Hypertension and blood pressure changes with dolutegravir or comparator antiretroviral therapy in randomized trials through 96 weeks.

Abstract

Background: To date, there are limited published data from randomized trials evaluating the effects of integrase strand transfer inhibitor-based regimens, including dolutegravir-based antiretroviral therapy (ART), on blood pressure (BP) in people with HIV-1 (PWH).

Objectives: This analysis evaluated BP changes from baseline and incident hypertension among ART-naive PWH randomized to dolutegravir-based three-drug ART or alternative comparator ART (cART) across pooled Phase 2/3 studies.

Methods: In this post hoc analysis of Phase 2/3 SPRING-1, SPRING-2, SINGLE and FLAMINGO clinical trials, BP was assessed at baseline, Week (W) 48 and W96. In PWH without evidence of hypertension at baseline, incident hypertension was defined as a single systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg measured after a 5 min rest, a hypertension adverse event and/or antihypertensive medication use during follow-up. Baseline factors associated with incident hypertension at W96 were assessed through multivariate analyses. BP changes between dolutegravir and cART were also assessed.

Results: Among 2345 randomized participants, 1815 (77%) had no evidence of hypertension at baseline; 927 received dolutegravir-based ART and 888 received cART. Through W96, incident hypertension did not differ between groups [dolutegravir, 23% (n = 180/779); cART, 21% (n = 139/665); adjusted OR, 1.02; 95% CI, 0.79-1.33]; ∼1% of participants initiated antihypertensive medication through W96 (dolutegravir, n = 3; cART, n = 1). At W96, no significant BP changes from baseline were observed (systolic BP, P = 0.741; diastolic BP, P = 0.683).

Conclusions: Relative to non-dolutegravir-containing cART, dolutegravir-containing three-drug ART did not show any impact on incident hypertension in ART-naive PWH without evidence of hypertension at baseline through W96.