creatinine eGFR [ml/min/1.73 m^2]	94.2 (53.4 to 134.1)	94.1 (53.5 to 131.2)	94.5 (56.6 to 134.1)
CKD-EPI Creatinine-Cystatin eGFR [ml/min/1.73 m^2]	88.7 (46.0 to 128.4)	86.8 (46.0 to 124.7)	90.7 (46.6 to 128.4)
NRTI-based ART prior to baseline
FTC/TDF + DRV/r	185 (77%)	110 (84%)	94 (71%)
FTC/TAF + DRV/r	24 (9%)	11 (8%)	13 (10%)
ABC/3TC + DRV/r	32 (12%)	9 (7%)	23 (17%)

All percent data refer to the given number of subjects within the subgroups, unless otherwise stated. Abbreviations: 2DR, dolutegravir + darunavir/ritonavir; 3DR, continuation of triple therapy with 2NRTI + darunavir/ritonavir; 3 TC, lamivudine; ABC, abcavir; ART, antiretroviral therapy; BMI, body mass index; CDC, Centers for Disease Control and Prevention; DRV/r, darunavir/ritonavir; eGFR, estimated glomerular filtration rate; FTC, emtricitabine; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; HCV, hepatitis C virus; HDL, high density lipoprotein; LDL, low density lipoprotein; MSM, men who have sex with men; NRTI, nucleoside reverse transcriptase inhibitor; TDF, tenofovir disoproxil; TAF, tenofovir alafenamide.

Figure 1. Metabolic changes. 2DR, dolutegravir + darunavir/ritonavir; 3DR, continuation of triple therapy of 2NRTI + darunavir/ritonavir; BMI, body mass index; HDL, high-density lipoprotein; LDL, low-density lipoprotein.

Data sharing statement

For the time being, data sharing is not planned. On request, we will decide on sharing data on a by-case basis.