Xogta wajiga III ee daawada taajka afka ee Shiinaha ee NEJM waxay muujineysaa waxtarka aan ka hooseynin Paxlovid

Saacadihii hore ee 29kii Diseembar, NEJM waxay khadka internetka ku daabacday weji cusub oo caafimaad oo III ah oo ku saabsan coronavirus-ka cusub ee Shiinaha VV116. Natiijooyinku waxay muujiyeen in VV116 aysan ka xumaanin Paxlovid (nematovir/ritonavir) marka la eego muddada soo kabashada bukaan-socodka oo ay lahaayeen dhacdooyin aan fiicneyn.

Isha sawirka:NEJM

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

VV116 waa daawada nucleoside-ka afka laga qaato ee ka-hortagga coronavirus-ka cusub (SARS-CoV-2) oo la sameeyay iyadoo lala kaashanayo Junsit iyo Wang Shan Wang Shui, waana horjooge RdRp oo ay weheliso remdesivir Gilecaad, Merck Sharp & Dohme's molnupiravir iyo Real Biologics' azelvudine.

2021, wajiga II tijaabada caafimaad ee VV116 ayaa lagu dhameeyay Uzbekistan. Natiijooyinka daraasaddu waxay muujisay in kooxda VV116 ay si fiican u wanaajin karto calaamadaha kiliinikada waxayna si weyn u yaraynaysaa halista horumarka qaabka muhiimka ah iyo dhimashada marka la barbardhigo kooxda kantaroolka. Iyada oo ku saleysan natiijooyinka togan ee tijaabadan, VV116 waxaa laga oggolaaday Uzbekistan daawaynta bukaannada qaba dhexdhexaad-ilaa daran COVID-19, waxayna noqotay dawadii ugu horreysay ee halbowleyaasha afka ee cusub ee loo oggolaaday suuqgeynta dibedda Shiinaha [1].

Marxaladdan III tijaabada bukaan-socod[2] (NCT05341609), oo uu hoggaaminayo Prof. Zhao Ren oo ka tirsan Isbitaalka Shanghai Ruijin, Prof. Gaoyuan oo ka tirsan Isbitaalka Shanghai Renji iyo Academician Ning Guang ee Isbitaalka Shanghai Ruijin, ayaa la dhameystiray intii uu dillaacay oo uu sababay kala duwanaanshaha Omicron ( B.1.1.529) laga bilaabo Maarso ilaa Maajo ee Shanghai, iyada oo ujeedadu tahay in lagu qiimeeyo waxtarka iyo badbaadada VV116 iyo Paxlovid ee daawaynta hore ee bukaanada qaba COVID-19 fudud ilaa dhexdhexaad. Ujeeddadu waxay ahayd in la qiimeeyo waxtarka iyo badbaadada VV116 iyo Paxlovid ee daawaynta hore ee bukaannada qaba COVID-19 fudud iyo dhexdhexaad.

Isha sawirka: Tixraaca 2

Xarun-badan, indho-indho-indho, kala sooc lahayn, tijaabo la kontorooli karo oo ah 822 bukaan oo qaangaar ah oo Covid-19 ah oo halis sare ugu jira horumarka oo leh calaamado khafiif ah ama dhexdhexaad ah ayaa la sameeyay intii u dhaxaysay 4 Abriil iyo 2 Maajo 2022 si loo qiimeeyo u-qalmitaanka ka-qaybgalayaasha toddobo isbitaal oo ku yaal Shanghai, Shiinaha. Ugu dambeyntii, 771 kaqeybgalayaashu waxay heleen VV116 (384, 600 mg 12 saacadood kasta maalintii 1 iyo 300 mg 12 saacadoodba maalmaha 2-5) ama Paxovid (387, 300 mg nimatuvir + 100 mg ritonavir 12 saacadoodba 5 maalmood) dawo afka laga qaato.

Natiijooyinka daraasaddan caafimaad waxay muujisay in daawaynta hore ee VV116 ee dhexdhexaadka ah iyo dhexdhexaadka ah ee COVID-19 ay la kulantay dhammaadka aasaasiga ah (waqtiga soo kabashada bukaan-socodka joogtada ah) ee uu saadaaliyay borotokoolka bukaan-socodka: Waqtiga dhexe ee soo kabashada bukaan-socodka wuxuu ahaa 4 maalmood kooxda VV116 iyo 5 maalmo kooxda Paxlovid (saamiga khatarta, 1.17; 95% CI, 1.02 ilaa 1.36; xadka hoose). >0.8).

Ilaalinta wakhtiga soo kabashada kiliinikada

Qodobbada ugu dambeeya ee waxtarka aasaasiga ah iyo sare (falanqaynta guud ee dadweynaha)

Isha sawirka: Tixraaca 2

Marka la eego nabdoonaanta, ka qaybgalayaasha helaya VV116 waxay soo sheegeen dhacdooyin aan fiicneyn (67.4%) marka loo eego kuwa helaya Paxlovid (77.3%) dabagalka 28-maalmood, iyo dhacdooyinka fasalka 3/4 ee dhacdooyinka xun ayaa ka hooseeyay VV116 (2.6% ) marka loo eego Paxlovid (5.7%).

Dhacdooyinka xun xun (dadka badbaadada leh)

Isha sawirka: Tixraaca 2

Muran iyo su'aalo

Maajo 23, 2022, Juniper wuxuu daaha ka qaaday in daraasadda kiliinikada ee diiwaangelinta Wajiga III ee VV116 iyo PAXLOVID ee daawaynta hore ee dhexdhexaadka ah ee COVID-19 (NCT05341609) ay la kulantay barta ugu dambaysa ee daraasadda.

Isha sawirka: Tixraaca 1

Waqti ay faahfaahinta maxkamaddu maqan tahay, muranka ku saabsan daraasadda Wajiga III wuxuu ahaa laba arrimood: kow, waxay ahayd daraasad indho-la'aan ah iyo, maqnaanshaha xakamaynta placebo, waxaa laga baqay inay adagtahay in la xukumo. daroogada si buuxda si ula kac ah; Marka labaad, waxaa jiray su'aalo ku saabsan dhammaadka bukaan-socodka.

Shuruudaha ka mid noqoshada bukaan-socodka ee Juniper waa (i) natiijooyin togan oo ku saabsan baarista taajka cusub, (ii) hal ama in ka badan oo khafiif ah ama calaamado COVID-19 ah, iyo (iii) bukaannada khatarta sare ugu jira COVID-19 daran, oo ay ku jirto geeri. Si kastaba ha noqotee, meesha kaliya ee ugu dambeysa ee kiliinikada aasaasiga ah waa 'waqtiga soo kabashada bukaan-socodka waara'.

Wax yar ka hor intaan lagu dhawaaqin, Maajo 14, Juniper wuxuu dib u eegay qodobbada kiliinikada isagoo meesha ka saaray mid ka mid ah qodobbada asaasiga ah ee bukaan-socodka, "qaybta beddelka jirro halis ah ama dhimasho" [3].

Isha sawirka: Tixraaca 1

Labadan qodob ee ugu muhiimsan ee la isku hayo ayaa sidoo kale si gaar ah looga hadlay daraasadda la daabacay.

Sababo la xiriira dillaaca degdega ah ee Omicron, soo saarista kiniinnada placebo ee Paxlovid lama dhammaystirin ka hor bilawga tijaabada, sidaas darteed baarayaashu way awoodi waayeen inay sameeyaan tijaabadan iyadoo la adeegsanayo naqshad laba-indho-la'aan ah, naqshad labajibaaran. Marka loo eego dhinaca hal-indho la'aanta ee tijaabada kiliinikada, Juniper wuxuu sheegay in borotokoolka la sameeyay ka dib markii lala xiriiriyay maamulada sharciyeynta iyo in naqshadeynta indhoolaha kaliya ay ka dhigan tahay in baaraha (oo ay ku jiraan qiimeeyaha barta dhamaadka daraasadda) iyo kafaala-qaaduhu uusan ogaan doonin. qoondaynta daawaynta gaarka ah ilaa xogta ugu dambaysa la xidho dhamaadka daraasadda.

Ilaa wakhtiga falanqaynta kama dambaysta ah, mid ka mid ah ka qaybgalayaasha tijaabada ma helin dhimasho ama u gudubka dhacdo daran oo Covid-19 ah, sidaa darteed ma jirto gabagabo laga soo saari karo waxtarka VV116 ee ka hortagga u gudubka daran ama halista Covid-19 ama geeri. Xogtu waxay muujisay in waqtiga dhexdhexaadka ah ee lagu qiyaasay laga bilaabo kala soocidda ilaa dib-u-celinta joogtada ah ee calaamadaha bartilmaameedka ee Covid-19 ay ahayd 7 maalmood (95% CI, 7 ilaa 8) labada kooxood (saamiga khatarta, 1.06; 95% CI, 0.91 to 1.22) [2]. Ma adka in la sharaxo sababta meesha ugu dambaysa ee ugu dambaysa ee 'heerka u beddelashada jirro daran ama dhimasho', oo markii hore la dejiyay ka hor dhammaadka maxkamadaynta, laga saaray.

Markay ahayd 18 Maajo 2022, joornaalka Emerging Microbes & Infections ayaa daabacay natiijadii tijaabadii ugu horeysay ee caafimaad ee VV116 ee bukaanada uu ku dhacay kala duwanaanshaha Omicron [4], oo ah mid furan, daraasad kooxeed la filayo oo lala yeeshay 136 bukaan-jiif.

Xogta laga helay daraasadda ayaa muujisay in bukaannada qaba caabuqa Omicron ee isticmaala VV116 5 maalmood gudahooda ee baaritaanka ugu horreeya ee nucleic acid ay heleen wakhti ay dib ugu noqdaan nucleic acid maalmo 8.56, wax ka yar maalmaha 11.13 ee kooxda kantaroolka. Maamulka VV116 ee bukaannada calaamadaha leh muddada daraasaddan (2-10 maalmood ee baaritaanka ugu horreeya ee nucleic acid) waxay hoos u dhigtay wakhtiga dib u noqoshada nucleic acid ee dhammaan bukaannada. Marka la eego badbaadada daroogada, wax saameyn xun oo xun laguma arag kooxda daaweynta VV116.

Isha sawirka: Tixraaca 4

Waxaa jira saddex tijaabo oo caafimaad oo socda VV116, oo laba ka mid ah ay yihiin daraasado wejiga III ah oo ku saabsan COVID-19 fudud iyo dhexdhexaad (NCT05242042, NCT05582629). Tijaabada kale ee dhexdhexaadka ah iyo midka daran ee COVID-19 waa xarun caalami ah oo caalami ah, kala sooc lahayn, laba-indho la'aan daraasad bukaan-socod III (NCT05279235) si loo qiimeeyo waxtarka iyo badbaadada VV116 marka la barbar dhigo daaweynta caadiga ah. Marka loo eego ku dhawaaqista Juniper, bukaankii ugu horreeyay ayaa la diiwaan geliyay oo la qaatay bishii Maarso 2022.

Isha sawirka:clinicaltrials.gov

Tixraacyo:

[1] Junshi Biotech: Ogaysiis ku saabsan barta dhamaadka ugu weyn ee Wajiga III ee ka diiwaan gashan daraasadda caafimaad ee VV116 iyo PAXLOVID ee daawaynta hore ee dhexdhexaad ilaa dhexdhexaad ah 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) 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.