Leishmaniasis, a chronic and persistent intracellular protozoal infection caused by many different species within the genus Leishmania, is an unfamiliar disease to most North American providers. Clinical presentations may include asymptomatic and symptomatic visceral leishmaniasis (so-called Kala-azar), as well as cutaneous or mucosal disease. Although cutaneous leishmaniasis (caused by Leishmania mexicana in the United States) is endemic in some southwest states, other causes for concern include reactivation of imported visceral leishmaniasis remotely in time from the initial infection, and the possible long-term complications of chronic inflammation from asymptomatic infection. Climate change, the identification of competent vectors and reservoirs, a highly mobile populace, significant population groups with proven exposure history, HIV, and widespread use of immunosuppressive medications and organ transplant all create the potential for increased frequency of leishmaniasis in the U.S. Together, these factors could contribute to leishmaniasis emerging as a health threat in the U.S., including the possibility of sustained autochthonous spread of newly introduced visceral disease. We summarize recent data examining the epidemiology and major risk factors for acquisition of cutaneous and visceral leishmaniasis, with a special focus on implications for the United States, as well as discuss key emerging issues affecting the management of visceral leishmaniasis.
Background In response to the ongoing COVID-19 pandemic, an emergency use authorization (EUA) was issued for neutralizing antibody therapies including BAM. Licensing trials suggest that use of BAM reduces hospitalizations when compared with placebo (1.6% vs 6.3%). However, the real world impact of BAM is not well-described. In this study, risk factors, outcomes, and hospitalization rates among high-risk outpatients presenting with mild-to-moderate COVID-19 who received BAM were examined. Methods This is a single center retrospective analysis of all patients who received BAM monotherapy between 11/11/2020 and 3/16/2021. Electronic health records were reviewed for baseline demographics, EUA indications, comorbidities, and outcomes to include infusion reactions, hospitalizations, and deaths occurring within 29 days of BAM administration. Moderate COVID-19 was defined as having any infiltrate on chest imaging prior to BAM administration. Chi-squared or Fisher’s exact tests were used to compare categorical values as appropriate, and Mann-Whitney U for continuous variables. Results Of the 101 patients who received BAM (median age 64 years; 21% black; 4% Hispanic; 55% male), 13 were subsequently admitted. 22 patients (22%) had moderately severe disease as evidenced by abnormal imaging. Severity on presentation, number of indications for therapy, hypertension, stroke, diabetes, and number of co-morbidities were significantly associated with subsequent admission (table 1). No patients had adverse infusion reactions. Of those hospitalized, 8 (61.5%) were for COVID-19, the median duration of hospitalization was 2 days, and 4 received guideline-directed treatment for COVID-19 (table 2). Table 1. Factors Associated with Hospitalization Following Bamlanivimab (BAM) Administration Table 1. (Continued) Factors Associated with Hospitalization Following Bamlanivimab (BAM) Administration Table 2: Characteristics and Resource Utilization of Patients Hospitalized After Bamlanivimab Therapy (n=13) Conclusion In a high-risk population, hospitalization rates were higher than those observed in clinical trials, with 8% of subjects being admitted for COVID-19. Disease severity on presentation, multiple indications for therapy, and the presence of multiple co-morbidities were all associated with subsequent admission. Reassuringly, BAM was well tolerated, and in those requiring admission, hospitalizations were short, resource utilization was low, and there were no deaths. Disclosures Benjamin L. Custer, M.D., Alexion Pharmaceuticals (Shareholder)Armata Pharmaceuticals (Shareholder)Biomarin Pharmaceutical (Shareholder)Crispr Therapeutics (Shareholder)CVS Health Corp (Shareholder)Editas Medicine (Shareholder)Gilead (Shareholder)Glaxo Smith Kline (Shareholder)Hologic Inc (Shareholder)Merck (Shareholder)Mesoblast LTD (Shareholder)Pfizer (Shareholder)Sanofi (Shareholder)Unitedhealth Group (Shareholder)Vertex Pharmaceuticals (Shareholder) Dana M. Blyth, MD, Nothing to disclose
Background In 2012, pneumococcal conjugate vaccine (PCV13) and pneumococcal polysaccharide vaccine (PPSV23) were recommended for immunocompromised adults ≥19 years, but pneumococcal vaccination (PV) in these patients (pts) remains suboptimal. With a new PV (PCV20) allowing for simplified PV, we study rates of PV in pts on infliximab (INX) 1 year post-initiation of a pt and provider education-based quality improvement project aiming to increase PV in pts on Tumor Necrosis Factor-alpha inhibitors (TNF-αI). Methods Starting in 11/2020, pamphlets detailing PV indications were distributed to the Walter Reed National Military Medical Center infusion center and pharmacies to be given to pts prescribed/administered TNF-αI. Provider educational materials and pt pamphlets were given to services prescribing TNF-αI. Provider education was also offered to these services. Up to date (UTD) on PV was defined as receipt of PCV13 and PPSV23 (including additional PPSV23 dose ≥5 years post-initial PPSV23 if applicable). Ongoing INX (o-INX) was defined as INX initiation before 10/1/2020. Newly initiated INX (new-INX) was 10/1/2020-10/1/2021. One-year post implementation, we reviewed the PCV13 and PPSV23 immunization records of pts ≥19 years of age on INX from 1/1/21-12/31/21. This project was approved by the IRB under a non-research determination. Results 111 pts prescribed INX between 1/1/21-12/31/21 met inclusion criteria (87 o-INX and 24 new-INX). Prior to the intervention, of 87 o-INX pts, 45 (52%), 45 (52%), and 18 (21%) pts had received PCV13, ≥1 PPSV23 dose, and were UTD on PV respectfully. Between 1/1/21-12/31/21, 14 o-INX pts had PV (1 PCV13 and PPSV23, 7 PCV13, and 6 PPSV23), with 7 newly UTD (10% of the 69 previously not UTD), totaling 25 (29%) o-INX pts UTD on PV (figure 1). Of 24 new-INX pts, only 12 (48%), 9 (36%), and 6 (24%) had had PCV13, PPSV23, and were UTD on PV as of 12/31/21. No services prescribing TNF-αI requested the offered PV educational talks. Conclusion Despite frequent healthcare in a system where vaccination has no out of pocket expense, guideline-concordant PV was low in this cohort. With new, simplified PV, next steps include updated pt and targeted provider education. However, with prior small gains using multidisciplinary education, additional efforts to remove PV barriers may be needed. Disclosures Benjamin L. Custer, MD, Beam Therapeutics: Stocks/Bonds|CRISPR Therapeutics: Stocks/Bonds|glaxo-smith-kline: Stocks/Bonds|Hologic: Stocks/Bonds|Moderna: Stocks/Bonds|Pfizer: Stocks/Bonds|Regeneron: Stocks/Bonds|sanofi: Stocks/Bonds|Vertex Pharmaceuticals: Stocks/Bonds.
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