Database NACREG 1 v21feb2018

Database NACREG 1 v21feb201

Characteristics of STALWART participants at study entry and at the beginning of the extension phase.

*<p>more than one may apply.</p

Hazard Ratios for Key Events by Study Phase.

<p>Table gives number of patients experiencing an event during the indicated study period and rate per 100 patient months follow-up. HR = hazard ratio (IL-2 versus control) from a proportional hazards model stratified by region. <i>Main study</i> refers to the period from randomization to 28 February 2009, the original planned end of the study (patients at risk: 176 IL-2, 91 control). <i>Extension</i> refers to the extended follow-up phase, from 1 March 2009 through 28 February 2011 (patients at risk: 142 IL-2, 80 control). Interaction p-values shown are for treatment group by study phase interaction.</p>*<p>This reflects one additional OD event, in the control group, that was reported after the analysis and publication of the original study data.</p

CD4+ cell count response after initiating continous ART.

<p>CD4+ cell count response after initiating continous ART.</p

Demographics and D-dimer levels.

<p>(a) SMART/ESPRIT/SILCAAT; adjusted for demographics, HIV-specific variables and biomarkers of inflammation. (b) SMART/ESPRIT; as in (a) and also adjusted for co-morbidities (CVD, DM and hepatitis B/C) and eGFR. (c) SMART only; as in (b) and also adjusted for smoking, cystatin C and cholesterol levels.</p

Figure 2. D-dimer levels across age groups stratified by gender (a).

<p>(a) SMART/ESPRIT/SILCAAT; adjusted for demographics, HIV-specific variables and biomarkers of inflammation.</p

Baseline Characteristics by Dataset ESPRIT, SILCAAT and SMART Patients.

<p>*Not ascertained for patients in SILCAAT.</p><p>**Not ascertained for patients in SILCAAT or ESPRIT.</p><p>***Data available for n = 245 participants.</p><p>****Data available for n = 860 participants.</p

HIV-specific variables and D-dimer levels.

<p>(a) SMART/ESPRIT/SILCAAT (N = 9848; 821 of whom were off ART at baseline); adjusted for demographics, HIV-specific variables and biomarkers of inflammation. (b) SMART/ESPRIT (N = 6928); as in (a) and also adjusted for co-morbidities (CVD, DM and hepatitis B/C) and eGFR<b>.</b> (c) SMART (N = 4488); as in (b) and also adjusted for smoking, cystatin C and cholesterol levels.</p

Biomarkers of Inflammation and D-dimer levels.

<p>(a) SMART/ESPRIT/SILCAAT (N = 9848); adjusted for demographics, HIV-specific variables and biomarkers of inflammation<b>.</b> (b) SMART/ESPRIT (N = 6928); as in (a) and also adjusted for co-morbidities (CVD, DM and hepatitis B/C) and eGFR. (c) SMART (N = 4488); as in (b) and also adjusted for smoking, cystatin C and cholesterol levels.</p

Correlation between D-dimer and IL-6 levels*.

<p>* Plotted values refer to log₁₀ transformed levels of units of measurement based on the molecular masses of D-dimer and IL-6 (nmol/L for D-dimer and fmol/L for IL-6).</p