Deta ya Gawo Lachitatu pa mankhwala atsopano a korona opangidwa ku China mu NEJM ikuwonetsa kuti mphamvu yake si yocheperapo poyerekeza ndi Paxlovid

M'maola oyambirira a pa 29 Disembala, NEJM inafalitsa pa intaneti kafukufuku watsopano wa gawo lachitatu la kachilombo ka corona ka ku China VV116. Zotsatira zake zinasonyeza kuti VV116 sinali yoipa kuposa Paxlovid (nematovir/ritonavir) pankhani ya nthawi yomwe kachilomboka kamachira ndipo sinali ndi zotsatirapo zoyipa zambiri.

Chithunzi chochokera: NEJM

Nthawi yochira yapakati ndi masiku 4, kuchuluka kwa zovuta ndi 67.4%

VV116 ndi mankhwala oletsa kachilombo ka corona omwe amapangidwa ndi Junsit ndi Wang Shan Wang Shui, ndipo ndi mankhwala oletsa kachilombo ka RdRp pamodzi ndi Gilead's remdesivir, Merck Sharp & Dohme's molnupiravir ndi Real Biologics' azelvudine.

Mu 2021, mayeso achipatala a gawo lachiwiri la VV116 adamalizidwa ku Uzbekistan. Zotsatira za kafukufukuyu zidawonetsa kuti gulu la VV116 likhoza kusintha bwino zizindikiro zachipatala ndikuchepetsa kwambiri chiopsezo cha kupita patsogolo mpaka kufa kwakukulu poyerekeza ndi gulu lowongolera. Kutengera zotsatira zabwino za mayesowa, VV116 yavomerezedwa ku Uzbekistan kuti ichite chithandizo cha odwala omwe ali ndi COVID-19 yocheperako mpaka yoopsa, ndipo yakhala mankhwala oyamba atsopano amtima operekedwa pakamwa ovomerezeka kuti agulitsidwe kunja kwa dziko ku China [1].

Kuyesa kwachipatala kwa gawo lachitatu [2] (NCT05341609), kotsogozedwa ndi Pulofesa Zhao Ren wa Chipatala cha Shanghai Ruijin, Pulofesa Gaoyuan wa Chipatala cha Shanghai Renji ndi Katswiri wa Maphunziro Ning Guang wa Chipatala cha Shanghai Ruijin, kunamalizidwa panthawi ya kufalikira kwa kachilombo komwe kunayambitsidwa ndi mtundu wa Omicron (B.1.1.529) kuyambira Marichi mpaka Meyi ku Shanghai, ndi cholinga chowunikira momwe kachilombo ka VV116 motsutsana ndi Paxlovid kamathandizira odwala omwe ali ndi COVID-19 yocheperako mpaka yapakati. Cholinga chake chinali kuwunika momwe kachilomboka kamathandizira komanso momwe kachilomboka kamathandizira odwala omwe ali ndi COVID-19 yocheperako mpaka yapakati.

Chithunzi chochokera: Buku Lofotokozera 2

Kuyesedwa kwa odwala 822 akuluakulu a Covid-19 omwe ali pachiwopsezo chachikulu chopita patsogolo komanso omwe ali ndi zizindikiro zochepa mpaka zochepa kunachitika pakati pa 4 Epulo ndi 2 Meyi 2022 kuti awone ngati ali oyenerera kutenga nawo mbali m'zipatala zisanu ndi ziwiri ku Shanghai, China. Pamapeto pake, ophunzira 771 adalandira VV116 (384, 600 mg maola 12 aliwonse patsiku loyamba ndi 300 mg maola 12 aliwonse patsiku lachiwiri mpaka lachisanu) kapena Paxovid (387, 300 mg nimatuvir + 100 mg ritonavir maola 12 aliwonse kwa masiku asanu) ngati mankhwala omwa.

Zotsatira za kafukufuku wa zachipatalayu zinasonyeza kuti chithandizo choyambirira cha VV116 cha COVID-19 yocheperako mpaka yapakati chinakwaniritsa cholinga chachikulu (nthawi yoti munthu achire bwino) chomwe chinanenedweratu ndi njira yachipatala: nthawi yapakati yoti munthu achire inali masiku 4 mu gulu la VV116 ndi masiku 5 mu gulu la Paxlovid (chiŵerengero cha zoopsa, 1.17; 95% CI, 1.02 mpaka 1.36; malire otsika. >0.8).

Kusunga nthawi yochira kuchipatala

Mapeto oyambira ndi achiwiri ogwira ntchito bwino (kusanthula kwathunthu kwa anthu)

Chithunzi chochokera: Buku Lofotokozera 2

Ponena za chitetezo, anthu omwe adalandira VV116 adanena kuti zotsatirapo zake zinali zochepa (67.4%) kuposa omwe adalandira Paxlovid (77.3%) pa nthawi yotsatila ya masiku 28, ndipo kuchuluka kwa zotsatirapo zoyipa za Giredi 3/4 kunali kotsika kwa VV116 (2.6%) kuposa Paxlovid (5.7%).

Zochitika zoipa (anthu otetezeka)

Chithunzi chochokera: Buku Lofotokozera 2

Mikangano ndi mafunso

Pa Meyi 23, 2022, Juniper adavumbulutsa kuti kafukufuku wachipatala wa Gawo Lachitatu wa VV116 motsutsana ndi PAXLOVID wokhudza chithandizo choyambirira cha COVID-19 yofatsa mpaka yapakati (NCT05341609) adakwaniritsa mfundo yake yayikulu yophunzirira.

Chithunzi chochokera: Buku Loyamba

Pa nthawi imene tsatanetsatane wa kafukufukuyu unalibe, mkangano wokhudza kafukufuku wa Gawo Lachitatu unali wawiri: choyamba, unali kafukufuku wosawona ndipo, popanda placebo control, anthu ankaopa kuti zingakhale zovuta kuweruza mankhwalawo mopanda tsankho; chachiwiri, panali mafunso okhudza mapeto a zachipatala.

Njira zochizira matenda a Juniper ndi (i) zotsatira zabwino za mayeso atsopano a korona, (ii) chizindikiro chimodzi kapena zingapo za COVID-19, komanso (iii) odwala omwe ali pachiwopsezo chachikulu cha COVID-19, kuphatikizapo imfa. Komabe, cholinga chachikulu chachipatala ndi 'nthawi yoti munthu achire'.

Pasanathe nthawi yolengeza, pa Meyi 14, Juniper adasintha ma endpoints azachipatala pochotsa chimodzi mwa ma endpoints oyamba azachipatala, "chiwerengero cha kusintha kukhala matenda aakulu kapena imfa" [3].

Chithunzi chochokera: Buku Loyamba

Mfundo ziwiri zazikuluzikulu zomwe zikukanganazi zinakambidwanso mwachindunji mu kafukufuku wofalitsidwa.

Chifukwa cha kufalikira kwadzidzidzi kwa Omicron, kupanga mapiritsi a placebo a Paxlovid sikunamalizidwe mayeso asanayambe ndipo chifukwa chake ofufuzawo sanathe kuchita mayesowa pogwiritsa ntchito kapangidwe ka double-blind, double-mock. Ponena za mbali ya single-blind ya mayeso azachipatala, Juniper adati ndondomekoyi idachitika pambuyo polankhulana ndi akuluakulu oyang'anira ndipo kapangidwe ka single-blind kamatanthauza kuti wofufuza (kuphatikizapo wowunikira kumapeto kwa kafukufukuyu) kapena wothandizira sadzadziwa kugawa kwa mankhwala enieni ochiritsira mpaka database yomaliza itatsekedwa kumapeto kwa kafukufukuyu.

Mpaka nthawi yomaliza yofufuza, palibe aliyense mwa omwe adachita nawo kafukufukuyu amene adakumana ndi imfa kapena kupita patsogolo mpaka kufika pa chochitika chachikulu cha Covid-19, kotero palibe mfundo zomwe zingapezeke zokhudza mphamvu ya VV116 poletsa kupita patsogolo mpaka kufika pa Covid-19 kapena imfa yoopsa kapena yovuta. Detayo inasonyeza kuti nthawi yapakati yoyerekeza kuyambira pakusintha kwachisawawa mpaka kubwereranso kwa zizindikiro zokhudzana ndi Covid-19 inali masiku 7 (95% CI, 7 mpaka 8) m'magulu onse awiri (chiŵerengero cha zoopsa, 1.06; 95% CI, 0.91 mpaka 1.22) [2]. N'zosavuta kufotokoza chifukwa chake mapeto oyamba a 'kuchuluka kwa matenda kapena imfa yoopsa', omwe poyamba adakhazikitsidwa mayeso asanafike, adachotsedwa.

Pa 18 Meyi 2022, magazini ya Emerging Microbes & Infections inafalitsa zotsatira za mayeso oyamba azachipatala a VV116 mwa odwala omwe ali ndi kachilombo ka Omicron [4], kafukufuku wotseguka, woyembekezeredwa wa gulu la odwala 136 omwe adatsimikizika kuti ali m'chipatala.

Deta yochokera mu kafukufukuyu inasonyeza kuti odwala omwe ali ndi kachilombo ka Omicron omwe adagwiritsa ntchito VV116 mkati mwa masiku 5 kuchokera pamene adayesa koyamba za nucleic acid anali ndi nthawi yobwerera ku nucleic acid kwa masiku 8.56, osachepera masiku 11.13 omwe anali m'gulu lolamulira. Kupereka VV116 kwa odwala omwe ali ndi zizindikiro mkati mwa nthawi ya kafukufukuyu (masiku 2-10 a mayeso oyamba a nucleic acid) kunachepetsa nthawi yobwerera ku nucleic acid mwa odwala onse. Ponena za chitetezo cha mankhwala, palibe zotsatirapo zoyipa zomwe zidawonedwa m'gulu la chithandizo cha VV116.

Chithunzi chochokera: Buku 4

Pali mayesero atatu azachipatala omwe akupitilira pa VV116, awiri mwa iwo ndi maphunziro a gawo lachitatu pa COVID-19 yofatsa mpaka yapakati (NCT05242042, NCT05582629). Mayeso ena a COVID-19 yocheperako mpaka yoopsa ndi kafukufuku wapadziko lonse lapansi wa magawo ambiri, wosasankhidwa, wakhungu kawiri (NCT05279235) kuti awone momwe VV116 imagwirira ntchito komanso chitetezo chake poyerekeza ndi chithandizo chokhazikika. Malinga ndi zomwe Juniper adalengeza, wodwala woyamba adalembetsedwa ndikupatsidwa mankhwala mu Marichi 2022.

Chithunzi chochokera: clinicaltrials.gov

Maumboni:

[1] Junshi Biotech: Chilengezo chokhudza mfundo yaikulu ya kafukufuku wolembetsedwa wa Gawo Lachitatu wa VV116 motsutsana ndi PAXLOVID kuti alandire chithandizo choyambirira cha COVID-19 yofatsa mpaka yapakati.

[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 Aiming Yi Zhang, Juming Xiao Zhang 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) Mbiri ya matenda a Omicron ndi udindo wa katemera pakati pa 1881 omwe amalandila chiwindi: gulu lapakati loyang'ana kumbuyo. Emerging Microbes & Infections 11:1, masamba 2636-2644.