Ko ngā raraunga Wāhanga III mō te rongoā karauna waha hou a Haina i roto i te NEJM e whakaatu ana i te whai huatanga kāore i iti iho i te Paxlovid

I ngā hāora wawe o te 29 o Hakihea, i whakaputa a NEJM i runga ipurangi i tētahi rangahau haumanu wāhanga tuatoru hou mō te mate korona Hainamana hou VV116. I whakaatuhia e ngā hua kāore a VV116 i kino atu i a Paxlovid (nematovir/ritonavir) mō te roa o te whakaoranga haumanu, ā, he iti ake ngā pānga kino.

Pūtake Whakaahua: NEJM

Ko te wā whakaora toharite he 4 rā, ko te auau pānga kino he 67.4%

Ko te VV116 he rongoā ā-waha nucleoside anti-new coronavirus (SARS-CoV-2) i whakawhanakehia i te mahi tahi me Junsit me Wang Shan Wang Shui, ā, he aukati RdRp me te remdesivir a Gilead, te molnupiravir a Merck Sharp & Dohme me te azelvudine a Real Biologics.

I te tau 2021, i oti te whakamātautau haumanu wāhanga tuarua o VV116 i Uzbekistan. I whakaatuhia e ngā hua o te rangahau ka taea e te rōpū VV116 te whakapai ake i ngā tohu haumanu me te whakaiti nui i te mōrearea o te haere whakamua ki te āhua kino me te mate ki te whakataurite ki te rōpū whakahaere. I runga i ngā hua pai o tēnei whakamātautau, kua whakaaetia a VV116 i Uzbekistan mō te maimoatanga o ngā tūroro e pāngia ana e te COVID-19 ngawari ki te kino, ā, koia te rongoā manawa hou tuatahi kua whakaaetia mō te hokohoko ki tāwāhi i Haina [1].

I oti tēnei whakamātautau haumanu wāhanga tuatoru[2] (NCT05341609), i arahina e Ahorangi Zhao Ren o te Hōhipera Shanghai Ruijin, Ahorangi Gaoyuan o te Hōhipera Shanghai Renji me te Kaiako Ning Guang o te Hōhipera Shanghai Ruijin, i te wā o te pakarutanga i puta mai i te momo Omicron (B.1.1.529) mai i Maehe ki Mei i Shanghai, me te whāinga ki te aromatawai i te whai huatanga me te haumaru o VV116 ki a Paxlovid mō te maimoatanga wawe o ngā tūroro me te COVID-19 ngawari ki te ngawari. Ko te whāinga he aromatawai i te whai huatanga me te haumaru o VV116 ki a Paxlovid mō te maimoatanga wawe o ngā tūroro me te COVID-19 ngawari ki te ngawari.

Pūtake ahua: Tohutoro 2

I whakahaerehia he whakamātautau matapōkere, he whakamātautau whakahaere-matapōkere, he whakamātautau maha-pokapū, o ngā tūroro Covid-19 pakeke e 822 e tino mōrearea ana ki te haere whakamua me ngā tohu ngawari ki te whakaōrite i waenga i te 4 o Paenga-whāwhā me te 2 o Mei 2022 hei aromatawai i te tika o ngā kaiuru mai i ngā hōhipera e whitu i Shanghai, Haina. I te mutunga, i whiwhi ngā kaiuru e 771 i te VV116 (384, 600 mg ia 12 hāora i te rā 1 me te 300 mg ia 12 hāora i ngā rā 2-5) i te Paxovid rānei (387, 300 mg nimatuvir + 100 mg ritonavir ia 12 hāora mō ngā rā 5) hei rongoā ā-waha.

I whakaatuhia e ngā hua o tēnei rangahau haumanu ko te maimoatanga wawe ki te VV116 mō te COVID-19 ngawari ki te whakaōrite i tutuki i te pito mutunga tuatahi (te wā ki te whakaora haumanu tonu) i matapaetia e te kawa haumanu: ko te wā toharite ki te whakaora haumanu he 4 rā i te rōpū VV116 me te 5 rā i te rōpū Paxlovid (ōwehenga mōrearea, 1.17; 95% CI, 1.02 ki te 1.36; rohe iti. >0.8).

Te pupuri i te wā whakaora haumanu

Ngā mutunga whai huatanga tuatahi me te tuarua (tātari whānui o te taupori)

Pūtake ahua: Tohutoro 2

Mō te haumaru, he iti ake ngā pānga kino i puta mai i ngā kaiuru i whiwhi VV116 (67.4%) i ērā i whiwhi Paxlovid (77.3%) i te whai muri i ngā rā 28, ā, he iti ake te auau o ngā pānga kino o te Tau 3/4 mō VV116 (2.6%) i tō Paxlovid (5.7%).

Ngā āhuatanga kino (ngā tāngata haumaru)

Pūtake ahua: Tohutoro 2

Ngā tautohetohe me ngā pātai

I te 23 o Mei, 2022, i whakaatu a Juniper kua tutuki te rangahau haumanu rēhitatanga Wāhanga III o VV116 me PAXLOVID mō te maimoatanga wawe o te COVID-19 ngawari ki te whakaraerae (NCT05341609) i tana pito tuatahi o te rangahau.

Pūtake ahua: Tohutoro 1

I te wā kāore i te nui ngā taipitopito o te whakamātautau, e rua ngā tautohetohe e pā ana ki te rangahau Wāhanga III: tuatahi, he rangahau matapo kotahi, ā, i te korenga o te mana whakahaere placebo, i wehingia he uaua ki te aromatawai i te rongoā i runga i te whakaaro tika; tuarua, i pātaihia ngā pātai mō ngā mutunga haumanu.

Ko ngā paearu whakauru haumanu mō Juniper ko (i) ngā hua pai mō te whakamātautau karauna hou, (ii) tētahi, neke atu rānei o ngā tohu COVID-19 ngawari, āhua rānei, me (iii) ngā tūroro e tino mōrearea ana ki te COVID-19 kino, tae atu ki te mate. Heoi, ko te mutunga haumanu matua anake ko te 'wā ki te whakaora haumanu tonu'.

I mua tata tonu i te panuitanga, i te 14 o Mei, i whakahoutia e Juniper ngā pito mutunga haumanu mā te tango i tētahi o ngā pito mutunga haumanu matua, arā, "te ōwehenga o ngā huringa ki te mate kino, ki te mate rānei" [3].

Pūtake ahua: Tohutoro 1

I arohia anō hoki ēnei take tautohetohe matua e rua i roto i te rangahau kua whakaputaina.

Nā te pakarutanga ohorere o Omicron, kāore i oti te hanga papa placebo mō Paxlovid i mua i te tīmatanga o te whakamātautau, nō reira kāore i taea e ngā kairangahau te whakahaere i tēnei whakamātautau mā te whakamahi i tētahi hoahoa matapo-rua, tauira-rua. Mō te taha matapo-kotahi o te whakamātautau haumanu, i kī a Juniper i whakahaerehia te kawa i muri i te whakawhitiwhiti kōrero ki ngā mana whakahaere, ā, ko te tikanga o te hoahoa matapo-kotahi kāore te kairangahau (tae atu ki te kaiaromatawai o te pito whakamutunga o te rangahau) me te kaitautoko e mōhio ki te tohatoha rongoā rongoā motuhake tae noa ki te raka o te pātengi raraunga whakamutunga i te mutunga o te rangahau.

Tae noa ki te wā o te tātaritanga whakamutunga, kāore tetahi o ngā kaiuru i te whakamātautau i pāngia e te mate, i te whanaketanga rānei ki tētahi mate kino o te Covid-19, nō reira kāore e taea te whakatau i te whai huatanga o te VV116 ki te aukati i te whanaketanga ki te mate kino, ki te mate kino rānei o te Covid-19. I whakaatuhia e ngā raraunga ko te wā waenga i whakatauhia mai i te whakarōpūtanga matapōkere ki te hokinga whakamuri tonu o ngā tohumate e pā ana ki te Covid-19 he 7 ngā rā (95% CI, 7 ki te 8) i roto i ngā rōpū e rua (ōwehenga mōrearea, 1.06; 95% CI, 0.91 ki te 1.22) [2]. Ehara i te mea uaua ki te whakamārama he aha i tangohia ai te pito whakamutunga matua o te 'tere o te tahuritanga ki te mate kino, ki te mate rānei', i whakatakotoria tuatahitia i mua i te mutunga o te whakamātautau.

I te 18 o Mei 2022, i whakaputaina e te puka Emerging Microbes & Infections ngā hua o te whakamātautau haumanu tuatahi o VV116 i roto i ngā tūroro i pangia e te momo Omicron [4], he rangahau whānui, tirohanga whakamua me te 136 tūroro kua whakapumautia.

I whakaatuhia e ngā raraunga mai i te rangahau ko ngā tūroro i pangia e te mate Omicron i whakamahi i te VV116 i roto i ngā rā e 5 i muri i tā rātou whakamātautau waikawa karihi pai tuatahi, he 8.56 ngā rā i pau ki te hoki whakamuri te waikawa karihi, he iti iho i te 11.13 ngā rā i roto i te rōpū whakahaere. Nā te tukunga o te VV116 ki ngā tūroro he tohumate i roto i te wā o tēnei rangahau (2-10 ngā rā o te whakamātautau waikawa karihi pai tuatahi) i whakaiti i te wā ki te hoki whakamuri te waikawa karihi i roto i ngā tūroro katoa. Mō te haumaru o te rongoā, kāore i kitea he pānga kino nui i roto i te rōpū maimoatanga VV116.

Pūtake ahua: Tohutoro 4

E toru ngā whakamātautau haumanu kei te haere tonu mō VV116, e rua o ēnei he rangahau wāhanga III mō te COVID-19 ngawari ki te whakaōrite (NCT05242042, NCT05582629). Ko tētahi atu whakamātautau mō te COVID-19 ngawari ki te kino he rangahau haumanu wāhanga III matapōkere-rua, maha-pokapū o te ao (NCT05279235) hei aromatawai i te whai huatanga me te haumaru o VV116 ki te whakataurite ki te maimoatanga paerewa. E ai ki te panuitanga a Juniper, i whakaurua te tūroro tuatahi, ā, i hoatu he horopeta ki a ia i te marama o Poutū-te-rangi 2022.

Pūtake whakaahua: clinicaltrials.gov

Ngā Tohutoro：

[1]Junshi Biotech: Pānui mō te mutunga matua o te rangahau haumanu rehita Wāhanga III o VV116 ki te PAXLOVID mō te maimoatanga wawe o te COVID-19 ngawari ki te ngawari

[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, Junao Jianming, Ximingu, Ximingo 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) Te ahua o nga mate o Omicron me te tuunga kano kano i waenga i nga kaiwhiwhi i te tau 1881: he roopu whakamuri o te pokapu maha. Emerging Microbes & Infections 11:1, api 2636-2644.