The burden of neuropsychiatric disorders in patients living with HIV-1 treated with antiretroviral therapies-A perspective from US Medicaid data.

BACKGROUND: People with human immunodeficiency virus (HIV)-1 face challenges with treatment adherence for various reasons, including consideration of neuropsychiatric disorders and neuropsychiatric adverse reactions associated with antiretroviral therapy (ART). METHODS: A retrospective cohort study was conducted using administrative claims data from the IBM MarketScan® Multi-State Medicaid Database (1/1/2014-12/31/2017). Adults (≥18 years) diagnosed with HIV-1 and newly initiated on antiretroviral therapy with continuous health plan enrollment were included. Primary outcome was the 6-month period prevalence of neuropsychiatric events (NPEs) of interest after ART initiation. RESULTS: Among 1971 newly treated patients included in the study, mean age (standard deviation [SD]) was 38.5 (12.7) years, and 41.4% were female. During the 6 months after ART initiation, 51.4% of patients had a claim for ≥1 NPE versus 30.3% of matched patients without HIV. Among newly treated patients, the most common (≥10%) NPE claims were for depression (42.2%), anxiety (15.8%), headache (11.9%), and bipolar/manic depression (10.1%). Also in this group, the mean (SD) total all-cause healthcare cost during the 6-month post-ART initiation was $16,632 ($33,928), of which $2914 ($18,233) was NPE-related. CONCLUSIONS: In summary, in this Medicaid study of people newly initiated on ART, there was a high prevalence of NPEs, and incremental NPE-associated costs were considerable.

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

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.

An assessment of weight change associated with the initiation of a protease or integrase strand transfer inhibitor in patients with human immunodeficiency virus.

OBJECTIVE: Evidence suggests that integrase strand transfer inhibitors (INSTIs) are associated with greater weight gain than other antiretrovirals. This real-world study compares weight/body mass index (BMI) change between insured US patients with human immunodeficiency virus (HIV-1) initiating a protease inhibitor (PI) or INSTI. METHODS: A retrospective longitudinal study was conducted using Decision Resources Group's Real World Data Repository (7/17/2017-6/1/2019). Adult patients with HIV-1 who initiated a new PI or INSTI on or after 7/17/2018 (index date) and had ≥12 months of continuous pre-index clinical activity were included. Baseline characteristics were balanced using inverse probability of treatment weighting. The proportion of patients with ≥5% weight/BMI increases and mean weight/BMI change from pre- to post-index were compared using odds ratios (ORs) and mean differences (MDs). RESULTS: 20,367 patients (9993 PI, 10,374 INSTI) were included (mean age = 50 years; ∼30% females). Pre- and post-index weight and BMI measurements were available in 429 and 430 PI patients, and 397 and 383 INSTI patients, respectively (mean time between index and post-index measurements: ∼7 months). The PI cohort was 39%/49% less likely to experience ≥5% weight/BMI increase than the INSTI cohort, respectively (OR [≥5% weight gain] = 0.61; p = .014; OR [≥5% BMI gain] = 0.51; p < .001). Mean weight/BMI gain was significantly lower in the PI cohort than the INSTI cohort (weight MD = -1.90 kg [-4.19 lbs], BMI MD = -0.61kg/m2; both p < .001). CONCLUSIONS: Relative to INSTI, patients initiating a new PI were less likely to experience ≥5% weight/BMI gain post-index. Additionally, mean weight/BMI gain was lower in the PI than in the INSTI cohort.