Phase III dhata yeChina nyowani yemuromo korona mushonga muNEJM inoratidza kushanda kusiri kwakaderera kune Paxlovid.

Mumaawa ekutanga emusi wa29 Zvita, NEJM yakaburitsa pamhepo chirongwa chitsva chekiriniki chikamu III cheiyo nyowani yeChinese coronavirus VV116. Zvigumisiro zvakaratidza kuti VV116 yakanga isina kuipa kupfuura Paxlovid (nematovir/ritonavir) maererano nenguva yekupora kwekliniki uye yakanga ine zviitiko zvishomanana zvakashata.

Mufananidzo kunobva: NEJM

Median kudzoreredza nguva 4 mazuva, yakashata chiitiko chiitiko 67.4%

VV116 is oral nucleoside anti-new coronavirus (SARS-CoV-2) mushonga wakagadzirwa nekubatana naJunsit naWang Shan Wang Shui, uye iri RdRp inhibitor pamwe neGiriyedhi remdesivir, Merck Sharp & Dohme's molnupiravir uye Real Biologics' azelvudine.

Muna 2021, chikamu chechipiri chekiriniki kuyedzwa kweVV116 chakapedzwa muUzbekistan. Zvigumisiro zvekudzidza zvakaratidza kuti boka reVV116 rinogona kuvandudza zviri nani zviratidzo zvekliniki uye kuderedza zvakanyanya njodzi yekufambira mberi kune fomu yakakosha uye rufu kana ichienzaniswa neboka rinodzora. Zvichienderana nemhedzisiro yakanaka yemuyedzo uyu, VV116 yakatenderwa muUzbekistan kurapwa kwevarwere vane mwero-kusvika-yakaomarara COVID-19, uye yave yekutanga nyowani yemuromo coronary mushonga wakabvumidzwa kushambadzira mhiri kwemakungwa muChina [1].

Ichi chikamu III chekiriniki yekuedza [2] (NCT05341609), inotungamirirwa naProf. Zhao Ren weShanghai Ruijin Hospital, Prof. Gaoyuan weShanghai Renji Hospital uye Academician Ning Guang weShanghai Ruijin Hospital, yakapedzwa panguva yekuputika kwakakonzerwa neOmicron variant ( B.1.1.529) kubva munaKurume kusvika Chivabvu muShanghai, nechinangwa chekuongorora kushanda nesimba nekuchengeteka. yeVV116 inopesana nePaxlovid yekurapa kwekutanga kwevarwere vane hunyoro kusvika pakati nepakati COVID-19. Chinangwa chaive chekuongorora kushanda nekuchengetedzeka kweVV116 maringe nePaxlovid yekurapa kwekutanga kwevarwere vane hunyoro kusvika pakati nepakati COVID-19.

Mufananidzo tsime: Reference 2

Muedzo wakasiyana-siyana, wakapofumadzwa, wakasarudzika, wakadzorwa wevarwere mazana masere nemakumi maviri nevaviri veCovid-19 vari panjodzi huru yekufambira mberi uye vane zviratidzo zvakapfava kusvika pakati nepakati zvakaitwa pakati pa4 Kubvumbi na2 Chivabvu 2022 kuti vaone kukodzera kwevatori vechikamu kubva kuzvipatara zvinomwe muShanghai, China. Pakupedzisira, vatori vechikamu 771 vakagamuchira VV116 (384, 600 mg maawa gumi nemaviri pazuva 1 uye 300 mg maawa gumi nemaviri pamazuva 2-5) kana Paxovid (387, 300 mg nimatuvir + 100 mg ritonavir maawa gumi nemaviri kwemazuva mashanu) mushonga wokunwa.

Mhedzisiro yechidzidzo chekiriniki iyi yakaratidza kuti kurapwa kwekutanga neVV116 kune nyoro kusvika pakati nepakati COVID-19 yakasangana nemagumo ekutanga (nguva yekusimbisa kupora) yakafanotaurwa nekiriniki protocol: yepakati nguva yekupora kukiriniki yaive mazuva mana muboka reVV116 uye mashanu. mazuva muboka rePaxlovid (hazard ratio, 1.17; 95% CI, 1.02 kusvika 1.36; muganho wakaderera. >0.8).

Kuchengetedza kliniki yekudzorera nguva

Yekutanga uye yechipiri efficacy endpoints (yakadzama ongororo yehuwandu hwevanhu)

Mufananidzo tsime: Reference 2

Panyaya yekuchengeteka, vatori vechikamu vanogamuchira VV116 vakarondedzera zviitiko zvishomanana zvakashata (67.4%) pane avo vanogamuchira Paxlovid (77.3%) pamazuva makumi maviri nemasere ekutevera, uye chiitiko cheGiredhi 3 / 4 zviitiko zvakashata zvakaderera zveVV116 (2.6% ) pane yePaxlovid (5.7%).

Zviitiko zvakashata (vanhu vakachengeteka)

Mufananidzo tsime: Reference 2

Makakatanwa nemibvunzo

Musi waChivabvu 23, 2022, Juniper akaburitsa kuti Phase III yekunyoresa kiriniki yekudzidza yeVV116 maringe nePAXLOVID yekurapwa kwehunyoro kusvika pakati nepakati COVID-19 (NCT05341609) yakasangana nemagumo ayo ekutanga ekudzidza.

Mufananidzo tsime: Reference 1

Panguva iyo ruzivo rwekutongwa rwakanga rusina, gakava rakapoteredza chidzidzo cheChikamu chechitatu rakanga rakapetwa kaviri: kutanga, kwaiva chidzidzo chimwechete-bofu uye, pasina nzvimbo yekutonga, yaitya kuti zvingava zvakaoma kutonga. mushonga wacho zvachose; chechipiri, pakanga paine mibvunzo pamusoro pemagumo ekliniki.

Makiriniki ekusanganisirwa maitiro eJuniper ndea (i) mhedzisiro yakanaka yekorona nyowani bvunzo, (ii) imwe kana anopfuura akapfava kana ane mwero COVID-19 zviratidzo, uye (iii) varwere vari panjodzi huru yeCOVID-19, kusanganisira rufu. Nekudaro, iyo chete yekutanga kliniki yekupedzisira ndiyo 'nguva yekusimbisa kupora kwekiriniki'.

Nguva isati yasvika chiziviso, musi waMay 14, Juniper akanga agadzirisa magumo ekliniki nekubvisa imwe yemakiriniki ekupedzisira ekupedzisira, "chikamu chekutendeuka kuchirwere chakakomba kana rufu" [3].

Mufananidzo tsime: Reference 1

Idzi pfungwa huru mbiri dzekukakavadzana dzakataurwawo zvakananga muchidzidzo chakabudiswa.

Nekuda kwekuputika kwakangoerekana kwaitika kweOmicron, kugadzirwa kwemapiritsi e placebo ePaxlovid kwakanga kusati kwapera kusati kwatanga kutongwa uye saka vaongorori havana kukwanisa kuitisa iyi bvunzo vachishandisa maviri-mapofu, maviri-anonyomba dhizaini. Kana iri chikamu chimwechete-bofu chekuongorora kwekliniki, Juniper akataura kuti protocol yakaitwa mushure mekukurukurirana nevane masimba ekutonga uye kuti dhizaini rimwechete-bofu rinoreva kuti hapana muongorori (kusanganisira muongorori wemagumo ekudzidza) kana mubatsiri achaziva. iyo chaiyo yekurapa mishonga yekugovera kusvika iyo yekupedzisira dhatabhesi yakavharwa pakupera kwechidzidzo.

Kusvika panguva yekuongororwa kwekupedzisira, hapana mumwe wevatori vechikamu mukutongwa anga afa kana kufambira mberi kune chiitiko chakakomba cheCovid-19, saka hapana mhedziso inogona kutorwa nezve kushanda kweVV116 mukudzivirira kufambira mberi kune yakaoma kana yakaoma Covid-19. kana rufu. Iyo data yakaratidza kuti inofungidzirwa yenguva yepakati kubva ku randomisation kusvika pakudzoreredzwa kwakasimba kwezviratidzo zveCovid-19-zvakanangana nezviratidzo zvaive mazuva manomwe (95% CI, 7 kusvika 8) mumapoka ese ari maviri (hazard ratio, 1.06; 95% CI, 0.91 kusvika 1.22) [2]. Hazvina kuoma kutsanangura kuti nei magumo ekutanga e'mwero wekutendeuka kuhurwere hwakanyanya kana kufa', iyo yakatanga kuiswa pamberi pekupera kwekutongwa, yakabviswa.

Musi wa18 Chivabvu 2022, bhuku reEmerging Microbes & Infections rakaburitsa mhedzisiro yekutanga kukiriniki kuyedzwa kweVV116 muvarwere vane hutachiona hweOmicron variant [4], yakavhurika, inotarisirwa cohort kudzidza ine 136 yakasimbiswa varwere.

Dhiyabhorosi kubva pakudzidza yakaratidza kuti varwere vane chirwere cheOmicron vakashandisa VV116 mukati memazuva mashanu ekutanga kwavo nucleic acid test vakawana nguva ye nucleic acid regression kwemazuva 8.56, pasi pemazuva 11.13 muboka rekutonga. Kutungamirirwa kweVV116 kune varwere vane zviratidzo mukati menguva yechidzidzo ichi (2-10 mazuva ekutanga nucleic acid test) yakaderedza nguva ye nucleic acid regression kune varwere vose. Mukutaura kwekuchengetedzwa kwezvinodhaka, hapana zvakakomba zvakashata zvakaonekwa muboka rekurapa VV116.

Mufananidzo tsime: Reference 4

Kune matatu arikuenderera mberi miedzo yekiriniki paVV116, maviri acho ari echikamu chechitatu zvidzidzo pane zvakapfava kusvika pakati nepakati COVID-19 (NCT05242042, NCT05582629). Mumwe muyedzo wepakati kusvika kune wakaomarara COVID-19 inzvimbo yepasi rose, isina kurongeka, yakapetwa kaviri-mapofu chikamu III chekiriniki yekudzidza (NCT05279235) yekuongorora kushanda uye kuchengetedzeka kweVV116 zvichienzaniswa nekurapa kwakajairwa. Zvinoenderana nechiziviso chakaitwa naJuniper, murwere wekutanga akanyoreswa uye akadhindwa munaKurume 2022.

Mufananidzo kunobva:clinicaltrials.gov

References:

[1]Junshi Biotech: Chiziviso padanho rekupedzisira rePhase III yakanyoreswa kiriniki kudzidza yeVV116 maringe nePAXLOVID yekurapa kwekutanga kwehunyoro kusvika pakati nepakati 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) Omicron hutachiona hwehutachiona uye mamiriro ekudzivirira pakati pe1881 chiropa vanogashira vanogamuchira: yakawanda-centre retrospective cohort. Emerging Microbes & Infections 11:1, mapeji 2636-2644.