Amakuru y'icyiciro cya gatatu ku muti mushya wo mu Bushinwa wo mu bwoko bwa crown muri NEJM agaragaza ko ubushobozi bwawo butari munsi ya Paxlovid

Mu masaha ya mbere yo ku itariki ya 29 Ukuboza, NEJM yasohoye kuri interineti ubushakashatsi bushya bw’icyiciro cya gatatu ku ndwara nshya ya coronavirus yo mu Bushinwa VV116. Ibisubizo byagaragaje ko VV116 itari mbi kurusha Paxlovid (nematovir / ritonavir) mu gihe cyo gukira kandi ko yagize ingaruka nke ku buzima.

Isoko y'ishusho: NEJM

Igihe cyo gukira hagati y'iminsi 4, igipimo cy'ingaruka mbi ni 67.4%

VV116 ni umuti urwanya coronavirus nshya uterwa n’imiti ya nucleoside (SARS-CoV-2) wakozwe ku bufatanye bwa Junsit na Wang Shan Wang Shui, kandi ni umuti ugabanya ubukana bwa RdRp hamwe na remdesivir ya Gilead, Merck Sharp & Dohme's molnupiravir na azelvudine ya Real Biologics.

Mu 2021, igerageza rya VV116 ry’icyiciro cya kabiri ryarangiye muri Uzbekistan. Ibisubizo by’ubushakashatsi byagaragaje ko itsinda rya VV116 rishobora kunoza neza ibimenyetso by’ubuvuzi no kugabanya cyane ibyago byo gukomeza kugeza ku rwego rukomeye ndetse n’urupfu ugereranije n’itsinda ryagenzuwe. Hashingiwe ku bisubizo byiza by’iri gerageza, VV116 yemejwe muri Uzbekistan mu kuvura abarwayi ba COVID-19 iri hagati kugeza ku ikomeye, kandi yabaye umuti mushya wa mbere wo mu kanwa wemewe kugurishwa mu mahanga mu Bushinwa [1].

Iri gerageza ry’icyiciro cya gatatu [2] (NCT05341609), riyobowe na Porofeseri Zhao Ren wo mu bitaro bya Shanghai Ruijin, Porofeseri Gaoyuan wo mu bitaro bya Shanghai Renji n’umuhanga mu by’amasomo Ning Guang wo mu bitaro bya Shanghai Ruijin, ryarangiye mu gihe cy’icyorezo cyatewe n’ubwoko bwa Omicron (B.1.1.529) kuva muri Werurwe kugeza Gicurasi i Shanghai, hagamijwe gusuzuma imikorere n’umutekano wa VV116 ugereranije na Paxlovid mu kuvura hakiri kare abarwayi bafite COVID-19 yoroheje kugeza ku iringaniye. Intego kwari ugusuzuma imikorere n’umutekano wa VV116 ugereranije na Paxlovid mu kuvura hakiri kare abarwayi bafite COVID-19 yoroheje kugeza ku iringaniye.

Ifoto ikomokaho: Imbonerahamwe ya 2

Igerageza ryakozwe mu bigo byinshi, ryifashishijwe n’indorerezi, ryakozwe ku buryo butaziguye, rigenzurwa ku barwayi 822 bakuru ba Covid-19 bari mu kaga gakomeye ko kwandura indwara kandi bafite ibimenyetso byoroheje kugeza ku biringaniye, hagati ya tariki ya 4 Mata na 2 Gicurasi 2022, kugira ngo harebwe niba abitabiriye baturutse mu bitaro birindwi byo muri Shanghai, mu Bushinwa bujuje ibisabwa. Amaherezo, abitabiriye 771 bahawe VV116 (384, 600 mg buri masaha 12 ku munsi wa mbere na 300 mg buri masaha 12 ku munsi wa 2-5) cyangwa Paxovid (387, 300 mg nimatuvir + 100 mg ritonavir buri masaha 12 mu minsi 5) nk'umuti unyobwa.

Ibisubizo by'ubu bushakashatsi bwakozwe ku buvuzi byagaragaje ko kuvurwa hakiri kare na VV116 kuri COVID-19 yoroheje kugeza ku iringaniye byahuye n'igihe cy'ibanze (igihe cyo gukira mu buryo buhoraho) cyateganijwe n'amabwiriza y'ubuvuzi: igihe cyo gukira mu buvuzi cyari iminsi 4 mu itsinda rya VV116 n'iminsi 5 mu itsinda rya Paxlovid (igipimo cy'ibyago, 1.17; 95% CI, 1.02 kugeza 1.36; ntarengwa yo hasi. >0.8).

Kugumana igihe cyo gukira indwara

Ingano z'ibanze n'iza kabiri z'umusaruro (isesengura ryimbitse ry'abaturage)

Ifoto ikomokaho: Imbonerahamwe ya 2

Ku bijyanye n'umutekano, abitabiriye inama bahawe VV116 bavuze ko ingaruka mbi nke (67.4%) ugereranyije n'abahawe Paxlovid (77.3%) mu ikurikirana ry'iminsi 28, kandi ingaruka mbi zo mu cyiciro cya 3/4 zari nke kuri VV116 (2.6%) ugereranyije na Paxlovid (5.7%).

Ibintu bibi (abantu bafite umutekano)

Ifoto ikomokaho: Imbonerahamwe ya 2

Ibibazo n'impaka

Ku ya 23 Gicurasi 2022, Juniper yatangaje ko inyigo y’itsinda rya gatatu ry’inyigo ku buvuzi bwa VV116 ugereranije na PAXLOVID ku kuvura hakiri kare COVID-19 yoroheje kugeza ku iringaniye (NCT05341609) yageze ku ntego yayo y’ibanze.

Ifoto ikomokaho: Icyitonderwa cya 1

Mu gihe amakuru arambuye ku igeragezwa yari abuze, impaka ku bushakashatsi bwa Phase III zari ebyiri: icya mbere, bwari ubushakashatsi bwakozwe ku buryo butari bwitaweho, kandi mu gihe nta buryo bwo kugenzura imiti ya placebo bwari buhari, byari bitinyitse ko byagorana gusesengura neza uwo muti; icya kabiri, hari ibibazo ku ngaruka z’ubuvuzi.

Ibipimo ngenderwaho byo kwiyandikisha muri Juniper ni (i) ibisubizo byiza ku ikizamini gishya cy’ikamba, (ii) ikimenyetso kimwe cyangwa byinshi byoroheje cyangwa biri hagati ya COVID-19, na (iii) abarwayi bafite ibyago byinshi byo kurwara COVID-19, harimo n’urupfu. Ariko, iherezo ry’ibanze ry’ubuvuzi ni 'igihe cyo gukomeza gukira'.

Mbere gato y’itangazo, ku ya 14 Gicurasi, Juniper yari yavuguruye ingingo z’ubuvuzi akuraho imwe mu ngingo z’ibanze z’ubuvuzi, "ikigereranyo cy’impinduka mu burwayi bukomeye cyangwa urupfu" [3].

Ifoto ikomokaho: Icyitonderwa cya 1

Izi ngingo ebyiri z'ingenzi zavuzweho cyane cyane mu bushakashatsi bwasohotse.

Bitewe n’icyorezo gitunguranye cya Omicron, gukora ibinini bya placebo bya Paxlovid ntibyari byararangiye mbere y’uko igerageza ritangira, bityo abashakashatsi ntibashoboye gukora iri gerageza bakoresheje igishushanyo mbonera cy’uburyo bwo gupima indwara. Ku bijyanye n’uburyo bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara bwo gupima indwara yo ...

Kugeza igihe isesengura rya nyuma ryakorwaga, nta n'umwe mu bitabiriye igerageza wari warigeze gupfa cyangwa kugera ku cyorezo gikomeye cya Covid-19, bityo nta mwanzuro ushobora gufatwa ku bijyanye n'ubushobozi bwa VV116 mu gukumira Covid-19 cyangwa urupfu rukabije cyangwa rukabije. Imibare yagaragaje ko igihe giteganijwe kuva ku kwiyanduza kugeza ku gusubira inyuma kw'ibimenyetso bifitanye isano na Covid-19 cyari iminsi 7 (95% CI, 7 kugeza 8) mu matsinda yombi (igipimo cy'ibyago, 1.06; 95% CI, 0.91 kugeza 1.22) [2]. Ntabwo bigoye gusobanura impamvu iherezo ry'ibanze ry' 'igipimo cy'uburwayi cyangwa urupfu rukomeye', cyari cyarashyizweho mbere y'uko igeragezwa rirangira, ryakuweho.

Ku ya 18 Gicurasi 2022, ikinyamakuru Emerging Microbes & Infections cyasohoye ibyavuye mu igeragezwa rya mbere rya VV116 ku barwayi banduye Omicron [4], ubushakashatsi bw’itsinda ry’abarwayi 136 bemewe ko barwariyemo.

Amakuru yavuye mu bushakashatsi yagaragaje ko abarwayi banduye Omicron bakoresheje VV116 mu minsi 5 nyuma yo gupimwa bwa mbere bwa aside nucleic acid, bafashe igihe cyo gusubira inyuma kwa aside nucleic acid mu minsi 8.56, munsi y'iminsi 11.13 mu itsinda ryagenzuwe. Gutanga VV116 ku barwayi bafite ibimenyetso mu gihe cy'ubu bushakashatsi (iminsi 2-10 nyuma yo gupimwa bwa mbere bwa aside nucleic acid) byagabanyije igihe cyo gusubira inyuma kwa aside nucleic acid mu barwayi bose. Ku bijyanye n'umutekano w'imiti, nta ngaruka mbi zikomeye zagaragaye mu itsinda ryavuwe na VV116.

Ifoto ikomokaho: Imbonerahamwe ya 4

Hari igeragezwa ritatu rikomeje kuri VV116, ribiri muri ryo rikaba ari inyigo z’icyiciro cya gatatu kuri COVID-19 yoroheje kugeza ku iri hagati (NCT05242042, NCT05582629). Irindi gerageza kuri COVID-19 iri hagati kugeza ku iri hagati ni inyigo mpuzamahanga y’ubushakashatsi ku rwego mpuzamahanga, ikorwa mu buryo butunguranye, budafite ubwitonzi ku cyiciro cya gatatu (NCT05279235) kugira ngo harebwe akamaro n’umutekano wa VV116 ugereranije n’ubuvuzi busanzwe. Nk’uko byatangajwe na Juniper, umurwayi wa mbere yanditswe kandi ahabwa imiti muri Werurwe 2022.

Ifoto ikomoka kuri: clinicaltrials.gov

Imbonerahamwe:

[1] Junshi Biotech: Itangazo ku gice cy'ingenzi cy'ubushakashatsi bwakozwe mu cyiciro cya gatatu kuri VV116 ugereranije na PAXLOVID kugira ngo havurwe hakiri kare COVID-19 yoroheje kugeza ku iringaniye.

[2] https://www.nejm.org/doi/wuzuye / 10.1056 / NEJMoa2208822 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.