Data Phase III na ọgwụ okpueze ọnụ ọhụrụ nke China na NEJM na-egosi nrụpụta adịghị ala karịa Paxlovid

N'isi elekere nke Disemba 29, NEJM bipụtara n'ịntanetị ihe ọmụmụ ụlọ ọgwụ ọhụrụ nke III nke coronavirus ọhụrụ China VV116. Nsonaazụ gosiri na VV116 adịghị njọ karịa Paxlovid (nematovir / ritonavir) n'ihe gbasara oge mgbake ụlọ ọgwụ ma nwee obere ihe ọjọọ.

Isi iyi onyonyo: NEJM

Oge mgbake etiti ụbọchị 4, ọnụego ihe omume ọjọọ 67.4%

VV116 bụ ọgwụ mgbochi nucleoside ọhụrụ nke coronavirus (SARS-CoV-2) mepụtara na mmekorita ya na Junsit na Wang Shan Wang Shui, ma bụrụ ihe mgbochi RdRp yana mgbake Gilead, Merck Sharp & Dohme's molnupiravir na Real Biologics' azelvudine.

N'afọ 2021, emechara nnwale ụlọ ọgwụ nke abụọ nke VV116 na Uzbekistan. Nsonaazụ nke ọmụmụ ahụ gosiri na otu VV116 nwere ike imeziwanye mgbaàmà ahụike nke ọma ma belata ihe ize ndụ nke ịga n'ihu na ụdị dị oke egwu na ọnwụ ma e jiri ya tụnyere otu njikwa. Dabere na nsonaazụ dị mma nke nnwale a, akwadoro VV116 na Uzbekistan maka ọgwụgwọ nke ndị ọrịa nwere oke COVID-19, ma bụrụkwa ọgwụ akwara ọnụ nke mbụ akwadoro maka ịre ahịa na mba ofesi na China [1].

Nke a na-adọ nke III Clinical ikpe [2] (NCT05341609), nke Prọfesọ Zhao Ren nke Shanghai Ruijin Hospital, Prof. Gaoyuan nke Shanghai Renji Hospital na Academician Ning Guang nke Shanghai Ruijin Hospital, emechara n'oge ntiwapụ nke Omicron variant kpatara ( B.1.1.529) site na March ruo May na Shanghai, na ebumnuche nke nyochaa arụmọrụ na nchekwa nke VV116 megide Paxlovid maka ọgwụgwọ mmalite nke ndị ọrịa nwere obere COVID-19 dị obere. Ebumnuche bụ inyocha nrụpụta na nchekwa nke VV116 megide Paxlovid maka ọgwụgwọ mmalite nke ndị ọrịa nwere obere COVID-19 na-agafeghị oke.

Isi iyi onyonyo: Ntụaka 2

A na-eme ọtụtụ ụlọ ọrụ, ndị kpuru ìsì, ndị kpuru ìsì, ndị a na-achịkwaghị achịkwa nke ndị ọrịa 822 ndị okenye Covid-19 nọ n'ihe ize ndụ nke ịga n'ihu ma nwee mgbaàmà dị nro n'etiti 4 Eprel na 2 Mee 2022 iji chọpụta ntozu nke ndị sonyere na ụlọ ọgwụ asaa na Shanghai, China. N'ikpeazụ, ndị sonyere 771 natara ma ọ bụ VV116 (384, 600 mg kwa awa 12 n'ụbọchị 1 na 300 mg kwa awa 12 na ụbọchị 2-5) ma ọ bụ Paxovid (387, 300 mg nimatuvir + 100 mg ritonavir kwa awa 12 maka ụbọchị 5) ọgwụ ọnụ.

Nsonaazụ nke ọmụmụ ụlọ ọgwụ a gosiri na ọgwụgwọ mbụ na VV116 maka obere obere COVID-19 zutere isi njedebe (oge iji kwado mgbake ụlọ ọgwụ) nke usoro ọgwụgwọ buru amụma: oge ​​etiti na mgbake ụlọ ọgwụ bụ ụbọchị 4 n'ime otu VV116 na 5. ụbọchị na Paxlovid otu (ihe ize ndụ ruru, 1.17; 95% CI, 1.02 ka 1.36; ala ala. > 0.8).

Na-edobe oge mgbake ụlọ ọgwụ

Isi njedebe arụmọrụ nke isi na nke abụọ (nyocha nyocha nke ọnụọgụgụ ndị mmadụ)

Isi iyi onyonyo: Ntụaka 2

N'ihe gbasara nchekwa, ndị sonyere na-anata VV116 kọrọ obere ihe ọjọọ (67.4%) karịa ndị na-anata Paxlovid (77.3%) na ntinye ụbọchị 28, na ihe omume ọjọọ nke Grade 3/4 dị ala maka VV116 (2.6% ) karịa maka Paxlovid (5.7%).

Ihe ọjọọ (ndị nchekwa)

Isi iyi onyonyo: Ntụaka 2

Esemokwu na ajụjụ

Na Mee 23, 2022, Juniper kpughere na ọmụmụ ụlọ ọgwụ ndebanye aha nke Atọ nke VV116 megide PAXLOVID maka ọgwụgwọ mmalite nke obere COVID-19 (NCT05341609) zutere njedebe ọmụmụ ya.

Isi iyi onyonyo: Ntụaka 1

N'oge a na-enweghị nkọwa nke ikpe ahụ, esemokwu gbara gburugburu ọmụmụ ihe nke atọ nke atọ bụ okpukpu abụọ: nke mbụ, ọ bụ otu ọmụmụ ihe na-ekpuchi anya na, na-enweghị nchịkwa placebo, a na-atụ egwu na ọ ga-esi ike ikpe ikpe. ọgwụ ahụ kpamkpam; Nke abuo, enwere ajụjụ gbasara njedebe ụlọ ọgwụ.

Usoro nsonye ụlọ ọgwụ maka Juniper bụ (i) nsonaazụ dị mma maka ule okpueze ọhụrụ, (ii) otu ma ọ bụ karịa akara COVID-19 dị nro ma ọ bụ na-agafeghị oke, yana (iii) ndị ọrịa nwere nnukwu ihe egwu nke COVID-19 siri ike, gụnyere ọnwụ. Agbanyeghị, naanị isi njedebe ụlọ ọgwụ bụ 'oge iji kwado mgbake ụlọ ọgwụ'.

Naanị tupu ọkwa ahụ, na Mee 14, Juniper emegharịla njedebe ụlọ ọgwụ site na iwepu otu n'ime isi njedebe nke ụlọ ọgwụ, "oke nke mgbanwe na ọrịa siri ike ma ọ bụ ọnwụ" [3].

Isi iyi onyonyo: Ntụaka 1

E kwukwara kpọmkwem isi ihe abụọ a nke esemokwu n'ọmụmụ ihe e bipụtara.

N'ihi ntiwapụ nke Omicron na mberede, mmepụta nke mbadamba nkume placebo maka Paxlovid agwụbeghị tupu mmalite nke ikpe ahụ, ya mere ndị nchọpụta enweghị ike ịme ule a site n'iji okpukpu abụọ kpuo ìsì, okpukpu abụọ. Banyere akụkụ kpuru ìsì nke nnwale ụlọ ọgwụ, Juniper kwuru na a na-eme usoro ahụ mgbe ya na ndị ọchịchị na-ekwurịta okwu yana na otu kpuru ìsì pụtara na ọ bụghị onye nyocha (gụnyere onye nyocha nke njedebe ọmụmụ) ma ọ bụ onye nkwado agaghị ama. oke ọgwụgwọ ọgwụgwọ kpọmkwem ruo mgbe a na-ekpochi nchekwa data ikpeazụ na njedebe nke ọmụmụ.

Ruo oge nyocha ikpeazụ, ọ dịghị onye ọ bụla n'ime ndị sonyere na nnwale ahụ nwetara ọnwụ ma ọ bụ ọganihu na ihe omume Covid-19 siri ike, yabụ enweghị ike nweta nkwubi okwu banyere ịdị irè nke VV116 na igbochi ọganihu na Covid-19 siri ike ma ọ bụ dị egwu. ma ọ bụ ọnwụ. Ihe omuma a gosiputara na oge etiti etiti site na randomisation rue nkwụghachi azụ nke mgbaàmà ebumnuche metụtara Covid-19 bụ ụbọchị 7 (95% CI, 7 ruo 8) n'ime otu abụọ ahụ (oke ihe egwu, 1.06; 95% CI, 0.91 ruo 1.22) [2]. Ọ naghị esiri ike ịkọwa ihe kpatara e wepụrụ isi njedebe nke 'ọnụego mgbanwe gaa na ọrịa siri ike ma ọ bụ ọnwụ', nke e debere na mbụ tupu njedebe nke ikpe ahụ.

Na 18 Mee 2022, akwụkwọ akụkọ Emerging Microbes & Infections bipụtara nsonaazụ nke nnwale ụlọ ọgwụ izizi nke VV116 n'ime ndị ọrịa butere ụdị Omicron [4], mmeghe, ọmụmụ otu ndị na-atụ anya ya na ndị ọrịa 136 kwadoro.

Data sitere na ọmụmụ ihe gosiri na ndị ọrịa nwere ọrịa Omicron bụ ndị jiri VV116 n'ime ụbọchị 5 nke nyocha mbụ nke nucleic acid nwere oge iji nwetaghachi nucleic acid regression nke ụbọchị 8.56, na-erughị ụbọchị 11.13 na njikwa njikwa. Nlekọta nke VV116 na ndị ọrịa na-ahụ maka mgbaàmà n'ime oge nke ọmụmụ a (ụbọchị 2-10 nke nyocha mbụ nke nucleic acid) na-ebelata oge iji nwetaghachi mmeghachi omume nucleic acid na ndị ọrịa niile. N'ihe gbasara nchekwa ọgwụ, ọ nweghị mmetụta ọjọọ dị njọ a hụrụ na otu ọgwụgwọ VV116.

Isi iyi onyonyo: ntụaka 4

Enwere nnwale ụlọ ọgwụ atọ na-aga n'ihu na VV116, abụọ n'ime ha bụ ọmụmụ ihe nke atọ na COVID-19 dị nro ma dị oke ala (NCT05242042, NCT05582629). Ọnwụnwa ọzọ maka oke COVID-19 dị oke ma dị njọ bụ mba ụwa multicentre, randomized, okpukpu abụọ nke kpuru ìsì III nyocha ụlọ ọgwụ (NCT05279235) iji nyochaa ịdị mma na nchekwa nke VV116 ma e jiri ya tụnyere ọgwụgwọ ọkọlọtọ. Dị ka ọkwa Juniper si kwuo, onye ọrịa mbụ debanyere aha wee nye ya ọgwụ na Machị 2022.

Isi iyi foto:clinicaltrials.gov

Ntụaka:

[1] Junshi Biotech: Nkwupụta na isi njedebe nke Phase III edebanye aha nyocha ụlọ ọgwụ nke VV116 megide PAXLOVID maka ọgwụgwọ mmalite nke obere obere 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) Profaịlụ ọrịa Omicron na ọkwa ịgba ọgwụ mgbochi ọrịa n'etiti 1881 ndị nnata transplant imeju: otu ndị na-atụgharị azụ azụ ọtụtụ etiti. Microbes & Ọrịa na-apụta 11:1, peeji 2636-2644.