Hōʻike ka ʻikepili o ka Phase III i ka lāʻau kalaunu waha hou o Kina ma NEJM e hōʻike i ka maikaʻi 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 hou o ka pae III o ka coronavirus Kina hou VV116. Ua hōʻike ʻia nā hopena ʻaʻole i ʻoi aku ka maikaʻi o ka VV116 ma mua o Paxlovid (nematovir/ritonavir) ma ke ʻano o ka lōʻihi o ka hoʻihoʻi ʻana i ka maʻi a ua liʻiliʻi nā hanana ʻino.

Puna kiʻi:NEJM

ʻO ka manawa hoʻihoʻi Median 4 mau lā, ka nui o ka hanana ʻino 67.4%

ʻO VV116 kahi lāʻau lapaʻau oral nucleoside anti-new coronavirus (SARS-CoV-2) i hoʻomohala ʻia me ka hui pū ʻana me Junsit a me Wang Shan Wang Shui, a he mea hoʻopaneʻe RdRp me ka remdesivir o Gileada, Merck Sharp & Dohme's molnupiravir a me Real Biologics 'azelvudine.

I ka makahiki 2021, ua hoʻopau ʻia kahi hoʻokolohua lapaʻau o ka pae II o VV116 ma Uzbekistan. Ua hōʻike nā hopena o ka noiʻi e hiki i ka hui VV116 ke hoʻomaikaʻi maikaʻi i nā hōʻailona maʻi a hoʻemi nui i ka hopena o ka holomua i ke ʻano koʻikoʻi a me ka make i hoʻohālikelike ʻia i ka pūʻulu mana. Ma muli o nā hopena maikaʻi o kēia hoʻāʻo, ua ʻae ʻia ʻo VV116 ma Uzbekistan no ka mālama ʻana i nā mea maʻi me ka COVID-19 haʻahaʻa-a-koʻikoʻi, a ua lilo ʻo ia ka lāʻau lapaʻau coronary waha hou mua i ʻae ʻia no ke kūʻai aku ma waho o Kina [1].

ʻO kēia māhele III hoʻokolohua hoʻokolohua [2] (NCT05341609), i alakaʻi ʻia e Prof. Zhao Ren o Shanghai Ruijin Hospital, Prof. Gaoyuan o Shanghai Renji Hospital a me Academician Ning Guang o Shanghai Ruijin Hospital, i hoʻopau ʻia i ka wā o ka outbreak i hoʻokumu ʻia e ka ʻano ʻano Omicron (B.1.1.529) mai Malaki a Mei i Shanghai, me ka manaʻo o ka versus V6cavalucy. ʻO Paxlovid no ka mālama mua ʻana i nā mea maʻi me ka COVID-19 maʻalahi. ʻO ka pahuhopu ka loiloi i ka maikaʻi a me ka palekana o VV116 versus Paxlovid no ka mālama mua ʻana i nā maʻi me ka COVID-19 maʻalahi.

Puna kiʻi: Reference 2

Ua mālama ʻia kahi multicentre, nānā makapō, randomised, controlled trial o 822 adult Covid-19 maʻi i ke kiʻekiʻe o ka piʻi ʻana a me nā hōʻailona haʻahaʻa a me ka haʻahaʻa i mālama ʻia ma waena o 4 ʻApelila a me 2 Mei 2022 e loiloi i ka pono o nā poʻe komo mai nā halemai ʻehiku ma Shanghai, Kina. ʻO ka hope loa, ua loaʻa iā 771 mau mea komo 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 mau hola no 5 mau lā) ma ke ʻano he lāʻau lapaʻau waha.

Ua hōʻike ʻia nā hopena o kēia noiʻi lapaʻau ʻo ka mālama mua ʻana me VV116 no ka COVID-19 haʻahaʻa a me ka haʻahaʻa i ka hopena mua (manawa e hoʻomau i ka hoʻolaʻa kino) i wānana ʻia e ka protocol clinical: ʻo ka manawa waena o ka hoʻolaʻa kino he 4 mau lā ma ka hui VV116 a me 5 mau lā ma ka hui Paxlovid (hazard ratio, 1.17; 95% CI, 1.06% palena haʻahaʻa).

Ka mālama ʻana i ka manawa hoʻōla kino

Nā helu hope o ka hana mua a me ke kula kiʻekiʻe (ka nānā ʻana o ka heluna kanaka)

Puna kiʻi: Reference 2

Ma ke ʻano o ka palekana, ʻoi aku ka liʻiliʻi o nā mea i loaʻa iā VV116 (67.4%) ma mua o ka poʻe i loaʻa iā Paxlovid (77.3%) i ka lā 28 mau lā, a ʻoi aku ka liʻiliʻi o nā hanana ʻino ma ka papa 3 / 4 no VV116 (2.6%) ma mua o Paxlovid (5.7%).

Nā hanana pōʻino (poʻe palekana)

Puna kiʻi: Reference 2

Nā hoʻopaʻapaʻa a me nā nīnau

Ma Mei 23, 2022, ua hōʻike ʻo Juniper ua loaʻa ka haʻawina hoʻopaʻa inoa Phase III o VV116 versus PAXLOVID no ka hoʻomaʻamaʻa mua ʻana i ka COVID-19 maʻalahi a me ka haʻahaʻa (NCT05341609) i hoʻokō i kāna kumu aʻo mua.

Puna kiʻi: Reference 1

I ka manawa i nele nā ​​kikoʻī o ka hoʻokolokolo ʻana, ʻo ka hoʻopaʻapaʻa e pili ana i ke aʻo ʻana o ka Phase III he ʻelua: ʻo ka mea mua, he noiʻi makapō hoʻokahi a, i ka loaʻa ʻole o kahi mana placebo, ua makaʻu ʻia e paʻakikī ke hoʻokolokolo pono i ka lāʻau; ʻO ka lua, aia nā nīnau e pili ana i nā hopena lapaʻau.

ʻO nā koina hoʻokomo ʻana i ka lāʻau lapaʻau no Juniper he (i) nā hopena maikaʻi no ka hoʻāʻo lei aliʻi hou, (ii) hoʻokahi a ʻoi aku paha nā hōʻailona COVID-19 haʻahaʻa a haʻahaʻa paha, a (iii) nā mea maʻi i pilikia nui i ka COVID-19 koʻikoʻi, me ka make. Eia nō naʻe, ʻo ka hopena o ka lāʻau lapaʻau mua wale nō ʻo ia ka 'manawa e hoʻomau i ka hoʻōla kino'.

Ma mua o ka hoʻolaha ʻana, ma ka lā 14 o Mei, ua hoʻoponopono hou ʻo Juniper i nā hopena o ka maʻi ma o ka wehe ʻana i kekahi o nā helu hope o ke kino, "ka hoʻololi ʻana i ka maʻi koʻikoʻi a i ʻole ka make" [3].

Puna kiʻi: Reference 1

ʻO kēia mau manaʻo koʻikoʻi ʻelua o ka paio i ʻōlelo ʻia i loko o 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 hoʻokō i kēia hoʻokolohua me ka hoʻohana ʻana i kahi hoʻolālā makapō pālua. No ka ʻaoʻao makapō hoʻokahi o ka hoʻokolohua lapaʻau, ua ʻōlelo ʻo Juniper ua mālama ʻia ka protocol ma hope o ke kamaʻilio ʻana me nā luna hoʻoponopono a ʻo ka hoʻolālā makapō hoʻokahi ʻo ia ka mea ʻaʻole ʻike ka mea noiʻi (me ka mea loiloi o ka hopena o ke aʻo ʻana) a me ka mea kākoʻo i ka hoʻokaʻawale ʻana i ka lāʻau lapaʻau a hiki i ka paʻa ʻana o ka waihona hope loa ma ka hopena o ke aʻo ʻana.

A hiki i ka manawa o ka loiloi hope, ʻaʻohe o nā mea i komo i ka hoʻokolokolo i ʻike i ka make a i ʻole ka piʻi ʻana i kahi hanana Covid-19 koʻikoʻi, no laila ʻaʻole hiki ke huki ʻia nā hopena e pili ana i ka pono o VV116 i ka pale ʻana i ka piʻi ʻana i ka Covid-19 koʻikoʻi a i ʻole ka make. Ua hōʻike ka ʻikepili i ka manawa median i manaʻo ʻia mai ka randomization a hiki i ka hoʻomau ʻana o nā hōʻailona e pili ana i ka Covid-19 e pili ana i nā lā 7 (95% CI, 7 a 8) i nā hui ʻelua (hazard ratio, 1.06; 95% CI, 0.91 a i 1.22) [2]. ʻAʻole paʻakikī ka wehewehe ʻana i ke kumu i wehe ʻia ai ka hopena mua o ka 'helu o ka huli 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 18 Mei 2022, ua paʻi ka puke pai ʻo Emerging Microbes & Infections i nā hopena o ka hoʻāʻo mua ʻana o VV116 i nā poʻe maʻi i loaʻa i ka ʻano Omicron [4], kahi noiʻi cohort wehe ʻia me 136 mau maʻi maʻi i hoʻopaʻa ʻia.

Hōʻike ka ʻikepili mai ka haʻawina i nā maʻi me ka maʻi Omicron i hoʻohana i ka VV116 i loko o 5 mau lā o kā lākou hoʻāʻo nucleic acid mua i loaʻa ka manawa i ka regression nucleic acid o 8.56 mau lā, ma lalo o nā lā 11.13 i ka hui hoʻomalu. ʻO ka lawelawe ʻana o VV116 i nā maʻi symptomatic i loko o ka manawa o kēia haʻawina (2-10 mau lā o ka hoʻāʻo mua ʻana o ka nucleic acid) hoʻemi i ka manawa i ka regression nucleic acid i nā maʻi āpau. Ma ke ʻano o ka palekana o ka lāʻau, ʻaʻohe hopena koʻikoʻi i ʻike ʻia ma ka hui mālama VV116.

Puna kiʻi: Reference 4

ʻEkolu mau hoʻokolohua lapaʻau e hoʻomau nei ma VV116, ʻelua o ia mau haʻawina pae III ma COVID-19 maʻalahi a haʻahaʻa (NCT05242042, NCT05582629). ʻO ka hoʻāʻo ʻē aʻe no ka COVID-19 haʻahaʻa a koʻikoʻi he international multicentre, randomised, double-blind phase III clinical study (NCT05279235) e loiloi i ka pono a me ka palekana o VV116 i hoʻohālikelike ʻia i ka mālama maʻamau. Wahi a ka hoʻolaha a Juniper, ua kākau inoa ʻia ka mea maʻi mua a kau ʻia ma Malaki 2022.

Puna kiʻi:clinicaltrials.gov

Kuhikuhi:

[1]Junshi Biotech: Hoʻolaha ma ka helu hope nui o ka Phase III i hoʻopaʻa ʻia i ka noiʻi lapaʻau o VV116 versus PAXLOVID no ka mālama mua ʻana i ka COVID-19 maʻalahi a maʻalahi.

[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.