Characteristics and outcomes of patients with COVID-19 at high risk of disease progression receiving sotrovimab, oral antivirals or no treatment in Scotland

Introduction: Severe acute respiratory syndrome coronavirus 2 is constantly evolving. The clinical benefit of coronavirus disease 2019 (COVID-19) treatments against new circulating variants remains unclear. We sought to describe the real-world use of, and clinical outcomes associated with, early COVID-19 treatments among non-hospitalised patients with COVID-19 at highest risk of developing severe disease in Scotland. Methods: Retrospective cohort study of non-hospitalised patients diagnosed with COVID-19 from 1 December 2021 to 25 October 2022, using administrative health data managed by Public Health Scotland and National Records of Scotland. Patients included in the study were aged [≥]18 years, met at least one of the National Health Service highest-risk conditions criteria for early COVID-19 treatment, and had received outpatient treatment with sotrovimab, nirmatrelvir/ritonavir or molnupiravir, or no early COVID-19 treatment. Index date was defined as the earliest of either COVID-19-positive diagnosis or early COVID-19 treatment during the study period. Baseline patient characteristics and acute clinical outcomes in the 28 days following the index date were reported. To protect patient confidentiality, values of [≤]5 were suppressed. Results: A total of 2548 patients were included (492: sotrovimab, 276: nirmatrelvir/ritonavir, 71: molnupiravir, and 1709 eligible highest-risk untreated). Patients aged [≥]75 years accounted for 6.9% (n=34/492) of the sotrovimab-treated group, 21.0% (n=58/276) of those treated with nirmatrelvir/ritonavir, 16.9% (n=12/71) of those treated with molnupiravir and 13.2% (n=225/1709) of untreated patients. Advanced renal disease was reported for 6.7% (n=33/492) of sotrovimab-treated and 4.7% (n=81/1709) of untreated patients, and five or fewer patients in the nirmatrelvir/ritonavir and molnupiravir cohorts. A high proportion of treated patients did not have a highest-risk condition reported in the database (71.7% for sotrovimab [n=353/492], 85.1% for nirmatrelvir/ritonavir [n=235/276], 85.9% for molnupiravir [n=61/71]). Five or fewer patients in each treated cohort experienced COVID-19-related hospitalisations during the 28-day acute period. For untreated patients, the percentage of COVID-19-related hospitalisations was 3.0% (n=48/1622). All-cause hospitalisations were experienced by 5.3% (n=25/476) of sotrovimab-treated patients, 6.9% (n=12/175) of nirmatrelvir/ritonavir-treated patients and 13.3% (n=216/1622) of untreated patients. Five or fewer patients in the molnupiravir cohort experienced all-cause hospitalisation. There were no deaths within 28 days of index for patients in the treated cohorts. Mortality was 4.3% (n=70/1622) in untreated patients (18.6% [n=13/70] had COVID-19 as the primary cause). In our analyses of outcomes for sotrovimab-treated and untreated patients during BA.1, BA.2 and BA.5 predominance, COVID-19-related hospitalisation rates were consistent, with n[≤]5 for sotrovimab-treated patients in each period. Conclusions: Our findings indicate that sotrovimab was often used amongst patients who were aged <75 years old and had advanced renal disease. Among patients who received early COVID-19 treatment, proportions of all-cause hospitalisation and death within 28 days of treatment were low.