Table 3.
Lipid and renal outcomes reported in people with HIV-1 using dolutegravir + lamivudine.
| Cohort lead study (substudy) | People using DTG + 3TC | Time point, wk* | Lipid outcomes with DTG + 3TC from BL to time point | Renal outcomes with DTG + 3TC from BL to time point |
|---|---|---|---|---|
| Dou et al[26] (Li et al) [34] |
Naive: 77 | 48 | No significant changes in lipids | – |
| Yanyun et al[41] | Naive: 54 | 48 | –† | sCr: Significant increase (70 to 81 µmol/L; P = .02); Urea: Significant increase (4.3 to 5.1 mmol/L; P = .00) |
| Hou et al[33] | Naive: 46 | 48 | No significant changes in lipids | sCr: No significant changes |
| Hui et al[28] | Naive: 54‡ | 3, 12, and 24 | Grade 1 to 2 dyslipidemia: BL: 0/21 (0%) Wk 3: 2/21 (9.5%) Wk 12: 2/21 (9.5%) Wk 24: 1/21 (4.8%) |
– |
| Long et al[43] | Naive: 145 | 48 | Adjusted change in TC: +0.5 mmol/L Adjusted change in TG: +0.2 mmol/L Adjusted change in HDL-C: +0.2 mmol/L Adjusted change in LDL-C: +0.4 mmol/L |
Creatinine clearance change: −10 (−20, −3.3) mL/min |
| Wei et al[39] | Naive: 200 | 12 and 24 | Wk 24: Significant increases in TC (3.97 to 4.58 mmol/L; P < .001) and HDL-C (1.03 to 1.27 mmol/L; P < .001) No significant changes in TG or LDL-C |
Wk 12: eGFR§: Significant decrease (116.12 to 98.38; P < .01) sCr: Significant increase (71.45 to 84.10 µmol/L; P < .01) No significant changes between wk 12 and 24 |
| Lee et al[67] | Naive: 20 Switch: 131 |
24 and 48 | Naive: No significant changes in lipids Switch: Significant decreases at wk 48 in median TG (188.91 to 161.52 mg/dL; P = .03) and TC (184.62 to 177.70 mg/dL; P = .00) |
Naive: sCr: Significant increase from BL (0.9 mg/dL) vs wk 24 (1.0 mg/dL) and 48 (1.1 mg/dL; P < .001) Switch: sCr: Significant increase from BL (0.99 mg/dL) to wk 24 (1.04 mg/dL) and wk 48 (1.02 mg/dL; P < .001) |
| Ling et al[27] | Naive: 14 Switch: 53 |
48 | Naive: Significant increase in HDL-C (P = .03) Switch: Significant increase in HDL-C (P = .00) and LDL-C (P = .02) |
Naive: eGFR: Significant decrease (P = .02)§ sCr: No significant change Switch: sCr: Significant increase (P = .00) eGFR: Significant decrease (P = .00)§ eGFR: Significant increase (P = .04)‖ |
| Adachi et al[46] | Switch: 119 | Median: 21 wk | People who switched from DTG + FTC/TAF or BIC/FTC/TAF had a significant increase in HDL-C (51 vs 52 mg/dL; P = .01) and decrease in TC/HDL (4.1 vs 3.8; P = .05) No significant changes in lipids after switch from DTG/ABC/3TC |
sCr: No significant changes after switch from DTG + FTC/TAF or BIC/FTC/TAF |
| Cheng et al[64] | Switch: 512 | 48 | Change in TC: −0.3 mg/dL Change in TG: −7.2 mg/dL Change in HDL-C: −1.1 mg/dL Change in LDL-C: −0.1 mg/dL |
– |
| Ergen[56] | Switch: 63 | Median: 10.4 mo | No significant changes in TC or TG | eGFR: No significant changes |
| Hou et al[32] | Switch: 79 | 48 | No significant changes in lipids | sCr: No significant changes |
| Konishi et al[49] | Switch: 10¶ | – | No significant changes in TC, HDL-C, or TG | No significant changes in eGFR, sCr, or cystatin C |
| Minami et al[50] | Switch: 91 | 48 | Mean change in LDL-C (n = 56): +3.17 mg/dL | eGFR: Mean change (n = 56): +0.61 mL/min/1.73 m2 Wk 48 vs 1 yr before BL (n = 56): eGFR: Significant change (−4.2 mL/min/1.73 m2) |
| Nagashima et al[52] (Nagashima et al)[51] | Switch: 52 | 24 | No significant changes in median TC, TG, LDL-C, or HDL-C | No significant changes in median eGFR or sCr |
| Shiyun et al[31] | Switch: 33 | 48 | Overall: Significant increase in LDL-C (median, 2.35 to 3.12 mmol/L; P < .001) Significant decrease in TG (median, 2.21 to 1.61 mmol/L; P = .02) People who switched due to dyslipidemia (n = 6): Significant reduction in TC (P = .00) and TG (P = .00) |
Overall: sCr: Significant increase (71.6 to 86.8 µmol/L; P = .00) eGFR: Significant decrease (106.4 to 88.6 mL/min/1.73 m2; P = .01) People who switched due to nephrotoxicity (n = 6): sCr: Significant decrease (113.2 to 96.1 µmol/L; P = .01) eGFR: Significant increase (77.4 to 87.1 mL/min/1.73 m2; P = .04) |
| Xin[40] | Switch: 100 | 24 and 48 | – | eGFR (BL eGFR < 60 or 60 to ≤ 90 mL/min): Significant increases at wk 24 and 48 (P < .01) eGFR (BL eGFR > 90 mL/min): No significant changes at wk 48 |
| Yağci-Çağlayik et al[55] | Switch: 107 | 48 | – | eGFR: No significant changes Proteinuria (switch from TDF): Significant decrease (155 to 92 mg/g; P = .02) |
| Yağci-Çağlayik et al[59] | Switch: 32 | Median: 30 wk | No significant changes in lipids | –† |
| Yang[44] | Switch: 121 | 48 | Significant increase in LDL-C (2.66 to 2.82 mmol/L; P < .05) | eGFR: Significant increase (90.99 to 99.12 mL/min/1.73 m2; P < .05)# |
| Zhong et al[30] | Switch: 112 | 24 | n = 1 abnormalities in lipid metabolism parameters with TG of up to 13.52 mmol/L Significant decrease in proportion with normal LDL-C (88.4% to 75%; P = .01) |
No significant changes in proportions with normal sCr or eGFR levels |
| Zhou et al[42] | Switch: 146 | 24 and 48 | Significant increase in LDL-C at wk 24 (2.38 to 2.69 mmol/L; P = .00) and wk 48 (P < .05) Significant decrease in TG at wk 48 (P = .04) |
sCr: No significant changes at wk 24 or 48 |
– = no data, 3TC = lamivudine, ABC = abacavir, BIC = bictegravir, BL = baseline, CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration equation, DTG = dolutegravir, eGFR = estimated glomerular filtration rate, FTC = emtricitabine, HDL-C = high-density-lipoprotein cholesterol, LDL-C = low-density-lipoprotein cholesterol, sCr = serum creatinine, TAF = tenofovir alafenamide, TC = total cholesterol, TDF = tenofovir disoproxil fumarate, TG = triglycerides.
*
Unless otherwise specified.
†
Outcome was reported in the publication; however, the lead study or a substudy with higher N is presented to represent this outcome for this cohort.
‡
Outcomes reported for n = 21 using DTG + 3TC.
§
Using the CKD-EPI formula based on sCr.
‖
Using the CKD-EPI formula based on serum cystatin C.
¶
Eleven people were included in the study, but 1 switched to DTG + rilpivirine.
#
Assumption; values increased but were reported as a decrease.