bluuebunny/crossref_metadata_2025 huggingface dataset:
311. The Role of Transthoracic Echocardiography in Staphylococcus aureus Bacteremia; A Retrospective Chart Review
Authors: Aldred Bruce M , Drekonja Dimitri M
Published: January 2021

Background

Evaluation for endocarditis is an essential step in the management of patients with Staphylococcus aureus bacteremia (SAB). A common approach, consistent with preeminent national guidelines, is to perform transthoracic echocardiography (TTE) followed by transesophageal echocardiography (TEE) in the majority of patients with SAB. It is unclear how often patient management decisions are influenced by the results of TTE versus TEE.

Methods

This retrospective chart review of 180 subjects evaluated adult veterans at a single large Veterans Affairs medical center who had SAB and completed both TTE and TEE. Institution-specific guidelines at this medical center, which were in place throughout the study time period, recommended completion of both TTE and TEE for all patients diagnosed with SAB if able to tolerate both studies. The timing of key patient-management decisions was correlated to the timing of each patient’s TTE and TEE. It was then inferred whether each decision would have been informed by TTE alone versus TTE plus subsequent TEE. Management decisions included: initiation of synergistic antibiotics, documentation of antibiotic treatment duration, consultation of specialists such as Cardiology or Cardiac Surgery, and performance of valve surgery.

Results

Preliminary results show that management decisions were typically not performed until patients had undergone both echocardiography studies. In 18% of patients, management was deemed to be influenced in any capacity following TTE, compared to 91% following both TTE and TEE.

Conclusion

Our findings question the utility of performing a TTE in patients with SAB who are planned to also undergo a subsequent TEE.

Disclosures

All Authors: No reported disclosures
47. Long Term Outcomes of Pulse-taper Corticosteroid Therapy (PCT) for Refractory Non-HIV Cryptococcal Meningoencephalitis
Authors: Anjum Seher , Williamson Peter , Magone Teresa , Edmond Fitzgibbon , Krieger Chantal , Murphy Elizabeth , Zalewski Chris , King Kelly , Chisholm Jennifer , Brewer Carmen , Nath Avindra , Billioux Jean , Kosa Peter , Bielekova Bibiana , Bennett John , Marr Kieren , Hammoud Dima , Dean Owen , Kim Jeff
Published: January 2021

Background

Cryptococcal meningoencephalitis (CM) is a major cause of mortality in HIV/AIDS, transplant recipients and previously healthy individuals. In the latter, a post-infectious inflammatory response syndrome (PIIRS) is associated with poor clinical response despite prior amphotericin therapy and CSF culture conversion. Data on effective treatment is limited.

Methods

Between March 2015 and March 2020, 15 patients with CM/PIIRS were treated with adjunctive pulse – taper corticosteroid therapy (PCT) consisting of intravenous methylprednisolone 1 gm daily for 1 week followed by oral prednisone 1 mg/kg/d, tapered based on clinical and radiological response plus oral fluconazole. Montreal cognitive assessments (MOCA), Karnofsky Performance scores, MRI brain scans, eye and audiologic exams were conducted at baseline and after pulse completion. CSF parameters were assessed prior to and after the pulse.

Results

80% of patients were male, median age 51 years. Median time from antifungal treatment to steroid initiation was 6 weeks. The most common symptoms at PIIRS diagnosis were progressive deterioration in mental status and vision changes. There was a significant improvement in MOCA(n=14) and Karnofsky(n=15) scores at 3 weeks (p< 0.0003), which was accompanied by improvements in CSF: serum, glucose ratios, CSF WBC, protein and activated CD4 T cells (n=14) post-pulse (p< 0.003). Additionally, soluble CSF IL-6 and sCD25 levels improved (p = 0.03). Neurofilament light chain levels (NFL), a biomarker of axonal damage, showed significant reductions over a 30-month period (Generalized Estimating Equation coefficient = 0.128) and a negative correlation with post pulse MOCA scores (r = - 0.8; p = 0.01).

Papilledema (n=8) and visual field deficits (n=11) improved significantly (p< 0.0005) after 2 months of pulse completion. Brain MRI showed improvement of radiological findings in 11 patients (p=0.001). Five out of 7 patients who underwent audiological testing demonstrated hearing improvement after 3 weeks post-pulse. CSF cultures remained negative.

Conclusion

PCT in this small cohort of PIIRS patients was associated with persistent improvements in CM-related complications with minimal toxicity and no recurrence of infection.

Disclosures

All Authors: No reported disclosures
50. Evaluation of Discordant Results Between Filmarray Meningitis/encephalitis Panel and Conventional Testing in Pediatric Patients: A Multi-site Retrospective Cohort Study
Authors: Ekambaram Maheswari , Nabower Aleisha M , Ampofo Krow , Gollehon Nathan S , Goodrich Nathaniel , Martin Kimberly C , McCulloh Russell , Rajbhandari Prabi , Snowden Jessica
Published: January 2021

Background

FilmArray Meningitis/Encephalitis Panel (ME panel) has a 11% false positive and 2.2% false negative rate compared to conventional testing. We aim to describe characteristics, treatment decisions and outcomes in pediatric patients with discordant results between ME panel and conventional testing.

Methods

We conducted a multisite (n=4) retrospective review of patients < 18 years with positive cerebrospinal fluid (CSF) results by ME panel or conventional testing (CSF culture, Herpes Simplex Virus [HSV] and enterovirus [EV] PCR) from time of local ME panel implementation to February 2019. We excluded CSF obtained for non-infectious reasons. Demographic and clinical data were extracted from electronic medical records. Comparison between concordant and discordant results were made using Mann-Whitney test for continuous and Fisher’s exact test for categorical variables.

Results

A total of 355 patients had at least 1 positive result. Baseline characteristics and pathogens are shown in Table 1 and 2. Of the 53 bacterial pathogens identifiable by ME panel, 31 (58%) had discordant results – 29 positive by ME panel only and 2 by culture only (both E.coli). Patients with bacterial pathogens identified by ME panel only had lower CSF WBC and protein but higher CSF glucose (Table 3). Five patients with bacteria identified on ME panel only were not treated as meningitis given lack of pleocytosis, no antibiotic pretreatment and negative repeat cultures. Of these, 4 recovered without complications but one had hypoxic encephalopathy.

Two patients had HSV noted in ME panel but individual PCR negative. The first was a 13-day-old with typical skin lesions and positive surface swab. The other was a 6-day old only with CSF pleocytosis. Both had abnormal neuroimaging and were treated as true cases. Of 24 who had both EV PCR and ME panel, 7 were positive by ME panel only and 3 by PCR only.

Table 1: Baseline Characteristics of the Study Population

Table 2: Pathogens identified via CSF Culture, ME panel or Conventional PCR

Table 3: Characteristics of Discordant Results for Bacterial Pathogens Tested in ME panel

Conclusion

More than half of bacterial pathogens identified by ME panel did not have a corresponding positive CSF culture. No difference was noted by antibiotic pretreatment. Treatment decisions based on positive ME panel should be made in the appropriate clinical context. Likewise, a negative ME panel does not rule out infection especially when atypical organisms are suspected.

Disclosures

Krow Ampofo, MBChB, Merck (Grant/Research Support)
55. Diabetes, Obesity and COVID-19 Disease: An Observational Study of Outcomes Among Hospitalized Patients in Boston, Massachusetts
Authors: Seiglie Jacqueline , Platt Jesse , Cromer Sara Jane , Bunda Bridget , Foulkes Andrea , Bassett Ingrid , Hsu John , Meigs James , Leong Aaron , Putman Melissa , Triant Virginia A , Wexler Deborah , Manne-Goehler Jennifer
Published: January 2021

Background

In the United States, diabetes mellitus (DM) is among the most common chronic diseases, with approximately 34.2 million people affected. DM has also emerged as a commonly reported risk factor among people hospitalized with coronavirus disease 2019 (COVID-19). In this study, we sought to evaluate whether people with DM who are hospitalized with COVID-19 were more likely to experience poor early outcomes and whether this association remained after adjustment for obesity status.

Methods

We analyzed data from the Massachusetts General Hospital (MGH) COVID-19 Data Registry. The sample included 450 people with PCR-confirmed SARS-CoV-2 infection who were hospitalized at MGH between March 11, 2020 and April 30, 2020. The primary outcomes were (1) admission to the intensive care unit (ICU) and (2) need for mechanical ventilation or death, both within 14 days of presentation to care. Data were obtained by manual chart review and via an EMR-associated database. Logistic regression was used to evaluate the relationship between diabetes and these outcomes. All models were adjusted for age, sex, race, BMI category and key comorbidities.

Results

In this study, 178 (39.6%) of 450 participants had DM and 346 (76.9%) were overweight or obese. People with DM were on average older and had a higher BMI than those without DM. A higher percentage of patients with DM were admitted to the ICU (42.1% vs 29.8%, p=0.007) and required mechanical ventilation or died (46.6% vs 27.7%, p< 0.001), compared with patients without DM (Figure 1). In adjusted models, DM was associated with a greater odds of ICU admission (aOR: 1.58 [95% CI: 1.01–2.46]) and mechanical ventilation or death (2.15 [1.38–3.34). Obesity was associated with a greater odds of ICU admission (2.15 [1.20–3.86]) but not with mechanical ventilation or death (1.52 [0.87–2.67]). Table 1 provides the model results in full.

Figure 1. ICU Admission and mechanical ventilation or death within 14-days by diabetes status among 450 people hospitalized with COVID-19

Conclusion

Diabetes was associated with poor outcomes within 14-days of presentation to care for COVID-19. These findings remained after adjustment for obesity. Our findings can help guide risk mitigation efforts and patient-centered care decision making for people with DM and obesity, particularly in areas of the US that have a high prevalence of DM and obesity and are in early phases of the SARS-CoV-2 outbreak.

Disclosures

Sara Jane Cromer, MD, Depuy-Synthes (a Johnson & Johnson company) (Employee) James Meigs, MD, Quest Diagnostics (Other Financial or Material Support, Academic Associate) Deborah Wexler, MD, Novo Nordisk (Other Financial or Material Support, Data Monitoring Committee)
63. Prognosis of COVID-19 Patients with Diabetic Ketoacidosis with or Without Hyperosmolar Hyperglycemic State
Authors: Chan Kok Hoe , Thimmareddygari Divya , Ramahi Amr , Atallah Liana , Slim Jihad
Published: January 2021

Background

One of the risk factors for poor outcome with SARS-CoV-2 infection is diabetes mellitus; diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state (HHS) are the most serious complications of diabetes mellitus. We aimed to explore the clinical characteristics and outcomes of COVID-19 patients presenting with isolated DKA or combined DKA/HHS to our institution.

Methods

A retrospective, hospital based observation case series was performed on patients with SARS-CoV-2 admitted to Intensive Care Unit between 03/20/20 and 04/20/20. Inclusion criteria were: 1) Blood Glucose >250mg/dL; 2) Serum bicarbonate < 18 mmol/L; 3) Anion Gap >10; 4) serum pH < 7.3; 4) ketonemia or ketonuria; and 5) positive SARS-CoV-2 RT-PCR. Hyperosmolality, on the other hand, was defined as an effective/calculated plasma osmolality >304 mOsm/kg.

Results

A total of 87 patients with COVID-19 were admitted to the ICU during the study period, 12 of them had either isolated DKA or DKA/HHS. Baseline demographics, lab values and outcome are summarized in Table 1. Six of the patients had isolated DKA and six had combined DKA and HHS. The median age for the patient was 49.5 years old (range from 19 to 62 years old). The male to female ratio was 5:1. Of the 12 patients, 10 patients (83%) had a history of DM, nine were type 2 and only one type 1; two patients were newly diagnosed DM, presenting as DKA, presumptively precipitated by COVID-19. Five patients (42%) had a BMI >30 kg/m2. As for ethnicity; seven were Hispanic (59%), four African American (33%), and one Caucasian (8%).

Patients with combined DKA/HHS, higher BMI, higher HbA1c, severe acidosis tended to have higher mortality. The striking feature was that isolated DKA or combined DKA/HHS was the initial presentation for COVID-19 for most of the cases.

Table 1: Demographic characteristic, inflammatory markers and outcome.

Conclusion

Our observational retrospective case series reinforces the need to watch for new onset DM and monitor blood sugar closely in those with known diabetes mellitus during SARS-CoV-2 infection, in order to avoid such serious complications as DKA and HHS.

Disclosures

Jihad Slim, MD, Abbvie (Speaker’s Bureau)Gilead (Speaker’s Bureau)Jansen (Speaker’s Bureau)Merck (Speaker’s Bureau)ViiV (Speaker’s Bureau)
69. Effective Contact Tracing Strategies for COVID-19: A Municipal Health Department’s Model
Authors: Persaud Paul , Suh Jin S , Bond Kate , Espinal-Mesa Alicia , Suh Bennett
Published: January 2021

Background

During the COVID-19 pandemic, contact tracing program as part of a larger epidemiological case investigation was effectively implemented by the local department of health in Paterson, NJ. The Paterson Communicable Disease Strike Team (PCDST) was established by leveraging skills and using existing public health staff of the health department team which led to a timely and robust public health intervention.

Methods

PCDST comprised of 25 communicable disease investigators/contact tracers established in preparation for public health response in the event of large-scale communicable disease outbreaks pre-COVID. In March 2020 with initial COVID-19 cases in Paterson, PCDST was activated utilizing NJ DOH’s Communicable Disease Reporting and Surveillance System (CDRSS). Additional staff members were cross-trained to augment team as new cases surged. A triage coordinator would identify and assign new cases to disease investigators at a 24/7 schedule. Disease Investigators would provide test results, perform epidemiological case interviews, elicit close contacts, and provide isolation/quarantine recommendations. Case-contact monitors followed up daily basis until completion of isolation/quarantine period.

Results

As of June 15, 2020, 6537 cases tested COVID-19 (+) in Paterson, NJ. 91% of cases and their contacts were interviewed. Peak occurred in mid-April with 263 cases on a single day. By mid-June, daily number of cases declined to 7/day. Reported COVID-19 mortality rate in Paterson (4.65%), compared to surrounding towns in the same county of Passaic (6%), other large cities in New Jersey (Newark 8%, Jersey City 7.4%) and New Jersey state (7.59%).

Conclusion

Despite limited resources, we were able to cross train and engage our frontline public health team (PCDST) to investigate and effectively contact trace new COVID-19 cases to help contain spread of infection. Although its unclear if our intervention impacted mortality rates, it is certain that contact tracing using a trained public health workforce is a model that has proven successful in Paterson. A local public health workforce vested in their communities can develop rapport needed to build trust and confidence in an intervention that elicits confidential medical information to limit viral transmission.

Disclosures

All Authors: No reported disclosures
84. Clarifying the Congenital Zika Syndrome Phenotype and Expanding to Congenital Zika Spectrum in the Absence of Laboratory Evidence
Authors: Zambrano Laura D , Delaney Augustina , Rose Charles E , Gilboa Suzanne , Tong Van , Valencia-Prado Miguel , Roth Nicole , Cragan Janet , Moore Jazmyn , Staples J Erin , Honein Margaret , Moore Cynthia
Published: January 2021

Background

Congenital Zika syndrome (CZS) is a term used to describe the pattern of anomalies in infants due to congenital Zika virus (ZIKV) infection. To date, published reports of infants with these anomalies have been primarily small case series of the most severely affected infants and attempts to determine the CZS phenotype have been based on those reports. Lack of a standard definition has led to inconsistencies in the term’s use in the literature and uncertainty about the full spectrum of anomalies, limiting the application for diagnostic and surveillance purposes.

Cluster analysis of brain and eye anomalies associated with congenital Zika infection. Clustering occurred independent of laboratory evidence of Zika virus infection, yielding a clinically distinct phenotype associated with congenital infection.

Methods

We sought to understand which defects co-occur with possible congenital ZIKV infection using data from 415 mother-infant dyads with laboratory evidence of confirmed or presumptive Zika virus infection from the U.S. Zika Pregnancy and Infant Registry, and a comparison group of 4534 mother-infant dyads with no documented or plausible ZIKV infection from the Zika Birth Defects Surveillance System. We use k-means cluster analysis, discriminant analysis, and regression approaches to identify combinations of defects consistent with possible congenital ZIKV infection.

Results

A clinically distinct phenotype emerged as a single cluster in infants for whom both brain and eye defects were recorded that corresponded to evidence of confirmed or probable ZIKV infection. A combination of six defects (sub-cortical calcifications, chorioretinal atrophy/pigmentary anomalies, arthrogryposis or clubfoot, cerebral atrophy or ventriculomegaly, abnormal cortical gyration, and optic nerve atrophy/pallor/other optic nerve abnormalities) predicted the presence of laboratory evidence (area under the receiver operating characteristics curve: 0.95, 95% confidence interval: 0.90–0.99).

Conclusion

Further analyses are underway to develop a scoring rubric to weigh evidence of specific congenital anomalies, separately and in combination, that are consistent with laboratory evidence of congenital ZIKV infection. A quantitatively determined spectrum of Zika-associated anomalies, based on the presence of specific combinations of congenital anomalies, will inform a clinical decision tool to improve patient counseling and public health surveillance practices.

Disclosures

All Authors: No reported disclosures
88. Impact of a Computerized Clinical Decision Support Tool on clostridioides Difficile Testing and Oral Vancomycin Utilization as a Balancing Metric
Authors: Hussain Cory , Aragon Deborah , Knepper Bryan C , Jenkins Timothy C , Shihadeh Katherine C , Young Heather
Published: January 2021

Background

Over diagnosis of hospital-onset Clostridioides difficile infection (HO-CDI) is directly tied to inappropriate C. difficile testing which does not distinguish between infected or colonized individuals. This can lead to inappropriate therapy. Multiple studies have utilized Computerized Clinical Decision Support (CCDS) tools to reduce inappropriate C. difficile testing. Our study looks at the impact of a Self-Assessment CCDS tools on C. difficile testing for HO-CDI and oral vancomycin utilization as a balancing metric.

Methods

Our institution utilizes a two-step test to diagnose HO-CDI that consists of toxin A/B enzyme immunoassay followed by a confirmatory PCR. We applied a self-assessment driven CCDS approach to reduce testing for HO-CDI. Our intervention was deployed in the 3rd quarter of 2018. It asked 3 questions about stool frequency, laxative use and previous C. difficile testing in the order itself. Inappropriate indications for testing included any of the following: < 3 bowel movements within 24 hours, receipt of a laxative within the past 48 hours, or a previous C. difficile test within the previous 7 days. Ordering providers would self-answer these questions. A ‘yes’ response to any of the three questions prevented further test ordering; though respondents had the freedom to change the answer and still proceed with the test order. We evaluated 3 metrics that were all calculated per 1000 inpatient census days: oral vancomycin usage, HO-CDI rates and C. difficile testing rates.

Results

Compared to baseline, our intervention resulted in a significant reduction of C. difficile testing and HO-CDI rates (Figure 1, Table 1). Oral vancomycin usage also decreased significantly (Figure 2, Table 1).

Figure 1. C. difficile testing and Hospital Onset C. difficile Infection Rates by Month, Before and After Intervention

Figure 2. Oral Vancomycin Utilization by Month, Before and After Intervention

Table 1. Changes in Median Rates of C. difficile testing, Hospital Onset C. difficile Infections and Vancomycin Utilization, Before and After Intervention.

Conclusion

Our self-assessment driven CCDS-based diagnostic stewardship resulted in a significant reduction in inappropriate C. difficile testing for HO-CDI and HO-CDI rates. Oral vancomycin utilization as a balancing metric also decreased significantly. This was despite the use of a self-assessment driven approach with the freedom to change the answers in order to proceed with the test order.

Disclosures

All Authors: No reported disclosures
97. Assessment of Personal Protective Equipment Adherence in Red Box Using Remote Video Auditing
Authors: Singh Vansha , Khatri Akshay , Khameraj Aradhana , Rasul Rehana , Schwartz Rebecca , Malhotra Prashant , Farber Bruce
Published: January 2021

Background

“Red box (RB)” is a delineated space in the entry way to a patient(pt) room(rm) that facilitates communication between pt and health care provider (HCP) without the latter needing to don/doff personal protective equipment (PPE). It decreases PPE use where unnecessary and increases pt satisfaction ratings. Remote Video Auditing (RVA) is a novel technique used to ensure adherence to isolation precautions. In this study, we used RVA to compare HCP compliance rates with PPE use in isolation rms with or without RB.

Methods

A prospective observational study (2/26/19-2/27/20) was designed to evaluate HCP compliance with PPE when entering or exiting droplet/contact isolation rms. RB was demarcated by red tape as a 3-ft area at rm entrance, >6 ft from the head of the bed. Cameras were placed at the entry of 4 rms with RB (RB rms) and 2 isolation rms without RB (control rms). Adherence to gowns, gloves, masks and hand hygiene (HH) was reviewed by trained independent remote observers to maintain uniformity. When HCPs stayed in the RB, compliance at exit was calculated. Compliance was compared between events of HCPs going beyond the RB and those of HCPs entering/exiting control rms using binomial regression models with log link.

Results

RVA captured 6959 pt encounters in 6 rms over a year. Consistent with RB protocol, when HCPs utilized the RB, 69.9% did not practice HH, 91.6% did not utilize gloves and 95.2% did not use gowns (Table 1). When HCPs went beyond the RB, there was significantly increased non-compliance with PPE and HH in RB rms compared with control rms (Table 2). Healthcare-associated infection (HAI) rates for this unit assessed using NHSN criteria demonstrated no increase as compared to prior years.

Table 1: Non-Compliance among those who entered Red Box but did not go into the room fully

Table 2: Comparison of non-compliance between group that went beyond Red Box Vs. Control group without Red Box

Conclusion

RVA, a novel, labor-efficient and objective method, was used for observing and comparing PPE compliance in RB rms. Consistent with the purpose of RB, >90% HCPs did not use PPE while confined within it. However, HCPs going beyond the RB were more non-compliant with PPE use as compared to HCPs in control rms. While HAI rates were not increased, this finding is concerning – HCPs going beyond RB may not have used PPE (even in close proximity) due to a false sense of security due to RB. Re-education about optimal use of the RB or discontinuing RB should be considered.

Disclosures

All Authors: No reported disclosures
105. Null Effect of Financial Incentives or Social Media Support on Prep Adherence in a Randomized Controlled Trial of Young Men Who Have Sex with Men of Colour
Authors: Ware Chelsea , Sparks Andrew D , Levy Matthew E , Wolf Hilary , Siegel Marc O
Published: January 2021

Background

Pre-exposure prophylaxis (PrEP) using emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) effectively reduces HIV transmission, with efficacy being dependent on adherence. We evaluated the effect of either social media-based support or financial incentives on PrEP adherence among young MSM of color in Washington, DC

Methods

MSM aged 18–29 were randomized 1:1:1 to standard of care (SOC) PrEP (Control group), SOC PrEP + invitation to a bidirectional Facebook group supervised by two clinicians (Social Media group), or SOC PrEP + $50 gift card at each of two follow-up visits (Financial Incentive group). Participants were asked to return at 3 and 6 months. Adherence was monitored with predefined dried blood spots (DBS) TFVdp levels with < 490, 490–979, 980–1749 and ≥1750 fmol/punch correlating with average of < 2, 2–4, 4–6, and 7 doses per week

Results

We enrolled 53 MSM. Average age was 22.5 years and 72% of participants were Black. At enrollment, 96% had previously heard of PrEP, 17% had ever taken PrEP but none had taken PrEP in the prior 6 months. 92% of participants reported condomless anal sex in the prior 3 months, 36% with an HIV-positive man or man of unknown HIV status (Table 1). 81% of participants returned for their 3-month visit and 70% for their 6-month visit. Mean self-reported PrEP adherence over the previous 3 months was 78% with no difference in adherence between the three groups at either visit. Based on DBS TFVdp levels, protective PrEP adherence (≥4 doses/week) was measured in 46% of the Financial Incentive group and in 57% of the Social Media group compared to in 67% of the Control group (p=0.38). Only 16% of TFVdp levels corresponded to taking PrEP 7 days a week (Figure 1). There was no change in sexual risk activity over the course of the study. 38 sexually transmitted infections were diagnosed in 26 participants (Figure 2). No participant tested positive for HIV. 3 months after study completion, 9 participants were still taking PrEP

Table I. Sexual risk behaviors over the previous 3 months for study participants assessed at baseline visit, as well as 3 month and 6 month follow up visits

Figure 1. PrEP Adherence.

Figure 2. Number of sexually transmitted infections by specific etiology and site diagnosed

Conclusion

Our study showed no impact of either offering financial incentives or providing access to a supervised Facebook-based support group on PrEP adherence. Financial compensation based on level of PrEP adherence and using a more age-appropriate social media platform may have a greater impact on adherence

Disclosures

All Authors: No reported disclosures
106. META-INSTI: Metabolic Adverse Events Following Integrase Strand Transfer Inhibitor Administration in Spontaneous Adverse Event Reports
Authors: Murray Milena M , Harpe Spencer E
Published: January 2021

Background

Unexpected metabolic effects of integrase inhibitors (INSTIs) have been reported in the literature. The FDA Adverse Event Reporting System (FAERS) is a publicly available database that captures spontaneously reported adverse events. Analysis of these data allows for the determination of whether rare or unknown events represent a cause for concern. The objective of this study was to evaluate the relationship between INSTIs and metabolic adverse events using the FAERS database.

Methods

FAERS data were queried from quarter 4 2007 through quarter 4 2019 and limited to adults. The Standardized MedDRA Query (SMQ) for hyperglycemia/new onset diabetes mellitus (H/DM) was used to identify metabolic adverse events of interest. Weight gain was defined as increased weight or increased BMI and was analyzed as a separate event. Reporting odds ratios (ROR) and 95% Confidence Intervals (CIs) were calculated for the INSTI class and for individual agents.

Results

Over 10.1 million FAERS reports were identified. H/DM was noted in 732,591 reports (7.2%); 109,566 (1.1%) reported weight gain. Consumers (49%) and physicians (23%) were the most common reporters. The most frequent countries of occurrence were the US, Great Britain, and Japan. The mean (SD) age was 57 (17) years with 63% females. Any INSTI was mentioned as a primary and/or secondary suspect agent in 18,400 (0.18%) reports (bictegravir: 1,414 [0.01%]; dolutegravir: 7,840 [0.08%]; elvitegravir: 4,034 [0.04%]; raltegravir: 5,551 [0.05%]). RORs (95% CI) for H/DM and weight gain for any INSTI were 1.20 (1.15, 1.27) and 2.16 (1.96, 2.38). For individual agents, RORs (95% CI) for H/DM and weight gain were bictegravir: 1.23 (1.10, 1.37) and 6.82 (5.50, 8.41); dolutegravir: 1.28 (1.19, 1.39) and 1.86 (1.58, 2.18); elvitegravir: 0.76 (0.56, 1.02) and 1.63 (1.37, 1.92); raltegravir: 1.00 (0.90, 1.11) and 3.29 (2.77, 3.91). H/DM was noted in 159 bictegravir and 712 dolutegravir reports.

Conclusion

Overall, H/DM was associated with bictegravir and dolutegravir; weight gain was associated with all INSTIs. Clinicians should be aware of the potential relationship with INSTIs and concerning metabolic effects and institute appropriate monitoring. Future clinical studies to evaluate these findings are warranted.

Disclosures

Milena M. Murray, PharmD, MSc, BCIDP, AAHIVP, Merck (Speaker’s Bureau)
107. Impact of Switching to an Antiretroviral Regimen Containing Tenofovir Alafenamide on Weight Gain and Development of Metabolic Side Effects
Authors: Darnell Julia , Karris Maile , Qin Huifang , Hill Lucas
Published: January 2021

Background

Tenofovir is a common backbone of many antiretroviral (ARV) regimens for the treatment of HIV. Although limited, data has shown that tenofovir alafenamide (TAF) may contribute to weight gain. Our study evaluated the impact on weight gain and metabolic effects of people living with HIV (PLWH) who were switched to ARV regimens containing TAF in the real-world setting.

Methods

Single center retrospective cohort study. Included were PLWH who were on an ARV regimen not containing TAF, who were switched to a TAF containing regimen between January 1, 2016 and September 30, 2018. The control group contained patients on a TAF free ARV regimen throughout the study period. The primary outcome was change in weight from baseline at 12 months post switch. Secondary outcomes were change in BMI, development of new diabetes, hypertension, and/or hypercholesteremia.

Results

A total of 446 patients were switched to a TAF containing regimen during the study period, and included as cases. Controls (n=162) consisted of patients who continued a regimen containing abacavir/lamivudine/dolutegravir during the study period. The control group was older (54 vs. 49 years, p< 0.0001), had a higher proportion of black patients (17.9% vs 11.4%, p=0.04), had a higher mean VACS score (27 vs 18, p< 0.0001), and had fewer patients with reported physical activity (21.6% vs 30%, p=0.04), although this was driven by a higher proportion of patients in the controls with unknown physical activity. Cases showed significantly more weight gain compared to controls at 12 months (2.01kg vs 0.77kg, p=0.001). There was a higher percentage of increase in BMI class in the cases compared to control at 12 months (18.2% vs 9.9%, p=0.01). Increase in weight at 12 months varied dependent on the rest of the antiretroviral regimen (Table 1). Cases had a significant increase in the number of patients with hypertension (35.9% pre vs 43.7% post, p=0.02) and hyperlipidemia after the switch (7.8% pre and 18.4% post, p< 0.00001), while controls only had a significant increase in hyperlipidemia (50.0% pre vs 67.9% post, p=0.01).

Conclusion

Patients switched to an ARV regimen containing TAF gained significantly more weight, and had higher rates of increase in BMI category than those who stayed on a non TAF containing regimen throughout the study period.

Disclosures

All Authors: No reported disclosures
110. Bone Mineral Density Screening in Veterans Living with HIV
Authors: Khanjee Naveed , Turin Christie G , Breaux Katharine , Armamento-Villareal Reina , Barradas Maria Rodriguez- , Clark Eva
Published: January 2021

Background

Low bone mineral density (BMD) is more prevalent in people living with HIV (PLWH) than in the general population. Although no consensus exists regarding when to start screening for BMD loss in PLWH, the Infectious Diseases Society of America (IDSA) recommends dual x-ray absorptiometry (DXA) for men aged ≥50 years, postmenopausal women, and patients with a history of fragility fracture, chronic glucocorticoid treatment, or at high fall risk. The objective of this study is to evaluate how well this guideline is being carried out in a population of veterans living with HIV (VLWH).

Methods

We retrospectively identified VLWH seen at the Veterans Affairs Medical Center (VAMC) in Houston, TX, between 2014–2018 via the VAMC HIV Registry. We extracted demographic, laboratory, and clinical variables, as well as DXA results via this registry database and subsequent chart review.

Results

We identified 1,306 VLWH who received care between 2014–2018; 197 turned 50 years old during this time period. Of those, only 32 (16.2%) underwent DXA (2 women, 30 men). DXA revealed normal BMD in 17 (53.1%), osteopenia in 12 (37.5%), and osteoporosis in 3 (9.4%), as defined by traditional DXA T-score cutoffs. Average CD4 count at time of DXA was 698 cells/mm3 (n=30) (average CD4 for those with normal DXA was 654 [n=16] and for those with osteopenia/osteoporosis it was 749 [n=14]; t-test p = 0.47). Thirty had HIV viral load (VL) < 100 copies/mL; the remaining 2 had VLs of 11,200 and 2,980, both with normal DXAs. Vitamin D (VD) levels were available for 1,005 (77%) VLWH in the study cohort. Of those, 278 (27.7%) were VD deficient (25-hydroxy VD level of < 20 ng/mL). VD levels were available for 31 of the 32 VLWH who had DXA after turning 50 years old; the average VD level was 22.76 (24.61 [n=16] for those with normal BMD and 20.78 [n=15] for those with osteoporosis/osteopenia; t-test p = 0.30).

Conclusion

Our results indicate that adherence to IDSA BMD screening guidelines in VLWH can be improved. Given that nearly half of the screened patients showed evidence of BMD loss on their initial DXA, efforts should be made to increase awareness and screening in this vulnerable population. Prevention, earlier diagnosis, and treatment of BMD loss in VLWH would likely lead to decreased morbidity associated with fractures due to low BMD in this population.

Disclosures

All Authors: No reported disclosures
112. A Quality Management Project of a Midwestern Academic HIV Clinic Operation During COVID-19: Implementation Strategy and Preliminary Outcomes
Authors: Fadul Nada
Published: January 2021

Background

During the COVID-19 pandemic, HIV clinics had to transform care delivery in order to ensure retention in care (RIC) for people with HIV (PWH). The objective of this quality management project is to maintain high rates of RIC and viral load suppression (VLS) during the pandemic for PWH receiving services at an academic HIV clinic in the Midwest.

Methods

We developed a multifaceted implementation strategy for clinic operation using a combination of telehealth and in-person visits. The strategy included: 1) assess for readiness and identify barriers and facilitators, 2) identify and prepare champions, 3) organize clinician implementation meetings, and 4) staff training. As a result, we developed an implementation blue print with criteria for telehealth vs. office visits, criteria for rescheduling patients, conducted staff training on telehealth and personal protective equipment, and changed the clinic structure to accommodate in-person visits for patients who did not meet telehealth criteria and walk-ins. We monitored VLS (defined as HIV RNA < 200 copies per mL) and RIC as measured by medical visit frequency (MVF, defined as percentage of patients who had one visit in each 6 months of the preceding 24 months with at least 60 days between visits); and gap in care (GiC, defined as no visit in the preceding 6 months).

Results

As of June 14, 2020, there were 1140 active PWH receiving care at the clinic. By February 29, 2020 there were 34 patients lost to care as (defined as no visit within the preceding 12 months). Between March 1 and June 14, 2020 we conducted a total 943 visits, out of which 642 (68%) were in person and 301 (32%) were telephone visits. By end of May 2020, there were 47 patients lost to care. MVF decreased to 40% compared to 69% for FY2020, and GiC increased to 25% compared to 14% for FY2020. VLS rate remained unchanged at 91%.

Conclusion

The COVID-19 pandemic resulted in a decrease in MVF and an increase in GiC for PWH. However, VLS remained high at 91%. Our implementation strategy facilitated quick adoption of telemedicine, which helped us provide clinical care to a third of PWH during the pandemic. Telemedicine provided a great tool for ensuring patients remain VLS. Evaluation of implementation outcomes including fidelity and reach remains ongoing.

Disclosures

All Authors: No reported disclosures
113. Advanced HIV Disease Among Adults in the African Cohort Study (AFRICOS)
Authors: Oboho Ikwo , Esber Allahna L , Dear Nicole , Paulin Heather , Iroezindu Michael , Bahemana Emmanuel , Kibuuka Hannah , Owuoth John , Maswai Jonah , Crowell Trevor A , Ake Julie A , Polyak Christina
Published: January 2021

Background

In the “test and treat” era, early ART may decrease the prevalence of advanced HIV disease (AHD), defined as having a CD4 cell count < 200 cells/µL or World Health Organization (WHO) clinical stage III or IV disease. We assessed trends in AHD and ART coverage and describe factors associated with AHD among adults living with HIV (LWH) across four countries before and during the “test and treat” era.

Methods

The African Cohort Study (AFRICOS) is a prospective cohort enrolling adults at risk for HIV or LWH from 12 facilities in Uganda, Kenya, Tanzania and Nigeria. Clinical history review and laboratory testing were performed at enrollment and every 6 months. Serum cryptococcal antigen screening (CrAg) was performed in a subset with CD4 < 200 at enrollment. Logistic regression was used to estimate odds ratios for factors associated with CD4 < 200.

Results

From January 2013–December 2019, 2934 adults LWH were enrolled (median age 38 years [interquartile range, 31–46 years], 41.5% men). Of 2903 with CD4 results at enrollment, 567 (19.5%) had CD4 < 200. Despite consistent increases in ART coverage since 2016, across all countries the prevalence of AHD did not decline below levels observed in 2013 until 2019. The prevalence of CD4 < 200 did not significantly decline from 11.9% (range 9.1–25.0%) in 2013 to 10.3% (range 0–16%) in 2019, p=0.7, while ART coverage increased from 74.7% (range 68.3–93.8%) in 2013 to 97.5% (range 86–100%) in 2019, p= < 0.01 (Figure 1). Factors associated with a higher risk of CD4 < 200 at enrollment were being enrolled in Tanzania, male sex, age >29 years, having a primary or some secondary education or above, and WHO stage II disease or higher. Factors associated with a lower risk of CD4 < 200 were >1 year since HIV diagnosis and being on ART for at least 6 months (Table 1). Among those with CD4 < 200 at enrollment, the most commonly reported comorbidities included HIV wasting syndrome (9.3%) and tuberculosis (TB) (2.3%); 19 (3.4%) of 564 adults screened were CrAg positive.

Figure 1: Trends in Percentage of Participants with CD4 <200 and ART coverage at Study Enrollment by Country and Year

Table 1: Factors associated with CD4 <200 cells/mm3 at Study Enrollment

Conclusion

Despite the scale-up of ART in the era of “test and treat”, AHD prevalence has only recently trended downward. Continued efforts towards early HIV diagnosis and timely ART initiation are needed to reduce the risk for CD4< 200. Strategies to increase TB screening, prophylaxis, and treatment are essential to reduce morbidity.

Disclosures

All Authors: No reported disclosures
114. HIV Prevalence and Associated Factors Among Persons Experiencing Homelessness (PEH) During a Multi-shelter Tuberculosis (TB) Outbreak in Atlanta, Georgia (2008 – 2018)
Authors: Onwubiko Udodirim
Published: January 2021

Background

Jointly and independently, HIV and homelessness are strong risk factors for acquiring tuberculosis (TB) in the United States (US). However, public health programs geared towards addressing TB among persons experiencing homelessness (PEH) are often not used as prime opportunities to also actively address HIV among PEH. Here, we describe the prevalence and risk factors associated with HIV among PEH who were screened during a city-wide TB screening program among PEH initiated in response to a multi-shelter TB outbreak in Atlanta, Georgia.

Methods

Retrospective analysis of data on 18,605 PEH screened for TB between 2008 and 2018 was done. HIV status was either self-reported (SR) or laboratory-confirmed (LC). Modified Poisson regression models with robust error variances were used to assess associations between socio-demographic characteristics and being HIV-positive.

Results

Of 18,605 PEH screened for TB, 9,308 (53%) had a known HIV status. Of these, 38% (n=3,559) received a HIV test while 62% (n=5,749) were only SR HIV status. The prevalence of HIV positivity among all PEH who SR a HIV status (n=7,404) was 4.0% (296/7404) while the prevalence of LC HIV infection was 3.6% (129/3559). Among PEH with LC HIV results, gender (male, transgender), year of screening (2008–2010, 2011–2013) and location of screening (onsite) were independently associated with higher HIV prevalence (p< 0.05). Adjusted analysis showed statistically significant interaction between gender and age [Adjusted prevalence ratio for men vs. women: young PEH (0–29 years) 8.47 (5.13, 14.00), p< 0.0001]. Year of screening and shelter of residence also remained significant in the adjusted model.

Conclusion

The prevalence of HIV among PEH in Atlanta is more than four times higher than the prevalence in the general Atlanta population (0.86%). In addition to essential TB control measures needed in congregate settings like homeless shelters, strong efforts to concurrently increase access to HIV prevention and care at homeless shelters may also help reduce both HIV transmission and TB acquisition in this at-risk population in the South and move the South closer to achieving the US End TB and Ending the HIV Epidemic goals.

Disclosures

All Authors: No reported disclosures
118. Eliminating Blood Culture Contamination with an Initial-specimen Diversion Device
Authors: Tompkins Lucy S , Madison Alexandra , Schaffner Tammy , Tran Jenny , Ang Pablito
Published: January 2021

Background

Blood samples obtained via traditional venipuncture can become contaminated by superficial and deeply embedded skin flora. We evaluated the hospital-wide use of an initial-specimen diversion device (ISDD) designed to shunt these microorganisms away from the culture bottle to reduce blood culture contamination (BCC) and sequelae: false-positive central line-associated bloodstream infections (CLABSIs), repeat blood culture draws, inappropriate antibiotic usage, increased patient length-of-stay and misdiagnosis. The study aimed to show the proportion of blood cultures containing contaminants drawn by phlebotomy staff using the ISDD versus those drawn using traditional methods. Nursing staff continued to use traditional methods to draw blood cultures in the emergency department (ED) and from inpatients.

Methods

Over a four-month trial at Stanford Health Care (SHC), 4,462 blood cultures were drawn by phlebotomy staff using the ISDD (Steripath Gen2, Magnolia Medical Technologies) in the ED and from inpatients; 922 blood cultures were obtained by phlebotomy staff using standard methods. Additionally, 1,413 blood cultures were drawn by nursing staff using standard methods. The number of matched sets (2 bottles [aerobic/anaerobic] plus 2 bottles [aerobic/anaerobic], with total volume 40 ml) obtained through traditional methods and by the ISDD were recorded. Contaminants were defined by the National Healthcare Safety Network (NHSN). In addition, sets in which 1 out of 4 bottles contained vancomycin-resistant Enterococcus (VRE) or Candida sp. were also recorded, even though these are not considered contaminants by the NHSN.

Results

Of 4,462 blood cultures obtained using the ISDD there were zero contaminants found (BCC rate 0%) versus 29 contaminated sets using traditional methods (BCC rate 3.15%). Twenty-eight contaminants were observed from nursing staff blood culture draws (BCC rate 1.98%). Zero false-positive CLABSIs were associated with use of the ISDD for the trial period. No matched sets containing 1 of 4 bottles with VRE or Candida sp. were observed.

Table Stanford Health Care blood culture collection methods and contamination events (March 15, 2019 - July 21, 2019)

Conclusion

The trial results encourage adoption of the ISDD as standard practice for blood culture at SHC.

Disclosures

All Authors: No reported disclosures
124. Six-year Longitudinal Analysis of an Inpatient Infectious Diseases Telemedicine Service at a Community Hospital
Authors: Gupta Nupur , Sanghvi Adit B , Mellors John , Abdel-Massih Rima
Published: January 2021

Background

Telemedicine (TM) has emerged as a viable solution to extend infectious disease (ID) expertise to communities without access to this specialty.1 TM allows clinicians in rural settings to connect with specialists at distant sites and provide the best care for their patients, often eliminating the need for hospital transfers. Here, we describe the experience from one of the longest standing inpatient Tele-ID consult services using live audio-video (AV) visits with the assistance of a telepresenter.

Methods

Longitudinal data were collected from a 126-bed rural hospital in Pennsylvania that had no access to ID consultation before 2014. Live AV consults during business hours began in 2014 and telephonic physician to physician consults were made available 24/7. All ID consult data were extracted from the hospital electronic health record between 2014 to 2019. Key outcomes assessed included the number of consult encounters, total hospital length of stay (LOS), discharges to home, transfer to tertiary care centers, and readmission rates at 30 days.

Results

Most consulted patients were Caucasians, and females with an average age of 64.7 years (Table 1). The number of unique consult encounters increased annually from 111 in 2014 to 469 in 2019 (Table 1). The Charlson Comorbidity Score and Elixhauser Comorbidity Index also increased each year beginning in 2016 (Table 1). By contrast, LOS decreased each year as did the 30-day readmission rate (Table 2). Most patients were not transferred (average 89.4% over 6 years) to tertiary care centers and more than half were discharged to home each year (Table 2).

Conclusion

This longitudinal 6-year observation study of an inpatient TM ID service at a rural hospital showed remarkable annual growth in consult encounters (total growth >400%). Despite increasing patient acuity, overall hospital LOS decreased over time (10.2 to 8.2 days). Patient transfers to tertiary care centers remained low (average 10.5% over 6 years) as did 30-day readmissions (average 16.3% over 6 years). The majority of patients were discharged to home (average 61.3% over 6 years). These findings show that a rural inpatient TM ID consult service can expand over time and is an effective alternative for hospitals without access to ID expertise.

Disclosures

John Mellors, MD, Abound Bio (Shareholder)Accelevir Diagnostics (Consultant)Co-Crystal Pharmaceuticals (Shareholder)Gilead (Consultant, Grant/Research Support)Merck (Consultant) Rima Abdel-Massih, MD, Infectious Disease Connect (Shareholder, Other Financial or Material Support, Chief Medical Officer)