Supplementary Table 2: Changes in lipids in trials comparing rilpivirine (RPV)-based regimens with other antiretroviral therapies (ART).
|
Study |
RPV group |
Comparator [p value*] |
|
Treatment -naive patients |
||
|
TMC278-C204 Pozniak 2010 [33] |
96-week (RPV 25 mg/day arm) Change from BL (mg/dL), mean (SD) Total cholesterol: 10 (28) HDL cholesterol: 6 (10) Total/HDL cholesterol: -0.4 (1.3) LDL cholesterol: 5 (25) Triglycerides: -8 (75) |
96-week Change from BL (mg/dL), mean (SD) Total cholesterol: 34 (31) HDL cholesterol: 11 (12) Total/HDL cholesterol: -0.1 (0.9) LDL cholesterol: 18 (28) Triglycerides: 29 (87) |
|
ECHO & THRIVE Molina 2011 [3] (ECHO week 48 results) Cohen 2011 [4] (THRIVE week 48 results) Cohen 2013 [5] (ECHO & THRIVE week 96 results) |
48-week ECHO Change from BL (mmol/L), mean (95% CI) Total cholesterol: 0.03 (-0.06, 0.11) HDL cholesterol: 0.07 (0.04, 0.10) Total/HDL cholesterol: -0.14 (-0.33, 0.05) LDL cholesterol: -0.04 (-0.10, 0.03) Triglycerides: -0.10 (-0.19, -0.01) 48-week THRIVE Change from BL (mmol/L), mean (95% CI) Total cholesterol: 0.08 (-0.01, 0.16) HDL cholesterol: 0.11 (0.08, 0.13) Total/HDL cholesterol: -0.36 (-0.48, -0.25) LDL cholesterol: -0.02 (-0.09, 0.05) Triglycerides: -0.07 (-0.17, 0.04) 96-week ECHO & THRIVE Change from BL (mmol/L), mean (95% CI) Total cholesterol: 0.12 (0.06-0.18) HDL cholesterol: 0.11 (0.09-0.13) Total/HDL cholesterol: NA LDL cholesterol: 0.03 (-0.02, 0.08) Triglycerides: -0.07 (-0.15, 0.005) |
48-week ECHO Change from BL (mmol/L), mean (95% CI) Total cholesterol: 0.63 (0.53, 0.73) [p < 0.0001] HDL cholesterol: 0.24 (0.21, 0.27) [p < 0.0001] Total/HDL cholesterol: -0.24 (-0.40, -0.09) [p = 0.25] LDL cholesterol: 0.31 (0.23-0.39) [p < 0.0001] Triglycerides: 0.16 (-0.07, 0.38) [p = 0.01] 48-week THRIVE Change from BL (mmol/L), mean (95% CI) Total cholesterol: 0.79 (0.69, 0.90) [p < 0.0001] HDL cholesterol: 0.27 (0.24, 0.30) [p < 0.0001] Total/HDL cholesterol: -0.28 (-0.38, -0.17) [p = 0.25] LDL cholesterol: 0.44 (0.34, 0.53) [p < 0.0001] Triglycerides: 0.14 (0.01, 0.26) [p < 0.0001] 96-week ECHO & THRIVE Change from BL (mmol/L), mean (95% CI) Total cholesterol: 0.74 (0.66-0.82) [p < 0.0001] HDL cholesterol: 0.29 (0.26-0.31) [p < 0.0001] Total/HDL cholesterol: NA [p = 0.17] LDL cholesterol: 0.37 (0.31-0.43) [p < 0.0001] Triglycerides: 0.14 (0.04-0.25) [p < 0.0001] |
|
STAR Cohen 2014 [32] (week 48 results) Van Lunzen 2016 [7] (week 96 results) |
48-week Change from BL (mg/dL), mean Total cholesterol: 1 HDL cholesterol: 2 Total/HDL cholesterol: -0.2 LDL cholesterol: 1 Triglycerides: -8 96-week Change from BL (mg/dL), mean (SD) Total cholesterol: 3 (33) HDL cholesterol: 2 (10) Total/HDL cholesterol: -0.2 (1.1) LDL cholesterol: 2 (27) Triglycerides: 8 (111) |
48-week Change from BL (mg/dL), mean Total cholesterol: 22 [p < 0.001] HDL cholesterol: 8 [p < 0.001] Total/HDL cholesterol: -0.2 LDL cholesterol: 14 [p < 0.001] Triglycerides: 8 [p < 0.001] 96-week Change from BL (mg/dL), mean (SD) Total cholesterol: 25 (32) [p < 0.001] HDL cholesterol: 9 (11) [p < 0.001] Total/HDL cholesterol: -0.2 (1.1) LDL cholesterol: 15 (28) [p < 0.001] Triglycerides: -5 (69) [p = 0.090] |
|
Treatment-experienced, virologically controlled patients |
||
|
SPIRIT Palella 2014 [10] |
48-week Change from BL (mg/dl), mean Total cholesterol: -24 HDL cholesterol: -2 Total/HDL cholesterol: -0.35 LDL cholesterol: -16 Triglycerides: -64 |
48-week Change from the late switch BL (~24 weeks RPV + FTC + TDF) (mg/dl), mean Total cholesterol: -24 HDL cholesterol: -4 Total/HDL cholesterol: -43 LDL cholesterol: -14 Triglycerides: -80 24-week Change from BL (~24 weeks of BL ART) (mg/dl), mean Total cholesterol: -1 HDL cholesterol: -1 Total/HDL cholesterol: +0.08 LDL cholesterol: 0 Triglycerides: +3 |
|
LATTE Margolis 2015 [28] |
No data for the maintenance-exposed population |
No data for the maintenance-exposed population |
|
Probe Maggiolo 2016 [11] |
48-week BL - week 48 (mg/dL), mean (SD) Total cholesterol: 183 (46) - 200 (40) HDL cholesterol: 47 (13) - 49 (17) Total/HDL cholesterol: NA LDL cholesterol: NA Triglycerides: 200 (181) - 173 (138) |
48-week BL - week 48 (mg/dL), mean (SD) Total cholesterol: 184 (37) - 188 (44) HDL cholesterol: 45 (12) - 45 (13) Total/HDL cholesterol: NA LDL cholesterol: NA Triglycerides: 128 (44) - 143 (63) |
|
GS-US-366-1160 DeJesus 2017 [34] (week 48 results) Hagins 2018 [12] (week 96 results) |
48-week Change from BL (mg/dL), median (q1, q3) Total cholesterol: -9 (-27, 9) HDL cholesterol: -4 (-9, 2) Total/HDL cholesterol: 0.1 (-0.3, 0.5) LDL cholesterol: -3 (-18, 13) Triglycerides: -4 (-35, 23) 96-week Change from BL (mg/dL), median (q1, q3) Total cholesterol: -13 (-32, 10) HDL cholesterol: -4 (-11, 1) Total/HDL cholesterol: 0.1 (-0.4, 0.5) LDL cholesterol: -2 (-20, 14) Triglycerides: 1 (-34, 24) |
48-week Change from BL (mg/dL), median (q1, q3) Total cholesterol: -3 (-18, 13) [p = 0.0012] HDL cholesterol: -1 (-6, 4) [p = < 0.0001] Total/HDL cholesterol: 0 (-0.3, 0.4) [p = 0.20] LDL cholesterol: -2 (-13, 11) [p = 0.20] Triglycerides: -2 (-27, 27) [p = 0.093] 96-week Change from BL (mg/dL) median (q1, q3) Total cholesterol: -3 (-19, 15) [p < 0.001] HDL cholesterol: 0 (-6, 6) [p < 0.001] Total/HDL cholesterol: 0 (-0.5, 0.4) [p = 0.06] LDL cholesterol: 0 (-13, 13) [p = 0.22] Triglycerides: 4 (-25, 35) [p = 0.14] |
|
SWORD-1 & SWORD-2 Llibre 2018 [10] (week 48 results) Aboud 2019 [2] (week 100 results) |
48-week BL - week 48 (mg/dL), mean Total cholesterol: 184.3 - 186.1 HDL cholesterol: 52.3 - 54.1 Total/HDL cholesterol: 3.78 - 3.67 LDL cholesterol: 107.2 - 109.0 Triglycerides: 126.4 - 118.0 100-week Change from BL (mmol/L), mean Total cholesterol: 0.1 HDL cholesterol: 0.01 Total/HDL cholesterol: 0.05 LDL cholesterol: 0.15 |
48-week BL - week 48 (mg/dL), mean Total cholesterol: 186.7 - 187.0 HDL cholesterol: 53.3 - 54.7 Total/HDL cholesterol: 3.73 - 3.65 LDL cholesterol: 108.8 - 107.5 Triglycerides: 126.3 - 125.8 100-week Change from the late-switch BL (~ 48 weeks of RPV + DTG) (mmol/L), mean Total cholesterol: 0.06 HDL cholesterol: -0.03 Total/HDL cholesterol: 0.11 LDL cholesterol: 0.16 |
|
SALIF Munderi 2019 [14] |
No data |
No data |
|
Petchkum2019 [16] |
48-week Change from BL (mg/dL), mean (95% CI) Total cholesterol: -17.1 (-29.69, -4.4) HDL cholesterol: -0.37 (-6.10, 5.36) Total/HDL cholesterol: -0.31 (-0.75, 0.13) LDL cholesterol: 0.53 (-11.8, 12.86) Triglycerides: -36.02 (-71.02, -1.12) |
48-week Change from BL (mg/dL), mean (95% CI) Total cholesterol: 7.25 (-0.87, 15.38) HDL cholesterol: 5.16 (2.46, 7.86) Total/HDL cholesterol: -0.22 (-0.47, 0.03) LDL cholesterol: 8.52 (1.63, 15.41) Triglycerides: -12.25 (-40.93, 16.43) |
Abbreviations: BL: Baseline; DTG: Dolutegravir; HDL: High-density lipoprotein; LDL: Low-density lipoprotein; NA: Not available; RPV: Rilpivirine.
*for comparison with the RPV group, as reported in the publication.