614. Evaluating the Use of Dalbavancin for Off-Label Indications

Abstract Background Dalbavancin (dalba) is a long-acting antibiotic (ABX) approved for skin and soft tissue infections. Post-marketing data suggests dalba is being used for off-label indications that require long term IV ABX; however, data assessing this off-label usage is limited. The purpose of this study was to evaluate the real-world efficacy, safety, and financial impact of off-label dalba use. Methods Setting: 4-hospital health system. Design: retrospective, observational study. Adult patients (pts) who received dalba from Jan 2018 to Jan 2021 for an off-label indication were included. Pts who were pregnant or had an infection caused by a pathogen outside dalba’s antimicrobial spectrum were excluded. Primary outcome was clinical success at 90 days defined as no need for additional ABX (excluding suppression therapy) or surgical intervention following dalba therapy and no positive cultures post treatment associated with the dalba-targeted infection. Secondary outcomes included safety (nephrotoxicity and hepatotoxicity). A financial analysis was performed by subtracting the cost of dalba from the anticipated cost of pt stay [&427/day for hospital; &262/day for skilled nursing facility (SNF)] if standard IV therapy was given. Results 50 pts met study criteria; 42% were IV drug users; 14% were self-pay. Indications included osteomyelitis (54%), endocarditis (22%), bacteremia (16%), and prosthetic joint infection (PJI) (8%). The predominant organism was S. aureus (60%), with 42% caused by MRSA. All but 1 pt received 1.5 g of dalba. 20 (40%) pts received 1 dose; 26 (52%) received 2. Overall, 43 (86%) pts achieved clinical success at 90 days, including 87% of osteomyelitis/PJI pts, 82% of endocarditis pts, and 100% of pts with bacteremia. There were no instances of nephrotoxicity or hepatotoxicity. Estimated cost avoidance per pt was &5210 and &1652 if traditional IV therapy was completed in the hospital and SNF, respectively. Because the alternative therapy to dalba could not be predicted, these costs were not included in analysis but likely would have increased calculated cost avoidance. Conclusion Dalba was associated with a relatively high success rate for the treatment of off-label indications and may have less total costs than traditional IV ABX. Disclosures James Johnson, PharmD, FLGT (Shareholder) Vera Luther, MD, Nothing to disclose

Progression of addiction severity before and after completion of self-administered outpatient parenteral antibiotic therapy pilot among patients with a history of drug use (N=10). Addiction severity was defined using the National Institute of Drug Abuse (NIDA) -Modified ASSIST Score.
Conclusion. We demonstrate that PWUD can successfully complete S-OPAT with simultaneous improvement in addiction severity and psychosocial factors. We hope to create a framework for the patient-centered administration of extended courses of antibiotics for PWUD and to advocate for the expansion of individualized approaches to extended courses of IV antibiotics for PWUD.
Disclosures. Background. Dalbavancin, a lipoglycopeptide with prolonged half-life targeting Gram-positive organisms, is approved for treatment of acute bacterial skin and soft tissue infection. It reduces hospital duration in patients with barriers to short-term rehabilitation or outpatient parenteral antimicrobial therapy (OPAT). Increasing evidence supports the off-label use of dalbavancin to treat other types of infection. We conducted a quality improvement study to evaluate outcomes following dalbavancin administration.
Methods. We performed a cohort study of recipients of ≥1 dose of dalbavancin from 1/31/2016-1/31/2021 at the Veterans Affairs Connecticut Healthcare System. Demographic, comorbidity, microbiological, antibiotic duration prior to dalbavancin, indication for dalbavancin, and type of infection data were collected. Outcomes included 1) lab abnormalities: hepatotoxicity within 2 weeks of dalbavancin; 2) clinical cure: resolution of symptoms of infection within 90 days; 3) all-cause readmission within 90 days; and 4) all-cause mortality within 90 days.

Conclusion.
Dalbavancin was associated with clinical cure for diverse infections with low rates of adverse events, readmission and mortality in patients ineligible for traditional OPAT. Although confirmatory data are needed from larger studies, dalbavancin appears to be a versatile therapeutic agent for Gram-positive infections.
Disclosures. Background. Dalbavancin (dalba) is a long-acting antibiotic (ABX) approved for skin and soft tissue infections. Post-marketing data suggests dalba is being used for off-label indications that require long term IV ABX; however, data assessing this off-label usage is limited. The purpose of this study was to evaluate the real-world efficacy, safety, and financial impact of off-label dalba use.
Methods. Setting: 4-hospital health system. Design: retrospective, observational study. Adult patients (pts) who received dalba from Jan 2018 to Jan 2021 for an off-label indication were included. Pts who were pregnant or had an infection caused by a pathogen outside dalba's antimicrobial spectrum were excluded. Primary outcome was clinical success at 90 days defined as no need for additional ABX (excluding suppression therapy) or surgical intervention following dalba therapy and no positive cultures post treatment associated with the dalba-targeted infection. Secondary outcomes included safety (nephrotoxicity and hepatotoxicity). A financial analysis was performed by subtracting the cost of dalba from the anticipated cost of pt stay [$427/ day for hospital; $262/day for skilled nursing facility (SNF)] if standard IV therapy was given.
Conclusion. Dalba was associated with a relatively high success rate for the treatment of off-label indications and may have less total costs than traditional IV ABX.

A Year with COVID19 -Experience from the Front Line in a Large Infectious Disease (ID) Clinical Practice
Ronald G. Nahass, MD 1 ; Angelo Giordano, MBA 1 ; Edward J. McManus, MD 2 ; 1 ID Care, Hillsborough, New Jersey; 2 IDCare, Randolph, New Jersey

Session: P-27. Clinical Practice Issues
Background. ID Care (IDC) is a large, 43 physician, 74 provider, practice that treats patients in 16 acute care hospitals (ACH) and 120 skilled nursing facilities (SNF) in NJ. March 4, 2021 was the first day a patient with COVID19 seen by IDC. Over the subsequent year IDC evaluated, treated, and tested over 23,000 persons for COVID19. Patients were seen in 2 distinct times -wave 1 (W1) March 5-August 31 and wave 2 (W2) September 1 to March 4. We compare the experience of these 2 waves and report on the year of COVID19 at IDC.
Methods. The administrative data base for IDC was queried for demographic, visit and testing information. A survey of providers was performed to capture incidence of COVID19 and vaccination rates. Daily census logs were used to create epi curves. Comparisons between waves were performed using student T Test or X 2 .
Results. Table 1 provides the comparisons between waves. More patients were seen in W2, however, the number of visits per patient was less, consistent with a shorter length of stay. Fewer patients were seen in SNF in W2 compared to W1. The age and sex distribution between the waves were the same. A total of 8741 molecular tests were performed. Test positivity peaked the week of December 31 at 6.99% and dropped to 0% by May 1 consistent with vaccination and the NJ epidemic curve. During the year of COVID19, 6/74 (8%) clinicians were infected with SARSCoV2. All recovered. Infections in providers were not clearly work-related exposures. 73/74 clinicians were vaccinated.