Re: [爆卦] 指揮中心採購抗體療法藥物美國已禁用

michaeltung 發表於 2021/6/7 下午12:02:49

看板Gossiping標題Re: [爆卦] 指揮中心採購抗體療法藥物美國已禁用作者

michaeltung

(Tung)時間Jun 7 12:02:49 2021推噓 8 推:9 噓:1 →:12

PTT推薦

其實點回去原始網頁看原文
會覺得朱大這樣子的解釋並不完全正確

原始網頁我翻譯給大家聽：

https://t.e2ma.net/message/bxbk2r/7h5dgfd

1. Update re: bamlanivimab monotherapy in the setting of SARS-CoV2 variants
這段是在說原本使用bamlanivimab單獨使用的模式要做調整

bamlanivimab monotherapy is unlikely to be active against the B.1.429/B.1.427variant, which is circulating in relatively high numbers in California.
這是說由於加州B.1.429/B.1.427（應該是加州變種）比例高，因此單一治療效果不佳

the California Department of Public Health recommends facilities and
providers stop administering bamlanivimab monotherapy in California.
因此加州政府不建議bamlanivimab單獨使用

2. New EUA for monoclonal antibody combination bamlanivimab plus etesevimab
這段是在說要對bamlanivimab + etesevimab合併使用的EUA
大意是說合併使用看起來效果不錯

再來看看5/28新發表的這篇：
https://t.e2ma.net/message/jv3mgs/7h5dgfd
On May 26, 2021, given the sustained increase in the P.1 and B.1.351
variants, the Assistant Secretary for Preparedness and Response (ASPR)
within the U.S. Department of Health and Human Services (HHS) stopped
the distribution of bamlanivimab plus etesevimab to California
他說的是因為p.1和b.1.351.（這分別是南非變種和巴西變種）在加州很多，
因此加州不再使用bamlanivimab + etesevimab合併使用

The FDA recommends that health care providers in California instead
use casirivimab plus imdevimab (i.e., REGEN-COV) therapy until
further notice.
因此FDA建議改成用casirivimab + imdevimab

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-
19-update-fda-revokes-emergency-use-authorization-monoclonal-antibody-
bamlanivimab
這篇說明為何FDA撤回bamlanivimab單獨使用的原因：
revoked the emergency use authorization (EUA) that allowed for the
investigational monoclonal antibody therapy bamlanivimab, when
administered alone,
即是撤回緊急使用許可，注意是單獨使用的EUA
Based on its ongoing analysis of emerging scientific data, specifically
the sustained increase of SARS-CoV-2 viral variants that are resistant
to bamlanivimab alone resulting in the increased risk for treatment
failure, the FDA has determined that the known and potential benefits
of bamlanivimab, when administered alone, no longer outweigh the known
and potential risks for its authorized use.
他說單獨使用可能會提高治療失敗的風險，因此建議不要再單獨使用
建議和其他抗病毒藥一起使用