Table 3.

Change From Baseline to Week 48 in Inflammation Biomarkers

Parameter	Treatment	n/N	Baseline Geometric Mean (95% CI)a	Visit to Baseline Ratio (95% CI)b	Treatment Ratio (95% CI)c	P Valued
Blood D-dimer, nmol/L FEU	DTG/3TC	334/369	1.69 (1.59, 1.79)	0.968 (.920, 1.019)	0.973 (.907, 1.044)	0.440
	TAF-based regimen	334/371	1.66 (1.58, 1.76)	0.995 (.948, 1.044)
Serum hs-CRP, mg/L	DTG/3TC	342/369	1.37 (1.23, 1.53)	1.012 (.911, 1.124)	0.934 (.811, 1.075)	0.341
	TAF-based regimen	342/371	1.30 (1.16, 1.46)	1.083 (.986, 1.190)
Serum IL-6, ng/L	DTG/3TC	343/369	1.64 (1.52, 1.78)	0.990 (.909, 1.078)	1.163 (1.045, 1.293)	0.006
	TAF-based regimen	340/371	1.67 (1.54, 1.80)	0.852 (.800, .907)
Serum sCD14, ng/L	DTG/3TC	343/369	1606.5 (1573.1, 1640.6)	0.953 (.933, .973)	0.971 (.942, 1.000)	0.048
	TAF-based regimen	343/371	1578.6 (1546.4, 1611.4)	0.982 (.962, 1.002)
Serum sCD163, µg/L	DTG/3TC	342/369	660.9 (630.5, 692.7)	0.916 (.889, .943)	1.013 (.974, 1.054)	0.508
	TAF-based regimen	342/371	642.0 (615.3, 670.0)	0.904 (.881, .927)

Abbreviations: 3TC, lamivudine; DTG, dolutegravir; FEU, fibrinogen equivalent unit; hs-CRP, high-sensitivity C-reactive protein; IL-6, interleukin-6; MMRM, mixed model repeated measures; sCD14, soluble CD14; sCD163, soluble CD163; TAF, tenofovir alafenamide.

^aGeometric mean is calculated by exponentiating the mean of log_e-transformed baselines values.

^bRatio is the estimated adjusted ratio (Week 48 to baseline) in each group calculated using MMRM applied to change from baseline in log_e-transformed data adjusting for the following: treatment, visit, baseline third agent class, CD4+ cell count (continuous), age (continuous), sex, race, body mass index (continuous), smoking status, hepatitis C virus coinfection status, log_e-transformed baseline biomarker (continuous), treatment-by-visit interaction, and baseline value-by-visit interaction, with visit as the repeated factor.

^cTreatment ratio is DTG/3TC to TAF-based regimen.

^d  P value for treatment comparison.