Xogta wejiga III ee daawada cusub ee afka laga qaato ee Shiinaha ee NEJM waxay muujinaysaa waxtarka aan ka hoosayn Paxlovid

Saacadihii hore ee 29 Diseembar, NEJM waxay internetka ku daabacday daraasad cusub oo heer caafimaad ah oo ku saabsan fayraska cusub ee Shiinaha ee VV116 ee cusub. Natiijooyinka waxay muujiyeen in VV116 uusan ka sii darnayn Paxlovid (nematovir/ritonavir) marka loo eego muddada soo kabashada caafimaad iyo dhacdooyin aan wanaagsanayn oo yaraaday.

Isha sawirka: NEJM

Waqtiga soo kabashada dhexdhexaadka ah 4 maalmood, heerka dhacdada xun 67.4%

VV116 waa daawo afka laga qaato oo ka hortagta fayraska cusub ee SARS (SARS-CoV-2) oo lagu sameeyay iskaashi lala sameeyay Junsit iyo Wang Shan Wang Shui, waana daawo ka hortagta RdRp oo ay weheliso remdesivir-ka Gilead, molnupiravir-ka Merck Sharp & Dohme iyo azelvudine-ka Real Biologics.

Sannadkii 2021, tijaabo caafimaad oo wejiga labaad ah oo VV116 ah ayaa lagu dhammeeyay Uzbekistan. Natiijooyinka daraasadda ayaa muujiyay in kooxda VV116 ay si fiican u hagaajin karto calaamadaha kiliinikada isla markaana ay si weyn u yareyn karto khatarta ah in loo gudbo qaabka halista ah iyo dhimashada marka la barbar dhigo kooxda xakamaynta. Iyada oo lagu saleynayo natiijooyinka wanaagsan ee tijaabadan, VV116 waxaa laga ansixiyay Uzbekistan daaweynta bukaanada qaba COVID-19 dhexdhexaad ilaa daran, waxayna noqotay dawadii ugu horreysay ee cusub ee afka laga qaato ee loo ansixiyo suuqgeynta dibadda ee Shiinaha [1].

Tijaabadan caafimaad ee wejiga saddexaad[2] (NCT05341609), oo uu hoggaaminayo Prof. Zhao Ren oo ka tirsan Isbitaalka Shanghai Ruijin, Prof. Gaoyuan oo ka tirsan Isbitaalka Shanghai Renji iyo Aqoonyahan Ning Guang oo ka tirsan Isbitaalka Shanghai Ruijin, ayaa la dhammeeyay intii uu socday cudurka faafa ee uu sababay nooca Omicron (B.1.1.529) laga bilaabo Maarso ilaa Maajo ee Shanghai, iyadoo ujeedadu tahay in la qiimeeyo waxtarka iyo badbaadada VV116 iyo Paxlovid ee daaweynta hore ee bukaanada qaba COVID-19 fudud ilaa dhexdhexaad ah. Ujeeddadu waxay ahayd in la qiimeeyo waxtarka iyo badbaadada VV116 iyo Paxlovid ee daaweynta hore ee bukaanada qaba COVID-19 fudud ilaa dhexdhexaad ah.

Isha sawirka: Tixraaca 2

Tijaabo la sameeyay oo xarun badan leh, indho la'aan ah, oo aan kala sooc lahayn, oo la xakameeyey oo lagu sameeyay 822 bukaan oo waaweyn oo Covid-19 ah oo halis sare ugu jira inay horumaraan isla markaana leh calaamado fudud ilaa dhexdhexaad ah ayaa la sameeyay intii u dhaxaysay 4 Abriil iyo 2 Maajo 2022 si loo qiimeeyo u-qalmitaanka ka qaybgalayaasha toddoba isbitaal oo ku yaal Shanghai, Shiinaha. Ugu dambeyntii, 771 ka qaybgalayaasha ayaa helay midkood VV116 (384, 600 mg 12kii saacadoodba mar maalinta 1aad iyo 300 mg 12kii saacadoodba mar maalmaha 2-5aad) ama Paxovid (387, 300 mg nimatuvir + 100 mg ritonavir 12kii saacadoodba mar muddo 5 maalmood ah) oo ah daawo afka laga qaato.

Natiijooyinka daraasaddan caafimaadku waxay muujiyeen in daawaynta hore ee VV116 ee COVID-19 fudud ilaa dhexdhexaad ah ay buuxisay heerka ugu dambeeya (waqtiga soo kabashada caafimaad ee joogtada ah) oo lagu saadaaliyay hab-raaca kiliinikada: waqtiga dhexdhexaadka ah ilaa soo kabashada kiliinikada wuxuu ahaa 4 maalmood kooxda VV116 iyo 5 maalmood kooxda Paxlovid (saamiga khatarta, 1.17; 95% CI, 1.02 ilaa 1.36; xadka hoose. >0.8).

Joogteynta waqtiga soo kabashada caafimaad

Dhammaadka waxtarka aasaasiga ah iyo kan labaad (falanqayn dhammaystiran oo ku saabsan dadweynaha)

Isha sawirka: Tixraaca 2

Marka laga hadlayo badbaadada, ka qaybgalayaasha helaya VV116 waxay soo sheegeen dhacdooyin aan wanaagsanayn oo ka yar (67.4%) marka loo eego kuwa qaatay Paxlovid (77.3%) dabagalka 28-ka maalmood ah, dhacdooyinka dhacdooyinka aan wanaagsanayn ee Fasalka 3/4 ayaa ka hooseeyay VV116 (2.6%) marka loo eego Paxlovid (5.7%).

Dhacdooyinka xunxun (dadka badbaadada leh)

Isha sawirka: Tixraaca 2

Muran iyo su'aalo

Maajo 23, 2022, Juniper wuxuu shaaca ka qaaday in daraasadda kiliinikada diiwaangelinta wejiga III ee VV116 iyo PAXLOVID ee daaweynta hore ee COVID-19 fudud ilaa dhexdhexaad ah (NCT05341609) ay gaartay heerkeedii ugu horreeyay ee daraasadda.

Isha sawirka: Tixraaca 1

Waqtigii faahfaahinta tijaabada la waayay, muranka ku saabsan daraasadda Wajiga Saddexaad wuxuu ahaa laba qaybood: marka hore, waxay ahayd daraasad indho la'aan ah, iyadoo aan la helin xakamaynta placebo, waxaa laga baqayay inay adkaan doonto in si buuxda loogu qiimeeyo daawada; marka labaad, waxaa jiray su'aalo ku saabsan natiijooyinka caafimaad.

Shuruudaha ka mid noqoshada kiliinikada ee Juniper waa (i) natiijooyin togan oo loogu talagalay baaritaanka cusub ee taajka, (ii) hal ama in ka badan oo calaamado COVID-19 ah oo fudud ama dhexdhexaad ah, iyo (iii) bukaanada khatarta sare ugu jira COVID-19 daran, oo ay ku jirto dhimasho. Si kastaba ha ahaatee, dhammaadka kiliinikada ee aasaasiga ah waa 'waqtiga soo kabashada kiliinikada ee joogtada ah'.

Wax yar ka hor ku dhawaaqista, Maajo 14, Juniper wuxuu dib u eegay qodobbada ugu dambeeya ee kiliinikada isagoo ka saaray mid ka mid ah qodobbada ugu horreeya ee kiliinikada, "saamiga isbeddelka loo beddelo cudur daran ama dhimasho" [3].

Isha sawirka: Tixraaca 1

Labadan qodob ee ugu muhiimsan ee doodda laga keenay ayaa sidoo kale si gaar ah loogu soo hadal qaaday daraasadda la daabacay.

Sababo la xiriira faafitaanka degdegga ah ee Omicron, soo saarista kiniiniyada placebo ee Paxlovid lama dhammaystirin ka hor bilowga tijaabada sidaas darteedna baarayaashu ma aysan awoodin inay sameeyaan tijaabadan iyagoo adeegsanaya naqshad laba-indhoole ah, oo laba-indhoole ah. Dhinaca hal-indhoole ah ee tijaabada caafimaad, Juniper wuxuu sheegay in hab-maamuuska la sameeyay ka dib markii lala xiriiray hay'adaha sharci-dejinta iyo in naqshadda hal-indhoole ah ay ka dhigan tahay in baaraha (oo ay ku jiraan qiimeeyaha dhammaadka daraasadda) iyo kafaala-qaadaha uusan ogaan doonin qoondaynta daawada gaarka ah ilaa xogta ugu dambeysa laga xiro dhammaadka daraasadda.

Ilaa iyo waqtigii falanqaynta kama dambaysta ah, mid ka mid ah ka qaybgalayaasha tijaabada ma uusan la kulmin dhimasho ama u gudbida dhacdo daran oo Covid-19 ah, sidaa darteed ma jiraan wax gunaanad ah oo ku saabsan waxtarka VV116 ee ka hortagga u gudbida Covid-19 daran ama mid halis ah. Xogtu waxay muujisay in waqtiga dhexdhexaadka ah ee la qiyaasay laga bilaabo kala soocida ilaa dib u dhac joogto ah oo calaamadaha bartilmaameedka la xiriira Covid-19 ay ahaayeen 7 maalmood (95% CI, 7 ilaa 8) labada kooxoodba (saamiga khatarta, 1.06; 95% CI, 0.91 ilaa 1.22) [2]. Ma aha wax adag in la sharaxo sababta meesha ugu dambeysa ee 'heerka beddelka cudur daran ama dhimasho', kaas oo markii hore la dejiyay ka hor dhammaadka tijaabada, laga saaray.

18kii Maajo 2022, joornaalka Emerging Microbes & Infections ayaa daabacay natiijooyinka tijaabadii ugu horreysay ee caafimaad ee VV116 ee bukaanada qaba nooca Omicron [4], oo ah daraasad furan oo la filayo oo lala yeeshay 136 bukaan oo la xaqiijiyay.

Xogta laga helay daraasadda ayaa muujisay in bukaanada qaba cudurka Omicron ee isticmaalay VV116 5 maalmood gudahood markii baaritaankoodii ugu horreeyay ee nucleic acid ee togan uu helay waqti uu ku noqdo nucleic acid regression oo ah 8.56 maalmood, taasoo ka yar 11.13 maalmood ee kooxda xakamaynta. Maamulka VV116 ee bukaanada calaamadaha leh muddada daraasaddan (2-10 maalmood ee baaritaanka nucleic acid ee togan ee ugu horreeya) wuxuu yareeyay waqtiga uu ku dhacayo nucleic acid regression ee dhammaan bukaanada. Marka laga eego badbaadada daawada, ma jirin wax saameyn xun oo halis ah oo lagu arkay kooxda daaweynta VV116.

Isha sawirka: Tixraaca 4

Waxaa jira saddex tijaabo caafimaad oo socda oo ku saabsan VV116, laba ka mid ah waa daraasado wejiga III ah oo ku saabsan COVID-19 fudud ilaa dhexdhexaad ah (NCT05242042, NCT05582629). Tijaabada kale ee COVID-19 ee dhexdhexaad ilaa daran waa daraasad caafimaad oo heer caalami ah oo xarun badan leh, oo aan kala sooc lahayn, oo laba-indhoole ah wejiga III (NCT05279235) si loo qiimeeyo waxtarka iyo badbaadada VV116 marka loo eego daaweynta caadiga ah. Sida ku cad ogeysiiska Juniper, bukaankii ugu horreeyay ayaa la diiwaangeliyey oo la siiyay qiyaas bishii Maarso 2022.

Isha sawirka:clinicaltrials.gov

Tixraacyada:

[1]Junshi Biotech: Ku dhawaaqida dhamaadka ugu weyn ee daraasadda caafimaad ee diiwaangashan ee Wejiga III ee VV116 iyo PAXLOVID ee daaweynta hore ee COVID-19 fudud ilaa dhexdhexaad ah

[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, Juming Xung, Yi Zhang Gang, Yi Zhang 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) Muuqaalka caabuqyada Omicron iyo heerka tallaalka ee 1881 qaatayaasha beerka tallaalka: koox-kooxeed dib-u-eegis ah oo dhowr xarun ah. Soo baxaya Microbes & Infekshannada 11:1, bogagga 2636-2644.