Icyiciro cya III amakuru yerekeye imiti mishya yubushinwa mu kanwa muri NEJM yerekana imikorere itari munsi ya Paxlovid

Mu rukerera rwo ku ya 29 Ukuboza, NEJM yasohoye kuri interineti ubushakashatsi bushya bw’ubuvuzi icyiciro cya gatatu cy’ubushakashatsi bushya bwa coronavirus VV116. Ibisubizo byerekanye ko VV116 itari mbi kurusha Paxlovid (nematovir / ritonavir) ukurikije igihe cyo gukira kwa muganga kandi ifite ibintu bike bibi.

Inkomoko yishusho ： NEJM

Igihe cyo gukira giciriritse iminsi 4, igipimo cyibintu 67.4%

V.

Muri 2021, muri Uzubekisitani hasuzumwe icyiciro cya kabiri cy’amavuriro ya VV116. Ibyavuye mu bushakashatsi byagaragaje ko itsinda rya VV116 rishobora kurushaho kunoza ibimenyetso by’amavuriro no kugabanya cyane ibyago byo gutera imbere ku buryo bukomeye n’urupfu ugereranije n’itsinda rishinzwe kugenzura. Hashingiwe ku bisubizo byiza by’uru rubanza, VV116 yemejwe muri Uzubekisitani kugira ngo ivure abarwayi bafite COVID-19 yoroheje kandi ikabije, kandi ibaye imiti ya mbere y’imiti mvaruganda yemewe yo kwamamaza mu mahanga mu Bushinwa [1].

Iki cyiciro cya III cy’amavuriro [2] (NCT05341609), kiyobowe na Prof. Zhao Ren wo mu bitaro bya Shanghai Ruijin, Prof. Gaoyuan wo mu bitaro bya Shanghai Renji na Academic Ning Guang w’ibitaro bya Shanghai Ruijin, cyarangiye mu cyorezo cyatewe na Omicron variant ( B.1.1.529) kuva muri Werurwe kugeza Gicurasi muri Shanghai, hagamijwe gusuzuma imikorere n'umutekano bya VV116 na Paxlovid kuri kuvura hakiri kare abarwayi bafite COVID-19 yoroheje cyangwa yoroheje. Icyari kigamijwe kwari ugusuzuma imikorere n'umutekano bya VV116 na Paxlovid yo kuvura hakiri kare abarwayi bafite COVID-19 yoroheje cyangwa yoroheje.

Inkomoko yishusho: Reba 2

Hakozwe hagati ya 4 Mata na 2 Gicurasi 2022 kugira ngo harebwe niba abitabiriye ibitaro birindwi byo muri Shanghai, bafite amahirwe menshi yo gutera imbere kandi bafite ibimenyetso byoroheje kandi bitagereranywa by’abarwayi 822 bakuze ba Covid-19. Ubushinwa. Ubwanyuma, abitabiriye 771 bakiriye haba VV116 (384, 600 mg buri masaha 12 kumunsi wa 1 na 300 mg buri masaha 12 kumunsi 2-5) cyangwa Paxovid (387, 300 mg nimatuvir + 100 mg ritonavir buri masaha 12 muminsi 5) nkuko imiti yo mu kanwa.

Ibyavuye muri ubu bushakashatsi bw’amavuriro byerekanye ko kuvura hakiri kare hamwe na VV116 kuri COVID-19 yoroheje kandi yoroheje byujuje iherezo ryambere (igihe cyo gukira kwa muganga) byahanuwe na protocole y’amavuriro: igihe cyo gukira kwa muganga cyari iminsi 4 mu itsinda rya VV116 na 5 iminsi mu itsinda rya Paxlovid (igipimo cya hazard, 1.17; 95% CI, 1.02 kugeza 1.36; imipaka yo hasi.> 0.8).

Kubungabunga igihe cyo gukira kwa muganga

Iherezo ryibanze nicyiciro cya kabiri (isesengura ryuzuye ryabaturage)

Inkomoko yishusho: Reba 2

Ku bijyanye n’umutekano, abitabiriye kwakira VV116 bavuze ko ibintu bibi bitari bike (67.4%) ugereranije n’abakira Paxlovid (77.3%) mu minsi 28 yakurikiranwe, kandi ibyabaye mu cyiciro cya 3/4 byabaye bibi kuri VV116 (2.6%) ) kuruta kuri Paxlovid (5.7%).

Ibintu bibi (abantu bafite umutekano)

Inkomoko yishusho: Reba 2

Impaka n'ibibazo

Ku ya 23 Gicurasi 2022, Juniper yatangaje ko ubushakashatsi bw’ubuvuzi bwa Phase III bwanditse kuri VV116 na PAXLOVID bwo kuvura hakiri kare COVID-19 yoroheje (NCT05341609) yujuje ibyibanze by’ubushakashatsi.

Inkomoko yishusho: Reba 1

Mu gihe amakuru arambuye y’urubanza yabuze, impaka zerekeranye n’ubushakashatsi bwo mu cyiciro cya III zari ebyiri: icya mbere, ni ubushakashatsi bw’impumyi imwe, kandi mu gihe hatabonetse igenzura ry’ibibanza, byatinyaga ko bigoye guca urubanza ibiyobyabwenge rwose; icya kabiri, hari ibibazo byerekeranye n'amavuriro.

Ibipimo byo kwinjizamo kwa Juniper ni (i) ibisubizo byiza ku kizamini gishya cy'ikamba, (ii) kimwe cyangwa byinshi byoroheje cyangwa bitagereranywa COVID-19, na (iii) abarwayi bafite ibyago byinshi byo kwandura COVID-19, harimo n'urupfu. Nyamara, iherezo ryibanze rya clinique ni 'igihe cyo gukira kwa muganga'.

Mbere y’itangazo, ku ya 14 Gicurasi, Juniper yari yaravuguruye aho ivuriro ryakuyeho imwe mu ngingo z’ibanze z’amavuriro, “umubare w’abahindukira ku ndwara zikomeye cyangwa urupfu” [3].

Inkomoko yishusho: Reba 1

Izi ngingo zombi zingenzi zaganiriweho kandi mubushakashatsi bwatangajwe.

Kubera icyorezo gitunguranye cya Omicron, umusaruro w’ibinini bya Paxlovid wari utararangira mbere y’urubanza rutangira bityo abashinzwe iperereza ntibashoboye gukora uru rubanza bakoresheje igishushanyo mbonera cy’impumyi ebyiri. Ku bijyanye n’impumyi imwe y’urubanza rw’amavuriro, Juniper yavuze ko protocole yakozwe nyuma yo kuvugana n’inzego zishinzwe kugenzura kandi ko igishushanyo mbonera gihumye bivuze ko yaba umupererezi (harimo nuwasuzumye iherezo ry’inyigo) cyangwa umuterankunga uzabimenya. kugenera imiti yihariye yo kuvura kugeza data base yanyuma ifunze nyuma yubushakashatsi.

Kugeza igihe cyo gusesengura bwa nyuma, nta n'umwe mu bitabiriye urwo rubanza wigeze agira urupfu cyangwa gutera imbere mu gikorwa gikomeye cya Covid-19, bityo rero nta mwanzuro ushobora gufata ku bijyanye n'ingaruka za VV116 mu gukumira iterambere kuri Covid-19 ikomeye cyangwa ikomeye. cyangwa urupfu. Imibare yerekanaga ko igihe cyagereranijwe cyo kuva igihe cyo guhitamo kugeza igihe cyo kugaruka kwa ibimenyetso bya Covid-19 byari iminsi 7 (95% CI, 7 kugeza 8) mumatsinda yombi (igipimo cy’ibyago, 1.06; 95% CI, 0.91 kugeza 1.22) [2]. Ntibyoroshye gusobanura impamvu iherezo ryibanze ry '' igipimo cyo guhinduka indwara zikomeye cyangwa urupfu ', cyari cyashyizweho mbere y’urubanza rutarangiye.

Ku ya 18 Gicurasi 2022, ikinyamakuru Emerging Microbes & Infections cyasohoye ibyavuye mu igeragezwa rya mbere ry’amavuriro rya VV116 ku barwayi banduye Omicron variant [4], ubushakashatsi bweruye kandi buteganijwe hamwe n’abarwayi 136 bemejwe n’abarwayi.

Imibare yavuye mu bushakashatsi yerekanye ko abarwayi bafite ubwandu bwa Omicron bakoresheje VV116 mu minsi 5 uhereye igihe bapimye bwa mbere aside aside nucleique bafite igihe cyo gusubira inyuma kwa aside nucleic iminsi 8.56, munsi yiminsi 11.13 mu itsinda rishinzwe kugenzura. Ubuyobozi bwa VV116 kubarwayi bafite ibimenyetso mugihe cyubu bushakashatsi (iminsi 2-10 yo kwipimisha bwa mbere bwa nucleic aside) byagabanije igihe cyo gusubira inyuma kwa acide nucleic mubarwayi bose. Ku bijyanye n’umutekano w’ibiyobyabwenge, nta ngaruka mbi zikomeye zagaragaye mu itsinda ry’ubuvuzi VV116.

Inkomoko y'amashusho: Reba 4

Hariho ibigeragezo bitatu byamavuriro bikomeje kuri VV116, bibiri muribi ni icyiciro cya III ubushakashatsi kuri COVID-19 yoroheje cyangwa yoroheje (NCT05242042, NCT05582629). Ikindi kigeragezo cya COVID-19 giciriritse kandi gikabije ni mpuzamahanga mpuzamahanga, itabishaka, impumyi ebyiri icyiciro cya gatatu cy’ubuvuzi (NCT05279235) kugirango isuzume imikorere n’umutekano bya VV116 ugereranije n’ubuvuzi busanzwe. Nk’uko byatangajwe na Juniper, umurwayi wa mbere yiyandikishije kandi arafungwa muri Werurwe 2022.

Inkomoko yishusho: ivuriro.gov

Reba ：

[1] Junshi Biotech: Itangazo kumurongo wanyuma wicyiciro cya III cyanditseho ubushakashatsi bwubuvuzi bwa VV116 na PAXLOVID kugirango bivurwe hakiri kare COVID-19 yoroheje

[2] https://www.nejm.org/doi/yuzuye / 10.1056 / NEJMoa2208822 , 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. . Microbes Zivuka & Indwara 11: 1, urupapuro rwa 2636-2644.