4. Discussion
impaired immune systems, infection, COVID-19 infection, ESRD
ADVERSE REACTIONS, SARS-COV-2 INFECTION, CNS INFECTIONS, COVID-19 INFECTION, ADVERSE EFFECTS, INFECTION, END-STAGE RENAL DISEASE, ESRD
In this double-blind, non-randomized, placebo-controlled interventional trial, the short-term safety and immunogenicity of tixagevimab–cilgavimab against COVID-19 infection were evaluated in end-stage renal disease (ESRD) patients on chronic HD. The titer of COVID-19-neutralizing antibodies was assessed at baseline and after 1 and 6 months. Antibody levels significantly increased one month after tixagevimab–cilgavimab injection and remained steady for six months. The adverse effects of tixagevimab–cilgavimab were mild, well-tolerated, and did not require hospitalization. Within six months of taking tixagevimab–cilgavimab, approximately one-fifth of patients developed a COVID-19 infection, which was less severe than in patients who did not receive tixagevimab–cilgavimab and was not associated with ICU admission or mortality.Patients with HD are prone to COVID-19 due to their impaired immune systems and hospitalizations for life-sustaining treatment [Preexposure preventive treatment with monoclonal antibodies considerably reduced the occurrence of serious COVID-19 infection [In the current study, the antibody level increased dramatically one month after tixagevimab–cilgavimab injection and remained stable for the following six months. In contrast, the titer of neutralizing antibodies in the non-tixagevimab–cilgavimab group decreased significantly during the same time period. The current findings seem to agree with the PROVENT (Prophylaxis Prevention) experiment, which estimated that tixagevimab–cilgavimab efficacy would remain for at least six months [In the current study, only seven individuals in the tixagevimab–cilgavimab group experienced mild, well-tolerated adverse effects, none of whom required hospitalization. Based on limited experience and the approvals in the United States and the United Kingdom, tixagevimab–cilgavimab may be a crucial product for delivering COVID-19 protection to patients who have previously experienced severe adverse reactions to the COVID-19 vaccine. Moreover, increased data collection and reporting are urgently required due to the scarcity of data [In the present study, approximately one-fifth of patients acquired COVID-19 infection within six months in both groups, which was less severe than in the non- tixagevimab–cilgavimab group, and it was not associated with ICU admission or mortality. It was hypothesized that monoclonal antibodies used as a preventative approach reduce the incidence of serious infections in immunocompromised people by a substantial amount [The answer to the question of whether an Evusheld dosage of 300 mg is sufficient to prevent Omicron infection has not yet been determined. Benotmane I and colleagues [In the current study, three of the six patients in the non-tixagevimab–cilgavimab group with a confirmed COVID-19 infection required ICU care, while the remaining three patients died from COVID-19 infection. In general, tixagevimab–cilgavimab reduces the risk of SARS-CoV-2 infection and COVID-19-related hospitalization in immunocompromised patients, with hazard ratios of 0.75 and 0.41, respectively [Despite the short duration of follow-up and the small number of patients, this study included a special subset of immunocompromised patients, namely HD patients. In the intervention group, we included patients with an anticipated increased likelihood of COVID-19 morbidity and lower vaccination efficacy. This study validated the short-term safety and humoral and clinical efficacy of tixagevimab–cilgavimab in this patient cohort, underlining the potential usefulness of this medicine in this group of patients. However, additional trials with a greater number of HD patients and longer follow-ups are necessary to corroborate these findings.