bluuebunny/crossref_metadata_2025_split huggingface dataset:
1294. Acceptability and Feasibility of a Pharmacist-led Pre-exposure Prophylaxis Program in the Midwestern United States
Authors: Bares Sara , Havens Joshua , Scarsi Kimberly , Klepser Donald , Swindells Susan 
Published: November 2018

Abstract

Background
Despite evidence that HIV pre-exposure prophylaxis (PrEP) substantially reduces the risk of infection in at-risk populations, significant barriers exist to its prescription and use. Utilizing pharmacists may help increase patient access to PrEP services. We designed and implemented a novel pharmacist-led PrEP program in Omaha, Nebraska.

Methods
Our pharmacist-led PrEP program was developed in the fall of 2016. Six pharmacists from four sites (one community pharmacy, two community-based clinics and one HIV-specialized clinic) were selected for participation based on interest, senior management support, and availability of appropriate infrastructure. All pharmacists received training for the provision of PrEP. Through a collaborative practice agreement, pharmacists met with patients individually, obtained a medical history, performed a risk assessment and point-of-care laboratory testing (HIV screen, creatinine, and syphilis), and collected samples for gonorrhea and chlamydia. They also provided medication and adherence counseling, and prescribed emtricitabine-tenofovir DF when appropriate. Pharmacists completed a survey reporting their experience after each visit. Presented here are patient demographics, retention rates, and pharmacist-reported experience from the first 6 months of the program.

Results
Sixty patients enrolled in the pharmacist-led PrEP program between January and June 2017 and completed 139 visits. 95% of participants were men, 83% were white, 80% were privately insured, and 90% had completed some college or higher. The mean age of participants was 34 years (range 20–61 years) and 88% identified as men who have sex with men. 73% were retained in care at 3 months and 58% were retained in care at 6 months. To date, no patient has seroconverted. Pharmacists reported feeling comfortable performing point-of-care testing at all visits and only reported feeling uncomfortable counseling patients on three occasions (2.2%). Finally, pharmacist-reported workflow disruption only occurred on 1 occasion (0.7%).

Conclusion
Implementation of a pharmacist-led PrEP program is feasible, associated with high rates of pharmacist acceptability, and results in retention rates that are comparable to other real-world PrEP programs.

Disclosures
S. Bares, Gilead: Grant Investigator, Grant recipient. S. Swindells, Merck: Investigator, Research support. ViiV: Investigator, Research support.
1311. Incorporating an “Escape Room” Game Design in Infectious Diseases Instruction
Authors: Cotner Sarah , Smith Kelly M , Simpson Leah , Burgess David S , Cain Jeffrey 
Published: November 2018

Abstract

Background
As health professions education evolves toward active learning environments, interest in using games as an educational tool is increasing. One contemporary commercial game that has design potential for learning activities is an “escape” or “breakout” room. Escape rooms are live-action games where teams of players work to achieve a common goal in a set amount of time. Limited literature is available assessing this type of gaming format for education design. This study investigated the design and implementation of an escape room learning activity in a third-year pharmacy infectious disease elective course at the University of Kentucky College of Pharmacy.

Methods
During a Gram-positive antimicrobial resistance module, third-year pharmacy students participated in both patient case-based instruction and an escape room learning activity. Three IRB-approved surveys were distributed electronically to students; the first was completed prior to class and functioned as a standard teaching tool to assess mastery of content based on pre-assigned reading and previous coursework. Two surveys were completed after the session to assess knowledge and perceptions gained during each learning activity. Students answered multiple-choice knowledge-based questions and then responded to five statements using a Likert scale from 1 to 7 (1 = Not at all, 4 = Somewhat, and 7 = Very much) to indicate perceptions of each instructional activity.

Results
Nineteen students participated in the study. The mean correct scores for knowledge-based assessment were 90.5% in the pre-class survey, 82.1% in the post-case survey, and 90.5% in the post-escape room survey. There was an overall positive perception of both learning activities based on results of the survey questions. The escape room learning activity was preferred by 18 of 19 students (94.7%), but only 11 of 19 (57.9%) indicated they learned better from the escape room.

Conclusion
This study illustrates an escape room designed to meet lecture learning objectives is a feasible active learning technique. While students demonstrated knowledge gained from the activity and indicated positive perceptions, this approach warrants further evaluation.

Disclosures
All authors: No reported disclosures.
1317. Online Simulation-Based Education to Improve Primary Care Providers’ Knowledge About Best Practices in HIV Preexposure Prophylaxis Care
Authors: Gardner Allison , Evans David , McCord Alan , Krakower Douglas 
Published: November 2018

Abstract

Background
Primary care providers’ (PCPs’) lack of knowledge about and use of pre-exposure prophylaxis (PrEP) represent important barriers to its effective implementation on a national scale. To address these barriers, a collaboration of infectious diseases clinicians, patient advocates, and continuing medical education (CME) specialists developed and tested an educational intervention for PCPs to increase their knowledge about best practices for providing PrEP-related care.

Methods
An interactive, online CME-accredited simulation prompted PCPs to make clinical decisions about a hypothetical case of a 44-year-old African-American man seeking treatment for rectal gonorrhea who thus had indications for PrEP. The intervention included real-time educational feedback on clinical decisions and an opportunity to revisit suboptimal care decisions after feedback. PCPs were recruited via email and links on CME/patient advocacy websites and public health listservs. Outcomes included proportions of learners selecting correct answers prior to and after receiving feedback on their decisions.

Results
During October 2017–April 2018, 234 PCPs (88% physicians, 7% NP, 5% PA) completed the simulation for a total of 4,701 unique clinical decisions. Less than half (45%) of PCPs elicited a comprehensive sexual health history to begin the visit, which improved to 83% after feedback. Two-thirds (67%) of PCPs sought permission before asking about sexual behaviors, which increased to 82% after feedback. Nearly one-quarter of PCPs (24%) needed corrective action to nonjudgmentally ask about condom use. Almost all PCPs (91%) identified that PrEP was appropriate for the case patient on their first attempt. However, only 54% of PCPs initially selected all recommended baseline laboratory tests for PrEP; 75% did so after feedback. Of providers recommending PrEP, 29% selected regimens not FDA approved for this indication.

Conclusion
Many PCPs participating in an online simulation enacted clinical decisions that were inconsistent with best practices for providing PrEP-related care, but hypothetical care decisions improved after real-time educational feedback. Future studies to test the impact of this educational intervention on clinical practices are warranted.

Disclosures
D. Evans, Project Inform: Employee, Educational grant. A. McCord, Project Inform: Employee, Educational grant. D. Krakower, Gilead Sciences: Grant Investigator, Research grant.
1319. Examining PrEP Knowledge and Prescribing Likelihood Among Medical Residents Before and After PrEP Education
Authors: Christian Elizabeth , Craig Wendy , Thakarar Kinna 
Published: November 2018

Abstract

Background
Pre-exposure prophylaxis (PrEP) is effective for HIV prevention, but prescribing rates remain low. We examined the effect of an educational intervention on PrEP knowledge and prescribing likelihood among medical residents.

Methods
This was a prospective study using a convenience sample of Internal Medicine and Internal Medicine-Pediatrics residents at a tertiary care center in Portland, Maine. Participants attended a resident-led teaching session on PrEP and completed pre- and post-session surveys. PrEP knowledge was measured with five questions (definition, evidence, patient selection criteria, medication choice, and guidelines), and prescribing likelihood was assessed on a Likert scale. Participants identified motivating factors and barriers to prescribing. Survey data were analyzed with McNemar’s test or a paired Student’s t test as appropriate.

Results
Thirty residents completed the study; of these, 24 (83%) had at least 1 patient that they considered at high risk for HIV, and 14 (46%) reported having &gt;5 such patients. None had ever prescribed PrEP. Average PrEP knowledge score increased after the intervention (pre = 2.33 vs. post = 4.1, P &lt; 0.001). After the intervention, more participants reported that they would be likely to prescribe PrEP (pre = 76% vs. post = 90%, P = 0.014), fewer identified unfamiliarity with PrEP guidelines as a barrier (pre = 73% vs. post = 27%, P &lt; 0.001), and Òother residents are prescribing PrEPÓ became a significant motivating factor (pre = 47% vs. post = 70%, P = 0.04). Preceptor comfort with prescribing PrEP was a consistently important influence on prescribing likelihood (90% vs. 82%, P = 0.22).

Conclusion
Familiarity with PrEP is relevant to resident practice, and an educational intervention is effective in the short term for addressing inadequate knowledge as a barrier to offering PrEP. Resident practice is influenced by preceptors and peers, suggesting that it may be helpful to include attending physicians in future PrEP education efforts at our institution.

Disclosures
All authors: No reported disclosures.
1328. Medical Education in an Epidemic: Historical Lessons From the Early Days of HIV in America (1982–1986)
Authors: Koretzky Maya Overby 
Published: November 2018

Abstract

Background
Much historical work has investigated the impact of HIV on patient rights, American culture, and medical research; however, there is little scholarship on the impact of HIV on medical education. This study asks how the process of training at the epicenter of an epidemic disease that was poorly understood, incurable, and contagious shaped a cohort of physicians’ experience of residency, beliefs about the role of the doctor in society, and their approach to practicing medicine.

Methods
Members of the University of California San Francisco (UCSF) intern classes of 1982 and 1983 were interviewed, as well as individuals who were young faculty at San Francisco hospitals in the 1980s. Other sources included academic publications from the 1980s on HIV and medical education, archival documents, nursing and volunteer communications books from the SF General Hospital AIDS Ward, and patient ephemera such as thank you notes and obituaries.

Results
These interviews and documents highlight themes of commitment to care for HIV patients regardless of risk, lack of formal institutional support for residents engaged in HIV care, and differences in professional norms that allowed nurses and volunteers access to modes of reflection that were unavailable to trainee physicians. For residents, the day to day experience of the HIV epidemic became an important locus for a narrative of medical professionalism and resilience that continues to animate medical education today. Provider narratives about the encounter with HIV served a parallel function to the creation of HIV clinics and public health programs—both were interventions that made HIV into an intelligible cultural and biological entity that could be managed by the medical profession.

Conclusion
Using the HIV epidemic in San Francisco as a historical example, this project argues that formalizing narrative practices by setting aside time for journaling and verbal reflection in residency and fellowship training can build resilience and prevent burnout. Historical narratives of provider experience, like the oral histories collected in this project, may also be valuable in undergraduate medical education to generate discussion about professional ethics and the responsibilities of providers in an epidemic.

Disclosures
All authors: No reported disclosures.
1345. Comparative Activity of Plazomicin and Other Aminoglycosides Against Enterobacteriaceae Isolates From Various Infection Sources From Hospitalized Patients in the United States
Authors: Castanheira Mariana , Streit Jennifer M , Serio Alisa W , Krause Kevin M , Flamm Robert K 
Published: November 2018

Abstract

Background
Plazomicin is a next-generation aminoglycoside that is currently under review at the United States Food and Drug Administration for complicated urinary tract infections (cUTIs), including acute pyelonephritis, and bloodstream infections (BSIs) due to certain Enterobacteriaceae (ENT) in patients who have limited or no alternative treatment options. We evaluated the activity of plazomicin and aminoglycosides against ENT isolates collected in US hospitals during 2014 to 2017 by site of infection.

Methods
A total of 8,510 ENT isolates were collected from BSIs (2,133), pneumonia in hospitalized patients (PIHP; 1,826), skin and skin structure infections (SSSIs; 1,155), intra-abdominal infections (IAIs; 731), UTIs (2,508), and other or unknown infection sites (others; 157) in 71 US hospitals during 2014 to 2017. Isolates were susceptibility (S) tested by reference broth microdilution methods and results were interpreted using CLSI breakpoints.

Results
Plazomicin (MIC50/90 ranges, 0.25–0.5/1–2 µg/mL) inhibited 98.8–99.9% of the ENT isolates at ≤4 µg/mL across all infection types (figure). At ≤4 µg/mL, plazomicin inhibited 93.8–100% of the carbapenem-resistant ENT (CRE) isolates stratified by infection type. The S rates for amikacin ranged from 98.7% to 99.7% against ENT isolates overall. However, amikacin S rates for CRE ranged from 53.1% for UTI to 100% for IAI isolates. Gentamicin (89.2–93.6%S) and tobramycin (88.8–94.3%S) were slightly less active than plazomicin and amikacin against the ENT isolates stratified by infection source. Gentamicin S rates against CRE isolates ranged from 43.8% to 66.7% while tobramycin inhibited &lt;45% of the CRE isolates from the different infection sources.

Conclusion
The activity of plazomicin and amikacin was similar against ENT isolates from US hospitals and did not vary by infection type; however, amikacin activity against CRE isolates varied by infection source while plazomicin remained active against CRE isolates regardless of infection source. These results highlight the potential role of plazomicin for treating serious infections caused by CRE. This project was partially funded under BARDA Contract No. HHSO100201000046C.

Disclosures
M. Castanheira, Achaogen: Research Contractor, Research support. J. M. Streit, Achaogen: Research Contractor, Research support. A. W. Serio, Achaogen: Employee, Salary. K. M. Krause, Achaogen: Employee, Salary. R. K. Flamm, Achaogen: Research Contractor, Research support.
1350. Therapeutic Effects of Baloxavir Marboxil against Influenza A Virus Infection in Ferrets
Authors: Kitano Mitsutaka , Matsuzaki Takanobu , Oka Ryoko , Baba Kaoru , Noda Takahiro , Yoshida Yuki , Sato Kenji , Yoshida Ryu , Sato Akihiko , Kamimori Hiroshi , Shishido Takao , Naito and Akira 
Published: November 2018

Abstract

Background
Baloxavir marboxil (BXM) is a novel small molecule inhibitor of cap-dependent endonuclease that is essential for influenza virus transcription and replication. In this study, pharmacokinetic profiles of BXM and baloxavir acid (BXA), an active form of BXM, were first examined in ferrets, and then the therapeutic effects of BXM against influenza A virus infection were compared with that of oseltamivir phosphate in ferrets.

Methods
The plasma exposure of BXA and BXM was examined after a single oral administration of BXM at doses of 10 and 30 mg/kg. The concentrations in plasma were determined by liquid chromatography-tandem mass spectrometry(LC/MS/MS). For efficacy study, ferrets infected intranasally with A/Kadoma/2006 (H1N1) were administrated 10 or 30 mg/kg of BXM orally twice daily for 1 day, starting at 1 day post-infection (p.i.) or administrated 10 mg/kg of BXM orally twice daily for 1 day, starting at 2 days p.i.. Oseltamivir phosphate was administered at doses of 5 mg/kg orally twice daily for 2 days as a comparison. The virus titer in the nasal washes and body temperature change were monitored during infection.

Results
BXA was detected in ferret plasma after a single oral administration of BXM at 10 and 30 mg/kg, in more than a dose-proportional manner. When the treatment was initiated at 1 day p.i., BXM at 10 and 30 mg/kg showed reduction of virus titer to an undetectable level on day 2 p.i. and statistically significant reduction in virus titer over time from day 2 to 3 p.i. compared with vehicle and oseltamivir phosphate. Moreover, the change of body temperature over time from 8 hours after the first administration to 3 days p.i. was significantly lower in BXM at 10 and 30 mg/kg than vehicle and oseltamivir phosphate. These effects were also observed in ferrets treated with BXM at 10 mg/kg even when administered at 2 day p.i. where ferret exhibit fever that is more than 1 degree higher than on 1 day p.i..

Conclusion
Single-day oral administration of BXM had beneficial effects on viral titer and symptoms in ferrets infected with influenza A virus, which were superior to those observed with oseltamivir phosphate and vehicle.

Disclosures
M. Kitano, Shionogi & Co., Ltd.: Employee, Salary. T. Matsuzaki, Shionogi & Co., Ltd.: Employee, Salary. R. Oka, Shionogi & Co., Ltd.: Employee, Salary. K. Baba, Shionogi TechnoAdvance Research & Co., Ltd.: Employee, Salary. T. Noda, Shionogi TechnoAdvance Research & Co., Ltd.: Employee, Salary. Y. Yoshida, Shionogi & Co., Ltd.: Employee, Salary. K. Sato, Shionogi & Co., Ltd.: Employee, Salary. R. Yoshida, Shionogi & Co., Ltd.: Employee, Salary. A. Sato, Shionogi & Co., Ltd.: Employee, Salary. H. Kamimori, Shionogi & Co., Ltd.: Employee, Salary.
T. Shishido, Shionogi & Co., Ltd.: Employee, Salary. A. Naito, Shionogi & Co., Ltd.: Employee, Salary.
1356. Improvement in Quality of Life for Adults With Acute Bacterial Skin and Skin Structure Infections Following Treatment With Omadacycline or Linezolid
Authors: Tzanis Evan , Chitra Surya , Curran Marla , McGovern Paul , Hinahara Jordan , Goss Thomas 
Published: November 2018

Abstract

Background
The appearance of multidrug-resistant Gram-positive bacteria is a major challenge in clinical care. Omadacycline is the first aminomethylcycline antibiotic (semisynthetic compounds related to tetracyclines) in late-stage clinical development for acute bacterial skin and skin structure infections (ABSSSI), and demonstrates potent in vitro activity against many pathogens.

Methods
Seven hundred thirty-five patients were enrolled in the OASIS-2 randomized controlled trial comparing omadacycline and linezolid for the treatment of adult subjects with ABSSSI known or suspected to be due to a Gram-positive pathogen, with 368 and 367 enrolled in each group, respectively. Subjects completed the 36-Item Short Form Health Survey Version 2 (SF-36v2), a validated questionnaire on physical and mental health, at both screening and post-treatment evaluation. Results of the SF-36v2 were analyzed in accordance with established norm-based standards for the survey (Ware 2000) for the intention-to-treat population.

Results
Subjects who received omadacycline experienced a 3.25 point mean improvement in overall physical health (P &lt; 0.001, Figure 1) and reported significant improvements across all but one component parameter of overall physical and mental health, including physical functioning, bodily pain, role physical, vitality, role emotional, mental health, and social functioning (Figure 2). In contrast, while overall physical health improved for subjects who received linezolid, the improvement in vitality, role emotional, mental health, and general health was not significant (Figure 2). Although omadacycline achieved greater increase from baseline than linezolid across all domains analyzed, the difference in scores was not statistically significant at the P &lt; 0.05 level (Figure 1).

Conclusion
Omadacycline provides significant improvement in the physical component of quality of life over baseline for adult subjects with ABSSSI known or suspected to be due to a Gram-positive pathogen. Although the OASIS-2 trial was neither designed nor powered to measure differences in quality of life following treatment, trends identified in this analysis merit further investigation.
References
1. Ware JE. SF-36 Health Survey Update. SPINE 2000; 25(24); 3130–3139.

Disclosures
E. Tzanis, Paratek Pharmaceuticals: Employee, Salary. M. Curran, Paratek Pharmaceuticals: Employee, Salary. P. McGovern, Paratek Pharmaceuticals: Employee, Salary. J. Hinahara, Paratek Pharmaceuticals: Consultant, Consulting fee. T. Goss, Paratek Pharmaceuticals: Consultant, Consulting fee.
1371. Safety, Tolerability, and Pharmacokinetics of Multiple Doses of TP-6076, a Novel, Fully Synthetic Tetracycline, in a Phase 1 Study
Authors: Tsai Larry , Moore Alison 
Published: November 2018

Abstract

Background
TP-6076 is a novel, fully synthetic tetracycline being developed for the treatment of serious bacterial infections, including those caused by multidrug-resistant Acinetobacter baumannii. TP-6076 has demonstrated potent activity in vitro against carbapenem-resistant strains of A. baumannii, with MIC90 64 times lower compared with tigecycline and 256 times lower compared with minocycline. We now report the results of a multiple ascending dose study in normal healthy volunteers.

Methods
This was a phase 1, single-site, randomized, double-blind, placebo-controlled dose-escalating, multiple dose study in healthy adults who met the inclusion/exclusion criteria and provided informed consent prior to any study procedure. Cohorts of eight subjects each (six active and two placebo) received daily doses of 6.0 to 40.0 mg TP-6076 or placebo for 7 days. Plasma and urine samples for pharmacokinetic (PK) analyses were collected starting immediately prior to dosing until 96 hours after the last dose. Safety was assessed through collection of adverse events (AEs), clinical laboratories, vital signs, ECG, and physical examination data.

Results
The geometric mean derived PK parameters for TP-6076 were:
There were no serious or severe AEs reported. The most frequently reported AEs were gastrointestinal events, including nausea and vomiting, and localized infusion site reactions. There were no clinically significant changes in clinical laboratory values, ECG parameters, or physical examination findings.

Conclusion
Following multiple IV doses of TP-6076, plasma exposure increased as dose increased. Multiple IV doses of TP-6076 were generally well tolerated, with higher gastrointestinal adverse event rates in the higher dose groups.

Disclosures
L. Tsai, Tetraphase Pharmaceuticals: Employee and Shareholder, Salary. A. Moore, Tetraphase Pharmaceuticals: Employee, Salary.