Phase III cov ntaub ntawv ntawm Tuam Tshoj tus tshiab lub qhov ncauj yas tshuaj nyob rau hauv NEJM qhia tau hais tias ua tau zoo tsis inferior rau Paxlovid

Thaum ntxov ntawm 29 Lub Kaum Ob Hlis, NEJM tau tshaj tawm hauv online qhov chaw kho mob tshiab III txoj kev tshawb fawb ntawm tus kabmob tshiab Suav VV116. Cov txiaj ntsig tau pom tias VV116 tsis zoo dua li Paxlovid (nematovir / ritonavir) raws li lub sijhawm ntawm kev kho mob rov qab thiab muaj cov xwm txheej tsis zoo.

Image source: NEJ

Lub sijhawm rov qab nruab nrab 4 hnub, qhov tshwm sim tsis zoo 67.4%

VV116 yog qhov ncauj nucleoside tiv thaiv tus kabmob tshiab (SARS-CoV-2) cov tshuaj tsim los ntawm kev koom tes nrog Junsit thiab Wang Shan Wang Shui, thiab yog RdRp inhibitor ua ke nrog Gilead's remdesivir, Merck Sharp & Dohme's molnupiravir thiab Real Biologics 'azelvudine.

Hauv 2021, theem II kev soj ntsuam ntawm VV116 tau ua tiav hauv Uzbekistan. Cov txiaj ntsig ntawm txoj kev tshawb fawb pom tau tias pawg VV116 tuaj yeem txhim kho cov tsos mob zoo dua thiab txo qhov kev pheej hmoo ntawm kev loj hlob mus rau daim ntawv tseem ceeb thiab kev tuag piv rau pawg tswj hwm. Raws li cov txiaj ntsig tau zoo ntawm qhov kev sim no, VV116 tau pom zoo hauv Uzbekistan rau kev kho mob ntawm cov neeg mob uas muaj tus kab mob nruab nrab-rau-hnyav COVID-19, thiab tau dhau los ua thawj cov tshuaj tiv thaiv kab mob hauv qhov ncauj tau pom zoo rau kev lag luam txawv teb chaws hauv Suav teb [1].

Qhov no theem III kev soj ntsuam kuaj[2] (NCT05341609), coj los ntawm Prof. Zhao Ren ntawm Shanghai Ruijin Tsev Kho Mob, Prof. Gaoyuan ntawm Shanghai Renji Tsev Kho Mob thiab Academician Ning Guang ntawm Shanghai Ruijin Tsev Kho Mob, tau ua tiav thaum lub sij hawm tshwm sim los ntawm Omicron variant ( B.1.1.529) txij lub Peb Hlis Ntuj txog Lub Tsib Hlis hauv Shanghai, nrog rau lub hom phiaj ntawm kev soj ntsuam kev ua tau zoo thiab kev nyab xeeb ntawm VV116 piv rau Paxlovid rau kev kho mob thaum ntxov ntawm cov neeg mob me me mus rau nruab nrab COVID-19. Lub hom phiaj yog txhawm rau ntsuas qhov ua tau zoo thiab kev nyab xeeb ntawm VV116 piv rau Paxlovid rau kev kho mob thaum ntxov ntawm cov neeg mob me me mus rau nruab nrab COVID-19.

Duab Source: Reference 2

Ib lub chaw ntau, saib-dig muag, randomised, tswj kev sim ntawm 822 tus neeg laus Covid-19 cov neeg mob uas muaj kev pheej hmoo ntawm kev loj hlob thiab nrog cov tsos mob me me mus rau nruab nrab tau ua thaum lub Plaub Hlis 4 thiab 2 Tsib Hlis 2022 los ntsuas qhov tsim nyog ntawm cov neeg koom los ntawm xya lub tsev kho mob hauv Shanghai, Tuam Tshoj. Thaum kawg, 771 cov neeg koom tau txais VV116 (384, 600 mg txhua 12 teev nyob rau hnub 1 thiab 300 mg txhua 12 teev nyob rau hnub 2-5) lossis Paxovid (387, 300 mg nimatuvir + 100 mg ritonavir txhua 12 teev rau 5 hnub) raws li tshuaj qhov ncauj.

Cov txiaj ntsig ntawm qhov kev tshawb fawb soj ntsuam no tau pom tias kev kho mob ntxov nrog VV116 rau me me mus rau nruab nrab COVID-19 tau ntsib lub ntsiab lus tseem ceeb (lub sijhawm rau kev kho mob kom zoo) tau kwv yees los ntawm cov txheej txheem kho mob: lub sijhawm nruab nrab rau kev kho mob rov qab yog 4 hnub hauv pawg VV116 thiab 5. hnub hauv pawg Paxlovid (kev phom sij piv, 1.17; 95% CI, 1.02 rau 1.36; qis qis> 0.8).

Tuav lub sijhawm kho kom rov zoo

Cov ntsiab lus tseem ceeb thiab theem nrab kev ua tau zoo kawg nkaus (kev txheeb xyuas cov pej xeem)

Duab Source: Reference 2

Hais txog kev nyab xeeb, cov neeg tuaj koom tau txais VV116 qhia tsawg dua cov xwm txheej tsis zoo (67.4%) dua li cov neeg tau txais Paxlovid (77.3%) ntawm 28-hnub rov qab, thiab qhov tshwm sim ntawm Qib 3 / 4 cov xwm txheej tsis zoo yog qis dua rau VV116 (2.6% ) dua rau Paxlovid (5.7%).

Cov xwm txheej tsis zoo (cov neeg nyab xeeb)

Duab Source: Reference 2

Kev sib cav thiab lus nug

Thaum Lub Tsib Hlis 23, 2022, Juniper tau tshaj tawm tias Theem III kev sau npe tshuaj xyuas kev tshawb fawb ntawm VV116 piv rau PAXLOVID rau kev kho mob thaum ntxov ntawm me me mus rau nruab nrab COVID-19 (NCT05341609) tau ntsib nws thawj qhov kev kawm kawg.

Duab Source: Reference 1

Thaum lub sij hawm uas tsis muaj cov ntsiab lus ntawm qhov kev sim siab, qhov kev tsis sib haum xeeb nyob ib puag ncig ntawm Kev Kawm Qib III yog ob zaug: thawj zaug, nws yog ib qho kev kawm tsis pom kev thiab, thaum tsis muaj kev tswj hwm cov placebo, nws tau ntshai tias nws yuav nyuaj rau kev txiav txim. tshuaj kiag li objectively; thib ob, muaj cov lus nug txog qhov kawg ntawm qhov chaw kho mob.

Cov kev kuaj mob suav nrog rau Juniper yog (i) cov txiaj ntsig zoo rau kev kuaj mob tshiab, (ii) ib lossis ntau dua cov tsos mob me me lossis nruab nrab ntawm COVID-19, thiab (iii) cov neeg mob uas muaj kev pheej hmoo siab ntawm COVID-19 hnyav, suav nrog kev tuag. Txawm li cas los xij, tsuas yog qhov chaw kho mob tseem ceeb kawg nkaus yog 'lub sijhawm rau kev kho kom rov zoo'.

Tsuas yog ua ntej tshaj tawm, thaum Lub Tsib Hlis 14, Juniper tau hloov kho qhov kawg ntawm qhov chaw kho mob los ntawm kev tshem tawm ib qho ntawm qhov chaw kho mob thawj qhov kawg, "feem ntau ntawm kev hloov pauv mus rau mob hnyav lossis tuag" [3].

Duab Source: Reference 1

Ob lub ntsiab lus tseem ceeb ntawm kev sib cav no kuj tau hais tshwj xeeb hauv kev tshawb fawb luam tawm.

Vim muaj qhov tshwm sim tam sim ntawd ntawm Omicron, kev tsim cov ntsiav tshuaj placebo rau Paxlovid tsis tau ua tiav ua ntej pib qhov kev sim thiab yog li cov neeg tshawb xyuas tsis tuaj yeem ua qhov kev sim no siv ob qhov muag tsis pom kev, ob chav-mock tsim. Raws li rau ib leeg-dig muag qhov muag ntawm qhov kev sim tshuaj, Juniper tau hais tias cov txheej txheem tau ua tom qab kev sib txuas lus nrog cov neeg saib xyuas kev tswj hwm thiab kev tsim ib qhov muag tsis pom kev txhais tau hais tias tsis yog tus kws tshawb fawb (xws li tus kws ntsuas qhov kawg ntawm qhov kev kawm) lossis tus neeg txhawb nqa yuav paub. cov kev faib tshuaj kho tshwj xeeb kom txog rau thaum cov ntaub ntawv kawg raug kaw thaum kawg ntawm txoj kev tshawb fawb.

Txog rau lub sijhawm ntawm kev tshuaj xyuas zaum kawg, tsis muaj ib tus neeg koom nrog hauv qhov kev sim no tau ntsib kev tuag lossis kev loj hlob mus rau qhov xwm txheej Covid-19 hnyav, yog li tsis muaj kev txiav txim siab tuaj yeem txiav txim siab txog qhov ua tau zoo ntawm VV116 hauv kev tiv thaiv kev kis mus rau Covid-19 hnyav lossis tseem ceeb. los yog kev tuag. Cov ntaub ntawv qhia tau hais tias qhov kwv yees nruab nrab ntawm lub sijhawm los ntawm randomisation mus rau kev hloov pauv ntawm Covid-19 cov tsos mob ntsig txog lub hom phiaj yog 7 hnub (95% CI, 7 txog 8) hauv ob pawg (kev phom sij, 1.06; 95% CI, 0.91 txog 1.22) [2]. Nws tsis yog qhov nyuaj los piav qhia tias vim li cas lub ntsiab lus tseem ceeb ntawm 'kev hloov pauv mus rau kev mob hnyav lossis kev tuag', uas yog thawj zaug tau teeb tsa ua ntej qhov kawg ntawm qhov kev sim, raug tshem tawm.

Thaum Lub Tsib Hlis 18, 2022, phau ntawv xov xwm Emerging Microbes & Infections tau luam tawm cov txiaj ntsig ntawm thawj qhov kev sim tshuaj ntsuam xyuas ntawm VV116 hauv cov neeg mob uas kis tus kab mob Omicron variant [4], qhib, kev tshawb fawb yav tom ntej nrog 136 tus neeg mob pom zoo.

Cov ntaub ntawv los ntawm txoj kev tshawb fawb pom tias cov neeg mob uas muaj tus kab mob Omicron uas siv VV116 nyob rau hauv 5 hnub ntawm lawv thawj qhov zoo nucleic acid kuaj tau lub sij hawm rau nucleic acid regression ntawm 8.56 hnub, tsawg dua 11.13 hnub hauv pawg tswj. Kev tswj hwm ntawm VV116 rau cov neeg mob symptomatic nyob rau lub sijhawm ntawm txoj kev tshawb no (2-10 hnub ntawm thawj qhov zoo nucleic acid test) txo lub sijhawm rau nucleic acid regression hauv txhua tus neeg mob. Hais txog kev nyab xeeb ntawm cov tshuaj, tsis muaj kev cuam tshuam loj heev tau pom nyob rau hauv pawg kho mob VV116.

Duab Source: Reference 4

Muaj peb qhov kev sim tshuaj kho mob tsis tu ncua ntawm VV116, ob ntawm cov uas yog theem III cov kev tshawb fawb ntawm me me mus rau nruab nrab COVID-19 (NCT05242042, NCT05582629). Lwm qhov kev sim rau qhov nruab nrab mus rau qhov hnyav COVID-19 yog qhov chaw thoob ntiaj teb multicentre, randomised, ob-dig muag theem III kev tshawb fawb soj ntsuam (NCT05279235) los ntsuas qhov ua tau zoo thiab kev nyab xeeb ntawm VV116 piv rau kev kho tus qauv. Raws li kev tshaj tawm los ntawm Juniper, thawj tus neeg mob tau sau npe thiab muab tshuaj rau lub Peb Hlis 2022.

Duab qhov chaw: clinicaltrials.gov

Cov ntaub ntawv:

[1]Junshi Biotech: Tshaj tawm ntawm lub ntsiab lus kawg ntawm Theem III tau sau npe kev tshawb fawb soj ntsuam ntawm VV116 piv rau PAXLOVID rau kev kho mob ntxov ntawm me me mus rau nruab nrab COVID-19

[2]https://www.nejm.org/doi/full/10.1056/NEJMoa2208822?query=featured_home[3]https://clinicaltrials.gov/ct2/show/record/NCT05341609[4] Ensi Ma, Jingwen Ai , Yi Zhang, Jianming Zheng, Xiaogang Gao, Junming Xu, Hao Yin, Zhiren Fu, Hao Xing, Li Li, Liying Sun, Heyu Huang, Quanbao Zhang, Linlin Xu, Yanting Jin, Rui Chen, Guoyue Lv, Zhijun Zhu, Wenhong Zhang, Zhengxin Wang. (2022) Omicron kab mob profile thiab txhaj tshuaj tiv thaiv kab mob ntawm 1881 cov neeg tau txais lub siab hloov pauv: ntau qhov chaw rov qab los ntawm pawg. Emerging Microbes & Infections 11:1, nplooj 2636-2644.