1434. Treatment Patterns, Healthcare Resource Use, and Associated Costs in Females with Uncomplicated Urinary Tract Infection in the United States

Abstract Background Urinary tract infections (UTIs) disproportionately affect women and are a substantial burden on healthcare systems. We assessed the effect of antibiotic (AB) switching on UTI recurrence, healthcare resource use (HRU), and related costs among adolescent and adult females in the US with uncomplicated UTIs (uUTIs). Methods This retrospective cohort study used US Optum claims data (United Healthcare, January 1, 2013–December 31, 2018). Eligible patients were females ≥ 12 years of age with an acute uUTI diagnosis at outpatient or emergency department (ED) visit (index date) and an oral AB prescription within ± 5 days of index. Patients with recurrent UTIs (rUTIs), defined as 2 UTI diagnoses (including index) in 6 months or ≥ 3 UTI diagnoses (including index) in 12 months, were included; those with complicated UTI were excluded. Patients were assigned to two groups: AB switch (≥ 2 filled prescriptions of different AB within 28 days post index [uUTI episode]) and no AB switch. Results In 5870 eligible patients (mean age 44.5 years; 76.6% White), ciprofloxacin (CIP; 38.6%), nitrofurantoin (NFT; 31.4%), and trimethoprim-sulfamethoxazole (TMP-SMX; 25.6%) were the most commonly prescribed first-line ABs at index, and 567 (9.7%) patients switched AB. CIP was switched to NFT and TMP-SMX in 2.0% and 1.7% of patients, respectively. NFT was switched to CIP and TMP-SMX in 2.6% and 1.5% of patients, respectively. TMP-SMX was switched to CIP and NFT in 3.0% and 2.4% of patients, respectively. During index visit, the AB switch group had higher mean ambulatory care and pharmacy claims (both p < 0.001), and higher total mean HRU costs (&2186.4) per patient compared with the no switch group (&1508.8; p = 0.011). More patients had rUTI in the AB switch group (18.9%) versus the no switch group (14.2%; p < 0.001), and more had ED visits in the AB switch group than the no switch group (p < 0.0001) (Table 1). During follow-up, the AB switch group had a higher mean number of uUTI episodes per patient (p < 0.001; Table 1), and more patients had UTI-related ED visits (10.8%) compared with the no switch group (7.7%; p = 0.010; Table 2). Table 1. Primary outcomes of uncomplicated UTI outpatients during January 1, 2013–December 31, 2018, stratified by any switch in AB use during index episode Table 2. Primary outcomes of uncomplicated UTI outpatients during January 1, 2013–December 31, 2018, stratified by any switch in AB use during 12-month follow-up Conclusion US females with uUTI who switched AB had more rUTI cases and increased overall costs and HRU compared with those who did not switch AB, suggesting an unmet need for improved prescribing practices. Disclosures Rena Moon, MD, Premier Applied Sciences, Premier Inc. (Employee) Alen Marijam, MSc, GlaxoSmithKline plc. (Employee, Shareholder) Fanny S. Mitrani-Gold, MPH, GlaxoSmithKline plc. (Employee, Shareholder) Daniel C. Gibbons, PhD, GlaxoSmithKline plc. (Employee, Shareholder) Alex Kartashov, PhD, Premier Applied Sciences, Premier Inc. (Employee) Ning Rosenthal, MD, Premier Applied Sciences, Premier Inc. (Employee, Shareholder) Ashish V. Joshi, PhD, GlaxoSmithKline plc. (Employee, Shareholder)

Patient and encounter characteristics found to be significantly associated with non-specific symptoms, p < 0.05.
Conclusion. Symptoms not specific to the urinary tract are the most frequently reported symptoms in patients with NB and encounters with a UTI diagnosis. Change in urine odor/color were reported often; however, guidelines recommend against using these for UTI diagnosis. Providers should ensure that alternate sources of non-specific symptoms are evaluated prior to attributing them to UTI. Antibiotic stewardship interventions targeted to physical medicine and rehabilitation (PM&R) and primary care providers in inpatient settings may improve UTI diagnosis in patients with NB.
Disclosures. Charlesnika T. Evans, PhD, MPH, BioK+ (Consultant) Background. In 2019, the FDA issued guidance on drug development for treatment of UTIs. To explore the impact of this guidance, we compared clinical and microbiological outcomes of the fluoroquinolones norfloxacin and ciprofloxacin and the β-lactams pivmecillinam and sulopenem for treatment of uUTIs from original publications versus recent analyses conducted in accordance with the FDA guidance.

Impact of 2019 US Food and Drug Administration (FDA) Guidance on Developing Drugs for Urinary Tract Infection (UTI) on the Perceived Efficacy of
Methods. The efficacy of pivmecillinam 400 mg twice daily (BID), 3 days (3d) versus norfloxacin 400 mg BID, 3d was reported in a 2002 publication. Patient-level data were used to re-analyze clinical and microbiological outcomes in the microbiological intent-to-treat population in accordance with the 2019 FDA guidance. For descriptive comparison, we present the efficacy of ciprofloxacin 250 mg BID, 3d vs sulopenem 500 mg BID, 5d in the 2020 SURE-1 trial (also conducted in accordance with FDA guidance) alongside historical efficacy data for ciprofloxacin.
Results. Re-analysis of data from the trial of pivmecillinam and norfloxacin showed microbiological responses for pivmecillinam and norfloxacin of 64% and 79%, respectively. Microbiological responses were higher, 75% for pivmecillinam and 91% for norfloxacin, in the original analysis. For clinical response, re-analysis showed 75% for pivmecillinam and 88% for norfloxacin, while historical data were 82% and 88%, respectively. In the SURE-1 trial, the microbiological response of patients assessed at Day 12 was 76.6% for sulopenem and 79.1% for ciprofloxacin. In a 2002 publication, bacterial eradication at 4 to 11 days after treatment was 93.7% for ciprofloxacin 250 mg, a higher response rate than that reported in SURE-1. For clinical response, rates were 78.7% for ciprofloxacin in SURE-1 and 92.7% for the historical ciprofloxacin data.
Conclusion. When assessed in accordance with the 2019 FDA guidance, clinical and microbiological efficacy of both fluoroquinolones and β-lactam antibiotics appears lower than has been published in the past. Healthcare providers should be aware that newer antibiotics may appear to have a lower efficacy than older antibiotics due to the application of more stringent definitions in the FDA guidance.
Disclosures Background. Urinary tract infections (UTIs) disproportionately affect women and are a substantial burden on healthcare systems. We assessed the effect of antibiotic (AB) switching on UTI recurrence, healthcare resource use (HRU), and related costs among adolescent and adult females in the US with uncomplicated UTIs (uUTIs).
Methods. This retrospective cohort study used US Optum claims data (United Healthcare, January 1, 2013-December 31, 2018). Eligible patients were females ≥ 12 years of age with an acute uUTI diagnosis at outpatient or emergency department (ED) visit (index date) and an oral AB prescription within ± 5 days of index. Patients with recurrent UTIs (rUTIs), defined as 2 UTI diagnoses (including index) in 6 months or ≥ 3 UTI diagnoses (including index) in 12 months, were included; those with complicated UTI were excluded. Patients were assigned to two groups: AB switch (≥ 2 filled prescriptions of different AB within 28 days post index [uUTI episode]) and no AB switch.
Results. In 5870 eligible patients (mean age 44.5 years; 76.6% White), ciprofloxacin (CIP; 38.6%), nitrofurantoin (NFT; 31.4%), and trimethoprim-sulfamethoxazole (TMP-SMX; 25.6%) were the most commonly prescribed first-line ABs at index, and 567 (9.7%) patients switched AB. CIP was switched to NFT and TMP-SMX in 2.0% and 1.7% of patients, respectively. NFT was switched to CIP and TMP-SMX in 2.6% and 1.5% of patients, respectively. TMP-SMX was switched to CIP and NFT in 3.0% and 2.4% of patients, respectively. During index visit, the AB switch group had higher mean ambulatory care and pharmacy claims (both p < 0.001), and higher total mean HRU costs ($2186.4) per patient compared with the no switch group ($1508.8; p = 0.011). More patients had rUTI in the AB switch group (18.9%) versus the no switch group (14.2%; p < 0.001), and more had ED visits in the AB switch group than the no switch group (p < 0.0001) ( Table 1). During follow-up, the AB switch group had a higher mean number of uUTI episodes per patient (p < 0.001; Table 1), and more patients had UTI-related ED visits (10.8%) compared with the no switch group (7.7%; p = 0.010; Table 2). Table 1. Primary outcomes of uncomplicated UTI outpatients during January 1, 2013-December 31, 2018, stratified by any switch in AB use during index episode Table 2. Primary outcomes of uncomplicated UTI outpatients during January 1, 2013-December 31, 2018, stratified by any switch in AB use during 12-month follow-up Conclusion. US females with uUTI who switched AB had more rUTI cases and increased overall costs and HRU compared with those who did not switch AB, suggesting an unmet need for improved prescribing practices.
Disclosures Background. Uncomplicated urinary tract infections (uUTI) are one of the most common bacterial infections in women. Understanding unmet needs of physicians in diverse healthcare systems is important for developing novel uUTI treatment (tx).

Methods.
A cross-sectional survey of physicians in the US and Germany (DE). Physicians were recruited via specialist panel and the survey was piloted (1 US, 1 DE physician) prior to recruitment. Primary objectives were understanding physician tx goals, management approaches, and prescribing patterns for uUTI. Secondary objectives included understanding perceptions of uUTI impact on patients and awareness of antibiotic (AB) resistance. Descriptive statistics were used for analysis. See Table for inclusion/exclusion criteria.  1). Physicians estimated ~20% of patients do not achieve complete relief from initial AB tx. Generally, urinalysis, dip stick, and symptom review were most commonly used in diagnosis, with culture and AB susceptibility tests mostly used to aid tx decisions (Fig. 2). For first-line AB, US physicians reported trimethoprim-sulfamethoxazole (TMP-SMX; 76%) and nitrofurantoin (57%) as most prescribed; in DE, fosfomycin (61%) and TMP-SMX (50%) were prescribed most. In both countries, ciprofloxacin (US 51%, DE 45%) was most prescribed after ≥ 2 tx failures. On a scale of "very poor" (1) to "exceptional" (7) for tx and management of uUTI, 58% of US physicians gave TMP-SMX a 6 or 7, and 62% of DE physicians gave fosfomycin a 6 or 7. More than 33% of physicians believed patients' quality of life was greatly impacted by 1 tx failure, rising to 60% of physicians for 2 tx failures, and 73% for ≥ 3. Most physicians (72% US, 83% DE) agreed that development of AB resistance was serious (Fig. 3), but fewer (56% US, 46% DE) were confident in their knowledge of AB resistance. Conclusion. Symptom relief was the primary uUTI tx goal for physicians. Physicians recognized that patients are greatly impacted by tx failure and AB resistance is a serious problem, but many were not confident or had insufficient information on AB resistance.
Disclosures. Megan O'Brien, BA, Adelphi Real World (Employee, Employee of Adelphi Real World, which received funding from GlaxoSmithKline plc. to conduct this study) Alen Marijam, MSc, GlaxoSmithKline plc. (Employee, Shareholder)