Real-life data on monoclonal antibodies and antiviral drugs in Italian inborn errors of immunity patients during COVID-19 pandemic

Abstract

BackgroundSince the beginning of the COVID-19 pandemic, patients with Inborn Errors of Immunity have been infected by SARS-CoV-2 virus showing a spectrum of disease ranging from asymptomatic to severe COVID-19. A fair number of patients did not respond adequately to SARS-CoV-2 vaccinations, thus early therapeutic or prophylactic measures were needed to prevent severe or fatal course or COVID-19 and to reduce the burden of hospitalizations.MethodsLongitudinal, multicentric study on patients with Inborn Errors of Immunity immunized with mRNA vaccines treated with monoclonal antibodies and/or antiviral agents at the first infection and at reinfection by SARS-CoV-2. Analyses of efficacy were performed according to the different circulating SARS-CoV-2 strains.ResultsThe analysis of the cohort of 192 SARS-CoV-2 infected patients, across 26 months, showed the efficacy of antivirals on the risk of hospitalization, while mabs offered a positive effect on hospitalization, and COVID-19 severity. This protection was consistent across the alpha, delta and early omicron waves, although the emergence of BA.2 reduced the effect of available mabs. Hospitalized patients treated with mabs and antivirals had a lower risk of ICU admission. We reported 16 re-infections with a length of SARS-CoV-2 positivity at second infection shorter among patients treated with mabs. Treatment with antivirals and mabs was safe.ConclusionsThe widespread use of specific therapy, vaccination and better access to care might have contributed to mitigate risk of mortality, hospital admission, and severe disease. However, the rapid spread of new viral strains underlines that mabs and antiviral beneficial effects should be re- evaluated over time.

Case report: Sotrovimab, remdesivir and nirmatrelvir/ritonavir combination as salvage treatment option in two immunocompromised patients hospitalized for COVID-19

“…As recently suggested by other experiences, combination therapy with monoclonal antibodies and one antiviral, also for a prolonged time, could contribute to virological success in immunocompromised patients (34,35).…”

Safety of mRNA COVID-19 Vaccines in Patients with Inborn Errors of Immunity: an Italian Multicentric Study

“…A variable proportion of CVID patients have ITP as an hematologic comorbidity in their medical history [49]. We did not observe de novo or relapses of ITP in the postvaccine observation period, while for instance a relapse has been observed during SARS-CoV-2 infection in our PID cohort [50]. Since some AEs of vaccines such as ITP are immune-mediated, it is possible that use of immunoglobulin replacement therapy in PID patients may provide some risk reduction against these adverse effects by its immunomodulatory effect [51].…”

Lessons learned and implications of early therapies for coronavirus disease in a territorial service centre in the Calabria region: a retrospective study

“…Despite the lack of data on the combination of mAbs and antiviral therapy in patients affected by COVID-19 [ 22 ] and albeit it was not recommended by two operational procedures, including that adopted in the Calabria region [ 23 , 24 ], this strategy was applied in our algorithm based on the rationale of reducing the escaping mutants of the SARS-CoV-2, and considering preliminary observations and cases, which were subsequently published [ 19 – 21 , 27 , 28 ], indicating possible increased efficacy.…”