Prevalence and Accuracy of Empiric Treatment Among Patients with Vaginitis Symptoms in the United States

ABSTRACT Background Evidence suggests low diagnostic test utilization and high empiric prescribing rates for vaginitis symptoms. This study retrospectively assessed real-world bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and trichomoniasis (TV) treatment patterns in the United States (US) relative to test results and their timing. Methods Patients with vaginitis or related symptom diagnosis were identified between 2018-2023 in an ambulatory EMR database linked to prescription and outpatient medical claims databases. Pregnant and non-pregnant subgroups were stratified by test type (nucleic acid amplification test [NAAT] panel [BV, VVC, and TV], direct probe, or traditional methods) up to first diagnosis date +2 days. Treatment claims before (empiric) and up to 7 days after (informed) the test result date were assessed. Results There were 1,465 pregnant and 13,447 non-pregnant patients meeting selection criteria; 31.7%, 26.3% and 2.0% of pregnant and 26.6%, 16.1% and 2.0% of non-pregnant cohorts had positive results for BV, VVC, and TV, respectively. Empiric treatment was common across treated pregnant subgroups tested with laboratory NAAT panel (55.0%), direct probe (35.5%), and traditional methods (66.7%), and non-pregnant subgroups (55.7%, 52.2%, 74.2%, respectively). Many empiric treatments were not aligned to positive test results, including co-infections (e.g., 6.5-8.2% of pregnant and 11.7-13.0% of non-pregnant patients who tested BV-positive by NAAT panel or direct probe were empirically treated with anti-fungal agents for VVC). Conclusions High empiric treatment rates and evidence of inappropriate treatment highlight the potential utility for rapid, accurate tests to diagnose common vaginal infections, to inform clinical decision-making and results-guided prescribing at the point-of-care.