Lintlha tsa Phase III mabapi le moriana o mocha oa molomo oa China ho NEJM li bonts'a katleho e seng tlase ho Paxlovid.

Lihoreng tsa pele tsa la 29 Tšitoe, NEJM e phatlalalitse marang-rang thuto e ncha ea kliniki ea mohato oa III mabapi le coronavirus e ncha ea China VV116. Liphetho li bonts'itse hore VV116 e ne e se mpe ho feta Paxlovid (nematovir/ritonavir) mabapi le nako ea ho hlaphoheloa ha tleliniki mme e bile le liketsahalo tse mpe tse fokolang.

Mohloli oa setšoantšo: NEJM

Nako ea ho hlaphoheloa ea mahareng matsatsi a 4, sekhahla sa ketsahalo e mpe 67.4%

VV116 ke sethethefatsi sa oral nucleoside anti-new coronavirus (SARS-CoV-2) se entsoeng ka tšebelisano le Junsit le Wang Shan Wang Shui, 'me ke RdRp inhibitor hammoho le remdesivir ea Gileade, Merck Sharp & Dohme's molnupiravir le Real Biologics' azelvudine.

Ka 2021, teko ea kliniki ea karolo ea II ea VV116 e ile ea phethoa Uzbekistan. Liphello tsa phuputso li bontšitse hore sehlopha sa VV116 se ka ntlafatsa matšoao a kliniki hantle 'me sa fokotsa haholo kotsi ea tsoelo-pele ho ea ho mofuta o boima le lefu ha li bapisoa le sehlopha sa taolo. Ho ipapisitsoe le liphetho tse ntle tsa teko ena, VV116 e amohetsoe Uzbekistan bakeng sa kalafo ea bakuli ba nang le COVID-19 e itekanetseng, 'me e fetohile moriana oa pele o mocha oa molomo o lumelletsoeng ho rekisoa mose ho maoatle Chaena [1].

Teko ena ea kliniki ea karolo ea III [2] (NCT05341609), e etelletsoeng pele ke Prof. Zhao Ren oa Sepetlele sa Shanghai Ruijin, Moprofesa Gaoyuan oa Sepetlele sa Shanghai Renji le Academician Ning Guang oa Sepetlele sa Shanghai Ruijin, e ile ea phethoa nakong ea koluoa ​​​​e bakiloeng ke mofuta oa Omicron (B.1.1.529) ho tloha ka Hlakubele ho isa Shanghai ho tloha ka Hlakubele ho isa ho la 29 Mots'eanong. ea VV116 khahlano le Paxlovid bakeng sa kalafo ea pele ea bakuli ba nang le COVID-19 e bobebe ho isa ho e itekanetseng. Sepheo e ne e le ho lekola katleho le polokeho ea VV116 khahlano le Paxlovid bakeng sa kalafo ea pele ea bakuli ba nang le COVID-19 e bobebe ho isa ho e itekanetseng.

Mohloli oa setšoantšo: Reference 2

Teko e laoloang ke batho ba baholo ba 822 ba Covid-19 ba kotsing e kholo ea ho tsoela pele le ba nang le matšoao a bobebe ho isa ho a itekanetseng e entsoe pakeng tsa la 4 Mmesa le la 2 Mots'eanong 2022 ho lekola ho tšoaneleha ha barupeluoa ba tsoang lipetleleng tse supileng tsa Shanghai, China. Qetellong, barupeluoa ba 771 ba amohetse VV116 (384, 600 mg lihora tse ling le tse ling tse 12 ka letsatsi la 1 le 300 mg lihora tse ling le tse ling tse 12 ka matsatsi a 2-5) kapa Paxovid (387, 300 mg nimatuvir + 100 mg ritonavir lihora tse ling le tse ling tse 12 bakeng sa matsatsi a 5).

Liphetho tsa boithuto bona ba tleliniki li bonts'itse hore kalafo ea pele ea VV116 bakeng sa COVID-19 e bonolo ho isa ho e itekanetseng e fihletse pheletso ea mantlha (nako ea ho hlaphoheloa ha kliniki) e boletsoeng esale pele ke protocol ea kliniki: nako e mahareng ea ho hlaphoheloa tleliniking e ne e le matsatsi a 4 sehlopheng sa VV116 le matsatsi a 5 sehlopheng sa Paxlovid (karolelano ea kotsi, 1.17; 95% CI ho isa moeling oa 1.3> 1.

Ho boloka nako ea ho hlaphoheloa kliniki

Liphello tsa katleho ea mantlha le ea bobeli (tlhahlobo e felletseng ea baahi)

Mohloli oa setšoantšo: Reference 2

Mabapi le tšireletseho, barupeluoa ba fumanang VV116 ba tlalehile liketsahalo tse fokolang tse fokolang (67.4%) ho feta ba fumanang Paxlovid (77.3%) nakong ea morao-rao ea matsatsi a 28, 'me liketsahalo tse mpe tsa Grade 3 / 4 li ne li le tlaase ho VV116 (2.6%) ho feta Paxlovid (5.7%).

Liketsahalo tse mpe (batho ba bolokehileng)

Mohloli oa setšoantšo: Reference 2

Likhohlano le lipotso

Ka la 23 Mots'eanong 2022, Juniper o ile a senola hore thuto ea kliniki ea ngoliso ea Phase III ea VV116 khahlano le PAXLOVID bakeng sa kalafo ea pele ea COVID-19 e bobebe ho isa ho e itekanetseng (NCT05341609) e fihletse pheletso ea eona ea mantlha ea thuto.

Mohloli oa setšoantšo: Reference 1

Nakong eo ka eona lintlha tsa nyeoe li neng li haella, phehisano e potolohileng thuto ea Mokhahlelo oa Boraro e ne e le habeli: ea pele, e ne e le thuto e foufetseng e le 'ngoe' me, ha ho se na taolo ea placebo, ho ne ho tšosoa hore ho tla ba thata ho ahlola lithethefatsi ka ho feletseng; ea bobeli, ho ne ho e-na le lipotso mabapi le liphello tsa kliniki.

Maemo a kenyelletso ea bongaka bakeng sa Juniper ke (i) liphetho tse ntle bakeng sa tlhahlobo e ncha ea moqhaka, (ii) matšoao a le mong kapa ho feta a bobebe kapa a itekanetseng a COVID-19, le (iii) bakuli ba kotsing e kholo ea COVID-19, ho kenyeletsoa lefu. Leha ho le joalo, ntlha e le 'ngoe feela ea mantlha ea kliniki ke 'nako ea ho fola ho tsitsitseng'.

Nakoana pele ho phatlalatso, ka May 14, Juniper o ne a ntlafalitse liphello tsa kliniki ka ho tlosa e 'ngoe ea lintlha tse ka sehloohong tsa kliniki, "karolo ea liphetoho ho kula kapa lefu le tebileng" [3].

Mohloli oa setšoantšo: Reference 1

Lintlha tsena tse peli tsa sehlooho tsa likhang le tsona li ile tsa buuoa ka ho khetheha thutong e hatisitsoeng.

Ka lebaka la ho qhoma ka tšohanyetso ha Omicron, tlhahiso ea matlapa a placebo bakeng sa Paxlovid e ne e e-s'o phethoe pele nyeoe e qala, kahoo bafuputsi ba ne ba sitoa ho etsa nyeoe ena ka mokhoa o sa boneng habeli, oa ho soma habeli. Ha e le karolo e le 'ngoe e foufetseng ea teko ea kliniki, Juniper o boletse hore protocol e entsoe ka mor'a puisano le balaoli ba tsamaiso le hore moralo o le mong o foufetseng o bolela hore leha e le mofuputsi (ho kenyeletsoa le mohlahlobi oa qetello ea thuto) kapa motšehetsi ba tla tseba kabo e khethehileng ea phekolo ea meriana ho fihlela database ea ho qetela e notletsoe qetellong ea thuto.

Ho fihlela nakong ea tlhahlobo ea ho qetela, ha ho le ea mong oa bankakarolo nyeoeng ea kileng a shoa kapa a tsoela pele ketsahalong e matla ea Covid-19, kahoo ha ho liqeto tse ka fihleloang mabapi le katleho ea VV116 ho thibela tsoelo-pele ho Covid-19 e matla kapa e mahlonoko kapa lefu. Lintlha li bonts'itse hore nako e hakantsoeng ea mahareng ho tloha ho randomisation ho ea ho ts'ebetso e tsitsitseng ea matšoao a amanang le Covid-19 e ne e le matsatsi a 7 (95% CI, 7 ho 8) lihlopheng ka bobeli (karolelano ea kotsi, 1.06; 95% CI, 0.91 ho 1.22) [2]. Ha ho thata ho hlalosa hore na ke hobane'ng ha qetello ea mantlha ea 'tekanyo ea ho sokolohela ho kula ho matla kapa lefu', e neng e behiloe qalong pele nyeoe e fela, e ile ea tlosoa.

Ka la 18 Motšeanong 2022, koranta ea Emerging Microbes & Infections e phatlalalitse liphetho tsa teko ea pele ea bongaka ea VV116 ho bakuli ba tšoaelitsoeng ke mofuta oa Omicron [4], phuputso e bulehileng ea sehlopha se lebelletsoeng le bakuli ba 136 ba netefalitsoeng.

Lintlha tse tsoang thutong li bontšitse hore bakuli ba nang le ts'oaetso ea Omicron ba sebelisitseng VV116 matsatsing a 5 a tlhahlobo ea bona ea pele e ntle ea nucleic acid ba na le nako ea ho fokotseha ha nucleic acid ea matsatsi a 8.56, ka tlase ho matsatsi a 11.13 sehlopheng sa taolo. Tsamaiso ea VV116 ho bakuli ba nang le matšoao ka nako ea nako ea thuto ena (matsatsi a 2-10 a tlhahlobo ea pele e ntle ea nucleic acid) e fokolitse nako ea ho fokotseha ha nucleic acid ho bakuli bohle. Mabapi le tšireletso ea lithethefatsi, ha ho liphello tse mpe tse mpe tse ileng tsa bonoa sehlopheng sa phekolo ea VV116.

Mohloli oa setšoantšo: Reference 4

Ho na le liteko tse tharo tse tsoelang pele tsa tleliniki ho VV116, tse peli tsa tsona e le lithuto tsa mohato oa III ho COVID-19 e bobebe ho isa ho e itekanetseng (NCT05242042, NCT05582629). Teko e 'ngoe bakeng sa COVID-19 e itekanetseng ho isa ho e matla ke setsi sa machaba sa thuto ea bongaka e sa boneng habeli, e sa boneng habeli (NCT05279235) ho lekola katleho le polokeho ea VV116 ha e bapisoa le kalafo e tloaelehileng. Ho latela phatlalatso ea Juniper, mokuli oa pele o ile a ngolisoa mme a fuoa tekanyetso ka Hlakubele 2022.

Mohloli oa setšoantšo:clinicaltrials.gov

Litšupiso:

[1]Junshi Biotech: Phatlalatso mabapi le ntlha ea mantlha ea thuto ea bongaka e ngolisitsoeng ea Phase III ea VV116 khahlano le PAXLOVID bakeng sa kalafo ea pele ea COVID-19 e bobebe ho isa ho e itekanetseng.

[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 Aiming Yi Zhang, Juming Xheng Xiao 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) Boemo ba ts'oaetso ea Omicron le boemo ba ho entoa har'a baamoheli ba transplant ea sebete ba 1881: sehlopha sa litsi tse ngata tsa retrospective. Emerging Microbes & Infections 11:1, maqephe 2636-2644.