Khan Behram A, Pagsinohin Marlyn, Lu Lucy M, Tan Pauline, Teo Rachel
Department of Medicine, National University of Singapore, Singapore, SGP.
Department of Nursing, The National Kidney Foundation Singapore, Singapore, SGP.
Cureus. 2023 Jul 3;15(7):e41297. doi: 10.7759/cureus.41297. eCollection 2023 Jul.
Hemodialysis patients are deemed to be immunosuppressed and may not be able to mount an adequate response to vaccination against the SARS-CoV-2 virus. Due to the higher morbidity and mortality in this vulnerable group, pre-exposure prophylaxis with monoclonal antibodies was introduced as an additional measure for protection in selected community-based hemodialysis patients in Singapore. Tixagevimab and cilgavimab, available as Evusheld, were used for this purpose.
A government-sponsored clinical administration program with the provision of 200 doses of Evusheld at no cost to the patients was implemented. Patient selection criteria to further risk-stratify this vulnerable hemodialysis patient cohort was developed and 200 patients were finally selected. Evusheld administration was done over a period of two months, as two consecutive injections were given at two separate intramuscular sites, which constituted one administration. Data were collected as part of a retrospective clinical audit, as part of a routine quality monitoring process for this patient care program. Real-world evidence was generated to assess the impact on mortality, hospitalization rate, reason for hospitalization, and any associated morbidity.
No adverse events from the Evusheld administration were noted. All recipients had received COVID-19 vaccinations prior to Tixa-Cilga, with a range of one to five doses. A total of 198 (99%) completed two doses and 189 (95%) completed three doses, out of which, 14 (7%) patients contracted COVID-19 infection over three months. The overall hospitalization rate was 2% (four out of 200 patients). Severe illness that required intensive care unit stay was therefore seen in only 2 (1%) out of 200 patients. None of the infected patients died.
A significant reduction in severity of illness, hospitalization rate, and mortality was found with pre-exposure prophylaxis with tixagevimab and cilgavimab, in this real-world experience from Singapore. Evusheld administration reduced the hospitalization rate from 42.5% to 2%, which is a reduction of 95.3% (p<0.0001). Symptoms in infected patients were mild, with only 1% being admitted to the intensive care unit. The mortality rate from COVID-19 infection was reduced from 2.5% to 0% with Evusheld. Conclusion: Mass administration of prophylactic treatments for vulnerable populations can be challenging in community-based settings and the successful implementation of such a program has been described. The findings can have health policy implications for the protection of such immunocompromised patients in the future. The combination of tixagevimab and cilgavimab, available as Evusheld in Singapore, was safe to use in hemodialysis patients, with no adverse events noted. There was a significant reduction in hospitalization rates and intensive care unit admissions with a zero-mortality rate due to COVID-19 infection, after pre-exposure prophylaxis.
血液透析患者被认为存在免疫抑制，可能无法对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）病毒疫苗产生足够的免疫反应。由于这一弱势群体的发病率和死亡率较高，在新加坡，单克隆抗体暴露前预防被作为一项额外措施，用于保护选定的社区血液透析患者。替沙格韦单抗和西加韦单抗以恩适得（Evusheld）的名称上市，被用于此目的。
实施了一项由政府资助的临床给药计划，为患者免费提供200剂恩适得。制定了患者选择标准，以便对这一脆弱的血液透析患者群体进行进一步的风险分层，最终选定了200名患者。恩适得的给药在两个月内完成，因为要在两个不同的肌肉注射部位连续注射两次，这构成一次给药。作为回顾性临床审计的一部分，收集了数据，这也是该患者护理计划常规质量监测过程的一部分。生成了真实世界证据，以评估其对死亡率、住院率、住院原因以及任何相关发病率的影响。
未观察到恩适得给药产生的不良事件。所有接受者在接受替沙格韦单抗-西加韦单抗治疗前均已接种过严重急性呼吸综合征冠状病毒2（COVID-19）疫苗，接种剂量范围为1至5剂。在200名患者中，共有198名（99%）完成了两剂接种，189名（95%）完成了三剂接种，其中14名（7%）患者在三个月内感染了COVID-19。总体住院率为2%（200名患者中有4名）。因此，200名患者中只有2名（1%）因病情严重需要入住重症监护病房。没有感染患者死亡。
在新加坡的这一真实世界经验中，发现替沙格韦单抗和西加韦单抗暴露前预防可显著降低疾病严重程度、住院率和死亡率。恩适得给药使住院率从42.5%降至2%，降低了95.3%（p<0.0001）。感染患者的症状较轻，只有1%的患者入住重症监护病房。恩适得使COVID-19感染的死亡率从2.5%降至0%。结论：在社区环境中，为弱势群体大规模实施预防性治疗可能具有挑战性，本文描述了这样一个计划的成功实施。这些发现可能对未来保护此类免疫功能低下患者的卫生政策产生影响。在新加坡以恩适得上市的替沙格韦单抗和西加韦单抗联合用药在血液透析患者中使用是安全的，未观察到不良事件。暴露前预防后，住院率和重症监护病房入院率显著降低，COVID-19感染死亡率为零。
