美國NIH《COVID-19治療指南》專家小組發佈關於君實/禮來雙抗體療法EUA聲明
近日，有媒體注意到，美國生物醫學界最權威研究機構——美國國立衞生研究院(NIH)於本月23日在官網上更新了其專家小組發佈的《COVID-19治療指南》，此次更新內容為專家小組關於bamlanivimab 700mg和etesevimab 1400mg雙抗體療法緊急使用授權的聲明。
專家小組在聲明中表示，美國食品藥品監督管理局(FDA)在本月9日批准了bamlanivimab 700mg和etesevimab 1400mg雙抗體療法的緊急使用授權(EUA)，該療法被授予用於治療伴有進展為重度COVID-19和/或住院風險的輕中度COVID-19患者，小組在審閲現有相關研究數據後做出聲明。
● 建議使用bamlanivimab 700mg和etesevimab 1400mg雙抗體療法治療伴有進展為重度COVID-19和/或住院風險的輕中度COVID-19患者。患者在確診COVID-19、並在出現症狀後10天內，應儘快開展相關治療。
● 不建議對非臨牀試驗中的COVID-19住院患者使用bamlanivimab 700mg和etesevimab 1400mg雙抗體療法，但對因COVID-19以外原因住院且符合EUA標準的輕中度COVID-19患者，可考慮用藥。
● 鑑於bamlanivimab和etesevimab兩種藥物可能出現供應量有限，以及藥物分配和注射給藥方面的挑戰，應根據EUA相關標準對COVID-19進展風險最高的患者進行優先治療。
● 盡力讓遭受COVID-19影響最嚴重的社區獲得bamlanivima和etesevimab的平等供應機會。
● 如果醫生在臨牀治療中認為雙抗體療法的潛在益處大於潛在風險，則不應當停止對有高風險進展為重度COVID-19孕婦患者開展etesevimab和bamlanivimab雙抗體療法。
● 針對有着嚴重疾病風險因素的COVID-19非住院兒童患者，目前仍沒有足夠的兒科臨牀數據來支撐是否推薦或反對在治療過程中使用bamlanivimab+etesevima或其他抗體治療。基於現有的成人臨牀研究結果，針對符合EUA標準的患兒，特別是上述標準或年齡16歲及以上的患兒，可在兒科傳染病專家的諮詢建議下，考慮根據具體情況使用bamlanivimab和etesevimab雙抗體療法。
值得注意的是，專家小組在推薦理由中指出，鑑於BLAZE-1研究III期臨牀試驗擁有更大樣本量和更多臨牀事件數量，相對其他單抗選擇，專家小組對bamlanivimab和etesevimab雙抗體療法臨牀療效的現有證據有更強的信心。因此，在條件允許的情況下，應根據EUA將bamlanivimab+etesevimab用於高風險門診患者。顯而易見，以上所指稱的其他單抗選擇應該包括了再生元單抗，555單藥，以及其它目前NIH評價過的所有單抗。
資料顯示，bamlanivimab由禮來與加拿大生物技術公司AbCellera合作開發，etesevimab (JS016)由禮來從中國的君實生物(688180.SH/01877.HK)引進。目前，除了bamlanivimab和etesevimab雙抗體療法，美國FDA還批准了bamlanivimab的單藥療法，以及再生元casirivimab和imdevimab組合。
參考資料：The COVID-19 Treatment Guidelines Panel’s Statement on the Emergency Use Authorization of the Bamlanivimab Plus Etesevimab Combination for the Treatment of COVID-19
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