Table 1.
Characteristics of the Participants at Baseline
| Median (Q1-Q3) or No. (%) | |||
|---|---|---|---|
| Total (n = 6905) | Pitavastatin (n = 3451) | Placebo (n = 3454) | |
| Age,* y | 53 (48–57) | 53 (48–57) | 52 (48–57) |
| 40–49 | 2302 (33) | 1139 (33) | 1163 (34) |
| 50–59 | 3536 (51) | 1774 (51) | 1762 (51) |
| ≥60 | 1067 (15) | 538 (16) | 529 (15) |
| Sex at birth | |||
| Male | 4698 (68) | 2346 (68) | 2352 (68) |
| Female | 2207 (32) | 1105 (32) | 1102 (32) |
| Gender identity | |||
| Cisgender | 6769 (98) | 3391 (98) | 3378 (98) |
| Transgender spectrum | 113 (2) | 53 (2) | 60 (2) |
| Not reported | 23 (<0.5) | 7 (<0.5) | 16 (<0.5) |
| Racea | |||
| Black or African American | 2835 (41) | 1386 (40) | 1449 (42) |
| White | 2319 (34) | 1166 (34) | 1153 (33) |
| Asian | 1097 (16) | 551 (16) | 546 (16) |
| Other | 654 (9) | 348 (10) | 306 (9) |
| Ethnicityb | |||
| Hispanic or Latino | 596 (18) | 310 (19) | 286 (18) |
| Not Hispanic or Latino | 2601 (81) | 1290 (80) | 1311 (81) |
| Unknown | 28 (1) | 12 (1) | 16 (1) |
| GBD region | |||
| High income | 3394 (49) | 1696 (49) | 1698 (49) |
| Latin America and Caribbean | 1357 (20) | 670 (19) | 687 (20) |
| Southeast/East Asia | 582 (8) | 298 (9) | 284 (8) |
| South Asia | 478 (7) | 234 (7) | 244 (7) |
| Sub-Saharan Africa | 1094 (16) | 553 (16) | 541 (16) |
| Smoking statusc | |||
| Current | 1643 (24) | 770 (22) | 873 (25) |
| Former | 1684 (24) | 868 (25) | 816 (24) |
| Never | 3570 (52) | 1809 (52) | 1761 (51) |
| Substance used | |||
| Current | 126 (2) | 59 (2) | 67 (2) |
| Former | 1886 (27) | 941 (27) | 945 (27) |
| Never | 4885 (71) | 2448 (71) | 2437 (71) |
| Cholesterol, mg/dLe | |||
| Total | 186 (162–209) | 186 (163–210) | 185 (162–209) |
| LDL, calculated | 108 (87–128) | 109 (87–129) | 108 (87–128) |
| HDL | 48 (39–59) | 48 (39–59) | 48 (39–59) |
| Nonstatin lipid-lowering therapy* | 186 (3) | 101 (3) | 85 (2) |
| Hypertensionf,* | 3117 (45) | 1528 (44) | 1589 (46) |
| Antihypertensive medication* | 1859 (27) | 898 (26) | 961 (28) |
| Diabetes* | 190 (3) | 107 (3) | 83 (2) |
| ASCVD risk score, % | 4.5 (2.1–7.0) | 4.4 (2.1–7.0) | 4.5 (2.2–7.1) |
| BMI,* kg/m2 | |||
| <30 | 5286 (77) | 2610 (76) | 2676 (78) |
| ≥30 | 1613 (23) | 838 (24) | 775 (22) |
| Time since HIV diagnosis,* y | 15 (10–22) | 15 (10–22) | 15 (10–22) |
| Nadir CD4, cells/mm3 | |||
| <200 | 3446 (50) | 1706 (49) | 1740 (50) |
| 200–349 | 1802 (26) | 906 (26) | 896 (26) |
| ≥350 | 1456 (21) | 731 (21) | 725 (21) |
| Unknown | 201 (3) | 108 (3) | 93 (3) |
| Total ART use,* y | 12.1 (7.9–17.3) | 12.0 (7.9–17.4) | 12.1 (7.9–17.3) |
| ART regimen class* | |||
| NRTI + INSTI | 2966 (43) | 1475 (43) | 1491 (43) |
| NRTI + NNRTI | 2540 (37) | 1285 (37) | 1255 (36) |
| NRTI + PI | 815 (12) | 401 (12) | 414 (12) |
| NRTI sparing | 225 (3) | 112 (3) | 113 (3) |
| Other NRTI containing | 359 (5) | 178 (5) | 181 (5) |
| CD4 count,* cells/mm3 | |||
| <500 | 2056 (30) | 1019 (30) | 1037 (30) |
| ≥500 | 4849 (70) | 2432 (70) | 2417 (70) |
| HIV-1 RNA,g,* copies/mL | |||
| <LLQ | 5549 (87) | 2754 (86) | 2795 (87) |
| LLQ to <400 | 645 (10) | 341 (11) | 304 (9) |
| ≥400 | 210 (3) | 103 (3) | 107 (3) |
All statistics are calculated out of participants with data collected. Missing data: smoking status (n = 8), substance use (n = 8), BMI (n = 6), time since HIV diagnosis (n = 4), total ART use (n = 2), and HIV-1 RNA (n = 501).
Abbreviations: ART, antiretroviral therapy; ASCVD, atherosclerotic cardiovascular disease; BMI, body mass index; GBD, Global Burden of Disease; HDL, high-density lipoprotein; INSTI, integrase strand transfer inhibitor; LDL, low-density lipoprotein; LLQ, lower limit of quantitation; NNRTI, nonnucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; PI, protease inhibitor; REPRIEVE, Randomized Trial to Prevent Vascular Events in HIV.
*Data as of 1 January 2020; otherwise, data are shown as of REPRIEVE study entry.
aOther race includes participants self-identifying as native or indigenous to the enrollment region, more than 1 race (with no single race noted as predominant), or unknown.
bEthnicity presented per National Institutes of Health definition for participants in United States (including Puerto Rico) and Canada only; not applicable in other geographic regions.
cSmoking is defined as cigarette smoking.
dSubstance use includes use of cocaine, methamphetamine, and injection drugs.
eScreening lipid panel from clinical care used for eligibility is presented. Fasting was not required if random laboratory values to determine eligibility were within the range specified by the protocol.
fHypertension was defined as any of the following: hypertension diagnosis, use of antihypertensive treatment for elevated blood pressure, systolic blood pressure ≥140 mm Hg, or diastolic blood pressure ≥90 mm Hg.
gHIV-1 RNA was captured if available through standard of care. The assays used for testing varied, including assays with LLQs between 20 and 400 copies/mL.