Real-World Experience With Available, Outpatient COVID-19 Therapies in Solid Organ Transplant Recipients During the Omicron Surge

Christopher Radcliffe; Carlo Foppiano Palacios; Marwan M. Azar; Elizabeth Cohen; Maricar Malinis

Disclosures

American Journal of Transplantation. 2022;22(10):2458-2463. 

In This Article

Abstract and Introduction

Abstract

The SARS-CoV-2 pandemic continues to place a substantial burden on healthcare systems. Outpatient therapies for mild-to-moderate disease have reduced hospitalizations and deaths in clinical trials, but the real-world effectiveness of monoclonal antibodies and oral antiviral agents in solid organ transplant recipients (SOTR) with coronavirus disease-2019 (COVID-19) is largely uncharacterized. We conducted a single-center, retrospective review of 122 SOTR diagnosed with COVID-19 in the outpatient setting during the Omicron surge to address this knowledge gap. The mean age was 54 years, 57% were males, and 67% were kidney transplant recipients. The mean time from transplant to COVID-19 diagnosis was 75 months. Forty-nine (40%) received molnupiravir, 24 (20%) received sotrovimab, and 1 (0.8%) received nirmatrelvir/ritonavir. No outpatient therapy was administered in 48 (39%). All 122 SOTR had >30 days follow-up. Rates of hospitalization within 30 days of initiating therapy for molnupiravir, nirmatrelvir/ritonavir, and sotrovimab were 16% (8/49), 0% (0/1), and 8% (2/24), respectively, compared to 27% (13/48) in patients without outpatient therapy. There were no deaths in those who received any therapy versus 3 (6%) deaths in patients without outpatient therapy (p = .002). Overall, our experience suggests a role for monoclonal antibodies and oral antiviral agents in reducing COVID-19-related morbidity and mortality in SOTR.

Introduction

With over 980 000 deaths and 80 million cumulative cases in the United States as of April 24, 2022,[1] the SARS-CoV-2 pandemic places a substantial burden on healthcare delivery systems, and the Omicron variant ensures the continued relevance of coronavirus disease-2019 (COVID-19).[2] Vaccination, in combination with other mitigation efforts, is a key strategy to reduce infection rates. Nonetheless, persons with immune dysfunction are at heightened risk for breakthrough infections after vaccination,[3] and vaccinated solid organ transplant recipients (SOTR) remain at risk for severe disease.[4]

In this setting, outpatient therapies for mild-to-moderate disease are vital for reducing the risk of disease progression and preventing both COVID-19-related hospitalizations and deaths.[5] Monoclonal antibodies (e.g., sotrovimab[6]) and oral antiviral agents (e.g., molnupiravir[7] and nirmatrelvir/ritonavir[8]) have proven efficacious in preventing hospitalization and death in at-risk adults in clinical trials, but the real-world effectiveness of these therapies for COVID-19 in SOTR during the Omicron era is largely uncharacterized. To address this knowledge gap, we conducted a retrospective review of our transplant center's experience with outpatient therapies in SOTR during the recent Omicron surge.

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