Hypertension and blood pressure changes with dolutegravir or comparator antiretroviral therapy in randomized trials through 96 weeks
Bibliographic record
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.022 | 0.026 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.008 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".