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. 2023 Feb 6:57:101836.
doi: 10.1016/j.eclinm.2023.101836. eCollection 2023 Mar.

Change in body weight and risk of hypertension after switching from efavirenz to dolutegravir in adults living with HIV: evidence from routine care in Johannesburg, South Africa

Affiliations

Change in body weight and risk of hypertension after switching from efavirenz to dolutegravir in adults living with HIV: evidence from routine care in Johannesburg, South Africa

Alana T Brennan et al. EClinicalMedicine. .

Abstract

Background: The integrase strand transfer inhibitor (INSTI) dolutegravir is recommended in World Health Organization guidelines, but is associated with weight gain. We evaluated weight change in patients switching from efavirenz to dolutegravir in first-line antiretroviral therapy (ART) in Johannesburg, South Africa.

Methods: We conducted a prospective cohort study of adults (≥16 years) of black African ancestry with HIV who initiated ART between January 2010-December 2020. Patients were propensity score-matched 1:1 (unexposed i.e. remaining on efavirenz: exposed i.e. switched from efavirenz to dolutegravir) on sex, age, months on ART, first ART regimen, haemoglobin, body mass index (BMI), blood pressure, viral load and CD4 count. We used linear regression to assess the effect of switching from efavirenz to dolutegravir on weight change and hypertension 12 months after exposure.

Findings: We matched 794 patients switching to dolutegravir to 794 remaining on efavirenz. Exposed patients had a higher mean change in weight (1.78 kg; 95% confidence interval (CI):1.04,2.52 kg) from start of follow-up to 12 months vs. unexposed. We also found a 14.2 percentage point increase (95% CI: 10.6,17.7) in the risk of hypertension in those exposed to dolutegravir vs those that remained on efavirenz.

Interpretation: In a real-world population, patients gained more weight and were at higher risk of hypertension after switching from efavirenz to dolutegravir than those remaining on efavirenz. Longer follow-up is needed, however, to determine if INSTI-associated weight gain is associated with changes in non-communicable disease risk over the long-term, or whether weight gain is sustained, as seen in clinical trials.

Funding: This study has been made possible by the generous support of the American People and the President's Emergency Plan for AIDS Relief (PEPFAR) through the United States Agency for International Development (USAID), under the terms of cooperative agreement cooperative Agreement 72067419CA00004. In addition to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 1K01MH105320-01A1.

Keywords: Dolutegravir; Efavirenz; Hypertension; Integrase strand transfer inhibitors; South Africa; Weight.

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Conflict of interest statement

Emma Kileel (EM) has received contractor fees from Massachusetts General Hospital for work unrelated to the present manuscript. Andrew Stokes (AS) has received research support from Johnson & Johnson, Inc. For work unrelated to the present manuscript. Willem DF Venter's (WDFV) unit receives funding from the 10.13039/100000865Bill and Melinda Gates Foundation, SA 10.13039/501100000265Medical Research Council, National Institutes for Health, Unitaid, Foundation for Innovative New Diagnostics (FIND) and the Children's Investment Fund Foundation (CIFF). WDFV has previously received funding from USAID, and receives drug donations from ViiV Healthcare, Merck, J&J and Gilead Sciences for investigator-led clinical studies. WDFV's unit does investigator-led studies with Merck, J&J and ViiV providing financial support and is doing commercial drug studies for Merck. WDFV's unit performs evaluations of diagnostic devices for multiple biotech companies. Individually, WDFV receives honoraria for educational talks and advisory board membership for Gilead, ViiV, Mylan/Viatris, Merck, Adcock-Ingram, Aspen, Abbott, Roche, J&J, Sanofi and Virology Education. All other authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Selection of study patients for a study of the effects of dolutegravir vs. efavirenz in people living with HIV in Johannesburg, South Africa (n = 13,227).

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