Renal safety of coformulated tenofovir/emtricitabine vs other nucleoside analogues in combination therapy in antiretroviral-naive patients aged 50 years or older in Spain: The TRIP study

Figures & data

Table 1. Baseline characteristics, stratified by baseline regimen

	Non-FTC/TDF group N = 30	FTC/TDF group N = 73	Total N = 103	p value
Age in years, median (IQR)	54.6 (51.2, 59.3)	55.1 (52.2, 59.2)	54.9 (52.1, 59.4)	0.544
Gender: males, n (%)	25 (83.3)	59 (80.8)	84 (81.6)	0.765
Place of origin, n (%)
Spain	24 (80.0)	58 (79.5)	82 (79.6)	0.413
Western Europe	1 (3.3)	5 (6.8)	6 (5.8)
Latin-America	4 (13.3)	4 (5.5)	8 (7.8)
Others/unknown	1 (3.3)	6 (8.2)	7 (5.6)
HIV transmission category, n (%)
Men who have sex with men	8 (26.7)	25 (34.2)	33 (32.0)	0.029
Heterosexual	17 (56.7)	37 (50.7)	54 (52.4)
Injection drug use	2 (6.7)	11 (15.1)	13 (12.6)
Other/undeterminated	3 (10.0)	0	3 (2.9)
Weight (kg), median (IQR)	65.5 (58.4, 80.2)	74.0 (61.0, 82.2)	70.0 (61.0, 82.0)	0.232
Weight < 60 kg, n (%)	7 (29.2)	13 (19.7)	20 (22.2)	0.339
HIV status
CDC stage C, n (%)	8 (26.7)	18 (24.7)	26 (25.2)	0.764
Nadir CD4 cell count, median (IQR)	233 (107, 334)	194 (132, 286)	198 (130, 306)	0.359
Baseline CD4 cell count, median (IQR)	317 (135, 395)	237 (135, 319)	247 (140, 350)	0.223
Baseline viral load (log), median (IQR)	4.7 (4.0, 5.7)	4.7 (4.0, 5.1)	4.7 (4.0, 5.2)	0.202
Glomerular filtration rate by CKD-EPI (ml/min/1.73 m^2), median (IQR)	93.1 (84.9, 105.3)	93.7(84.9,105.3)	93.6 (83.2,102.3)	0.542
Regimen class, n (%)
NRTIs	29 (96.7)	0
Lamivudine	16 (53.3)	1 (1.4)	29 (28.2)
Abacavir	10 (33.3)	0	17 (16.5)
Zidovudine	4 (13.3)	0	10 (9.7)
Didanosine	15 (50.0)	40 (54.8)	4 (3.9)
NNRTIs	12 (40.0)	35 (47.9)	55 (53.4)
Efavirenz	3 (10.0)	5 (6.8)	47 (45.6)
Nevirapine	12 (40.0)	31 (42.5)	8 (7.8)
PIs	5 (16.7)	19 (26.0)	43 (41.7)
Lopinavir	4 (13.3)	5 (6.8)	24 (23.3)
Fosamprenavir	2 (6.7)	5 (6.8)	9 (8.7)
Atazanavir	1 (3.3)	1 (1.4)	7 (6.8)
Darunavir	0	1 (1.4)	2 (1.9)
Saquinavir	2 (6.7)	1 (1.4)	1 (1.0)
Others			3 (2.9)
Comorbidities, n (%)
Hypertension	8 (26.7)	17 (23.3)	25 (24.3)	0.602
Coronary heart disease	4 (13.3)	0	4 (3.9)	0.005
Diabetes	4 (13.3)	6 (8.2)	10 (9.7)	0.455
Dyslipidemia	8 (26.7)	8 (11.0)	13 (12.6)	0.5
Hepatitis B coinfection	0	4 (5.5)	4 (3.9)	0.572
Hepatitis C coinfection	4 (13.3)	14 (19.2)	18 (17.5)	0.52

Note: FTC, emtricitabine; TDF, tenofovir; IQR, interquartile range; CKD-EPI, Chronic Kidney Disease Epidemiology Collaboration; NRTIs, nucleoside reverse transcriptase inhibitors; NNRTIs, non-nucleoside reverse transcriptase inhibitors; PIs, protease inhibitors.

Table 2. Evolution of glomerular filtration rate (CKD-EPI), and proportion and risk of renal events

		Among TDF/FTC users
Non-FTC/TDF vs FTC/TDF		PI vs NNRTI	LPV vs EFV
Glomerular filtration rate by CKD-EPI (ml/min/1.73 m^2)
Baseline (median)	93.1 vs 93.7	90.7 vs 95.3	89.2 vs 95.9
Month 12 (median)	105.8 vs 95.4 (p < 0.05)	94.3 vs 97.8	71.2 vs 98.9 (p < 0.05)
Renal events by 48 months of follow-up (progression to an EPI-CKD value < 60 ml/min/1.73 m^2 in subjects with baseline values >60)
Cases (n, %)	2/30 (6.7%) vs 8/72 (11.1%)	4/31 (12.9) vs 4/39 (10.3)	3/19 (15.8) vs 3/34 (8.8)
Crude HR (95% CI)	1.47 (0.31, 6.95)	1.55 (0.38, 6.36)	2.92 (0.58, 14.67)
Adjusted HR** (95% CI)	1.76 (0.35, 8.78)	2.45 (0.51, 11.69)	6.15 (0.83, 45,48)
Log rank (time to event)	0.623	0.537	0.172

Note:

* All comparisons between arms, and between baseline and month 24 were not statistically significant unless otherwise indicated.

** Adjusted by age, sex, transmission category and baseline CD4 count and viral load.

FTC, emtricitabine; TDF, tenofovir; LPV, lopinavir; EFV, efavirenz; CKD-EPI, Chronic Kidney Disease Epidemiology Collaboration; NNRTI, non-nucleoside reverse transcripase inhibitor; HR, hazard ratio; CI, confidence interval.

Figure 1. Analysis of time to renal event according to study group. EFV = efavirenz; FTC = emtricitabine; LPV/r = ritonavir-boosted lopinavir; NNRTI = non-nucleoside reverse transcriptase inhibitors; PI = protease inhibitors; TDF = tenofovir.