Table 1.
| Demographic/clinical characteristic | Three-drug ART regimen(‘lower IL-6’) | Two-drug ART regimen(‘higher IL-6’) |
|---|---|---|
| TANGO study | ||
| N | 372 | 369 |
| Median (range) age, years | 39 (18–73) | 40 (20–74) |
| Male, n (%) | 339 (91) | 344 (93) |
| Median (range) CD4+ cell count, cells/mm3 | 720 (119–1,810) | 682 (133–1,904) |
| ART regimens, n | ||
| TAF-based | 372 | – |
| DTG/3TC | – | 369 |
| AIR study | ||
| N | 90b | 58b |
| Mean (SD) age, years | 37 (9) | 40 (11) |
| Male, n (%) | 78 (87) | 50 (86) |
| Median (IQR) CD4+ cell count, cells/mm3 | 300 (151–373) | 259 (112–382) |
| ART regimens, n (%) | ||
| PI-based | ||
| ABC+3TC+bDRV | 7 (7.8) | – |
| TDF+F+bDRV | 30 (33.3) | – |
| ABC+3TC+LPVr | 1 (1.1) | – |
| F+TDF+ATVr | 2 (2.2) | – |
| F+TAF+DRVc | 2 (2.2) | – |
| 3TC+bATV | – | 2 (3.5) |
| 3TC+bDRV | – | 13 (22.4) |
| INSTI-based | ||
| ABC+3TC+DTG | 24 (26.7) | – |
| ABC+3TC+RAL | 7 (7.8) | – |
| F+TAF+EVGc | 4 (4.4) | – |
| F+TDF+EVGc | 4 (4.4) | – |
| F+TDF+DTG | 2 (2.2) | – |
| F+TDF+RAL | 7 (7.8) | – |
| DTG+3TC | – | 7 (12.1) |
| DTG+RPV | – | 36 (62.1) |
| ART regimen | ||
| Analysis of SMART, ESPRIT, and SILCAAT studies | ||
| N | 3,766 | |
| Median age, years | 42 | |
| Female, % | 21 | |
| Median CD4+ cell count, cells/mm3 | 500 | |
3TC, lamivudine; ABC, abacavir; ATVr, atazanavir/ritonavir; bATV, boosted atazanavir; bDRV, boosted darunavir; DRVc, darunavir/cobicistat; DTG, dolutegravir; EVGc, elvitegravir/cobicistat; F, emtricitabine; IL-6, interleukin-6; LPVr, lopinavir/ritonavir; RAL, raltegravir; RPV, rilpivirine; SNAE, serious non-AIDS event; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.
aModel outputs were based on results from TANGO (N=741), the basis for the IL-6 distribution for the first three years, and results from the AIR study (N=148), which determined the distribution of patients across IL-6 health states during the following 3 years. While TANGO and AIR were adopted to distinguish between two- and three-drug ART regimens in terms of IL-6 progression, Grund et al., 2016 (8) (n=934, 949, 939, and 949 for IL-6 quartiles 4 [highest], 3, 2 and 1 [lowest], respectively) was adopted to inform the likelihood of SNAEs, conditional on IL-6 levels; bIndividuals selected with ≥3 stored plasma samples for analysis after HIV RNA suppression.