Early combination of sotrovimab with nirmatrelvir/ritonavir or remdesivir is associated with low rate of persisting SARS CoV-2 infection in immunocompromised outpatients with mild-to-moderate COVID-19: an Italian prospective single-centre study

Italian-based researchers have published results from an observational, prospective study evaluating the combination of XEVUDY (IV injection, anti-SARS-CoV-2 nAb, 500mg, generic name sotrovimab) with either VEKLURY (N=19) or PAXLOVID (N=33) in 52 immunocompromised outpatients with mild-to-moderate COVID-19 within 7 days from symptom onset.

Primary outcome was hospitalization within 30 days. Secondary outcomes were: needing for oxygen therapy; development of persistent infection; death within 60 days and reinfection or relapse within 90 days.

Results: No patient was hospitalized within 30 days of disease onset, required oxygen administration, died within 60 days, or experienced a reinfection or clinical relapse within 90 days.The clearance rates were 67% and 97% on the 14th day after the end of therapy and at the end of the follow-up period, respectively.Factors associated with longer infection were initiation of therapy 3 days after symptom onset and enrollment for more than 180 days from the beginning of the study. However, only the latter factor was independently associated with a longer SARS-CoV-2 infection, suggesting a loss of efficacy of this strategy with the evolution of SARS-CoV-2 variants.

Conclusions: Overall, there were no differences in viral clearance between XEVUDY-PAXLOVID and XEVUDY-VEKLURY treatment groups as well as no severe adverse drug reactions or early treatment discontinuations. Early administration of combination therapy with a direct antiviral and sotrovimab seems to be effective in preventing hospitalization, progression to severe COVID-19, and development of prolonged/persisting SARS-CoV-2 infection in immunocompromised patients.

Source: Annals of Medicine DOI: 10.1080/07853890.2024.2439541