Safety Profile and Outcomes of Early COVID-19 Treatments in Immunocompromised Patients: A Single-Centre Cohort Study

Abstract

Background: Early treatment with remdesivir (RMD) or monoclonal antibodies (mAbs) could be a valuable tool in patients at risk of severe COVID-19 with unsatisfactory responses to vaccination. We aim to assess the safety and clinical outcomes of these treatments among immunocompromised subjects. Methods: We retrospectively reviewed all nonhospitalized patients who received an early treatment with RMD or mAbs for COVID-19, from 25 November 2021 to 25 January 2022, in a large tertiary hospital. Outcomes included frequency of adverse drug reaction (ADR), duration of symptoms and molecular swab positivity, emergency department access, hospital or intensive care unit admission, and mortality in the 14 days following treatment administration. Results: Early treatments were administered to 143 patients, 106/143 (74.1%) immunocompromised, including 41 solid organ and 6 hematopoietic stem cell transplant recipients. Overall, 23/143 (16.1%) subjects reported ADRs. Median time from treatment start to SARS-CoV-2 nasopharyngeal swab negativity and symptom resolution was 10 (IQR 6–16) and 2.5 days (IQR 1.0–6.0), respectively, without differences between immunocompromised and nonimmunocompromised patients. In the 14 days after treatment administration, 5/143 patients (3.5%) were hospitalized and one died as a result of causes related to COVID-19, all of them were immunocompromised. Conclusions: RMD and mAbs have minimal ADRs and favourable outcomes in immunocompromised patients.

Preliminary Evidence of Good Safety Profile and Outcomes of Early Treatment With Tixagevimab/Cilgavimab Compared to Previously Employed Monoclonal Antibodies for COVID-19 in Immunocompromised Patients

“…The study included immunocompromised patients [(i) history of any connective tissue disease, autoimmune disease, or primary immunodeficiency, (ii) history of an active solid or hematologic tumour, (iii) neutropenia due to haematological cancer, (iv) diagnosis of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), (v) history of splenectomy, solid organ transplantation (SOT), and/or hematopoietic stem cell transplantation (HSCT), (vi) ongoing treatment with steroids (for at least 4 weeks), chemotherapy, and/or immunosuppressive agents], with COVID-19 diagnosis, evaluated at the outpatient clinic or hospitalized for a non-COVID-19 related reason in the ward of the Infectious Diseases Unit, IRCCS Ospedale Maggiore Policlinico, Milano, Italy, from August 28 to October 15, 2022, who received early treatment with TIX/CIL. This group was compared to subjects who had received other mAbs (casirivimab/imdevimab, bamlanivimab/etesevimab, sotrovimab) between November 25, 2021, and January, 25, 2022, as previously published [6]. We compared clinical outcomes (i.e., hospitalization and mortality within 14 days from administration) and time to the negativity of nasal swabs.…”

Remdesivir Use in the Real-World Setting: An Overview of Available Evidence

“…In another study, where early RDV and sotrovimab were used individually as outpatient treatments, hospitalizations and visits to the emergency department were significantly less likely within 29 days from symptom onset (RDV: 11% versus 23.3%; OR = 0.41; sotrovimab: 8% versus 23.3%; OR = 0.28).There was no significant difference between sotrovimab and RDV [ 31 ]. Three independent studies (one prospective and two retrospective) later confirmed the significant reduction in hospitalizations and deaths when RDV was initiated early in the progression of COVID-19 [ 32 , 33 , 34 ].…”

“…The evidence of RDV efficacy and safety among immunocompromised populations has come from cohorts or case series, highlighting the potential of a combination of antiviral therapies or prolonged courses of RDV ( Table 1 ) with variable results [ 32 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 ]. Persistent infection in immunocompromised patients remains a concern, as it seems to drive virus evolution and the selection of new variants [ 84 ]; hence, experience of individualized successful treatment is necessary.…”

What is New in Prophylaxis and Treatment of Covid- 19 in Renal Transplant Patients?

“…In addition, the study confirms previous studies (73,74,75,76) who used different associations of monoclonal antibodies. Another study evaluated the association of monoclonal antibodies with remdesivir (RMD) as early treatment in immune compromised patients with unsatisfactory answer to vaccination (77). The conclusion of the study were that the association of RMD and mAbs does not have relevant adverse events, while resulting in good outcomes of the disease.…”