Ruzivo rwechikamu chechitatu pamusoro pemushonga mutsva wekunwa wekorona wekuChina muNEJM runoratidza kushanda kwakanaka kwete pasi pePaxlovid

Mumaawa ekutanga emusi wa29 Zvita, NEJM yakaburitsa online chidzidzo chitsva chekiriniki chechikamu chechitatu chechirwere chitsva cheChinese coronavirus VV116. Zvakabuda zvakaratidza kuti VV116 yakanga isiri yakaipa kupfuura Paxlovid (nematovir/ritonavir) kana tichitarisa nguva yekupora kwechirwere uye yakanga isina matambudziko akawanda.

Mufananidzo unobva: NEJM

Nguva yekupora yepakati pemazuva mana, huwandu hwezviitiko zvisina kunaka 67.4%

VV116 mushonga wekurwisa coronavirus mutsva unonzi nucleoside (SARS-CoV-2) wakagadzirwa pamwe chete naJunsit naWang Shan Wang Shui, uye mushonga weRdRp inhibitor pamwe chete neGilead's remdesivir, Merck Sharp & Dohme's molnupiravir uye Real Biologics' azelvudine.

Muna 2021, bvunzo yekiriniki yechikamu chechipiri cheVV116 yakapedzwa muUzbekistan. Zvakabuda muchidzidzo ichi zvakaratidza kuti boka reVV116 rinogona kuvandudza zviratidzo zvekiriniki zviri nani uye kuderedza zvakanyanya njodzi yekufambira mberi kusvika padanho rakakosha uye kufa zvichienzaniswa neboka rekutonga. Zvichibva pamhedzisiro yakanaka yeongororo iyi, VV116 yakatenderwa muUzbekistan yekurapa varwere vane COVID-19 iri pakati nepakati kusvika yakanyanya, uye yave mushonga wekutanga mutsva wecoronary unonwiwa wakatenderwa kutengeswa kunze kwenyika muChina [1].

Muedzo uyu wekiriniki wechikamu chechitatu [2] (NCT05341609), uchitungamirwa naProf. Zhao Ren weShanghai Ruijin Hospital, Prof. Gaoyuan weShanghai Renji Hospital uye Academician Ning Guang weShanghai Ruijin Hospital, wakapedzwa panguva yekupararira kwechirwere ichi kwakakonzerwa neOmicron variant (B.1.1.529) kubva munaKurume kusvika Chivabvu muShanghai, nechinangwa chekuongorora kushanda uye kuchengetedzeka kweVV116 versus Paxlovid pakurapa varwere vane COVID-19 iri pakati nepakati. Chinangwa chaive chekuongorora kushanda uye kuchengetedzeka kweVV116 versus Paxlovid pakurapa varwere vane COVID-19 iri pakati nepakati.

Mufananidzo unobva: Referensi 2

Kuedzwa kwevarwere vakuru 822 veCovid-19 vari panjodzi huru yekuenderera mberi uye vane zviratidzo zvishoma kusvika pakati nepakati kwakaitwa pakati pa4 Kubvumbi na2 Chivabvu 2022 kuti vaongorore kukodzera kwevatori vechikamu kubva kuzvipatara zvinomwe muShanghai, China. Pakupedzisira, vatori vechikamu 771 vakapihwa VV116 (384, 600 mg maawa gumi nemaviri ega ega pazuva rekutanga uye 300 mg maawa gumi nemaviri ega ega pazuva rechipiri kusvika reshanu) kana Paxovid (387, 300 mg nimatuvir + 100 mg ritonavir maawa gumi nemaviri ega ega kwemazuva mashanu) semushonga unonwiwa.

Mhedzisiro yechidzidzo ichi chekiriniki yakaratidza kuti kurapwa kwekutanga neVV116 kweCOVID-19 iri pakati nepakati kwakasvika padanho rekutanga (nguva yekupora kwenguva refu) yakafanotaurwa nemaitiro ekiriniki: nguva yepakati yekupora kwekiriniki yaive mazuva mana muboka reVV116 uye mazuva mashanu muboka rePaxlovid (hazard ratio, 1.17; 95% CI, 1.02 kusvika 1.36; muganho wakaderera. >0.8).

Kuchengetedza nguva yekupora kwekiriniki

Magumo ekutanga neapachipiri ekubudirira (kuongorora kwakazara kwevanhu)

Mufananidzo unobva: Referensi 2

Panyaya yekuchengetedzeka, vatori vechikamu vakapihwa VV116 vakataura nezvezviitiko zvishoma zvakashata (67.4%) pane avo vakapihwa Paxlovid (77.3%) pakutevera kwemazuva makumi maviri nemasere, uye kuwanda kwezviitiko zvakaipa zveGiredhi 3/4 kwakaderera kune VV116 (2.6%) pane kuna Paxlovid (5.7%).

Zviitiko zvakaipa (vanhu vakachengeteka)

Mufananidzo unobva: Referensi 2

Gakava nemibvunzo

Musi wa23 Chivabvu, 2022, Juniper akaburitsa pachena kuti chidzidzo chekiriniki cheVV116 chichienzaniswa nePAXLOVID chekurapa COVID-19 isina kunyanya kuipa (NCT05341609) chakazadzisa mhedzisiro yacho huru yekudzidza.

Mufananidzo wakabva: Referensi 1

Panguva iyo ruzivo rwemuyedzo rwakanga rusina, gakava rakapoteredza chidzidzo chePhase III raive rakapetwa kaviri: chekutanga, chaive chidzidzo chega-blind uye, pasina kudzora kwe placebo, zvaityirwa kuti zvaizova zvakaoma kutonga mushonga wacho nenzira yakatwasuka; chechipiri, paive nemibvunzo nezvemhedzisiro yekiriniki.

Zvinodiwa pakurapa kweJuniper zvinosanganisira (i) mhedzisiro yakanaka yebvunzo itsva yekorona, (ii) chiratidzo chimwe chete kana kupfuura cheCOVID-19 chisina kusimba kana kuti chiri pakati nepakati, uye (iii) varwere vari panjodzi huru yeCOVID-19, kusanganisira kufa. Zvisinei, mugumo wekutanga wekiriniki inguva yekupora kwenguva refu kwekiriniki.

Nguva pfupi isati yaziviswa, musi wa14 Chivabvu, Juniper akanga agadzirisa magumo ekurapa nekubvisa imwe yemagumo ekutanga ekurapa, "chikamu chekuchinja kuita chirwere chakakomba kana rufu" [3].

Mufananidzo wakabva: Referensi 1

Pfungwa huru mbiri idzi dzakataurwawo zvakananga muchidzidzo chakabudiswa.

Nekuda kwekubuda kamwe kamwe kweOmicron, kugadzirwa kwemapiritsi eplacebo ePaxlovid kwakanga kusati kwapera kuedzwa kusati kwatanga saka vaongorori havana kukwanisa kuita kuedzwa uku vachishandisa dhizaini ye "double-blind", "double-mock design". Nezvechikamu che "single-blind" chekuedzwa kwekiriniki, Juniper akati protocol iyi yakaitwa mushure mekutaurirana nevatungamiriri vemutemo uye kuti dhizaini ye "single-blind" zvinoreva kuti muongorori (kusanganisira muongorori we "endpoint" yekudzidza) kana mutsigiri haazozive kugoverwa kwemishonga chaiyo yekurapa kusvika database yekupedzisira yavharwa pakupera kwechidzidzo.

Kusvika panguva yekuongorora kwekupedzisira, hapana mumwe wevatori vechikamu mukuyedzwa akange afa kana kufambira mberi kusvika pachiitiko chakanyanya cheCovid-19, saka hapana mhedziso inogona kutorwa nezvekushanda kweVV116 mukudzivirira kufambira mberi kusvika paCovid-19 kana rufu. Ruzivo rwakaratidza kuti nguva inofungidzirwa kubva pakusarongeka kusvika pakudzokera shure kwezviratidzo zvine chekuita neCovid-19 yaive 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 mugumo wekutanga we'kutendeuka kuenda kuchirwere chakanyanya kana rufu', uyo wakatanga wakatarwa bvunzo isati yapera, wakabviswa.

Musi wa18 Chivabvu 2022, magazini inonzi Emerging Microbes & Infections yakaburitsa mhedzisiro yekuyedzwa kwekutanga kwekiriniki kweVV116 muvarwere vane hutachiona hweOmicron [4], chidzidzo chakavhurika, cheboka revanhu vane 136 vakasimbiswa kuti vakapinda.

Data kubva muchidzidzo ichi rakaratidza kuti varwere vane hutachiona hweOmicron vakashandisa VV116 mukati memazuva mashanu kubva pakuongororwa kwavo kwekutanga kwe nucleic acid vaive nenguva yekudzokera shure kwe nucleic acid kwemazuva 8.56, mazuva asingasviki 11.13 muboka rekutonga. Kupihwa kweVV116 kuvarwere vane zviratidzo mukati menguva yechidzidzo ichi (mazuva 2-10 ekuongororwa kwekutanga kwe nucleic acid) kwakaderedza nguva yekudzokera shure kwe nucleic acid muvarwere vese. Panyaya yekuchengetedzeka kwemushonga, hapana migumisiro yakaipa yakaonekwa muboka rekurapa reVV116.

Mufananidzo wacho wakabva: Referensi 4

Kune miedzo mitatu iri kuenderera mberi yekiriniki paVV116, miviri yacho iri yechikamu chechitatu cheCOVID-19 iri pakati nepakati (NCT05242042, NCT05582629). Imwe miedzo yeCOVID-19 iri pakati nepakati kusvika pakanyanya ndeyekudzidza kwekiriniki kwechikamu chechitatu chepasi rose, kwakaitwa munzvimbo dzakasiyana-siyana, kwakarongeka, kusingaonekwi kaviri (NCT05279235) kuongorora kushanda uye kuchengetedzeka kweVV116 zvichienzaniswa nekurapwa kwakajairika. Sekureva kwekuzivisa kwaJuniper, murwere wekutanga akanyoreswa uye akapinzwa mushonga munaKurume 2022.

Mufananidzo unobva: clinicaltrials.gov

Mareferensi:

[1]Junshi Biotech: Chiziviso pamusoro pechikamu chikuru chekudzidza kwakanyoreswa kwechikamu chechitatu cheVV116 nePAXLOVID pakurapa COVID-19 isina kunyanya kuipa.

[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 Xiao, Jingwean Aiming Yi Zhang Xing 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) Omicron hutachiona hwehutachiona uye mamiriro ekudzivirira pakati pe1881 chiropa vanogashira vanogamuchira: yakawanda-centre retrospective cohort. Emerging Microbes & Infections 11:1, mapeji 2636-2644.