A phase IV, open-label three-arm study investigating the impact of a combination of tenofovir disoproxil fumarate/emtricitabine with raltegravir or dolutegravir or elvitegravir/cobicistat on renal function in HIV-1 antiretroviral naïve patients

Figures & data

Figure 1 Patients distribution.

Table 1 Baseline characteristics

(n)	Raltegravir^20	Dolutegravir^20	Elvitegravir/c^20
Age, y (range)	40 (22–58)	36 (20–56)	31 (20–52)
Female, n	1	0	2
Black or African descent, n	2	1	1
BMI (range)	25.3 (20.5–39.9)	24 (18.9–30.2)	24 (18.9–32.2)
HIV VL (cp/mL)	30’278 (5′958–113’910)	43’324 (13′369–76′273)	24’104 (11′225–50′542)
CD4+ (cells/mm3)	450	488	548
eGFR MDRD (mL/min)	109.8	114.6	115.7
eGFR CKD cystatin (mL/min)	92	101.7	109.1
RBP/creatinine	7	7	7
α1 microglobulin (mg/L)	6	5	3
β2-microglobulin (mcg/L)	101 (63–399)	117 (96–228)	72 (58–103)
Urine protein/creatinine	9 (6–10)	7 (5–8)	6 (5–8)
Fractional phosphate excretion (%)	7 (6–9.5)	8.5 (5.5–9.9)	9.1 (7.3–14.5)

Figure 2 Changes in urinary RBP/Creatinine from baseline.

Table 2 Urinary changes in tubular markers from baseline at W12, W24 and W48

RBP/Cr (μg/mmol)	BL Median (IQR)	W12	W24	W48
RAL	7 (5–8)	+1.9 (CI −2.29–6.11) p = 0.375	+ 4.7 (CI 0.43–8.98) p = 0.032	+3.3 (CI −1.05–7.65) p = 0.138
DTG	7 (6–11)	+2.17 (CI −2.07–6.43) p = 0.317	+ 4.96 (CI 0.77–9.15) p = 0.021	+ 8.67 (CI 4.35–13) p < 0.001
EVG/c	7 (5–11)	+4.47 (CI 0.23–8.70) p = 0.039	+6.95 (CI 2.53–11.36) p = 0.002	+8.19 (CI 3.92–12.45) p < 0.001
α1-microglobulin (mg/L)	BL Median (IQR)	W12	W24	W48
RAL	6 (2–13)	+3.36 (CI −2.22–8.94) p = 0.239	+6.20 (CI 0.61–11.78) p = 0.030	+2.84 (CI −2.83–8.52) p = 0.327
DTG	5 (2–9)	+5.30 (CI −0.17–10.77) p = 0.059	+6.30 (CI 0.82–11.77) p = 0.025	+6.12 (CI 0.56–11.68) p = 0.031
EVG/c	3 (2–7)	+10.41 (CI 4.85–15.98) p < 0.001	+8.15 (CI 2.67–13.62) p = 0.003	+8.55 (CI 3.07–14.02) p = 0.002
β2-microglobulin (ug/L)	BL Median (IQR)	W12	W24	W48
RAL	101 (63–399)	−51.50 (CI −473–370) p = 0.811	+31.03 (CI −356–418) p = 0.875	−46.56 (CI −475–382) p = 0.832
DTG	117 (96–228)	+91.02 (CI −292–474) p = 0.642	+434.4 (CI 34.4–834) p = 0.035	+26.18 (CI −371–423) p = 0.897
EVG/c	72 (58–103)	+253 (CI −156–663) p = 0.228	+894.1 (CI 455–1332) p < 0.001	+77.12 (CI −335–490) p = 0.715

Figure 3 Estimates of glomerular filtration with C-G, MDRD, CKD-EPI (creatinine) and CKD – EPI (creatinine and cystatin) at week 12, 24 and 48.

Figure 4 Change in weight.

Figure 5 Changes in lipids at week 24.

Sax PE, Erlandson KM, Lake JE, Mccomsey GA, Orkin C, Esser S, et al. Weight gain following initiation of antiretroviral therapy: risk factors in randomized comparative clinical trials. Clin Infect Dis. 2020;71(6):1379–1389.

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