Real-World Assessment of Weight Change in People with HIV-1 After Initiating Integrase Strand Transfer Inhibitors or Protease Inhibitors

Abstract

Background: Studies have shown an increase in weight among people living with human immunodeficiency virus (PLWH) who have also initiated integrase strand transfer inhibitors (INSTI). However, limited data are available regarding comparison of these changes with other antiretroviral regimens. Objective: To assess differences in weight gain after initiating INSTI- versus protease inhibitor (PI)- based regimens among treatment-naïve PLWH overall, and among a subpopulation of females only. Methods: This retrospective, observational cohort study included data from the Optum® deidentified Electronic Health Record (EHR) database. Adult PLWH who initiated INSTI- or PI-based regimens between March 1, 2016 and June 30, 2018 (index date was the first INSTI or PI prescription in this period) with ≥12-month baseline and follow-up periods, ≥1 weight measure during each period, and no prior antiretroviral use were included. The last weight measure between 12 months pre- and 30 days post-index was defined as baseline weight; the last measure between the months 4 and 12 of follow-up was defined as post-weight. Weight change was reported as absolute change and proportion of patients with increased weight. Cohorts were balanced using propensity score (PS) matching. Multivariable models were used to compare outcomes of interest. Results: After matching, 1588 patients were included (794 per cohort). At baseline, 46% were <50 years old, 26% were females, 12% had Type II diabetes and 30% had hypertension (mean baseline weight: INSTI: 83 kg (183 lb), PI: 82 kg (181 lb); P = 0.3). The mean time to follow-up weight measure was 9.3 months; INSTI initiators had a 1.3 kg (2.9 lb) greater mean weight gain (95% CI: 0.5–2.0), and a higher proportion with ≥5% weight gain (30.7% vs 26.1%; [OR=1.3, 95% CI: 1.0–1.6]) than PI initiators. Differences in weight gain between regimens were larger among females; female INSTI initiators had a 2.5 kg (5.3 lb) greater mean weight gain (95% CI: 0.7–4.2) and a higher proportion with ≥5% weight gain (37.5% vs 26.4%; OR=1.7; 95% CI [1.1–2.6]) than PI initiators. Conclusion: In a real-world setting, compared to PI-based regimens, INSTI-based regimens are associated with greater weight gain for treatment-naïve PLWH. This study may inform HIV treatment choice for health care providers.

Real-World Assessment of Weight Change in African American Females and Hispanics with HIV-1 After Initiating Integrase Strand-Transfer Inhibitors or Protease Inhibitors

“…6,7 These findings are consistent with previous clinical and real-world studies reporting increased weight or BMI within approximately 1 year of initiating ARV, and greater weight gain with INSTIs vs other regimens, especially among females and African Americans. 20,22,[27][28][29] In a recent real-world study of treatment naïve PLWH, Chen et al reported a higher risk of 5% weight gain for INSTI vs. PI initiators among the overall study population (1.3 kg greater mean weight gain for INSTI) and among females (2.5 kg greater weight gain for INSTI). 29 A similar real-world study using a different database reported a higher risk of 5% weight gain for INSTI vs. PI initiators overall (1.5 kg greater weight gain for INSTI), but the differences did not reach statistical significance among females, perhaps due to smaller sample size.…”

“…20,22,[27][28][29] In a recent real-world study of treatment naïve PLWH, Chen et al reported a higher risk of 5% weight gain for INSTI vs. PI initiators among the overall study population (1.3 kg greater mean weight gain for INSTI) and among females (2.5 kg greater weight gain for INSTI). 29 A similar real-world study using a different database reported a higher risk of 5% weight gain for INSTI vs. PI initiators overall (1.5 kg greater weight gain for INSTI), but the differences did not reach statistical significance among females, perhaps due to smaller sample size. 30 In a pooled analysis of 8 clinical trials, Sax et al reported approximately 1.5 kg greater mean weight gain for INSTIs vs. PIs, with female and African Americans/Black patients having greater risk of ≥10% weight gain.…”

“…26 Current guidelines also specify that weight gain may be especially prevalent in certain patient populations (eg, women, African Americans, and Hispanics), consistent with recent reports of gender and racial differences in the risk of weight gain upon initiating INSTI-based regimens. 20,22,27,28 Recent studies have shown that African Americans and women are at a higher risk of weight gain with INSTI-based regimens vs other regimens, 22,29 but data specifically focused on African American females and Hispanics are lacking. Therefore, the current study aimed to understand the difference in weight gain among treatment-naïve female African American PLWH or Hispanic PLWH after initiating INSTI-based vs PI-based ARV regimens.…”

Association Between Weight Gain and the Incidence of Cardiometabolic Conditions Among People Living with HIV-1 at High Risk of Weight Gain Initiated on Antiretroviral Therapy

“…Prior evidence also suggest that weight gain has been observed in the year following initiation of ART [ 10 , 11 ], sometimes as early as 3 months after treatment initiation [ 9 ]. ART-related weight gain also does not affect all PLWH equally, as certain demographic groups, including female, Black and Hispanic PLWH, are generally at greater risk of ART-related weight gain [ 10 , 12 , 13 ], particularly following initiation of INSTI-based regimens [ 14 ].…”

Association between Duration of Protease Inhibitor Therapy and BMI in HIV Patients

“…[14,15] To our knowledge, studies regarding ARV therapy in weight gain had different results. [11,16,17] PI therapy was associated with weight gain in some studies. [1,11,18] Todd et al reported PI drugs were not associated with overweight or obesity.…”