Pre-exposure Prophylaxis Discontinuation During the COVID-19 Pandemic Among Men Who Have Sex With Men in a Multisite Clinical Cohort in the United States.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic continues to put strain on health systems in the United States, leading to significant shifts in the delivery of routine clinical services, including those offering HIV pre-exposure prophylaxis (PrEP). We aimed to assess whether individuals discontinued PrEP use at higher rates during the COVID-19 pandemic and the extent to which disruptions to usual clinical care were mitigated through telehealth. METHODS: Using data from an ongoing prospective cohort of men who have sex with men (MSM) newly initiating PrEP in 3 mid-sized cities (n = 195), we calculated the rate of first-time discontinuation of PrEP use in the period before the COVID-19 pandemic and during the COVID-19 pandemic and compared these rates using incidence rate ratios (IRRs). Furthermore, we compared the characteristics of patients who discontinued PrEP use during these periods with those who continued to use PrEP during both periods. RESULTS: Rates of PrEP discontinuation before the COVID pandemic and during the COVID-19 pandemic were comparable [4.29 vs. 5.20 discontinuations per 100 person-months; IRR: 1.95; 95% confidence interval (CI): 0.83 to 1.77]. Although no significant differences in the PrEP discontinuation rate were observed in the overall population, the rate of PrEP discontinuation increased by almost 3-fold among participants aged 18-24 year old (IRR: 2.78; 95% CI: 1.48 to 5.23) and by 29% among participants covered by public insurance plans at enrollment (IRR: 1.29; 95% CI: 1.03 to 5.09). Those who continued to use PrEP were more likely to have had a follow-up clinical visit by telehealth in the early months of the pandemic (45% vs. 17%). CONCLUSIONS: In this study, rates of PrEP discontinuation were largely unchanged with the onset of the COVID-19 pandemic. The use of telehealth likely helped retain patients in PrEP care and should continue to be offered in the future.

Impact of SARS-CoV-2 Test-based Strategy to Reduce Quarantine Days among Asymptomatic Healthcare Workers after Household Exposure

Background. Appropriate staffing is essential to provide safe patient care. During the COVID-19 pandemic, healthcare workers (HCWs) are missing work days due to illness or high-risk exposure (HRE) to an infected person. To avoid staffing shortages, we implemented a SARS-CoV-2 test-based strategy among asymptomatic HCWs after HRE to facilitate early return to work. Methods. In July 2020, our institution implemented a SARS-CoV-2 RT-PCR testbased strategy among HCWs within 7 days of HRE. HCWs were defined as any paid or unpaid persons directly or indirectly involved in patient care. HRE was defined as close contact < 6 feet with an infected household member without use of mask and lasting for ≥ 15 minutes. Contact with a patient or coworker was not considered high-risk due to universal masking and eye protection use. HCWs underwent SARS-CoV-2 RT PCR testing of a nasopharyngeal swab at least once (1-2 days post-exposure) or twice (5-7 days post-exposure). HCWs with symptoms at baseline were excluded. HCWs who were asymptomatic during evaluation were considered as truly asymptomatic (TA). Saved work-days (SWD) were calculated based on number of days saved due to testing strategy compared to the Centers for Disease Control and Prevention's recommended 14-day quarantine. HCWs were allowed to return to work within 7 days of HRE if they tested negative, or after completing 10-day isolation period ± improvement in symptoms from symptom onset if they tested positive. Results. Between 07/01/2020 to 12/31/2020, 450 unique asymptomatic HCWs underwent SARS-CoV-2 testing. Of those, 84% were women and median age was 36 years, 347 tested negative and 103 tested positive. Of those positives, 33% of HCWs tested positive on day 2 after HRE with 141 SWDs (average 2 days/person). Only 37% were TA positives. Of those negatives, 94% were TA SARS-CoV-2 negative with 2620 SWDs (average 7.5 days/person). There were no healthcare outbreaks related to HCWs allowed to return to work following this strategy. Asymptomatic healthcare workers commonly tested positive for SARS-CoV-2 on day 2 from household exposure compared to other days Conclusion. Test-based strategy among asymptomatic HCWs with HRE reduced loss of workdays and helped limit staffing shortages. Majority of positive HCWs developed symptoms after positive SARS-CoV-2 testing, which may support allowing most fully vaccinated HCWs with no COVID-like symptoms to continue to work unless symptomatic.

Risk of COVID-19 among Healthcare Workers after Launch of Vaccination Campaign at an Academic Medical Center

Background. Coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 virus affected healthcare workers (HCWs) adding additional burden on staffing shortages. COVID-19 vaccination (mRNA 1273 and BNT162b2) has been shown to protect against severe disease, death and reduced risk of asymptomatic infection and transmission from fully vaccinated individuals. Here, we present the impact of COVID-19 vaccination (CoVac) on risk of developing COVID-19 based on test results among unvaccinated and vaccinated HCWs. Methods. Our academic medical center with 11,785 HCWs on its Jackson campus initiated non-mandatory CoVac among HCWs with BNT162b2 on December 16, 2020. Individuals ≥ 2 weeks after 1st dose of vaccine were defined as partially vaccinated and those ≥2 weeks from 2nd dose of vaccine were defined as fully vaccinated. Per facility policy, all symptomatic HCWs (irrespective of vaccination status) were recommended to undergo SARS-CoV-2 RT-PCR testing. Asymptomatic HCWs were also tested upon household exposure, however, this policy was changed on March 9th 2021 to allow fully vaccinated asymptomatic HCWs to work without need for quarantine or testing. Universal masking policy among HCWs remained effective at our center during study period. Results. Between the launch of COVID-19 vaccination on December 16, 2020 and April 30, 2021, 5,855 HCWs received one dose of vaccine, and 5,687 received both doses. A total of 1,329 unique HCWs underwent COVID-19 testing between January 4, 2021 and April 30, 2021. Of those, 217 (16.3%) tested positive for SARSCoV-2 infection;204 were unvaccinated, 7 were partially vaccinated, and 6 were fully vaccinated (figure 1). Of the 6 fully vaccinated employees, 1 was asymptomatic (testing for travel purposes), 4 had mild symptoms, and one elderly employee required hospitalization with oxygen supplementation and had a complete recovery. No facility outbreaks were reported related to asymptomatic, work exposed, fully vaccinated HCWs. Unvaccinated healthcare workers were more likely to test positive for SARS-CoV-2 compared to partially and fully vaccinated healthcare workers. Conclusion. COVID-19 vaccination protected HCWs by reducing risk for developing COVID-19. Vaccinating healthcare workers is a crucial infection prevention measure to reduce disease burden, avoid staffing shortages and create a safe environment in the healthcare facility to prevent transmission to other staff and at-risk patients.

Leflunomide and severe COVID-19 outcome: Acautionary observation from the COVID-19 ScottishRegistry of Autoimmune Rheumatic Diseases (SCAR-19)

Background/AimsLeflunomide, a conventional disease modifying drug (csDMARD), isused in a variety of autoimmune rheumatic diseases (ARD) due to itsimmunomodulating, immunosuppressive and antiproliferative properties. This agent does however confer a greater infection risk and, dueto its long half-life, drug washout procedures are often advised in thecontext of serious infections. Interestingly, Leflunomide is currentlybeing tested as a potential therapy for COVID-19 in the generalpopulation. It is unknown whether leflunomide therapy is associatedwith a poor or favourable outcome among ARD patients infected withCOVID-19.MethodsA Scottish-wide registry was rapidly developed in March 2020. Clinicalcharacteristics and outcomes of infected cases were collated acrossall Scottish health boards. Eligible patients included any adultleflunomide treated ARD patients with a confirmed (clinically or PCR)diagnosis of COVID-19.ResultsOf the 69 cases included in the registry, n = 4 were treated withleflunomide (75% female;mean age 61, SD 4.2). N = 2 were treatedwith combination baricitinib or hydroxychloroquine respectively, whilstn = 1 received recent corticosteroid therapy (intramuscular Kenalog).Comorbidities observed in this sub-cohort include diabetes mellitusn = 3, hypertension n = 2, cardiovascular disease n = 1, lung diseasen = 1 and latent TB n = 1. At presentation, all patients (n = 4)experienced the established COVID-19 related symptom triad ofdyspnoea, cough and fever and promptly developed acute respiratorysyndrome. Diarrhoea was also recorded in n = 2 and constitutionalupset n = 3. All patients suffered a serious COVID-19 disease outcome(defined as a requirement of invasive or non-invasive ventilation (n = 4)and/ or death (n = 2).ConclusionPreliminary data from this Scotland-wide registry has identified only asmall number of leflunomide treated ARD patients infected withCOVID-19. However, it is concerning that all cases experienced aserious outcome. Given the relatively infrequent prescription of thisdrug, combining similar national registry data is necessary to ensurethis observation is not spurious. If confirmed, leflunomide washoutprocedures should be encouraged among such patients when theyfirst present with COVID-19.

Variation in immunosuppressant impact onsevere COVID-19 outcome: Preliminary results fromthe COVID-19 Scottish Registry of AutoimmuneRheumatic Diseases (SCAR-19)

Background/AimsThe novel infectious disease COVID-19 is associated with a widespectrum of clinical severity amongst the general population. Patientswith autoimmune rheumatic diseases (ARD) are more likely toexperience serious COVID-19 related events, although risk factorsfor such outcomes have yet to be established. In particular, the riskprofiles of specific ARD therapies are unknown.MethodsA Scottish wide registry was rapidly developed in March 2020. Clinicalcharacteristics and outcomes of infected cases were collated acrossall Scottish health boards, leveraging the Scottish Systemic VasculitisNetwork and Scottish Society for Rheumatology. Eligible patientsincluded any adult ARD patients with a confirmed (clinically or PCR)diagnosis of COVID-19. Simple descriptive statistics were employed toevaluate associations between ARD therapies and a serious COVID-19disease outcome, as defined by a requirement of invasive or noninvasive ventilation, and/or death.ResultsA total of 69 patients (59% female;mean age 65.6, SD15.5) wererecruited to the registry , 92% of which required hospitalisation. Caseswere most commonly diagnosed with rheumatoid arthritis (n = 32, 46.4%) followed by spondyloarthritis (n = 19, 27.5%) and systemicvasculitis (n = 9, 13.0%). Anti-TNF therapy (n = 8, 11.6%) andmethotrexate (n = 31, 44.9%) were the commonest biologic andconventional disease modifying drug (bDMARD and csDMARD) usedrespectively. N = 20 (29%) received background corticosteroid therapy (15.9% prednisolone >5mg, 13% prednisolone 5mg). A severeoutcome was observed in n = 25(31.9%);n = 11 required assistedventilation and n = 19 died. With the exception of Leflunomide, conventional and biologic DMARDs did not appear to confer ahigher risk for severe outcome (table 1). Of note, anti-TNF therapywas associated with a non-serious outcome (p = 0.04) and prednisolone>5mg with a serious outcome (p = 0.08). ConclusionPreliminary data from this Scotland-wide ARD COVID-19 registryevidences variation in the impact of standard ARD therapies on theseverity of COVID-19 outcome. In general, background csDMARD andbDMARD use does not appear to be a risk factor for severe outcomes.However, anti-TNF therapy may confer a favourable outcome, whileleflunomide and corticosteroids may have the opposite effect.Rheumatologists should be aware of these possible risk factors andcontinue to contribute to registries to help establish whether theseputative signals are clinically relevant.