Idatha yesigaba III esingubeni esisha somqhele somlomo waseChina ku-Nejm Show Effession ayiphansi kwePaxlovid

Ngasekuqaleni kuka-29 Disemba, uNejm ushicilelwe ku-inthanethi isigaba esisha sesigaba se-III Isifundo seCoronavirus Vv116 entsha. Imiphumela ikhombisile ukuthi i-VV116 yayimbi kakhulu kunePaxlovid (Nematovir / Ritonavir) ngokwesikhathi sokululama kwemitholampilo futhi yayinemicimbi embalwa engemihle.

Umthombo Wezithombe: Nejm

Isikhathi Sokubuyiselwa Kwezinsuku ezi-4, umcimbi ongemuhle 67.4%

I-VV116 iyi-oral ye-anti-New anti-New coronavirus (SARS-Cov-2) yakhiwa ngokubambisana neJunsit kanye ne-Wang Shan Wang Shui, futhi i-RDRP Shan's Molnupiravir kanye ne-Melk Sharp & Dohme's Molnupiravir kanye ne-azelvudine yangempela.

Ngo-2021, kwaqedwa ukuqulwa kweSigaba II Clinical se-VV116 e-Uzbekistan. Imiphumela yocwaningo ikhombisile ukuthi iqembu le-VV116 lingathuthukisa kangcono izimpawu zemitholampilo futhi linciphise kakhulu ingozi yokuthuthuka kwefomu elibucayi nokufa uma kuqhathaniswa neqembu elibucayi. Ngokusekelwe emiphumeleni emihle yalesi sivivinyo, i-Vv116 ivunyelwe e-Uzbekistan ekwelapheni iziguli ezine-covion ezilinganiselwe ukuya ezilinganiselwe - 19, futhi sekuyisidakamizwa sokuqala esisha se-comonary esivunyelwe sokumakelisa phesheya kweChina [1].

Lesi sigaba sesigaba III [2] (NCT05341609), saholwa nguProf Zhao Ren weShanghai Ruijin Hospital, u-Prof. Ukusebenza ngempumelelo nokuphepha kwe-VV116 nokuqhathanisa ne-Paxlovid yokwelashwa kwangaphambili kweziguli ezinomnene kuya kwe-covion ye-19 Inhloso bekuwukuhlola ukusebenza kahle nokuphepha kwe-VV116 ngokuqhathanisa ne-Paxlovid yokwelashwa kwakuqala kweziguli ezinomoya omnene-19.

Umthombo Wezithombe: Reference 2

I-multicentre, evikelekile - evikelekile, elawulwa njengezifundo ezingama-822 abantu abadala bendawo-abangu-19 engcupheni enkulu yokuthuthuka futhi ezimbalwa ezilinganiselwe zenziwa phakathi kwemibono emi-4 Ephreli noMeyi 2022 ukuhlola ukufaneleka kwababambe iqhaza ezibhedlela eziyisikhombisa eShanghai, eChina. Ekugcineni, ababambiqhaza abangama-771 bathola i-VV116 (384, 600 MG njalo emahoreni ayi-12 ngosuku 1 no-300 mg njalo nge-100 mg ama-naitonavir njalo emahoreni ayi-12 izinsuku ezingama-5) njengomuthi womlomo.

Imiphumela yalolu cwaningo lwemitholampilo ikhombisile ukuthi ukwelashwa kusenesikhathi nge-VV116 ye-COMSOT COVID-19 kuhlangane nge-Primity Remoploft Remond ebhekiswe yi-Primitional Trofessional - izinsuku ezi-5, i-1.02 kuya ku-1.36;> 0,8).

Ukugcina Isikhathi Sokubuyisa Imitholampilo

Ama-endpoints e-Primary Nasesekokondabuko (Ukuhlaziywa okuphelele kwesibalo sabantu)

Umthombo Wezithombe: Reference 2

Mayelana nokuphepha, ababambiqhaza abathola i-VV116 babike ukuthi bambalwa imicimbi (67.4%) kunalabo abathola i-PaxLovid (77.3%) ngokulandela i-DV116 (2.6%) bephansi kwe-PAXLONID (5.7%).

Imicimbi Emibi (Abantu Abaphephile)

Umthombo Wezithombe: Reference 2

Izimpikiswano nemibuzo

NgoMeyi 23, 2022, uJuniper udalule ukuthi isifundo sesigaba se-III se-pax116 ngokuqhathaniswa ne-paxlovid yokuqala yokwelashwa okungu-19 (i-NCT05341609) kwahlangana nokuphela kwayo kokufunda.

Umthombo Wezithombe: Reference 1

Ngesikhathi lapho imininingwane yecala bentula, impikiswano ezungeze isifundo sesigaba se-III yayimbili: Okokuqala, kwakunguSifundo Esingasilo, kungekho okulawulwa yi-placebo, kwakungaba nzima ukwahlulela umuthi ngokuphelele; Okwesibili, bekunemibuzo mayelana neziphetho zemitholampilo.

Izindlela zokufakwa emtholampilo ze-juniper yilezi (i) imiphumela emihle yokuhlolwa okusha komqhele, (ii) okukodwa noma okuthe xaxa kwezimpawu zesikhathi zesikhathi eziyi-19, kanye (iii) neziguli ezisengozini enkulu ye-Covid ye-19, kubandakanya nokufa. Kodwa-ke, ukuphela kokuphela komtholampilo okuyisisekelo 'isikhathi sokuvuselela ukutholakala kwemitholampilo'.

Ngaphambi nje kwesimemezelo, ngoMeyi 14, uJuniper ubuyekeze iziphetho zomtholampilo ngokususa enye yezindlela zokuphela zomtholampilo, "ingxenye yokuguqulwa ekuguleni okungathi sína noma okungu-3].

Umthombo Wezithombe: Reference 1

Lawa maphuzu amabili aphambili engxabano nawo abhekiswe ngqo esifundweni esishicilelwe.

Ngenxa yokuqubuka okungazelelwe kwe-Omicron, ukukhiqizwa kwezibhebhe ze-Placebo yePaxlovid bekungaqediwe ngaphambi kokuqala kwecala ngakho-ke abaphenyi abakwazanga ukwenza lesi sivivinyo bengaboni kabili, design ehlekisayo. Ngokuqondene nesici esiyimpumputhe sokwelashwa, uJuniper wathi oProtocol wenziwa ngemuva kokuxhumana neziphathimandla ezilawulayo nokuthi umxhasi oyisisekelo uzokwazi ukwabiwa kwezidakamizwa okukodwa kuze kube sekupheleni kocwaningo.

Kuze kube yisikhathi sokuhlaziywa kokugcina, akekho noyedwa kwabahlanganyeli kuleli cala owake wafa noma ukuqhubekela phambili emcimbini onzima we-covid-19, ngakho-ke azikho iziphetho ezingenzeka mayelana nokusebenza kwe-VV116 ekuvinjelweni kwe-covid enzima noma okubucayi (ukufa. Imininingwane ikhombisile ukuthi isikhathi esilinganiselwe se-Median kusuka kwizimpawu zokugcina izimpawu zokuvuselela izimpawu zokuqondisa izimpawu ezihlobene nezinsuku eziyi-7 (95% CI, isilinganiso esingu-1,9%) [0.91 kuya ku-1.22) [2]. Akunzima ukuchaza ukuthi kungani ukuphela okuyisisekelo 'kwezinga lokuguqukela ekuguleni okukhulu noma ekufeni', okwakubekwe ekuqaleni ngaphambi kokuphela kwecala, kwasuswa.

Ngomhlaka 18 Meyi 2022, iphephabhuku elivelayo ama-virobes kanye nezifo ezihudule imiphumela yokuqulwa kwecala lokuqala lomtholampilo le-VV116 ezigulini ezingezelela [4], isifundo esivulekile, esisezingeni eliphakeme se-APPATIETS.

Imininingwane evela kulolu cwaningo ikhombisile ukuthi iziguli ezinegciwane elisebenzisa i-Vv116 kungakapheli izinsuku ezi-5 zokuhlolwa kwazo kokuqala kwe-nucleic acid kwafika isikhathi sokuvuselelwa kwe-nucleic acid ngezinsuku eziyi-8.5.13 eqenjini elilawulayo. Ukuphathwa kwe-VV116 kuya ezigulini ezibonakalayo kungakapheli i-Timeframe yalolu cwaningo (izinsuku ezingama-2-10 zokuhlolwa kokuqala kwe-nucleic acid) kuncishise isikhathi sokubuyiselwa kwe-nucleic acid kuzo zonke iziguli. Ngokuphepha kwezidakamizwa, akukho miphumela emibi ebibonwa eqenjini lokwelashwa kwe-VV116.

Umthombo Wezithombe: Reference 4

Kunezivivinyo ezintathu eziqhubekayo zomtholampilo ku-VV116, ezimbili zazo eziyizifundo zesigaba se-III ezimnene ze-Covid-19 (NCT05242042, NCT05582629). Elinye ilivilo lokulinganiselwa ku-Covid ye-Covid-19 elinamandla, i-armentwer, Isigaba Esingaboni Phambili, Isigaba Sokubukelayo I-III Clinical Study (NCT0527235) Ukuhlola ukusebenza kahle nokuphepha kwe-VV116 kuqhathaniswa nokwelashwa okujwayelekile. Ngokwesimemezelo nguJuniper, isiguli sokuqala sabhaliswa futhi sakhishwa ngoMashi 2022.

Umthombo Wezithombe: ClinicalTrials.gov

Izinkomba:

[1] junshi biotech: Isimemezelo Esikhathini Esisemaphethelweni Esibanzi Sokufundela Kwemitholampilo I-vv116 Ukuqhathanisa ne-Paxlovid Ukuqhathaniswa kwe-paxlovid kusenesikhathi ukwelashwa okuyisineke kuya komoya olinganiselayo

[2] https://www.nejm.org/doi/fung.1056/tejmoa2208822 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. . Ama-Microbes avelayo & izifo ezifuywayo 11: 1, amakhasi 2636-2644.