Weight and body mass index (BMI) change was assessed among women after switch to integrase inhibitors (INSTIs) and/or tenofovir alafenamide (TAF). From 2006 to 2019, 1,458 women living with HIV enrolled in the Women's Interagency HIV Study and on antiretroviral therapy (ART) with ‡1 study visit before and after switching to INSTIs and/or TAF were included. Weight and BMI were compared pre-and postswitch to INSTI (by class and type) and/or TAF using multivariable linear mixed effects models; all models were also stratified by preswitch presence or absence of obesity (BMI ‡30 vs. <30 kg/m 2 ). Mean age preswitch was 47 -6 years, 64% were black, mean CD4 = 475 -201 cells/mm 3 , 56% had HIV RNA <200 copies/mL, 36% switched to TAF but not INSTI, 60% to INSTI but not TAF, and 3.5% to TAF+INSTI. Time from pre-to postswitch was 12.8 -11.8 months. The INSTI-only group but not TAF groups had small but significant increases in weight and BMI: mean 79.2-80.6 kg and 30.2-30.7 kg/m 2 , p's < .001, respectively, with congruent findings by INSTI type ( p's £ .01). In stratified (preswitch BMI) analyses, only nonobese subgroups experienced increases in weight and BMI across all ART treatment groups ( p's < .05). Significant, although small-to-medium, increases in weight and BMI occurred among nonobese women who switched to INSTIs and/or TAF over short follow-up. Given long-term health consequences of obesity particularly as a low-grade inflammatory condition, identifying women at highest risk of ART-associated weight gain is imperative.
Background Intestinal and multivisceral transplantations are treatment options for patients with intestinal failure. Transplantation is often complicated by abdominal and/or bloodstream infections in the post‐operative period. Methods A retrospective chart review of all adults who underwent intestinal or multivisceral transplantation at our institution from 2003 to 2015 was performed. Data were collected for 2 years post transplant. Results A total of 106 intestinal or multivisceral transplants were performed in 103 patients. The median age at the time of transplant was 44 (IQR: 34‐52) with 55% (n = 58) male and 45% (n = 48) female. There were 46 (43%) intra‐abdominal infections post transplant among the 103 patients, and six transplant recipients (13%) developed concurrent bloodstream infections. The median time to first intra‐abdominal infection was 23 days (IQR: 10‐48). For those with organisms isolated in culture, forty‐seven percent of the isolates were gram negative, 39% gram positive, 7% anaerobes, and 7% yeast. The most common isolates were enterococci at 28%, E. coli at 14%, and Klebsiella spp at 13%. Sixty‐three percent of the enterococci were vancomycin‐resistant enterococci (VRE), and 22% of the gram‐negative isolates were extended spectrum beta‐lactamases (ESBLs). Patients with intra‐abdominal infections had longer hospital post‐transplant length of stays at a median of 35 days (IQR: 25‐48) vs 23 days (IQR: 17‐33) for those without infections, P = .0012. There was no difference in all‐cause mortality in patients with or without intra‐abdominal infections, P = .654. Conclusions Intra‐abdominal infections are common in intestinal or multivisceral transplant recipients, but despite this complication, we found no increased risk of mortality. These transplant recipients are also at risk for infection with drug‐resistant organisms.
Background Since the emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the number of cases of coronavirus disease (COVID-19) in the United States has exponentially increased. Identifying and monitoring individuals with COVID-19 and individuals who have been exposed to the disease is critical to prevent transmission. Traditional contact tracing mechanisms are not structured on the scale needed to address this pandemic. As businesses reopen, institutions and agencies not traditionally engaged in disease prevention are being tasked with ensuring public safety. Systems to support organizations facing these new challenges are critically needed. Most currently available symptom trackers use a direct-to-consumer approach and use personal identifiers, which raises privacy concerns. Objective Our aim was to develop a monitoring and reporting system for COVID-19 to support institutions conducting monitoring activities without compromising privacy. Methods Our multidisciplinary team designed a symptom tracking system after consultation with experts. The system was designed in the Georgetown University AvesTerra knowledge management environment, which supports data integration and synthesis to identify actionable events and maintain privacy. We conducted a beta test for functionality among consenting Georgetown University medical students. Results The symptom tracker system was designed based on guiding principles developed during peer consultations. Institutions are provided access to the system through an efficient onboarding process that uses clickwrap technology to document agreement to limited terms of use to rapidly enable free access. Institutions provide their constituents with a unique identifier to enter data through a web-based user interface to collect vetted symptoms as well as clinical and epidemiologic data. The website also provides individuals with educational information through links to the COVID-19 prevention recommendations from the US Centers for Disease Control and Prevention. Safety features include instructions for people with new or worsening symptoms to seek care. No personal identifiers are collected in the system. The reporter mechanism safeguards data access so that institutions can only access their own data, and it provides institutions with on-demand access to the data entered by their constituents, organized in summary reports that highlight actionable data. Development of the system began on March 15, 2020, and it was launched on March 20, 2020. In the beta test, 48 Georgetown University School of Medicine students or their social contacts entered data into the system from March 31 to April 5, 2020. One of the 48 users (2%) reported active COVID-19 infection and had no symptoms by the end of the monitoring period. No other participants reported symptoms. Only data with the unique entity identifier for our beta test were generated in our summary reports. Conclusions This system harnesses insights into privacy and data sharing to avoid regulatory and legal hurdles to rapid adaption by entities tasked with maintaining public safety. Our pilot study demonstrated feasibility and ease of use. Refinements based on feedback from early adapters included release of a Spanish language version. These systems provide technological advances to complement the traditional contact tracing and digital tracing applications being implemented to limit SARS-CoV-2 transmission during reopening.
Background Novel urine biomarkers have enabled the characterization of kidney tubular dysfunction and injury among persons living with HIV, a population at an increased risk of kidney disease. Even though several urine biomarkers predict progressive kidney function decline, antiretroviral toxicity, and mortality in the setting of HIV infection, the relationships among the risk factors for chronic kidney disease (CKD) and urine biomarkers are unclear. Methods We assessed traditional and infection-related CKD risk factors and measured 14 urine biomarkers at baseline and at follow-up among women living with HIV in the Women’s Interagency Health Study (WIHS). We then used simultaneously adjusted multivariable linear regression models to evaluate the associations of CKD risk factors with longitudinal changes in biomarker levels. Results Of the 647 women living with HIV in this analysis, the majority (67%) were Black, the median age was 45 years and median follow-up time was 2.5 years. Each traditional and infection-related CKD risk factor was associated with a unique set of changes in urine biomarkers. For example, baseline hemoglobin a1c was associated with worse tubular injury (higher interleukin [IL]-18), proximal tubular reabsorptive dysfunction (higher α1-microglobulin), tubular reserve (lower uromodulin) and immune response to injury (higher chitinase-3-like protein-1 [YKL-40]). Furthermore, increasing hemoglobin a1c at follow-up was associated with further worsening of tubular injury (higher kidney injury molecule-1 [KIM-1] and IL-18), as well as higher YKL-40. HCV co-infection was associated with worsening proximal tubular reabsorptive dysfunction (higher β2-microglobulin [β2m]), and higher YKL-40, whereas HIV viremia was associated with worsening markers of tubular and glomerular injury (higher KIM-1 and albuminuria, respectively). Conclusions CKD risk factors are associated with unique patterns of biomarker changes among women living with HIV, suggesting that serial measurements of multiple biomarkers may help in detecting and monitoring kidney disease in this setting.
Background: Integrase strand transfer inhibitors (INSTIs) are first-line regimens for HIV treatment. We aimed to examine their impact on cognitive performance and depressive symptoms in women with HIV (WWH). Setting: Women's Interagency HIV Study, a multisite, prospective, cohort study. Methods: WWH who started or switched to INSTI-based antiretroviral therapy (ART) and completed neuropsychological testing and the Center for Epidemiological Studies-Depression (CES-D) scale before and after INSTI start/switch were included in the analyses. Primary outcomes were demographically corrected cognitive domain T-scores. Linear mixed-effects models adjusted for relevant covariates were used to examine effects of start/switch of any INSTI and individual INSTI drugs on cognition and CES-D scores. Results: Six hundred thirty-nine WWH, median age 49 (interquartile range 12) years, 66% Black non-Hispanic, had neuropsychological and CES-D scale data before and after INSTI start/switch. Although 14% started INSTI-based ART, the remainder switched to INSTI-based ART from another regimen. Overall, any INSTI use was associated with poorer learning post-INSTI. Specifically, use of dolutegravir and elvitegravir, but not raltegravir, was associated with poorer learning. In analyses restricted to INSTI switch, any INSTI use, and dolutegravir use, was associated with poorer learning. Among those switching from a PI-based regimen, INSTIs overall and dolutegravir remained associated with poorer learning; switching from a nonnucleoside reverse transcriptase inhibitor to dolutegravir was also associated with poorer learning. INSTI start/switch was not related to depressive symptom changes. Conclusions: INSTI use was associated with poorer learning among WWH. These changes were mainly observed in elvitegravir and dolutegravir users, indicating that the impact of INSTI on cognition in WWH may not be a class effect.
Cognitive impairment remains frequent and heterogeneous in presentation and severity among virally suppressed (VS) women with HIV (WWH). We identified cognitive profiles among 929 VS-WWH and 717 HIV-uninfected women from 11 Women's Interagency HIV Study sites at their first neuropsychological (NP) test battery completion comprised of: Hopkins Verbal Learning Test-Revised, Trail Making, Symbol Digit Modalities, Grooved Pegboard, Stroop, Letter/Animal Fluency, and Letter-Number Sequencing. Using 17 NP performance metrics (T-scores), we used Kohonen self-organizing maps to identify patterns of high-dimensional data by mapping participants to similar nodes based on T-scores and clustering those nodes. Among VS-WWH, nine clusters were identified (entropy = 0.990) with four having average T-scores ≥45 for all metrics and thus combined into an “unimpaired” profile (n = 311). Impaired profiles consisted of weaknesses in: (1) sequencing (Profile-1; n = 129), (2) speed (Profile-2; n = 144), (3) learning + recognition (Profile-3; n = 137), (4) learning + memory (Profile-4; n = 86), and (5) learning + processing speed + attention + executive function (Profile-5; n = 122). Sociodemographic, behavioral, and clinical variables differentiated profile membership using Random Forest models. The top 10 variables distinguishing the combined impaired vs. unimpaired profiles were: clinic site, age, education, race, illicit substance use, current and nadir CD4 count, duration of effective antiretrovirals, and protease inhibitor use. Additional variables differentiating each impaired from unimpaired profile included: depression, stress-symptoms, income (Profile-1); depression, employment (Profile 2); depression, integrase inhibitor (INSTI) use (Profile-3); employment, INSTI use, income, atazanavir use, non-ART medications with anticholinergic properties (Profile-4); and marijuana use (Profile-5). Findings highlight consideration of NP profile heterogeneity and potential modifiable factors contributing to impaired profiles.
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