Risk of hypertension in people with HIV in the USA initiating modern antiretroviral regimens: pooled analysis of blood pressure data from five clinical trials

Background People with HIV have a greater risk of cardiovascular disease than the general population. Current literature suggests that some ARTs may exacerbate this risk. Objectives To estimate the risk of hypertension in treatment-naïve people with HIV receiving integrase strand transfer inhibitor (INSTI)/tenofovir alafenamide (TAF) or INSTI/non-TAF versus NNRTI/non-TAF regimens. Methods Post hoc pooled analysis evaluating data from US participants in five Phase 3 randomized studies. Adjusted prevalence of Stage 1 and 2 hypertension (American College of Cardiology/American Heart Association criteria) and conditional odds of higher blood pressure ratios were estimated using proportional odds mixed-effect regression through 108 weeks after ART initiation. Time to incident hypertension through 96 weeks was modelled using Cox proportional-hazards regression. Results In total, 2411 participants were included (528, 749 and 1134 received NNRTI/non-TAF, INSTI/non-TAF and INSTI/TAF regimens, respectively). Nearly half of participants had hypertension (Stage ≥1) at baseline. The Week 96 adjusted estimates of risk of hypertension (95% CI) were 1.06 (0.99, 1.13) and 1.12 (0.98, 1.27) for Stages ≥1 and ≥2 hypertension, respectively, for NNRTI/non-TAF versus INSTI/non-TAF, and 1.01 (0.95, 1.08) and 1.02 (0.91, 1.17) for Stages ≥1 and ≥2 hypertension, respectively, for NNRTI/non-TAF versus INSTI/TAF. There were no significant differences in conditional odds of high blood pressure between treatment groups. No significant differences were identified in time to incident composite hypertension for INSTI/non-TAF and INSTI/TAF versus NNRTI/non-TAF regimens; estimated hazard ratios (approximate 95% CI) were 0.88 (0.66, 1.17) and 0.98 (0.75, 1.28), respectively. Conclusions Results suggest the risk of hypertension is not significantly different across INSTI/TAF, INSTI/non-TAF and NNRTI/non-TAF regimens.