Association between transitioning to a dolutegravir-based regimen and risk of incident hypertension in adults with HIV in West Africa: a multicentre target trial emulation study.
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BACKGROUND: Although dolutegravir (DTG) has been linked to metabolic disturbances-especially among women and people of African descent - its effect on hypertension (HTN) remains uncertain. We assessed the impact of switching to DTG on the risk of HTN among people living with HIV (PLHIV) using target-trial emulation in West Africa. METHODS: We analysed routine data from the International Epidemiologic Databases to Evaluate AIDS in West Africa (IeDEA-WA), restricting to clinics with systematic blood pressure (BP) collection: Nigeria, Burkina Faso and Côte d'Ivoire. Eligible participants were adults (≥18 years) on ART with at least one follow-up visit including BP after site-level DTG introduction. ART initiators and patients with prevalent HTN were excluded. We emulated a target trial to estimate the effect of switching to DTG on the risk of developing hypertension (HTN), using weighted logistic regression. In the intention to treat analysis, participants were followed regardless of subsequent treatment changes. In the per-protocol analysis, follow-up was censored at the first deviation from the assigned strategy. In addition, a two-slope mixed linear model was applied to assess changes in systolic (SBP) and diastolic blood pressure (DBP) before and after the switch to DTG. FINDINGS: Among 15 485 actively followed PLHIV between January 1st, 2016 and January 1st, 2023, 9730 PLHIV (72.6% women-27.4% men) met eligibility. Among them, 9689 remained on non-DTG regimens and 7839 switched to DTG; over 4 years, 557 and 879 incident hypertension events occurred, respectively. DTG use was associated to a 19% higher risk of incident HTN (Risk ratio = 1.19, 95% CI: 1.08-1.32) in intention-to-treat and an 42% increase (1.42, 1.20-1.68) in per-protocol. 11482 participants switching to DTG were eligible for the second analysis. Before DTG transition, SBP and DBP increased by 0.38 mmHg/year [95% CI 0.26-0.50] and 0.39 mmHg/year [0.32-0.47], respectively. After DTG, slopes increased to 1.56 mmHg/year [1.34-1.78] and 1.20 mmHg/year [1.06-1.35]. INTERPRETATION: Our findings suggest that transitioning to a DTG-based regimen was associated with an increase in BP and a modest elevation in the estimated HTN risk, supporting integrated cardiovascular care within HIV programs in West Africa. Findings should be interpreted cautiously given the observational design, potential residual confounding, and the lack of standardized BP measurements and lifestyle-related data. FUNDING: Research reported in this publication is supported by the U.S. National Institutes of Health, National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health & Human Development, the National Heart, Lung, and Blood Institute, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, the Fogarty International Center and the National Cancer Institute.