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Background Integrase strand transfer inhibitors (INSTIs) have been associated with weight gain among women living with HIV. We aimed to investigate the association between INSTIs and change in cardiometabolic risk indicators. Setting Retrospective cohort. Methods Data from 2006 to 2017 were analyzed from women living with HIV enrolled in the longitudinal Women's Interagency HIV Study who were virally controlled on antiretroviral therapy (ART) for ≥5 consecutive semiannual visits. Women who switched/added an INSTI to ART (INSTI group) were compared with women who remained on non-INSTI ART (non-INSTI group). Outcomes included changes in fasting lipids and glucose, hemoglobin A1c (HbA1c), blood pressure (BP), and incident diabetes, hypertension, and insulin resistance. Outcomes were measured 6-12 months before and 6-18 months after INSTI switch/add in the INSTI group with comparable visits in the non-INSTI group. Longitudinal linear regression models compared change over time in each outcome by the study group. Results One thousand one hundred eighteen participants (234 INSTI, 884 non-INSTI) were followed for a median 2.0 (Q1 1.9, Q3 2.0) years. Participants were median age 49 years, 61% Black, and 73% overweight or obese (body mass index ≥25 kg/m). Compared with non-INSTI, the INSTI group experienced greater increases in HbA1c (+0.05 vs. -0.06 mg/dL, P = 0.0318), systolic BP (+3.84 vs. +0.84 mm Hg, P = 0.0191), and diastolic BP (+1.62 vs. -0.14 mm Hg, P = 0.0121), with greatest change in HbA1c among women on INSTIs with ≥5% weight gain. Conclusions INSTI use was associated with unfavorable changes in HbA1c and systolic and diastolic BP during short-term follow-up. Further research is needed to understand long-term cardiometabolic effects of INSTI use.

Background HIV disproportionally affects transgender women (TGW) of color, with a prevalence of 26% and 44% among Latinx and Black TGW, respectively. Low medication adherence likely contributed to suboptimal pre-exposure prophylaxis (PrEP) efficacy among TGW in clinical trials, but real-world PrEP outcome data for TGW is limited. In this study, we developed the PrEP care continuum for TGW referred to a PrEP program at a large, safety-net urban hospital in the Southeast. Figure 1. PrEP care continuum of TGW referred a PrEP program. Referrals include all TGW referred to PrEP clinic, eligibility includes all those referred who were deemed eligible for PrEP, linkage refers to those eligible who had ongoing care at the PrEP clinic, prescription refers to those who received their first prescription of PrEP, initiation includes those who started taking the PrEP they were prescribed, and persistence includes those who had a visit within 6 months of study end. Methods We analyzed data for those referred to the PrEP program from 3/2018 to 2/2020. We determined the proportion of TGW who were linked to the program, provided a PrEP prescription, started PrEP, and persisted in PrEP care, defined as having at least one follow-up visit within 6 months. Using a multivariate regression model, including age, race, ethnicity, mental health co-morbidities, and substance use, we determined factors associated with persistence in PrEP care. We calculated rates of sexually transmitted infections (STIs) and HIV incidence. Results Of the 321 total referrals for PrEP, 42 (13%) were TGW. 81% of TGW were referred from a co-located gender clinic. Median age was 28.5 years (IQR 23-34), 62% were Black, 21% had mental health co-morbidities, 45% used substances, and 35% engaged in transactional sex. Of all TGW who were referred, 37 (88%) were eligible for PrEP and linked to care, 36 (85.7%) were prescribed and initiated PrEP, and 22 (52.4%) persisted in care at the end of the study period. There were no factors associated with persistence in PrEP care. The most common STIs during the first visit were pharyngeal gonorrhea (22.7%) and syphilis (16.7%). STI incidence was highest for rectal chlamydia (12.5%) and pharyngeal gonorrhea (6.5%). There was one HIV seroconversion during the study period. Conclusion In a public hospital-based PrEP clinic in Atlanta with a co-located gender clinic, TGW had high rates of linkage to care and PrEP prescription and initiation, despite high rates of mental health diagnoses and substance use. However, there was a significant drop-off in persistence. STI prevalence and incidence were high, but there was only one HIV seroconversion, highlighting the potential benefits of PrEP. Future studies are needed to assess interventions to optimize persistence in PrEP care among TGW. Disclosures Bradley L. Smith, PharMD, AAHIVP, Gilead Sciences, Inc (Advisor or Review Panel member)

Background Integrase strand transfer inhibitor (INSTI)-based antiretroviral therapy (ART) is recommended first-line HIV treatment. We recently demonstrated increased weight gain associated with INSTI use among women living with HIV (WLH) enrolled in the Women’s Interagency HIV Study (WIHS), raising concern for cardiometabolic consequences. We, therefore, evaluated the effects of INSTI use on lipids, insulin resistance, and glycemic control in WLH. Methods Data from 2008 to 2017 were analyzed from WLH enrolled in WIHS. Women who switched to or added an INSTI to ART (SWAD group) were compared with women who remained on non-INSTI ART (STAY group). Outcomes included changes in fasting total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides (TG), and glucose; hemoglobin A1c; and incident insulin resistance (defined as homeostatic model assessment of insulin resistance [HOMA] score ≥2). Outcomes were measured 6–12 months before and 6–18 months after INSTI switch/add in the SWAD group with comparable time points in the STAY group. Linear regression models compared change over time in each outcome by SWAD/STAY group, adjusted for age, race, WIHS site, income, smoking status, statin use, and ART regimen at baseline. Results In total, 881 WIHS participants (182 SWAD and 699 STAY) were followed for a mean 1.8 (±1.1) years. Mean age was 49 (±8.8) years, BMI was 31 (±8.2) kg/m2, and 49% were Black. At baseline, SWAD vs. STAY was more likely to report NNRTI (vs. PI)-based ART and statin use (both P < 0.0001), but all baseline lipid and glucose variables were similar. Compared with STAY, the SWAD group experienced significantly greater decreases in HDL (−2.4 vs. +0.09 mg/dL, P = 0.03) and trended toward greater decreases in TC (−2.6 vs. −2.4 mg/dL, P = 0.07) at follow-up, without significant differences in TG or LDL. The SWAD group had significantly greater increases in A1c (+0.08% vs. −0.05%, P = 0.01) but trended toward lower incidence of insulin resistance (19% vs. 32%, P = 0.05). Conclusion Despite reported increases in weight, INSTI use was associated with only modest changes in lipid measurements and glycemic control during short-term follow-up of WLH compared with non-INSTI ART. Research is needed to elucidate long-term cardiometabolic effects. Disclosures Anandi N. Sheth, MD, MS, Gilead Sciences, Inc.: Research Grant.