Zambiri za Phase III pazamankhwala atsopano aku China ku NEJM zikuwonetsa kuti ndizocheperako kuposa Paxlovid

Kumayambiriro kwa Disembala 29, NEJM idasindikiza pa intaneti kafukufuku watsopano wagawo lachitatu la coronavirus yatsopano yaku China VV116. Zotsatira zake zidawonetsa kuti VV116 sinali yoyipa kuposa Paxlovid (nematovir/ritonavir) potengera nthawi yakuchira ndipo inali ndi zovuta zochepa.

Chithunzi chojambula:NEJM

Nthawi yochira yapakati masiku 4, chiwopsezo chazovuta 67.4%

VV116 ndi oral nucleoside anti-new coronavirus (SARS-CoV-2) mankhwala opangidwa mogwirizana ndi Junsit ndi Wang Shan Wang Shui, ndipo ndi RdRp inhibitor pamodzi ndi remdesivir ya Gileadi, Merck Sharp & Dohme's molnupiravir ndi Real Biologics' azelvudine.

Mu 2021, kuyesa kwachipatala kwa gawo lachiwiri la VV116 kudamalizidwa ku Uzbekistan. Zotsatira za phunziroli zinasonyeza kuti gulu la VV116 likhoza kusintha bwino zizindikiro zachipatala ndikuchepetsa kwambiri chiopsezo chopita ku mawonekedwe ovuta ndi imfa poyerekeza ndi gulu lolamulira. Kutengera zotsatira zabwino za mayesowa, VV116 yavomerezedwa ku Uzbekistan kuti ichiritse odwala omwe ali ndi COVID-19, ndipo yakhala mankhwala oyamba amkamwa omwe amavomerezedwa kuti azikagulitsa kunja ku China [1].

Gawo lachitatu la mayesero achipatala [2] (NCT05341609), motsogoleredwa ndi Prof. Zhao Ren wa chipatala cha Shanghai Ruijin, Prof. Gaoyuan wa chipatala cha Shanghai Renji Hospital ndi Academician Ning Guang wa chipatala cha Shanghai Ruijin Hospital, anamalizidwa panthawi yomwe inayambika chifukwa cha kusiyana kwa Omicron ( B.1.1.529) kuyambira Marichi mpaka Meyi ku Shanghai, ndi cholinga chowunika mphamvu ndi chitetezo. ya VV116 motsutsana ndi Paxlovid pochiza odwala omwe ali ndi COVID-19 wofatsa mpaka wocheperako. Cholinga chinali kuyesa mphamvu ndi chitetezo cha VV116 motsutsana ndi Paxlovid pakuchiza koyambirira kwa odwala omwe ali ndi COVID-19 wofatsa mpaka pang'ono.

Gwero la zithunzi: Reference 2

Mayesero osiyanasiyana, osawona, osasinthika, oyendetsedwa ndi odwala 822 achikulire a Covid-19 omwe ali pachiwopsezo chachikulu chokulirakulira komanso omwe ali ndi zofooka pang'ono adachitika pakati pa 4 Epulo ndi 2 Meyi 2022 kuti awone kuyenerera kwa omwe adatenga nawo gawo kuchokera kuzipatala zisanu ndi ziwiri ku Shanghai, China. Pamapeto pake, anthu 771 adalandira VV116 (384, 600 mg maola 12 aliwonse pa tsiku 1 ndi 300 mg maola 12 aliwonse pamasiku 2-5) kapena Paxovid (387, 300 mg nimatuvir + 100 mg ritonavir maora 12 aliwonse kwa masiku asanu) mankhwala amkamwa.

Zotsatira za kafukufuku wazachipatalayu zidawonetsa kuti chithandizo choyambilira ndi VV116 cha COVID-19 chochepa mpaka chochepa chinakumana ndi mathero oyambira (nthawi yochira bwino) yonenedweratu ndi njira yachipatala: nthawi yapakatikati kuti achire kuchipatala inali masiku 4 mgulu la VV116 ndi 5. masiku mu gulu la Paxlovid (chiŵerengero cha ngozi, 1.17; 95% CI, 1.02 mpaka 1.36; malire otsika. > 0.8).

Kusunga nthawi yochira kuchipatala

Zomaliza zogwira ntchito zoyambira ndi zachiwiri (kusanthula kwathunthu kwa anthu)

Gwero la zithunzi: Reference 2

Pankhani ya chitetezo, omwe adalandira VV116 adanenanso zochitika zochepa (67.4%) kuposa omwe adalandira Paxlovid (77.3%) pakutsatira kwa masiku 28, ndipo zochitika za Grade 3 / 4 zinali zochepa pa VV116 (2.6% ) kuposa Paxlovid (5.7%).

Zochitika zoyipa (anthu otetezeka)

Gwero la zithunzi: Reference 2

Mikangano ndi mafunso

Pa Meyi 23, 2022, Juniper adawulula kuti kafukufuku wachipatala wolembetsa wa Phase III wa VV116 motsutsana ndi PAXLOVID pakuchiza koyambirira kwa COVID-19 (NCT05341609) adakwaniritsa zomaliza zake.

Gwero lachithunzi: Tsamba 1

Panthawi yomwe tsatanetsatane wa mlanduwo analibe, kutsutsana kozungulira phunziro la Gawo lachitatu kunali kawiri: choyamba, kunali phunziro limodzi lakhungu ndipo, popanda kulamulira kwa placebo, ankawopa kuti zingakhale zovuta kuweruza. mankhwala kwathunthu mosaganizira; kachiwiri, panali mafunso okhudza mapeto a zachipatala.

Njira zophatikizira zachipatala za Juniper ndi (i) zotsatira zabwino za mayeso atsopano a korona, (ii) chizindikiro chimodzi kapena zingapo zofatsa kapena zochepera za COVID-19, ndi (iii) odwala omwe ali pachiwopsezo chachikulu cha COVID-19, kuphatikiza imfa. Komabe, mathero oyambira azachipatala ndi 'nthawi yochira bwino'.

Atangotsala pang'ono kulengeza, pa May 14, Juniper adakonzanso mapeto a zachipatala pochotsa chimodzi mwazotsatira zachipatala, "gawo la kutembenuka ku matenda aakulu kapena imfa" [3].

Gwero lachithunzi: Tsamba 1

Mfundo ziwiri zazikuluzikulu zotsutsanazi zinayankhidwanso mwachindunji mu phunziro lofalitsidwa.

Chifukwa cha kuphulika kwadzidzidzi kwa Omicron, kupanga mapiritsi a placebo a Paxlovid kunalibe kumalizidwa mlandu usanayambe ndipo chifukwa chake ofufuzawo sanathe kuchititsa mayeserowa pogwiritsa ntchito mawonekedwe akhungu awiri, awiri. Ponena za gawo limodzi lopanda khungu la mayesero a zachipatala, Juniper adanena kuti ndondomekoyi inachitika pambuyo poyankhulana ndi akuluakulu olamulira komanso kuti mapangidwe akhungu limodzi amatanthauza kuti palibe wofufuza (kuphatikizapo wowunika mapeto a phunzirolo) kapena wothandizira sangadziwe. kugawa kwapadera kwa mankhwala achire mpaka nkhokwe yomaliza itatsekedwa kumapeto kwa phunzirolo.

Mpaka nthawi yowunika komaliza, palibe aliyense mwa omwe adatenga nawo gawo pamlanduwo yemwe adamwalira kapena kupita patsogolo pamwambo woopsa wa Covid-19, kotero palibe chomwe chingaganizidwe pakuchita bwino kwa VV116 poletsa kupita patsogolo kwa Covid-19. kapena imfa. Deta idawonetsa kuti nthawi yapakatikati kuyambira pakusakhazikika mpaka pakukhazikika kwazomwe zikugwirizana ndi Covid-19 inali masiku 7 (95% CI, 7 mpaka 8) m'magulu onsewa (chiwerengero changozi, 1.06; 95% CI, 0.91 mpaka 1.22) [2]. Sizovuta kufotokoza chifukwa chake mapeto oyambirira a 'chiŵerengero cha kutembenuka ku matenda aakulu kapena imfa', yomwe idakhazikitsidwa poyamba mlandu usanathe, idachotsedwa.

Pa 18 Meyi 2022, magazini ya Emerging Microbes & Infections idasindikiza zotsatira za mayeso oyamba azachipatala a VV116 mwa odwala omwe ali ndi mtundu wa Omicron [4], kafukufuku wotseguka, woyembekezeredwa wamagulu omwe ali ndi odwala 136 otsimikizika.

Deta yochokera ku phunziroli inasonyeza kuti odwala omwe ali ndi matenda a Omicron omwe adagwiritsa ntchito VV116 mkati mwa masiku a 5 a mayeso awo oyambirira a nucleic acid anali ndi nthawi ya nucleic acid regression ya masiku 8.56, osachepera masiku a 11.13 mu gulu lolamulira. Kulamulira kwa VV116 kwa odwala omwe ali ndi zizindikiro mkati mwa nthawi ya phunziroli (masiku 2-10 a mayeso oyambirira a nucleic acid) anachepetsa nthawi ya nucleic acid regression kwa odwala onse. Pankhani ya chitetezo cha mankhwala, palibe zotsatira zoyipa zomwe zidawonedwa mu gulu lamankhwala la VV116.

Gwero lachithunzi: Buku la 4

Pali mayesero atatu azachipatala omwe akupitilira pa VV116, awiri mwa omwe ali maphunziro a gawo lachitatu pa COVID-19 (NCT05242042, NCT05582629). Kuyesa kwina kwa COVID-19 kwapakati kapena koopsa ndi kafukufuku wapadziko lonse lapansi, wosasinthika, wakhungu wapadziko lonse wachitatu (NCT05279235) kuti awunike mphamvu ndi chitetezo cha VV116 poyerekeza ndi chithandizo chanthawi zonse. Malinga ndi chilengezo cha Juniper, wodwala woyamba adalembetsedwa ndikumwedwa mu Marichi 2022.

Gwero lachithunzi:clinicaltrials.gov

Zolozera:

[1]Junshi Biotech: Chilengezo chakumapeto kwa gawo lachitatu la kafukufuku wachipatala wolembetsedwa wa VV116 motsutsana ndi PAXLOVID wa chithandizo choyambirira cha 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) 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.