ʻO ka ʻikepili Māhele III ma ka lāʻau lei aliʻi waha hou o Kina ma NEJM e hōʻike ana i ka pono ʻaʻole i emi iho ma mua o Paxlovid

I nā hola mua o Dekemaba 29, ua paʻi ʻo NEJM ma ka pūnaewele i kahi noiʻi pae III hou o ka maʻi coronavirus Kina hou ʻo VV116. Ua hōʻike nā hopena ʻaʻole ʻoi aku ka ʻino o VV116 ma mua o Paxlovid (nematovir/ritonavir) ma ke ʻano o ka lōʻihi o ka hoʻōla ʻana i ka maʻi a ua emi iho nā hopena ʻino.

Puna kiʻi：NEJM

ʻO ka manawa ho'ōla waena he 4 mau lā, ka helu hanana maikaʻi ʻole he 67.4%

He lāʻau lapaʻau nucleoside waha anti-new coronavirus (SARS-CoV-2) ʻo VV116 i hoʻomohala ʻia ma ka laulima ʻana me Junsit lāua ʻo Wang Shan Wang Shui, a he mea hoʻopaʻa RdRp pū me ka remdesivir a Gilead, ka molnupiravir a Merck Sharp & Dohme a me ka azelvudine a Real Biologics.

I ka makahiki 2021, ua hoʻopau ʻia kahi hoʻokolohua lapaʻau pae II o VV116 ma Uzbekistan. Ua hōʻike nā hopena o ke aʻo ʻana e hiki i ka hui VV116 ke hoʻomaikaʻi maikaʻi i nā hōʻailona lapaʻau a hōʻemi nui i ka pilikia o ka holomua i ke ʻano koʻikoʻi a me ka make i hoʻohālikelike ʻia me ka hui kaohi. Ma muli o nā hopena maikaʻi o kēia hoʻokolohua, ua ʻae ʻia ʻo VV116 ma Uzbekistan no ka mālama ʻana i nā maʻi me ka COVID-19 waena a koʻikoʻi, a ua lilo ia i lāʻau lapaʻau waha mua i ʻae ʻia no ke kūʻai aku ʻana ma nā ʻāina ʻē ma Kina [1].

Ua hoʻopau ʻia kēia hoʻokolohua lapaʻau pae III [2] (NCT05341609), i alakaʻi ʻia e Polopeka Zhao Ren o ka Halemai ʻo Shanghai Ruijin, ʻo Polopeka Gaoyuan o ka Halemai ʻo Shanghai Renji a me ke Akamai ʻo Ning Guang o ka Halemai ʻo Shanghai Ruijin, i ka wā o ka maʻi ahulau i hoʻokumu ʻia e ka ʻano Omicron (B.1.1.529) mai Malaki a Mei ma Shanghai, me ka pahuhopu o ka loiloi ʻana i ka pono a me ka palekana o VV116 versus Paxlovid no ka mālama mua ʻana i nā maʻi me ka COVID-19 akahai a kaulike. ʻO ka pahuhopu ka loiloi ʻana i ka pono a me ka palekana o VV116 versus Paxlovid no ka mālama mua ʻana i nā maʻi me ka COVID-19 akahai a kaulike.

Puna kiʻi: Kuhikuhi 2

Ua mālama ʻia kahi hoʻokolohua multicentre, observer-blinded, randomized, controlled o 822 mau maʻi Covid-19 makua me ka pilikia kiʻekiʻe o ka holomua a me nā hōʻailona palupalu a kaulike ma waena o 4 ʻApelila a me 2 Mei 2022 e loiloi i ke kūpono o nā mea komo mai ʻehiku mau haukapila ma Shanghai, Kina. I ka hopena, ua loaʻa i nā mea komo he 771 ʻo VV116 (384, 600 mg i kēlā me kēia 12 hola ma ka lā 1 a me 300 mg i kēlā me kēia 12 hola ma nā lā 2-5) a i ʻole Paxovid (387, 300 mg nimatuvir + 100 mg ritonavir i kēlā me kēia 12 hola no 5 mau lā) ma ke ʻano he lāʻau lapaʻau waha.

Ua hōʻike ʻia nā hopena o kēia noiʻi lapaʻau ua hālāwai ka mālama mua ʻana me VV116 no ka COVID-19 akahai a kaulike i ka hopena mua (ka manawa e hoʻōla mau ai i ka lapaʻau) i wānana ʻia e ke kaʻina hana lapaʻau: ʻo ka manawa waena i ka hoʻōla lapaʻau he 4 mau lā ma ka hui VV116 a me 5 mau lā ma ka hui Paxlovid (lakio pōpilikia, 1.17; 95% CI, 1.02 a 1.36; palena haʻahaʻa. >0.8).

Ka mālama ʻana i ka manawa hoʻōla lapaʻau

Nā hopena hopena mua a me ka lua (ka nānā piha ʻana o ka heluna kanaka)

Puna kiʻi: Kuhikuhi 2

Ma ke ʻano o ka palekana, ua hōʻike nā mea i komo i ka VV116 i nā hanana ʻino liʻiliʻi (67.4%) ma mua o ka poʻe i loaʻa iā Paxlovid (77.3%) i ka hahai ʻana i nā lā 28, a ʻoi aku ka haʻahaʻa o ka nui o nā hanana ʻino Grade 3 / 4 no VV116 (2.6%) ma mua o Paxlovid (5.7%).

Nā hanana ʻino (poʻe palekana)

Puna kiʻi: Kuhikuhi 2

Nā hoʻopaʻapaʻa a me nā nīnau

Ma ka lā 23 o Mei, 2022, ua hōʻike ʻo Juniper ua hoʻokō ka haʻawina lapaʻau hoʻopaʻa inoa Phase III o VV116 e kūʻē iā PAXLOVID no ka mālama mua ʻana o ka COVID-19 ʻoluʻolu a kaulike (NCT05341609) i kāna hopena mua o ka haʻawina.

Puna kiʻi: Kuhikuhi 1

I ka manawa i nele ai nā kikoʻī o ka hoʻokolokolo ʻana, ʻelua ʻano o ka hoʻopaʻapaʻa e pili ana i ka haʻawina Phase III: ʻo ka mea mua, he haʻawina makapō hoʻokahi ia, a i ka loaʻa ʻole o kahi kaohi placebo, ua hopohopo ʻia he paʻakikī ke hoʻoholo pono i ka lāʻau lapaʻau; ʻo ka lua, aia nā nīnau e pili ana i nā hopena lapaʻau.

ʻO nā pae hoʻokomo lapaʻau no Juniper (i) nā hopena maikaʻi no ka hoʻāʻo lei aliʻi hou, (ii) hoʻokahi a ʻoi aku paha nā hōʻailona COVID-19 akahai a kaulike paha, a me (iii) nā mea maʻi i ka pilikia kiʻekiʻe o ka COVID-19 koʻikoʻi, me ka make. Eia nō naʻe, ʻo ka hopena lapaʻau mua wale nō ka 'manawa e hoʻomau ai i ka hoʻōla lapaʻau'.

Ma mua iki o ka hoʻolaha ʻana, ma Mei 14, ua hoʻoponopono hou ʻo Juniper i nā hopena lapaʻau ma ka wehe ʻana i kekahi o nā hopena lapaʻau mua, "ka hapa o nā hoʻololi ʻana i ka maʻi koʻikoʻi a i ʻole ka make" [3].

Puna kiʻi: Kuhikuhi 1

Ua kamaʻilio pono ʻia kēia mau kumu nui ʻelua o ka paio ma ka haʻawina i paʻi ʻia.

Ma muli o ka puka koke ʻana o Omicron, ʻaʻole i hoʻopau ʻia ka hana ʻana o nā papa placebo no Paxlovid ma mua o ka hoʻomaka ʻana o ka hoʻokolokolo a no laila ʻaʻole hiki i nā mea noiʻi ke hana i kēia hoʻokolokolo me ka hoʻohana ʻana i kahi hoʻolālā makapō pālua, hoʻohālike pālua. No ka ʻaoʻao makapō hoʻokahi o ka hoʻokolokolo lapaʻau, ua ʻōlelo ʻo Juniper ua hana ʻia ke kaʻina hana ma hope o ke kamaʻilio ʻana me nā luna hoʻoponopono a ʻo ke ʻano o ka hoʻolālā makapō hoʻokahi ʻaʻole e ʻike ka mea noiʻi (me ka loiloi o ka hopena o ke aʻo ʻana) a ʻaʻole hoʻi ka mea kākoʻo i ka hoʻokaʻawale ʻana o ka lāʻau lapaʻau a hiki i ka laka ʻia ʻana o ka waihona ʻikepili hope loa i ka hopena o ke aʻo ʻana.

A hiki i ka manawa o ka loiloi hope loa, ʻaʻohe o nā mea i komo i ka hoʻokolokolo i ʻike i ka make a i ʻole ka holomua ʻana i kahi hanana Covid-19 koʻikoʻi, no laila ʻaʻohe hopena e hiki ke huki ʻia e pili ana i ka pono o VV116 i ka pale ʻana i ka holomua ʻana i ka Covid-19 koʻikoʻi a koʻikoʻi paha a i ʻole ka make. Ua hōʻike ka ʻikepili ʻo ka manawa waena i manaʻo ʻia mai ka randomisation a hiki i ka regression mau o nā hōʻailona pahuhopu e pili ana iā Covid-19 he 7 mau lā (95% CI, 7 a 8) ma nā hui ʻelua (hazard ratio, 1.06; 95% CI, 0.91 a 1.22) [2]. ʻAʻole paʻakikī ke wehewehe i ke kumu i wehe ʻia ai ke kumu mua o ka 'helu o ka hoʻololi ʻana i ka maʻi koʻikoʻi a i ʻole ka make', i hoʻonohonoho mua ʻia ma mua o ka pau ʻana o ka hoʻokolokolo.

Ma ka lā 18 o Mei 2022, ua paʻi ka puke pai ʻo Emerging Microbes & Infections i nā hopena o ka hoʻokolohua lapaʻau mua o VV116 i nā poʻe maʻi i loaʻa i ka ʻano Omicron [4], kahi noiʻi cohort hāmama a me ka manaʻolana me 136 mau maʻi i hōʻoia ʻia.

Ua hōʻike ʻia nā ʻikepili mai ke aʻo ʻana ua loaʻa i nā maʻi me ka maʻi Omicron i hoʻohana iā VV116 i loko o 5 mau lā o kā lākou hoʻāʻo mua ʻana i ka waikawa nucleic maikaʻi ka manawa e hoʻihoʻi ai i ka waikawa nucleic o 8.56 mau lā, ʻoi aku ka liʻiliʻi ma mua o 11.13 mau lā ma ka hui kaohi. ʻO ka lawelawe ʻana iā VV116 i nā maʻi me nā hōʻailona i loko o ka manawa o kēia haʻawina (2-10 mau lā o ka hoʻāʻo mua ʻana i ka waikawa nucleic maikaʻi) ua hōʻemi i ka manawa e hoʻihoʻi ai i ka waikawa nucleic i nā maʻi āpau. Ma ke ʻano o ka palekana o ka lāʻau lapaʻau, ʻaʻohe hopena maikaʻi ʻole i ʻike ʻia ma ka hui mālama VV116.

Puna kiʻi: Kuhikuhi 4

ʻEkolu mau hoʻokolohua lapaʻau e hana nei ma VV116, ʻelua o ia mau mea he mau haʻawina pae III ma ka COVID-19 ʻoluʻolu a kaulike (NCT05242042, NCT05582629). ʻO kekahi hoʻokolohua no ka COVID-19 ʻoluʻolu a koʻikoʻi he haʻawina lapaʻau pae III multicentre, randomized, double-blind international (NCT05279235) e loiloi i ka pono a me ka palekana o VV116 i hoʻohālikelike ʻia me ka lāʻau maʻamau. Wahi a ka hoʻolaha a Juniper, ua kākau inoa ʻia ka mea maʻi mua a ua hoʻokomo ʻia i ka lāʻau i Malaki 2022.

Puna kiʻi: clinicaltrials.gov

Nā Kuhikuhi：

[1]Junshi Biotech: Hoʻolaha ma ke kiko hope loa o ka haʻawina lapaʻau i hoʻopaʻa inoa ʻia ma ka Phase III o VV116 e kūʻē iā PAXLOVID no ka mālama mua ʻana o ka COVID-19 ʻoluʻolu a kaulike

[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, Junao Jianming, Ximingu, Yi Zhang, Junao Jianming 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) Hōʻike maʻi o Omicron a me ke kūlana o ka lāʻau lapaʻau ma waena o 1881 mau mea hoʻololi i ke akepaʻa: kahi hui retrospective multi-centre. Emerging Microbes & Infections 11:1, aoao 2636-2644.