Table 4.

The association between medication exposure and time to abnormal renal lab event (RLE) resolution for three separate analyses, considering time-varying HIV disease markers and HIV disease markers at the first RLE.

Analysis set	Parameter	Unadjusted Results		Adjusted Results1
		Hazard Ratio (95% CI)	P-value	Hazard Ratio (95% CI)	P-Value
Analysis set 1: time varying CD4, RNA2	Renal toxic HAART (time-varying)	0.89 (0.6,1.3)	0.58	0.94 (0.6,1.4)	0.79
	TDF Exposure (time-varying)	0.93 (0.6,1.5)	0.78	1.06 (0.6,1.8)	0.82
	IDV Exposure (time-varying)	0.86 (0.5,1.6)	0.63	0.83 (0.5,1.5)	0.53
	Renal toxic concomitant meds (time-varying)	0.88 (0.3,2.4)	0.81	1.06 (0.4,2.9)	0.92
Analysis set 2: CD4, RNA @ RLE3	Renal toxic HAART (time-varying)	0.89 (0.6,1.3)	0.58	0.83 (0.5,1.3)	0.42
	TDF Exposure (time-varying)	0.93 (0.6,1.5)	0.78	0.77 (0.5,1.3)	0.35
	IDV Exposure (time-varying)	0.86 (0.5,1.6)	0.63	0.88 (0.4,1.7)	0.71
	Renal toxic concomitant meds (time-varying)	0.88 (0.3,2.4)	0.81	1.34 (0.4,4.3)	0.62
Analysis set 3: CD4 @ RLE4	Renal toxic HAART (time-varying)	0.89 (0.6,1.3)	0.58	0.92 (0.6,1.4)	0.68
	TDF Exposure (time-varying)	0.93 (0.6,1.5)	0.78	0.98 (0.6,1.6)	0.94
	IDV Exposure (time-varying)	0.86 (0.5,1.6)	0.63	0.87 (0.5,1.6)	0.64
	Renal toxic concomitant meds (time-varying)	0.88 (0.3,2.4)	0.81	1.04 (0.4,2.8)	0.95

^†These analyses were carried out on the primary derived dataset, formed using medication exposure observations as the framework, adding in CD4 and RNA viral load values.

¹Results adjust for the final core models, which were developed with p < 0.20 to include and p < 0.15 to remain. Each row represents a separate time to event multivariate regression analysis.

²The core model for analysis 1 included Black race, CDC Stage C, CD4% < 25 (time varying)

³The core model for analysis 2 included Black race, CDC Stage C, HIV RNA at 1^st ARL > 100,000

⁴The core model for analysis 3 included CD4% at 1^st ARL< 25