ABSTRACT
DISCLAIMER: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. PURPOSE: To evaluate the success of a clinic for subcutaneous administration of casirivmab and imdevimab (REGEN-COV; Regeneron) for treatment of patients with symptomatic mild to moderate coronavirus disease 2019 (COVID-19) in terms of preventing disease progression and healthcare utilization. METHODS: This retrospective single-center, propensity-matched cohort study examined healthcare utilization outcomes for patients who received subcutaneous casirivimab and imdevimab at a pharmacist-led clinic of an academic health system. Eligible patients were treated between August 1, 2021, and January 5, 2022, and were at high risk for COVID-19 disease progression. Treatment patients were propensity matched with high-risk control patients with a diagnosis of COVID-19 in the same timeframe who did not receive casirivimab and imdevimab. Patients were followed for 30 days for collection of data on inpatient admissions, emergency department visits, and mortality. Risk of a 30-day healthcare utilization event was assessed and tested for statistical significance utilizing McNemar's test. RESULTS: A total of 585 patients who received treatment with subcutaneous casirivimab and imdevimab were matched with 585 patients who did not receive casirivimab and imdevimab therapy. Patients who received casirivimab and imdevimab had significantly lower risk of a 30-day all-cause inpatient admission event than untreated patients (relative risk reduction, 61.2%; P < 0.0001). Treated patients also had a significantly lower risk of 30-day all-cause emergency department visit than untreated subjects (relative risk reduction, 36.6%; P = 0.0021). There were 6 mortality events in the untreated group and no mortality events in the treatment group. CONCLUSION: This study provides evidence for the effectiveness of a subcutaneous casirivimab and imdevimab clinic in preventing progression of symptomatic mild to moderate COVID-19.
ABSTRACT
BACKGROUND: The goal of hepatitis C virus (HCV) treatment is to cure the patient of the infection, defined as a nondetectable HCV RNA at least 12 weeks after treatment completion, or sustained virologic response (SVR). The COVID-19 pandemic has presented new barriers to care in the treatment of patients with HCV that resulted in a transition to tele-health services at many health systems to overcome these barriers. OBJECTIVE: To assess the real-world impact of the COVID-19 pandemic and the subsequent shift to a telehealth model on collection of SVR data and other HCV treatment outcomes in a health-system setting. METHODS: Subjects who received a referral for an HCV direct-acting antiviral agent between January 1, 2018, and November 30, 2020, and were aged 18 years or older at time of enrollment were placed in either "pre-COVID-19" or "COVID-19" cohorts based on enrollment date. The primary endpoint of this study evaluated confirmed SVR to treatment determined by the absence of HCV RNA by polymerase chain reaction testing at least 12 weeks after completion of drug therapy. Secondary endpoints evaluated completion of medication therapy and adherence to laboratory appointments. RESULTS: 1,504 patients met study inclusion criteria (pre-COVID-19 cohort, n = 1,230; COVID-19 cohort, n = 274). The COVID-19 cohort demonstrated significantly lower therapy completion rates (P = 0.001), were less likely to obtain SVR laboratory tests (P < 0.001), and had a significantly lower confirmed SVR rate (P < 0.001) compared with the pre-COVID-19 cohort. In a subset of patients who completed therapy and had SVR laboratory tests collected, there were no significant differences observed in the rate of patients who achieved SVR (P = 0.959). CONCLUSIONS: During the COVID-19 pandemic, patients with HCV were significantly less likely to complete therapy or participate in SVR laboratory work. Further studies are needed to determine if offering a telehealth option for our patients in a post-COVID-19 environment would offer any additional advantage in increasing access to care for patients with HCV. DISCLOSURES: No outside funding supported this study. Dr Cooper is an employee of the University of Kentucky whose position was partially funded by Gilead Sciences, Inc.