Table 1.
Comparison of 4 week changes in oxidative stress (F2-isoprostanes), systemic inflammation (hsCRP, IL-6 and sVCAM-1), lipid fractions and insulin resistance between rilpivirine and efavirenz
| Biomarker | Study visit | Rilpivirine | Efavirenz | Mean difference | P value |
|---|---|---|---|---|---|
| F2-isoprostanes (pg/mL)a | entry | 164.2 (184.9) (n = 15) | 92.2 (71.8) (n = 15) | 72.0 (−35.5, 179.6) | 0.18 |
| week 4 | 83.3 (93.3) (n = 12) | 178.4 (149.2) (n = 15) | −95.0 (−196.8, 6.8) | 0.07 | |
| change from entry to week 4 | −101.4 (215.7) (n = 12) | 92.7 (178.6) (n = 14) | −194.1 (−353.7, −34.6) | 0.02 | |
| hsCRP (mg/L) | entry | 2.59 (4.88) | 2.75 (3.07) | −0.16 (−2.93, 2.60) | 0.43b |
| week 4 | 2.35 (3.37) | 3.49 (3.19) | −1.14 (−3.43, 1.16) | 0.20b | |
| change from entry to week 4 | −0.41 (6.01)c | 0.80 (2.47)c | −1.21 (−4.71, 2.30) | 0.35b | |
| IL-6 (pg/mL) | entry | 0.58 (5.37) | 2.24 (1.36) | −0.52 (−1.47, 0.43) | 0.14b |
| week 4 | 1.77 (1.88) | 4.23 (6.05) | −2.45 (−5.89, 0.98) | 0.11b | |
| change from entry to week 4 | 0.09 (2.51)c | 1.93 (5.63)c | −1.84 (−5.14, 1.46) | 0.21b | |
| sVCAM-1 (pg/mL) | entry | 580.33 (139.50) | 632.25 (133.20) | −51.92 (−139.20, 35.39) | 0.24 |
| week 4 | 541.67 (125.13) | 604.32 (182.44) | −62.65 (−168.6, 43.32) | 0.24 | |
| change from entry to week 4 | −20.92 (68.95)c | −27.62 (125.20)c | 6.70 (−62.49, 75.89) | 0.41 | |
| Total cholesterol (mg/dL) | entry | 165.20 (30.80) | 173.45 (28.81) | −8.25 (−27.34, 10.84) | 0.39 |
| week 4 | 157.00 (26.44) | 194.56 (28.72) | −37.56 (−56.25, −18.86) | <0.01 | |
| change from entry to week 4 | −5.78 (16.45) | 19.39 (23.90)c | −25.17 (−39.06, −11.27) | <0.01 | |
| LDL-C (mg/dL) | entry | 89.12 (25.38) | 97.53 (24.37) | −8.42 (−24.34, 7.51) | 0.29 |
| week 4 | 84.17 (23.57) | 110.54 (23.47) | −26.38 (−42.31, −10.44) | <0.01 | |
| change from entry to week 4 | −2.24 (13.43) | 13.29 (19.50)c | −15.54 (−26.88, −4.20) | <0.01 | |
| HDL-C (mg/dL) | entry | 60.05 (17.37) | 55.85 (17.44) | 4.20 (−6.94, 15.34) | 0.45 |
| week 4 | 59.00 (14.29) | 59.56 (18.52) | −0.56 (−11.76, 10.65) | 0.92 | |
| change from entry to week 4 | −1.28 (9.53) | 2.17 (10.35) | −3.44 (−10.18, 3.30) | 0.31 | |
| Total cholesterol/HDL-C | entry | 2.94 (0.92) | 3.35 (0.94) | −0.40 (−1.00, 0.19) | 0.18 |
| week 4 | 2.79 (0.73) | 3.57 (1.19) | −0.78 (−1.45, −0.11) | 0.02 | |
| change from entry to week 4 | −0.05 (0.49) | 0.29 (0.48)c | −0.35 (−0.67, −0.02) | 0.04 | |
| Non-HDL-C (mg/dL) | entry | 105.15 (28.14) | 117.60 (27.55) | −12.45 (−30.28, 5.38) | 0.17 |
| week 4 | 98.00 (25.58) | 135.00 (31.52) | −37.00 (−56.44, −17.56) | <0.01 | |
| change from entry to week 4 | −4.50 (17.96) | 17.22 (18.87)c | −21.72 (−34.20, −9.24) | <0.01 | |
| Triglycerides (mg/dL) | entry | 80.20 (39.13) | 101.20 (52.01) | −21.00 (−50.46, 8.46) | 0.16 |
| week 4 | 70.22 (31.32) | 122.33 (80.48) | −52.11 (−94.32, −9.90) | 0.02 | |
| change from entry to week 4 | −10.11 (31.79)c | 19.00 (62.11)c | −29.11 (−62.96, 4.74) | 0.11b | |
| HOMA-IR | entry | 1.47 (1.21) | 3.40 (5.37) | −1.93 (−4.50, 0.63) | 0.19b |
| week 4 | 2.02 (2.23) | 3.22 (4.49) | −1.19 (−3.63, 1.24) | 0.35b | |
| change from entry to week 4 | 0.60 (1.62) | −0.43 (1.50) | 1.03 (−0.03, 2.08) | 0.06b |
Data are presented as mean (SD) or as mean (95% CI). All P values are two-sided for the variables listed in this table.
aDue to incomplete assay reactions or to specimen hemolysis, the evaluable dataset with paired entry and week samples included only 14 in the efavirenz arm and 12 in the rilpivirine arm.
bP values for variables with non-normal distributions that were log-transformed prior to significance testing.
cP value for within-group change is <0.05.