Does early combination vs. Monotherapy improve clinical outcomes of clinically extremely vulnerable patients with COVID-19? Results from a retrospective propensity-weighted analysis

• Published in: European journal of medical research Vol. 29; no. 1; pp. 484 - 9
• Main Authors: Maria, Mazzitelli, Maraolo, Alberto Enrico, Cozzolino, Claudia, Sasset, Lolita, Ferrari, Anna, Basso, Monica, Vania, Eleonora, Bonadiman, Nicola, Scaglione, Vincenzo, Cattelan, Anna Maria
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 04.10.2024; BMC
• Subjects: Adenosine Monophosphate - analogs & derivatives; Adenosine Monophosphate - therapeutic use; Aged; Alanine - administration & dosage; Alanine - analogs & derivatives; Alanine - therapeutic use; Antiviral Agents - administration & dosage; Antiviral Agents - therapeutic use; Combined treatment; COVID-19 - mortality; COVID-19 Drug Treatment; Drug Therapy, Combination; Early treatment; Female; Hospitalization - statistics & numerical data; Humans; Immunocompromised Host; Male; Middle Aged; Monoclonal antibodies; Monotherapy; Mortality; Propensity Score; Retrospective Studies; Ritonavir - therapeutic use; SARS-CoV-2; Severe immunocompromised patients; Treatment Outcome; SARS-CoV-2; Combined treatment; Severe immunocompromised patients; Early treatment; Monotherapy
• ISSN: 2047-783X; 0949-2321; 2047-783X
• DOI: 10.1186/s40001-024-02062-5

The potential efficacy of early combination therapy, based on an antiviral plus a monoclonal antibody, for COVID-19 in severely immunocompromised patients is matter of debate. Our aim was to describe the impact on clinical outcomes of COVID-19 treatments in severely immunocompromised individuals, evaluating differences between a combination and a monotherapy. We included severely immunocompromised outpatients with mild-to-moderate COVID-19 who received an early treatment (either monotherapy with nirmatrelvir/ritonavir or remdesivir or the combination of an antiviral plus sotrovimab). We then assessed differences between the two treatment strategies on three main outcomes (30-day mortality, access to emergency department, hospitalization), separately and as a composite by using a propensity score weighted (PSW) approach. Eighty one severely immunocompromised patients were included, 39 receiving early combination therapy and 42 receiving monotherapy. No significant difference was observed in the 30-day mortality rate and hospitalization rate between subjects in the two groups, while access to the emergency department following treatment administration was significantly higher in people who received a combination therapy. After applying the PSW, it was observed that combination therapy impacted favourably on the composite outcome, in a statistically significant fashion. In addition, PSW approach for mortality showed that age was the only significant factor influencing the death as stand-alone outcome. Early combination therapy showed a favourable impact on a composite outcome (including mortality, hospitalizations and access to emergency department) in severely immunocompromised hosts who were all vaccinated. However, further studies are needed to support our results.