Bayanai na Mataki na III kan sabon maganin maganin kafeyin baki na kasar Sin a NEJM sun nuna cewa ingancinsa bai gaza na Paxlovid ba

A safiyar ranar 29 ga Disamba, NEJM ta buga wani sabon bincike na mataki na uku na asibiti game da sabon cutar coronavirus ta kasar Sin VV116. Sakamakon ya nuna cewa VV116 bai fi Paxlovid (nematovir/ritonavir) muni ba idan aka kwatanta da tsawon lokacin da aka dauka ana murmurewa kuma yana da karancin abubuwan da suka faru.

Tushen hoto: NEJM

Matsakaicin lokacin murmurewa kwanaki 4, ƙimar mummunan lamari 67.4%

VV116 magani ne na hana sabuwar cutar coronavirus (SARS-CoV-2) da aka samar tare da haɗin gwiwar Junsit da Wang Shan Wang Shui, kuma maganin hana RdRp ne tare da remdesivir na Gilead, molnupiravir na Merck Sharp & Dohme da azelvudine na Real Biologics.

A shekarar 2021, an kammala gwajin asibiti na mataki na II na VV116 a Uzbekistan. Sakamakon binciken ya nuna cewa ƙungiyar VV116 za ta iya inganta alamun cutar da kuma rage haɗarin ci gaba zuwa mummunan tsari da mutuwa idan aka kwatanta da ƙungiyar da ke kula da cutar. Dangane da sakamakon wannan gwaji mai kyau, an amince da VV116 a Uzbekistan don kula da marasa lafiya da ke fama da COVID-19 daga matsakaici zuwa mai tsanani, kuma ya zama sabon maganin zuciya na farko da aka amince da shi don tallatawa a ƙasashen waje a China [1].

An kammala wannan gwajin asibiti na mataki na uku[2] (NCT05341609), karkashin jagorancin Farfesa Zhao Ren na Asibitin Shanghai Ruijin, Farfesa Gaoyuan na Asibitin Renji na Shanghai da kuma Malamin Jami'a Ning Guang na Asibitin Shanghai Ruijin, a lokacin barkewar cutar da Omicron variant (B.1.1.529) ya haifar daga Maris zuwa Mayu a Shanghai, da nufin kimanta inganci da amincin VV116 da Paxlovid don maganin farko ga marasa lafiya da COVID-19 mai sauƙi zuwa matsakaici. Manufar ita ce a tantance inganci da amincin VV116 da Paxlovid don maganin farko ga marasa lafiya da COVID-19 mai sauƙi zuwa matsakaici.

Tushen hoto: Bayani na 2

An gudanar da wani gwaji mai cike da mutane 822, masu lura da marasa lafiya, waɗanda aka yi musu kallon marasa lafiya, waɗanda aka tsara bisa ga tsari, wanda aka tsara bisa ga tsari, tsakanin 4 ga Afrilu da 2 ga Mayu 2022 don tantance cancantar mahalarta daga asibitoci bakwai a Shanghai, China. A ƙarshe, mahalarta 771 sun karɓi ko dai VV116 (384, 600 mg a kowace sa'o'i 12 a rana ta 1 da 300 mg a kowace sa'o'i 12 a rana ta 2-5) ko Paxovid (387, 300 mg nimatuvir + 100 mg ritonavir a kowace sa'o'i 12 na tsawon kwanaki 5) a matsayin maganin da ake sha.

Sakamakon wannan binciken asibiti ya nuna cewa magani da wuri da VV116 don COVID-19 mai sauƙi zuwa matsakaici ya cika babban ƙarshen (lokacin zuwa warkewa mai ɗorewa na asibiti) wanda aka annabta ta hanyar ka'idar asibiti: matsakaicin lokacin zuwa warkewa na asibiti shine kwanaki 4 a cikin ƙungiyar VV116 da kwana 5 a cikin ƙungiyar Paxlovid (rabowar haɗari, 1.17; 95% CI, 1.02 zuwa 1.36; ƙarancin iyaka. >0.8).

Kula da lokacin murmurewa na asibiti

Ƙarshen inganci na farko da na sakandare (cikakken bincike na yawan jama'a)

Tushen hoto: Bayani na 2

Dangane da aminci, mahalarta da suka karɓi VV116 sun ba da rahoton ƙarancin abubuwan da suka faru marasa kyau (67.4%) fiye da waɗanda suka karɓi Paxlovid (77.3%) a bin diddigin kwanaki 28, kuma yawan abubuwan da suka faru marasa kyau na aji 3/4 ya yi ƙasa da na VV116 (2.6%) fiye da na Paxlovid (5.7%).

Abubuwan da suka faru marasa kyau (mutane masu aminci)

Tushen hoto: Bayani na 2

Tambayoyi da muhawara

A ranar 23 ga Mayu, 2022, Juniper ya bayyana cewa binciken asibiti na matakin III na VV116 da PAXLOVID don maganin COVID-19 mai sauƙi zuwa matsakaici (NCT05341609) ya cika babban burin bincikensa.

Tushen Hoto: Bayani na 1

A lokacin da babu cikakkun bayanai game da gwajin, takaddamar da ke tattare da binciken Mataki na III ta kasance iri biyu: na farko, bincike ne na makafi ɗaya, kuma idan babu maganin placebo, ana fargabar cewa zai yi wuya a yi hukunci kan maganin gaba ɗaya da gaskiya; na biyu, akwai tambayoyi game da ƙarshen binciken.

Sharuɗɗan shiga asibiti na Juniper sune (i) sakamako mai kyau na sabon gwajin kambi, (ii) alamu ɗaya ko fiye masu sauƙi ko matsakaici na COVID-19, da kuma (iii) marasa lafiya da ke cikin haɗarin kamuwa da COVID-19 mai tsanani, gami da mutuwa. Duk da haka, babban abin da za a yi la'akari da shi a asibiti shi ne 'lokacin da za a ci gaba da murmurewa a asibiti'.

Kafin sanarwar, a ranar 14 ga Mayu, Juniper ya sake duba ƙarshen asibiti ta hanyar cire ɗaya daga cikin manyan ƙarshen asibiti, "kason canzawa zuwa rashin lafiya mai tsanani ko mutuwa" [3].

Tushen Hoto: Bayani na 1

An kuma yi magana musamman kan waɗannan manyan batutuwa guda biyu da aka yi jayayya a kansu a cikin binciken da aka buga.

Saboda barkewar cutar Omicron kwatsam, ba a kammala samar da allunan placebo na Paxlovid ba kafin fara gwajin, don haka masu binciken ba su iya gudanar da wannan gwajin ta amfani da tsarin makafi biyu, mai tsari biyu ba. Dangane da ɓangaren makafi ɗaya na gwajin asibiti, Juniper ya ce an gudanar da tsarin ne bayan sadarwa da hukumomin da ke kula da lafiya kuma ƙirar makafi ɗaya tana nufin cewa mai binciken (gami da mai kimanta ƙarshen binciken) ko mai tallafawa ba za su san takamaiman rabon magungunan magani ba har sai an kulle bayanan ƙarshe a ƙarshen binciken.

Har zuwa lokacin nazarin ƙarshe, babu ɗaya daga cikin mahalarta gwajin da ya taɓa fuskantar mutuwa ko ci gaba zuwa wani mummunan lamari na Covid-19, don haka babu wani ƙarshe da za a iya yankewa game da ingancin VV116 wajen hana ci gaba zuwa Covid-19 mai tsanani ko mai tsanani. Bayanan sun nuna cewa matsakaicin lokacin da aka kiyasta daga bazuwar zuwa ci gaba da koma baya na alamun da suka shafi Covid-19 shine kwanaki 7 (95% CI, 7 zuwa 8) a cikin ƙungiyoyin biyu (rabowar haɗari, 1.06; 95% CI, 0.91 zuwa 1.22) [2]. Ba shi da wahala a bayyana dalilin da ya sa aka cire babban maƙasudin 'yawan juyawa zuwa rashin lafiya mai tsanani ko mutuwa', wanda aka fara saitawa kafin ƙarshen gwajin.

A ranar 18 ga Mayu 2022, mujallar Emerging Microbes & Infections ta buga sakamakon gwajin asibiti na farko na VV116 a cikin marasa lafiya da suka kamu da cutar Omicron variant [4], wani bincike mai cike da mutane 136 da aka tabbatar sun kamu da cutar a cikin asibiti.

Bayanai daga binciken sun nuna cewa marasa lafiya da ke dauke da cutar Omicron waɗanda suka yi amfani da VV116 cikin kwanaki 5 bayan gwajin farko na nucleic acid mai kyau sun sami lokacin komawa ga nucleic acid na kwanaki 8.56, ƙasa da kwanaki 11.13 a cikin rukunin kulawa. Ba da VV116 ga marasa lafiya da ke da alamun cutar a cikin lokacin wannan binciken (kwanaki 2-10 na gwajin farko na nucleic acid mai kyau) ya rage lokacin komawa ga komawa ga nucleic acid a cikin dukkan marasa lafiya. Dangane da amincin magani, ba a ga wani mummunan sakamako ba a cikin rukunin jiyya na VV116.

Tushen Hoto: Bayani na 4

Akwai gwaje-gwajen asibiti guda uku da ake ci gaba da yi kan VV116, biyu daga cikinsu nazarin mataki na uku ne kan COVID-19 mai sauƙi zuwa matsakaici (NCT05242042, NCT05582629). Sauran gwajin don COVID-19 mai matsakaici zuwa mai tsanani wani bincike ne na asibiti na duniya mai cibiyoyi da yawa, bazuwar, mai makanta biyu-biyu na mataki na uku (NCT05279235) don kimanta inganci da amincin VV116 idan aka kwatanta da magani na yau da kullun. A cewar sanarwar Juniper, an yi wa majiyyaci na farko rajista kuma an ba shi allurar a watan Maris na 2022.

Tushen hoto:clinicaltrials.gov

Nassoshi:

[1]Junshi Biotech: Sanarwa kan babban ƙarshen binciken asibiti na Mataki na III na VV116 da PAXLOVID don maganin COVID-19 mai sauƙi zuwa matsakaici

[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, Xian Zhang, Yi Zhang Gang 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) Bayanin kamuwa da cututtukan Omicron da matsayin allurar rigakafi a tsakanin masu karɓar dashen hanta na 1881: ƙungiyar ci gaba mai ci gaba da yawa. Ƙungiyoyin Ƙira & Cututtuka 11:1, shafuffuka 2636-2644.