Title

Evaluation of incident hypertension and blood pressure changes among people living with HIV-1 (PLWH) receiving dolutegravir (DTG)-based regimens or comparator antiretroviral therapy (CAR) in randomized clinical trials through 96 weeks

Presenter

Bryn Jones

Authors

P. Patel¹, A. Milinkovic², R. Grove³, L. Govan³, K. Chow⁴, M. McKenna³, C. Donovan¹, B. Wynne¹, N. Payvandi², B. Jones²

Institutions

¹ViiV Healthcare, Durham, United States, ²ViiV Healthcare, Brentford, United Kingdom, ³GSK, Brentford, United Kingdom, ⁴GSK, Collegeville, United States

BACKGROUND: An association between integrase strand transfer inhibitor–based antiretroviral therapy and incident hypertension (HTN) among PLWH has been reported. We evaluated incident HTN and blood pressure (BP) changes among participants without baseline (BL) HTN receiving a DTG-based regimen or CAR in pooled Phase 2/3 randomized studies through Week (W)96.
METHODS: Data from ART-naive participants randomized to DTG + ABC/3TC or TDF/FTC, or CAR including EFV/TDF/FTC, RAL + 2 NRTIs, or DRV/r + 2 NRTIs, were pooled from the SPRING-1, SPRING-2, SINGLE, and FLAMINGO clinical trials. BP and weight were assessed at BL, W24, W48, and W96. HTN at each timepoint was defined as a single systolic BP (SBP) =140 mmHg and/or diastolic BP (DBP) =90 mmHg measured after a 5-minute rest, history of HTN, and/or BL antihypertensive medication use. Proportion meeting HTN criteria was evaluated using logistic regression and BP changes using mixed-models repeated-measures analyses, with adjustment for relevant BL variables and pooled treatment (DTG or CAR).
RESULTS: Among 2345 participants, 23% (n=530) were excluded for BL HTN; of the remaining, 927 received a DTG-based regimen and 888 received CAR. At BL, median (range) age was 34 (18-85) years, 15% were female sex at birth, and 15% Black or African American race. At W96, no significant difference in odds of HTN between the DTG and CAR groups was observed (OR, 1.02; 95% CI, 0.79-1.33; between-study heterogeneity was observed based on differing data collection frequency). Age, sex, race, BL HIV-1 RNA, and BMI were associated with HTN at W96. At W96, in pooled DTG vs CAR groups, respectively, adjusted mean (SE) change from BL SBP was 2.42 (0.398) vs 2.62 (0.437) mmHg (treatment difference, -0.20 mmHg; 95% CI, -1.36, 0.97; P=0.741) and change from BL in DBP was 1.62 (0.624) vs 1.80 (0.629) mmHg (treatment difference, -0.18 mmHg; 95% CI, -1.05, 0.69; P=0.683). There was no evidence of heterogeneity between studies (P=0.312).
CONCLUSIONS: Odds of HTN were not statistically different between DTG and CAR at W96. Multiple factors were statistically associated with HTN except study treatment. Observed BP increases were small and comparable between groups at W96.

Download the e-Poster (PDF)

Download the e-Poster (Movie)