TABLE 3.
Sensitivity analyses of Incidence of hypertension by ART regimen
| Sensitivity analysis description | Number included | Number of hypertension events | Variable categories | Adjusted IRR (95% CI) | p‐Value |
|---|---|---|---|---|---|
| Primary analysis | 4606 | 1058 | INSTIs vs. NNRTIs | 1.76 (1.47–2.11) | <0.001 |
| INSTIs vs. PIs | 1.07 (0.89–1.29) | 0.460 | |||
| Only PLWH with normal BP (SBP <130 and DBP <85) included in the analysis | 2914 | 371 | INSTIs vs. NNRTIs | 2.19 (1.63–2.95) | <0.001 |
| INSTIs vs. PIs | 1.01 (0.76–1.34) | 0.937 | |||
| PLWH with CVD or CKD excluded from analysis | 4503 | 1038 | INSTIs vs. NNRTIs | 1.76 (1.47–2.11) | <0.001 |
| INSTIs vs. PIs | 1.07 (0.89–1.29) | 0.471 | |||
| Primary analysis but with adjustment made for D:A:D cardiovascular risk scores at baseline | 4606 | 1058 | INSTIs vs. NNRTIs | 1.62 (1.35–1.94) | <0.001 |
| INSTIs vs. PIs | 0.94 (0.78–1.13) | 0.481 | |||
| Primary analysis but with adjustment made for cohort | 4606 | 1058 | INSTIs vs. NNRTIs | 1.75 (1.46–2.10) | <0.001 |
| INSTIs vs. PIs | 1.08 (0.90–1.30) | 0.426 | |||
| Primary analysis but with primary endpoint based on BP only (initiation of antihypertensives ignored) | 4606 | 933 | INSTIs vs. NNRTIs | 1.75 (1.45–2.12) | <0.001 |
| INSTIs vs. PIs | 1.08 (0.89–1.31) | 0.461 | |||
| Primary analysis with the definition of hypertension just based on the initiation of anti‐hypertensives (high BP ignored) | 4606 | 282 | INSTIs vs. NNRTIs | 1.74 (1.18–2.57) | 0.005 |
| INSTIs vs. PIs | 0.83 (0.56–1.22) | 0.345 | |||
| 6 months washout | 4150 | 911 | INSTIs vs. NNRTIs | 1.63 (1.35–1.98) | <0.001 |
| INSTIs vs. PIs | 0.99 (0.82–1.20) | 0.918 | |||
| Baseline period pushed to 2014 a or after | 4617 | 1060 | INSTIs vs. NNRTIs | 1.77 (1.48–2.12) | <0.001 |
| INSTIs vs. PIs | 1.07 (0.89–1.29) | 0.454 | |||
| Participants with missing data excluded b | 3027 | 763 | INSTIs vs. NNRTIs | 1.83 (1.48–2.27) | <0.001 |
| INSTIs vs. PIs | 1.15 (0.92–1.43) | 0.225 | |||
| Participants with predicted 5‐year risk scores <5% | 4042 | 877 | INSTIs vs. NNRTIs | 1.75 (1.44–2.13) | <0.001 |
| INSTIs vs. PIs | 1.05 (0.86–1.28) | 0.610 |
In each of the presented analyses, we adjusted for potential confounders including the nucleoside/nucleotide reverse transcriptase inhibitor backbone, baseline BP levels and other covariates adjusted for in the primary analysis (Table 2). INSTIs vs. NNRTIs means that NNRTIs is the reference group; similarly, INSTIs vs. PIs means that PIs is the reference group.
Abbreviations: ART, antiretroviral therapy; BP, blood pressure; CI, confidence interval; CKD, chronic kidney disease; CVD, cardiovascular disease; D:A:D, Data Collection on Adverse Events of Anti‐HIV Drugs; DBP, diastolic blood pressure; INSTI, integrase strand transfer inhibitor; IRR, incidence rate ratio; NNRTI, non‐nucleoside reverse transcriptase inhibitor; PI, protease inhibitors; PLWH, people living with HIV; SBP, systolic blood pressure.
The date of initiation of ART initiation (ART‐naïve) or commencement of a new third antiretroviral regimen (for ART‐experienced) after 2014 (i.e., the date when dolutegravir was approved for use in Europe).
Model with participants with any missing data on the variables in the final models excluded.