Idatha yeSigaba III kwi-China entsha yesithsaba esitsha esitsha kwi-NEJM ukubonisa ukusebenza kwempumelelo kwe-paxlovivie

Kwiminyaka yama-29 kaDisemba, i-nejm yapapashe i-intanethi isigaba sekliniki yekliniki ye-III yeKlinikhi ye-Chinese Coronavirus vv116. Iziphumo zibonise ukuba i-VV116 yayingabi mbi ngakumbi kune-paxlovid (i-nematovir / i-ritonavir) ngokwexesha lokuvuselela iKlinikhi kwaye yayinemicimbi embalwa.

Umthombo weMifanekiso: i-NJM

Ixesha lokuBuyisa kweentsuku ezi-4, i-Adge Get Godwe i-67.4%

I-VV116 yi-nucleolis yomlomo ye-nucleodes (i-SARS-COV-2) ephuhliswe nge-Junssit kunye ne-Wang Shimivir, kwaye i-RDRP ethintele kunye ne-molple ye-biology.

Ngo-2021, kwagqitywa ukuvavanywa kwelinikhi ye-II kwi-VV116 eUzbekistan. Iziphumo zophando zibonise ukuba iqela le-VV116 linokuphucula ngcono iimpawu zeklinikhi kwaye inciphise umngcipheko wokuqhubela phambili kwifom ebalulekileyo kwindlela ebaluleke kakhulu nokufa xa kuthelekiswa neqela lolawulo. Ngokusekwe kwiziphumo ezilungileyo zoluvavanyo, i-VV116 ivunyiwe e-Uzbekistan kunyango lwezigulana ezinenkazana eliyi-19, kwaye iye yaba sisiyobisi sokuqala somlomo esivunyiweyo kwi-china [1].

Esi sigaba sekliniki ye-III 2] (NCT0534609), ekhokelwa ngu-Prof. Ukusebenza ngokufezekileyo kunye nokhuseleko lwe-VV116 ngokuchasene ne-paxlovid kunyango lwakwangoko lwezigulana ezinenyani yokumodareyitha iCovid-19. Injongo yayikukuvavanya ukusebenza kunye nokhuseleko lwe-VV116 ngokuchasene ne-paxlovid kunyango lwakwangoko lwezigulana ezinobulali ukuya kumodareyitha uCovid-19.

Umthombo womfanekiso: Isalathiso 2

I-Multicentre, eyamftiven-i-ofisi engafakwanga i-822 yezigulana ezingu-19 zabantu abadala ezi-822 zabaguli be-19 ngo-Epreli ukuya kwi-20 ka-Epreli ukuya kwi-20 ka-Epreli ukuya kwi-2 ka-Epreli ukuya kwi-2 ka-Meyi 2022 ukuvavanya ukufaneleka kwabathathi-nxaxheba kwizibhedlele ezisixhenxe eShanghai naseShanghai, China. Ekugqibeleni, abathathi-nxaxheba abangama-781 bafumana i-VV116 (i-384, 600 mg qho iiyure ezili-12 ukuya kwe-1 ukuya kwi-3-5 mg ritonavir qho kwiintsuku ezili-12) njengamayeza omlomo.

Iziphumo zolu phononongo lweklinikhi lubonise ukuba unyango lwangoko no-VV116 lwe-Vight ukuya kwi-Covid-19 Gatch Roction (ixesha lokubuyela kwi-vaxlovide (i-Deard Riations kwi-TAXLOICS) kwi-1,36;> I-0.8).

Ukugcina ixesha lokubuyisela kwiklinikhi

Iindawo zokuqala zenqanaba lokuqala kunye nezibini (uhlalutyo olubanzi lwabemi)

Umthombo womfanekiso: Isalathiso 2

Ngokokhuseleko, abathathi-nxaxheba abafumana i-VV116 baxele iziganeko ezimbalwa ezinamagqabi (67.4%) kunaleyo ilandelayo ye-28 / i-78.3% ye-28/4.

Iziganeko ezibi (abantu abakhuselekileyo)

Umthombo womfanekiso: Isalathiso 2

Iimpikiswano kunye nemibuzo

Nge-23 kaMeyi, 2022, uJuniper waxela ukuba isifundo sekliniki ye-III ye-III ye-VV116 ngokuchasene nonyango lwakuqhekezwa kweCovid-19 (NCT0534609) yahlangabezana nendawo yakhe yokufunda.

Umthombo womfanekiso: Isalathiso 1

Ngexesha apho iinkcukacha zetyala zazinqongophele, impikiswano ejikeleze isigaba sesigaba sesigaba sesigaba sesigaba sesigaba esibini: ekuqaleni, yayikukunqongophala okungaboniyo, bekuya kuba nzima ukugweba ichiza; Okwesibini, bekukho imibuzo malunga nesiphelo sekliniki.

I-Cestilial I-Ceeper I-Juniper i (i) Iziphumo ezilungileyo zovavanyo olutsha lokuzithuka, (ii) umntu onobulali okanye onobulali okanye iimpawu ezinobulali okanye ophakathi kwe-19, kuquka ekufeni. Nangona kunjalo, ekuphela kwesiphelo seklinikhi yeklinikhi 'lixesha lokufumana kwakhona kwiklinikhi'.

Kuphela ngaphambi kwesibhengezo, nge-14 kaMeyi, uJuniper wayehlaziye iziphelo zekliniki ngokususa enye yezikhundla zokuphelisa ezonyango, "ukuguqulwa kokunxibelelana ngokugula okanye ukufa" [3].

Umthombo womfanekiso: Isalathiso 1

Ezi ngongoma zimbini ziphambili zempikiswano ziye zaqwalaselwa ngqo kwisifundo esipapashiweyo.

Ngenxa yokuqhambuka kwe-omicron, ukuveliswa kweetafile ze-plaxivivid kwakungagqitywanga ngaphambi kokuqala kwetyala kwaye ngenxa yoko abaphandi bengakwazi ukuqhuba le tyala lisebenzisa uyilo oluphindwe kabini, eliphindwe kabini. Ngokuphathelele inkalo engaboniyo yeklinikhi, uJuniper wathi le protocol yenziwa emva konxibelelwano kunye nonxibelelwano oluthile (kubandakanya nomvavanyi wokuphela kwechiza) okanye inkxaso-mali eya kwazi ukuba i-datiment itshixiwe ekupheleni kwesifundo.

Ukuya kwixesha lohlalutyo lokugqibela, akukho namnye kubathathi-nxaxheba kwityala oye kwafunyanwa ekufeni okanye ukuqhubela phambili kumsitho omkhulu-19, ke akukho zigqibo kunokuthintela ukuqhubela phambili kubunzulu okanye ekufeni. Idatha ibonise ukuba ixesha eliqikelelweyo eliqikelelweyo ukusuka kwi-remored kwi-remogod yovavanyo lweentsuku ezisi-7 ezinxulumene ne-19. Akunzima ukuchaza ukuba kutheni isixhasi esiyintloko 'senqanaba lokuguqula kwisigulo esiqatha okanye ekufeni', kwasekuqaleni kwasekuqaleni ngaphambi kokuphela kwetyala, sasuswa.

Nge-18 Meyi 2022, uNjongo oSasulo oluhlumayo kunye noSuletion upapashe iziphumo zolingo lokuqala lweklinikhi ye-VV116 kwizigulana ezosulelwe yi-omicron eyahlukileyo [4], isifundo esivulekileyo, esibonakalayo esiqinisekisiweyo.

Idatha evela kolu phononongo ibonise ukuba abaguli abasebenzisa i-OICR116 kwiintsuku ezi-5 zovavanyo lwabo lokuqala lwe-acid bebenexesha le-nucleid kwiintsuku eziyi-8,56, ngaphantsi kweentsuku ezili-11.13 kwiqela elilawulayo. Ulawulo lwe-VV116 kwizigulana ezivelelayo phakathi kwexesha lophononongo (kwiintsuku ezingama-2 ukuya kweli-10 zovavanyo lokuqala lwe-nucleid) zinciphise ixesha kwi-nucleid remourses molossion. Ngokwendlela yokhuseleko lweziyobisi, akukho ziphumo zibi kakhulu zaqwalaselwa kwiqela le-VV116.

Umthombo womfanekiso: Isalathiso 4

Zintathu iimvavanyo zeklinikhi eqhubekayo kwi-VV116, ezimbini zazo zifundela iSigaba se-III kancinci ukuya kwi-Covid-19 (NCT05242042, NCT055826). Olunye ulingo lokumodareyitha kwiCodd-19 yindawo yemfundo yamazwe aphesheya, engafunekiyo, iSigaba-nqanaba lokuqala Ngokutsho kwesibhengezo ngeJuniper, isigulana sokuqala sabhaliswa saza sayifumana ngoMatshi 2022.

Umthombo womfanekiso: Iklinikhi.gov

Izalathiso:

[1] UJunshi Biothech: Isibhengezo kwinqaku lesigaba se-III leSigaba le-III elibhalisiweyo leKlinikhi ye-VV116 uthandana ne-Paxlovid kunyango lwangoko lwe-Covid-19

. I-Junling xu, Hao Yin, Zhiren Fu, Hao Ving, Linbao Zhang, Zlin xus, Zhijue LV, ZIGUNG ZHEX, ZHANGGIN BHAng, Zhengxin Wang. . I-microbes ezivelayo kunye nezifo 11: 1, IPHEPHA 2636-2644.