scholarly journals Post-exposure Prophylaxis or Preemptive Therapy for SARS-Coronavirus-2: Study Protocol for a Pragmatic Randomized Controlled Trial

2020 ◽  
Author(s):  
Sylvain A Lother ◽  
Mahsa Abassi ◽  
Alyssa Agostinis ◽  
Ananta S Bangdiwala ◽  
Matthew P Cheng ◽  
...  
Keyword(s):  
Intensive Care ◽  
Disease Severity ◽  
The United States ◽  
Ordinal Scale ◽  
Post Exposure Prophylaxis ◽  
Symptom Duration ◽  
Post Exposure ◽  
Trial Outcome ◽  
Exposure Prophylaxis

AbstractBackgroundThe severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in December 2019 causing the coronavirus disease 2019 (COVID-19) pandemic. Currently, there are a lack of evidence-based therapies to prevent COVID-19 following exposure, or to prevent worsening of symptoms following confirmed infection. We describe the design of a clinical trial of hydroxychloroquine for post-exposure prophylaxis and pre-emptive therapy for COVID-19.MethodsWe will conduct two nested multicenter international double-blind randomized placebo-controlled clinical trials of hydroxychloroquine for: 1) post-exposure prophylaxis (PEP) of asymptomatic household contacts or healthcare workers exposed to COVID-19 within the past four days, and 2) pre-emptive therapy (PET) for symptomatic outpatients with COVID-19 with a total symptom duration of less than 4 days. We will recruit 1500 patients for each the PEP and PET trials. Participants will be randomized 1:1 to receive 5 days of hydroxychloroquine or placebo. The primary PEP trial outcome will be the incidence of symptomatic COVID-19 disease. The primary PET trial outcome will be an ordinal scale of disease severity (not hospitalized; hospitalized without intensive care, hospitalization with intensive care, or death). Participant screening, informed consent, and follow up will be exclusively internet-based with appropriate regulatory and research ethics board approvals in Canada and the United States.DiscussionThese complementary randomized control trials are innovatively designed and adequately powered to rapidly answer urgent questions regarding the effectiveness of hydroxychloroquine to reduce transmission and disease severity of COVID-19 during a pandemic. In-person participant follow-up will not be conducted in order to facilitate social distancing strategies and reduce risks of exposure to study personnel. Innovative trial approaches are needed to urgently assess therapeutic options to mitigate the global impact of this pandemic.Trials Registrationclinicaltrials.gov (NCT04308668); 16 March 2020.

scholarly journals 987. Improving Patient Access to HIV Post-Exposure Prophylaxis with Pharmacist Involvement

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S522-S522
Author(s):  
Katlyn H Grossman
Keyword(s):  
Hospital Pharmacy ◽  
Medical Center ◽  
Cost Savings ◽  
The United States ◽  
Post Exposure Prophylaxis ◽  
Total Cost ◽  
Post Exposure ◽  
Exposure Prophylaxis ◽  
The Impact

Abstract Background Appropriate use of post-exposure prophylaxis (PEP) after isolated sexual, injection drug use, or other exposures to HIV is an effective tool to reduce the risk of HIV acquisition. PEP completion rates are low, with literature reporting only 40% of sexual assaulted persons adhering to a full 28-day course. One important barrier to adherence can be access to medications in a timely manner. In the United States, a four week course of PEP costs nearly $4,000 without insurance and can remain unaffordable with high copays and deductibles for patients who are underinsured. Methods A pharmacist in the Infectious Disease (ID) clinic was notified of all non-occupational post-exposure prophylaxis (nPEP) cases referred from the Emergency Department for follow up and coordinated benefits investigation, ensured low or no cost medication access, completed medication reconciliation, counseled on PEP adherence, and coordinated filling of same day prescriptions at the hospital based pharmacy. To assess the impact of pharmacist involvement, a retrospective review of nPEP cases over a 6 month period were compared to a 6 month period prior to pharmacist presence in clinic. Results 16 nPEP cases were seen by a pharmacist compared to 8 nPEP cases seen in the ID clinic without pharmacist involvement. 100% of patients received medications prior to leaving the medical center, compared to 63% of cases filling at the hospital pharmacy prior to pharmacist presence. 25% of patients required an insurance related override in order to access PEP urgently. The average out of pocket cost was $2.25 with maximum total cost being $7.30. Prior to pharmacist involvement, the average out of pocket cost was $475 for complete PEP regimen with a maximum total cost of $3,733.40. 42% of patients completed their entire PEP course and came to follow up appointment after pharmacist involvement, compared to 31% of patients prior to pharmacist presence. Conclusion Pharmacist involvement led to a substantial cost savings to patients receiving nPEP. It was also associated with higher capture rates of prescriptions filled at the hospital pharmacy along with a higher rate of PEP completion and follow up. Disclosures All Authors: No reported disclosures

scholarly journals 986. Improvement in Administration of HIV Post-Exposure Prophylaxis in the Emergency Department Following Sexual Assault

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S521-S522
Author(s):  
Jennifer R Silva-Nash ◽  
Stacie Bordelon ◽  
Ryan K Dare ◽  
Sherrie Searcy
Keyword(s):  
Emergency Department ◽  
Sexual Assault ◽  
Hiv Transmission ◽  
Post Exposure Prophylaxis ◽  
Intervention Period ◽  
Post Intervention ◽  
Post Exposure ◽  
Assault Victims ◽  
Exposure Prophylaxis

Abstract Background Nonoccupational post exposure prophylaxis (nPEP) following sexual assault can prevent HIV transmission. A standardized Emergency Department (ED) protocol for evaluation, treatment, and follow up for post assault victims was implemented to improve compliance with CDC nPEP guidelines. Methods A single-center observational study of post sexual assault patients before/after implementation of an ED nPEP protocol was conducted by comparing the appropriateness of prescriptions, labs, and necessary follow up. A standardized order-set based on CDC nPEP guidelines, with involvement of an HIV pharmacist and ID clinic, was implemented during the 2018-2019 academic year. Clinical data from pre-intervention period (07/2016-06/2017) was compared to post-intervention period (07/2018-08/2019) following a 1-year washout period. Results During the study, 147 post-sexual assault patients (59 Pre, 88 Post) were included. One hundred thirty-three (90.4%) were female, 68 (46.6%) were African American and 133 (90.4%) were candidates for nPEP. Median time to presentation following assault was 12.6 hours. nPEP was offered to 40 (67.8%) and 84 (95.5%) patients (P< 0.001) and ultimately prescribed to 29 (49.2%) and 71 (80.7%) patients (P< 0.001) in pre and post periods respectively. Renal function (37.3% vs 88.6%; P< 0.001), pregnancy (39.0% vs 79.6%; P< 0.001), syphilis (3.4% vs 89.8%; P< 0.001), hepatitis B (15.3% vs 95.5%; P< 0.001) and hepatitis C (27.1% vs 94.3%) screening occurred more frequently during the post period. Labratory, nPEP Prescription and Follow up Details for Patients Prescribed nPEP Conclusion The standardization of an nPEP ED protocol for sexual assault victims resulted in increased nPEP administration, appropriateness of prescription, screening for other sexually transmitted infectious and scheduling follow up care. While guideline compliance dramatically improved, further interventions are likely warranted in this vulnerable population. Disclosures Ryan K. Dare, MD, MS, Accelerate Diagnostics, Inc (Research Grant or Support)

scholarly journals Tracking HIV Post-Exposure Prophylaxis using Syndromic Surveillance in NYC Emergency Departments

2015 ◽  
Vol 7 (1) ◽  
Author(s):  
Stephanie Ngai ◽  
Zoe Edelstein ◽  
Julie Myers ◽  
Don Weiss
Keyword(s):  
New York ◽  
New York City ◽  
Emergency Departments ◽  
Syndromic Surveillance ◽  
The United States ◽  
Post Exposure Prophylaxis ◽  
Syndromic Surveillance System ◽  
Post Exposure ◽  
Threefold Increase ◽  
Exposure Prophylaxis

HIV post-exposure prophylaxis (PEP) prescriptions are not uniformly monitored in the United States. We developed a method to identify PEP-related visits in New York City emergency departments (EDs). Using ED data, we observed a threefold increase in PEP-related visits to NYC EDs from 2002-2013. 73% of PEP-related visits were among males, and 45% among adults ages 25-34 years. Incorporation of this method of PEP monitoring in the NYC syndromic surveillance system will be used to observe trends and inform HIV outreach efforts.

Characterization of Emergency Department Rabies Post-Exposure Prophylaxis Procedures with an Infectious Diseases Clinic Referral Process

2020 ◽  
pp. 001857872097388
Author(s):  
Jessica J. Frederickson ◽  
Alexandra K. Monroe ◽  
Gregory A. Hall ◽  
Kyle A. Weant
Keyword(s):  
Emergency Department ◽  
Retrospective Chart Review ◽  
Future Research ◽  
Post Exposure Prophylaxis ◽  
Referral Process ◽  
Post Exposure ◽  
Care Plans ◽  
Number Of Patients ◽  
Exposure Prophylaxis

Purpose: Rabies post-exposure prophylaxis (rPEP) in the emergency department (ED) is associated with high costs, complicated administration protocols, and a time-sensitive vaccination series that often requires ED follow-up visits for subsequent vaccine administration. This study sought to characterize the number of redirected vaccine administrations in those patients referred to ID Clinic, guideline compliance, and opportunities for improvement. Methods: Retrospective chart review of adult and pediatric patients presenting to the ED from 2016 to 2019 and prescribed rabies immunoglobulin. Results: Of the 89 patients included, 66.3% were referred to ID Clinic. Those referred to clinic had significantly fewer average visits to the ED for repeat vaccination ( P < .001). Of the 177 vaccinations prescribed for patients referred, 105 were administered in clinic. Overall, having insurance significantly increased the odds of completing the prescribed vaccination series (Odds Ratio (OR) = 4.34, 95% Confidence Interval (CI) = 1.34 to 15.52). Among those patients referred to clinic, having insurance significantly increased the odds of receiving any follow-up doses in clinic (OR = 6.00, 95% CI = 1.48 to 25.98), receiving all of their prescribed follow-up doses in clinic (OR = 10.00, 95% CI = 1.72 to 190.80), and completing the entirety of their vaccination series (OR = 5.89, 95% CI = 1.50 to 26.21). Conclusions: The use of an ID Clinic referral process for rPEP resulted in a significant reduction in the average number of visits to the ED for repeat vaccination, hence avoiding 105 ED visits. Insurance status was a significant factor in both the utilization of the ID Clinic referral system and overall completion of the vaccination series. Future research should explore workflows inclusive of both ED care and outpatient follow-up, care plans for the uninsured, and mechanisms to limit the number of patients that fail to complete the recommended vaccination series.

scholarly journals Post-exposure prophylaxis following occupational exposure to HIV and hepatitis B: an analysis of a 12-year record in a Nigerian tertiary hospital

2017 ◽  
Vol 19 (4) ◽  
pp. 184-189 ◽  
Author(s):  
Salisu Abubakar ◽  
Garba Iliyasu ◽  
Farouq Muhammad Dayyab ◽  
Salisu Inuwa ◽  
Rabiu Alhassan Tudun Wada ◽  
...  
Keyword(s):  
Occupational Exposure ◽  
Hepatitis B ◽  
Healthcare Workers ◽  
Tertiary Hospital ◽  
Post Exposure Prophylaxis ◽  
Post Exposure ◽  
Increased Risk ◽  
Exposure Prophylaxis ◽  
North Western

Background: Healthcare workers (HCWs) have an increased risk of occupational exposure to blood-borne pathogens. Aims/objectives: We aim to examine the utilisation and outcome of post-exposure prophylaxis (PEP) for both HIV and hepatitis B (HBV) among HCWs. Methods: This was a retrospective study conducted in a tertiary hospital in North-Western Nigeria. We reviewed data on HIV or HBV PEP given to HCWs between 2004 and 2016. Results: A total of 115 HCWs presented for PEP during the study period. Intern doctors were the most exposed group (40/115; 34.8%). There were 86/115 (74.8%) needle stick exposures. While 53/115 (46.1%) of the sources of exposure were HIV-positive, 9/115(7.83%) were HBV-positive. Zidovudine-based regimen (40/70) was the most commonly prescribed. No seroconversion occurred among those that completed PEP treatment and follow-up. Discussion: No seroconversion occurred among those that received either or both HIV and HBV PEP and completed PEP treatment.

Cost effectiveness of rabies post exposure prophylaxis in the United States

Vaccine ◽  
2008 ◽  
Vol 26 (33) ◽  
pp. 4251-4255 ◽  
Author(s):  
Praveen Dhankhar ◽  
Sagar A. Vaidya ◽  
Daniel B. Fishbien ◽  
Martin I. Meltzer
Keyword(s):  
United States ◽  
Cost Effectiveness ◽  
The United States ◽  
Post Exposure Prophylaxis ◽  
Post Exposure ◽  
Exposure Prophylaxis

Structural Stigma Affects Access to Pre- and Post-exposure Prophylaxis and HIV Risk among Men Who Have Sex with Men (MSM) in the United States

2014 ◽  
Vol 30 (S1) ◽  
pp. A22-A23 ◽  
Author(s):  
Catherine Oldenburg ◽  
Amaya Perez-Brumer ◽  
Mark Hatzenbuehler ◽  
Douglas Krakower ◽  
David Novak ◽  
...  
Keyword(s):  
United States ◽  
Hiv Risk ◽  
The United States ◽  
Post Exposure Prophylaxis ◽  
Post Exposure ◽  
Sex With Men ◽  
Exposure Prophylaxis

scholarly journals 688. Impact of Expanded Influenza Post-exposure Prophylaxis on Healthcare Worker Absenteeism at a Tertiary Care Center During the 2017–2018 Season

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S248-S248
Author(s):  
Mireia Puig-Asensio ◽  
Margaret Douglas ◽  
Stephanie Holley ◽  
Mary Beth Kukla ◽  
Oluchi Abosi ◽  
...  
Keyword(s):  
Sick Leave ◽  
Healthcare Worker ◽  
Care Center ◽  
Tertiary Care ◽  
Safety Net ◽  
The United States ◽  
Vaccination Status ◽  
Post Exposure Prophylaxis ◽  
Post Exposure ◽  
Exposure Prophylaxis

Abstract Background A severe 2017–2018 influenza season was expected for the United States. We hypothesized that a surge in influenza cases paired with decreased vaccine effectiveness could increase healthcare worker (HCW) absenteeism. Because of a potential public health emergency during the 2017–2018 season, we offered oseltamivir post-exposure prophylaxis (PEP) to exposed HCWs regardless of vaccination status. We describe PEP uptake, cost, and impact on absenteeism at the University of Iowa Hospital and Clinics (UIHC). Methods UIHC serves as a referral and safety net health system for Eastern Iowa. Influenza seasons were defined as the period between Week 40 from 1 year to Week 13 of the following year. During the 2016–2017 season, PEP (75 mg/day for 7 days) was offered free of charge to unvaccinated exposed HCWs. Exposure was defined as proximity within 3 ft of a confirmed influenza-infected person for ≥10 minutes without mask protection, or direct contact with respiratory secretions. During the 2017–2018 season, PEP was expanded to all exposed HCWs regardless of vaccination status. We reviewed surveillance, employee health, pharmacy, and human resources records for the 2016–2017 and 2017–2018 seasons. We defined PEP uptake as prescriptions picked up/all referrals and absenteeism rate as sick-leave requests/scheduled hours. Results During the 2016–2017 and 2017–2018 seasons, we detected 373 and 427 confirmed influenza cases among patients at UIHC. HCW vaccination rates were similar: 89.7% and 90.9%. PEP was recommended in 49 exposures during 2016–2017 and 280 exposures during 2017–2018. A total of 22 (44.9%) and 133 (47.5%) HCWs picked up oseltamivir from the pharmacy during the 2016–2017 and 2017–2018 seasons. The estimated cost of oseltamivir was $1,791 and $10,828, respectively. Overall, 6,187 sick-leave requests (median = 12 hours, absenteeism rate = 3.2%), and 6,174 sick-leave requests (median = 12 hours, absenteeism rate = 3.4%) were reported during the 2016–2017 and 2017–2018 seasons. Conclusion Influenza case counts mildly increased from the 2016–2017 to the 2017–2018 season. Expanding PEP to all exposed HCWs, regardless of vaccination status, had moderate uptake and was costly. Absenteeism rates remained similar during both seasons. Disclosures All authors: No reported disclosures.

scholarly journals 1283. Attitudes and Practices Regarding HIV Post-Exposure Prophylaxis

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S462-S462
Author(s):  
William Sherrerd-Smith ◽  
Katie O’Connell ◽  
Shanedeep Gill ◽  
Alice Kisteneff ◽  
Catherine Derber ◽  
...  
Keyword(s):  
Emergency Department ◽  
Unprotected Sex ◽  
Post Exposure Prophylaxis ◽  
Provider Education ◽  
Post Exposure ◽  
Attitudes And Practices ◽  
Significant Difference ◽  
Follow Up Care ◽  
Exposure Prophylaxis

Abstract Background Research suggests nonoccupational Post Exposure Prophylaxis (nPEP) is underprescribed when indicated in the Emergency Department (ED). This study is an assessment of ED providers’ attitudes and practices regarding administration of HIV nPEP. Methods This was an anonymous survey based on literature review and modified Delphi technique. We approached 153 ED providers at work over a 4-month period from 5 hospital-based and 2 freestanding EDs with an annual census between 35,000 and 75,000 patients. The EDs are a combination of urban, suburban, and rural EDs. There were 152 completed surveys: 80 attendings, 27 residents, and 44 physician assistants. Results The majority of surveyed providers (133/149, 89.3%) believe it is their responsibility as an emergency provider to provide HIV nPEP in the emergency department (Figure 1). Although 91% (138/151) and 87% (132/151) of respondents are willing to prescribe nPEP to a patient in the ED for IV drug use and unprotected sex, respectively, only 40% (61/152) of participants felt they could confidently prescribe the appropriate regimen. Ultimately, only 25% (37/151) of participants prescribed nPEP in the last year. Number of years in practice, age, and gender did not result in a significant difference in nPEP administration. Respondents noted time (27%), access to follow-up care (26%), cost to patients (23%), patients’ perceived interest in HIV counseling (15%), and concern for ongoing risky behaviors (9%) as barriers to prescribing nPEP (Figure 2). 64% (95/149) of respondents feel that it is their responsibility as an ED provider to refer patients at risk of nonoccupational exposures for risk-reduction counseling. Conclusion This study identified an opportunity for HIV prevention in the emergency department. The majority of participants had not prescribed nPEP in the past 12 months. Although most were willing to prescribe nPEP and felt it was their responsibility, the majority of participants were not confident in prescribing it. Future interventions to increase the use of nPEP in the ED should target provider education, cost, access to follow-up care and counseling. Disclosures All authors: No reported disclosures.

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