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Evaluating weight gain with the initiation of antiretroviral therapy: A comparison of integrase strand transfer inhibitors to other antiretrovirals

Parker, Leah M.
Connel, Christina A.
Cobbs, Tyler
Bury, John E.
Background: Existing research has observed a potential association between antiretroviral therapy (ART) exposed individuals and a high prevalence of weight gain and obesity. However, the impact of these metabolic changes imparted by integrase strand transfer inhibitor based regimens in particular remains unclear. The objective of this study is to evaluate weight change in treatment-naive patients with newly initiated ART in a Ryan White Clinic.
Methods: This IRB-approved, retrospective chart review study utilized EMR records to identify patients aged 18 years or older with a diagnosis of HIV-1, who are treatment-naive or have been without ART for >6 months, initiated on ART between January 1, 2013 and January 1, 2018, maintained therapy for ≥24 months, had weight values recorded at least twice during the study period, and were initiated on any three-drug NNRTI, INSTI, or PI-based regimen. The following data was collected, recorded without patient identifiers, and maintained confidentially: patient regimen, age, gender, ethnicity, AIDS status, plasma HIV-1 RNA (viral load), CD4+ T-cell count, weight, BMI, and BMI categories. Patient weight, BMI, and BMI categories were evaluated at baseline, 6 months, and 18 months on ART.
Results: Of the 3,054 patients identified, a total of 200 patients were included in the final analysis. The patient population consisted primarily of Caucasian (55.0%) males (81.0%) with an average age of 38.3 years. At initiation of treatment, the median CD4+ T-cell count = 356.2 cells/uL, HIV-1 RNA viral load = 481,801 copies/mL, weight = 80.8 kg, and BMI = 26.2 kg/m2. For all classes evaluated, the highest percentage of patients at baseline fell within BMI category indicating normal weight (18.5-24.9 kg/m2). A total of 42 (21.0%), 50 (25.0%), and 113 (56.5%) patients were initiated on NNRTI, PI, and INSTI-based regimens, respectively. Of the 113 patients who were initiated on an INSTI-based regimen, 82 (72.5%) patients began regimens containing doultegravir, 25 (22.1%) patients began regimens containing elvitegravir, and 6 (5.3%) patients began regimens containing raltegravir. All 6 patients who were initiated on raltegravir were also on concomitant darunavir. At 18 months of therapy, a median increase in weight of 2.2 kg and BMI of 0.5 kg/m2 was associated with NNRTI-based regimens, compared to a 3.9 kg and 1.3 kg/m2 increase associated with PI-based regimens. Of the INSTI-based regimens, use of dolutegravir was associated with a 4.3 kg and 1.7 kg/m2 increase, elvitegravir a 1.1 kg and 0.4 kg/m2 increase, and raltegravir a 7.7 kg and 2.5 kg/m2 increase in weight and BMI, respectively. At 18-months, 37.8% and 50.0% of patients initiated on dolutegravir and raltegravir-based therapy, respectively, were considered obese with an associated BMI of ≥ 30 kg/m2.
Conclusions: Treatment naive patients with HIV-1 initiating therapy with dolutegravir-based regimens were associated with a higher incidence of increase in weight and BMI at 18-months than those initiating elvitegravir, NNRTI, and PI-based regimens. Those initiating raltegravir-based regimens, which also contained the PI darunavir, were associated with the highest incidence of increase in weight and BMI at 18-months compared to all other regimens. Further study is recommended.