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A farkon sa'o'i na 29 ga Disamba, NEJM ta buga kan layi wani sabon binciken asibiti na III na sabon coronavirus na kasar Sin VV116. Sakamakon ya nuna cewa VV116 bai kasance mafi muni fiye da Paxlovid (nematovir / ritonavir) dangane da tsawon lokaci na farfadowa na asibiti kuma yana da ƙananan abubuwan da suka faru.
Tushen hoto: NEJM
Lokacin dawowa na tsaka-tsaki kwanaki 4, ƙimar aukuwar mara kyau 67.4%
VV116 magani ne na baka na nucleoside anti-sabon coronavirus (SARS-CoV-2) wanda aka haɓaka tare da haɗin gwiwar Junsit da Wang Shan Wang Shui, kuma mai hana RdRp ne tare da remdesivir na Gilead, Merck Sharp & Dohme's molnupiravir da Real Biologics' azelvudine.
A cikin 2021, an kammala gwajin gwaji na asibiti na kashi II na VV116 a Uzbekistan. Sakamakon binciken ya nuna cewa ƙungiyar VV116 na iya inganta haɓakar cututtuka na asibiti da kuma rage yawan haɗarin ci gaba zuwa nau'i mai mahimmanci da mutuwa idan aka kwatanta da ƙungiyar kulawa. Dangane da kyakkyawan sakamako na wannan gwaji, an amince da VV116 a Uzbekistan don kula da marasa lafiya masu matsakaici-zuwa mai tsanani na COVID-19, kuma ya zama sabon maganin cututtukan zuciya na farko da aka amince da shi don tallatawa a ketare a China [1].
An kammala wannan gwajin gwaji na asibiti na III [2] (NCT05341609), wanda Farfesa Zhao Ren na Asibitin Shanghai Ruijin ya jagoranta, Farfesa Gaoyuan na asibitin Shanghai Renji da kuma Academician Ning Guang na Asibitin Shanghai Ruijin, yayin barkewar cutar ta Omicron bambance-bambancen ( B.1.1.529) daga Maris zuwa Mayu a Shanghai, tare da manufar kimanta inganci da amincin VV116 tare da Paxlovid don farkon jiyya na marasa lafiya tare da COVID-19 mai sauƙi zuwa matsakaici. Manufar ita ce kimanta inganci da amincin VV116 tare da Paxlovid don farkon jiyya na marasa lafiya tare da COVID-19 mai sauƙi zuwa matsakaici.
Tushen hoto: Magana 2
An gudanar da wani cibiya da yawa, makafi, bazuwar, gwajin gwaji na manya 822 na marasa lafiya Covid-19 da ke cikin haɗarin ci gaba kuma tare da alamu masu sauƙi zuwa matsakaici tsakanin 4 ga Afrilu da 2 ga Mayu 2022 don tantance cancantar mahalarta daga asibitoci bakwai a Shanghai. China. Daga ƙarshe, mahalarta 771 sun karɓi ko dai VV116 (384, 600 MG kowane sa'o'i 12 a rana 1 da 300 MG kowane sa'o'i 12 a ranakun 2-5) ko Paxovid (387, 300 mg nimatuvir + 100 mg ritonavir kowane awa 12 na kwanaki 5) kamar yadda maganin baka.
Sakamakon wannan binciken na asibiti ya nuna cewa farkon jiyya tare da VV116 don sauƙi zuwa matsakaici COVID-19 ya sadu da ƙarshen ƙarshen ƙarshen (lokaci don ci gaba da farfadowa na asibiti) wanda ka'idar asibiti ta annabta: lokacin tsaka-tsaki zuwa farfadowa na asibiti shine kwanaki 4 a cikin rukunin VV116 da 5. kwanaki a cikin rukunin Paxlovid (haɗarin haɗari, 1.17; 95% CI, 1.02 zuwa 1.36; ƙananan iyaka. > 0.8).
Kula da lokacin dawowa na asibiti
Ƙarshen inganci na farko da na biyu (cikakkiyar nazarin yawan jama'a)
Tushen hoto: Magana 2
Dangane da aminci, mahalarta da ke karɓar VV116 sun ba da rahoton ƙarancin abubuwan da ba su da kyau (67.4%) fiye da waɗanda ke karɓar Paxlovid (77.3%) a biyo bayan kwanaki 28, kuma abubuwan da suka faru na Grade 3/4 sun kasance ƙasa da VV116 (2.6%) fiye da na Paxlovid (5.7%).
Abubuwan da ba su dace ba (mutane masu aminci)
Tushen hoto: Magana 2
Rigingimu da tambayoyi
A ranar Mayu 23, 2022, Juniper ya bayyana cewa binciken asibiti na rajista na Phase III na VV116 tare da PAXLOVID don farkon jiyya na COVID-19 mai sauƙi zuwa matsakaici (NCT05341609) ya haɗu da ƙarshen bincikensa na farko.
Tushen hoto: Magana 1
A lokacin da ba a sami cikakkun bayanai game da shari'ar ba, takaddamar da ke tattare da binciken na Mataki na III ya kasance sau biyu: na farko, nazarin makafi ne kuma, in babu wani wuribo, ana jin tsoron cewa zai yi wuya a yi hukunci. da miyagun ƙwayoyi gaba daya haƙiƙa; abu na biyu, akwai tambayoyi game da ƙarshen asibiti.
Sharuɗɗan haɗar asibiti na Juniper sune (i) sakamako mai kyau don sabon gwajin kambi, (ii) ɗaya ko fiye masu laushi ko matsakaicin alamun COVID-19, da (iii) marasa lafiya da ke cikin haɗarin COVID-19 mai tsanani, gami da mutuwa. Koyaya, kawai ƙarshen ƙarshen asibiti na farko shine 'lokacin dorewar farfadowa na asibiti'.
Kafin sanarwar, a ranar 14 ga Mayu, Juniper ya sake duba ƙarshen ƙarshen asibiti ta hanyar cire ɗaya daga cikin mahimman abubuwan ƙarshe na asibiti, "yawan juzu'i zuwa rashin lafiya mai tsanani ko mutuwa" [3].
Tushen hoto: Magana 1
Wadannan manyan batutuwa guda biyu kuma an tattauna su musamman a cikin binciken da aka buga.
Sakamakon fashewar kwatsam na Omicron, ba a kammala samar da allunan placebo don Paxlovid ba kafin a fara gwajin sabili da haka masu binciken sun kasa gudanar da wannan gwajin ta amfani da makafi biyu, zane-zane biyu. Dangane da batun makafi guda daya na gwajin asibiti, Juniper ya ce an gudanar da ka'idar ne bayan sadarwa tare da hukumomin gudanarwa kuma tsarin makafi guda ɗaya yana nufin cewa ba mai binciken (ciki har da mai kimanta ƙarshen binciken) ko mai tallafawa ba zai sani ba. ƙayyadaddun ƙayyadaddun magungunan warkewa har sai an kulle bayanan ƙarshe a ƙarshen binciken.
Har zuwa lokacin bincike na ƙarshe, babu ɗaya daga cikin mahalarta gwajin da ya sami mutuwa ko ci gaba zuwa wani babban taron Covid-19, don haka ba za a iya yanke shawara game da ingancin VV116 don hana ci gaba zuwa mai tsanani ko mahimmanci Covid-19. ko mutuwa. Bayanan sun nuna cewa kiyasin lokacin tsaka-tsaki daga bazuwar zuwa ci gaba da koma bayan alamun alamun da ke da alaƙa da Covid-19 shine kwanaki 7 (95% CI, 7 zuwa 8) a cikin ƙungiyoyin biyu (rabin haɗari, 1.06; 95% CI, 0.91 zuwa 1.22) [2]. Ba shi da wahala a bayyana dalilin da ya sa aka cire farkon ƙarshen 'yawan tuba zuwa ga rashin lafiya mai tsanani ko mutuwa', wanda aka kafa tun kafin ƙarshen gwaji.
A ranar 18 ga Mayu 2022, mujallar Emerging Microbes & Infections ta buga sakamakon gwajin gwaji na farko na VV116 a cikin marasa lafiya da suka kamu da bambance-bambancen Omicron [4], buɗaɗɗen, binciken ƙungiyar haɗin gwiwa tare da 136 da aka tabbatar da marasa lafiya.
Bayanai daga binciken sun nuna cewa marasa lafiya tare da kamuwa da Omicron wadanda suka yi amfani da VV116 a cikin kwanaki 5 na gwajin gwajin nucleic acid na farko suna da lokaci zuwa farfadowar acid nucleic na kwanaki 8.56, kasa da kwanakin 11.13 a cikin ƙungiyar kulawa. Gudanarwa na VV116 ga marasa lafiya na alamun bayyanar cututtuka a cikin lokacin wannan binciken (2-10 kwanakin farko na gwajin gwajin nucleic acid) ya rage lokaci zuwa koma baya na acid nucleic a duk marasa lafiya. Dangane da amincin miyagun ƙwayoyi, ba a sami mummunan tasiri ba a cikin rukunin jiyya na VV116.
Tushen hoto: Magana 4
Akwai gwaje-gwajen asibiti guda uku masu gudana akan VV116, biyu daga cikinsu karatun na III ne akan COVID-19 mai sauƙi zuwa matsakaici (NCT05242042, NCT05582629). Sauran gwaji don matsakaita zuwa mai tsanani COVID-19 babban cibiya ce ta ƙasa da ƙasa, bazuwar, nazarin asibiti na kashi biyu na makafi (NCT05279235) don kimanta inganci da amincin VV116 idan aka kwatanta da daidaitaccen magani. Dangane da sanarwar Juniper, an yi wa mara lafiya na farko rajista kuma an saka shi a cikin Maris 2022.
Tushen hoto:clinicaltrials.gov
Magana:
[1] Junshi Biotech: Sanarwa a kan babban ƙarshen ƙarshen Mataki na III binciken asibiti na VV116 da PAXLOVID don farkon 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 , 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) 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.
Lokacin aikawa: Janairu-06-2023
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