Icyiciro cya III ku miti mishya y'ikamba ry'Ubushinwa muri Nejm yerekana imikorere ntabwo iri munsi ya paxlovid

Mu masaha ya mbere yo ku ya 29 Ukuboza, Nejm yatangarije kumurongo Icyiciro gishya cy'amavuriro y'intara III Inyigisho nshya y'Ubushinwa VV116. Ibisubizo byerekanye ko vv116 ntabwo ari bibi kurusha Paxlovir (Nematovir / Ritonavir) ukurikije igihe cyo gukira k'ubuvuzi kandi yari ifite ibintu bike.

Isoko ISOKO: Nejm

Igihe cyo Kugarura Median Igihe cya 4, Icyabaye kibi cyibyabaye 67.4%

VV116 ni umunwa nucleoside irwanya coronavirus (SARS-COV-COV) ku bufatanye na Rehibiletivir na Wang Shan Wang & Molnupiravir ya Galeedi, kandi Dohme Mollogics na biologique nyayo's Azelivudine.

Muri 2021, ikigeragezo cya PHASE II Clinical ya VV116 yarangiye muri Uzubekisitani. Ibyavuye mu bushakashatsi bwerekanye ko itsinda rya VV116 rishobora guteza imbere ibimenyetso by'amavuriro kandi bigabanya cyane ibyago byo gutera imbere ku buryo bukomeye n'urupfu ugereranije n'itsinda rishinzwe kugenzura. Hashingiwe ku bisubizo byiza by'iki kigeragezo, VV116 yemerewe muri Uzubekisitani kugira ngo aduhe abarwayi bo mu buke-buke kuri-manini.

Ikigeragezo cya III cya III [2] (NCT0534161609), iyobowe na Prof. Zhao Ren y'ibitaro bya Shanghai Ruiji yo gusuzuma imikorere n'umutekano wa VV116 na Paxlovid yo kuvura hakiri kare abarwayi boroheje Coving Corte-19. Ikigamijwe kwari ugusuzuma imikorere n'umutekano wa VV116 na Paxlovid wo kuvura hakiri kare COVTI-yoroheje yoroheje.

ISOKO RY'IMAGA: Reba 2

Indorerezi, indorerezi, ihumye, igenzurwa na 822 abakuze bo mu gihe cyo gutera imbere ndetse no mu rwego rwo kwitonda mu gihe cy'ujuje ibisabwa mu bitaro birindwi byo mu bitaro birindwi muri Shanghai. Ubwanyuma, abitabiriye 771 bahawe na VV116 (384, 600 mg buri masaha 12 kumunsi wa 12 na 300 mg buri masaha 12 muminsi 5) nkimitirizo.

Ibisubizo by'ubu bushakashatsi bwa clinique bwerekanye ko kuvurwa hakiri kare vv116 kugira ngo ihure kandi yoroheje yo kugenwa (igihe cyo kugarura amavuriro (igipimo cyo hagati mu matsinda ya PV11 (95% Ci, 1.02 kuri 1.> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).> 0.8).

Kubungabunga igihe cyo gukira

Iherezo ryambere nayisumbuye (Isesengura ryuzuye ryabaturage)

ISOKO RY'IMAGA: Reba 2

Ku bijyanye n'umutekano, abitabiriye amahugurwa bakira vv116 batangaje ibyabaye bike (67.4%) kuruta abahabwa Paxlovid (77.3%) ku rukurikirane rw'iminsi 3/16.

Ibintu bibi (abantu bafite umutekano)

ISOKO RY'IMAGA: Reba 2

Impaka n'ibibazo

Ku ya 23 Gicurasi 2022, Juniper yatangaje ko icyicaro cya III cyo kwiyandikisha cya VV116 cya Paxlovid cyo kuvura imbere yoroheje Cuta-Passite Corte-19 (NCT05341609) yahuye nicyiciro cyayo cyibanze.

ISOKO RY'IMAGA: Reba 1

Igihe cy'iburanisha rirambuyemo amakuru arambuye, impaka zikikije icyiciro cya III zari ebyiri: Ubwa mbere, byari ubushakashatsi buhumye kandi ko bwatinyaga kuyobora, byatijwe ko bigoye gucira urubanza ibiyobyabwenge neza; Icya kabiri, hari ibibazo bijyanye n'amavuriro.

Ibipimo bya kanseri yo muri juniper ni (i) ibisubizo byiza kubizamini bishya byikangu, (II) Ibimenyetso bya Coving cyangwa Ibimenyetso 19, hamwe na (19, harimo n'urupfu. Ariko, impesi yonyine yibanze irarangiye ni 'igihe cyo gukira kwavuza'.

Mbere yo gutangaza, ku ya 14 Gicurasi, Juniper yari yavuguruye imperuka akuraho imwe mu mpinga z'ibanze, "ugereranije no guhinduka indwara zikomeye cyangwa urupfu" [3].

ISOKO RY'IMAGA: Reba 1

Izi ngingo ebyiri zingenzi zo gutekereza kandi zandikiwe mu bushakashatsi bwasohoye.

Kubera icyorezo gitunguranye cya omirron, umusaruro w'abasangirano rya Paxlovid kuri Paxlovid ntibyari bimaze igihe bitangira kandi bityo abashinzwe iperereza ntibashoboye gukora uru rubanza bakoresheje igishushanyo kikubye kabiri, gushiramo kabiri. Ku bijyanye n'impumyi imwe y'urubanza rw'amavuriro, Juniper yavuze ko Porotokole yakorewe nyuma yo gutumanaho hamwe n'inzego zihariye zo kwiga kugeza igihe ubumuga bwa nyuma bufunze nyuma yo kwiga.

Kugeza ku gihe cy'isesengura rya nyuma, nta n'umwe mu bitabiriye urubanza wari uhuye n'urupfu cyangwa iterambere ry'ikiro rikabije rya Coviddre ya Covid ya Covid ya Covid ya Covingd ya VV116 mu gukumira iterambere rikomeye cyangwa rikomeye - 19 cyangwa urupfu. Amakuru yerekanaga ko igihe cyagereranijwe cyo hagati kiva mu nkunga kugira ngo ibimenyetso bihamye bya Retmest ya Covid-9) mu matsinda yombi (95% ci, 0.91 kugeza kuri 1.22) [2]. Ntabwo bigoye gusobanura impamvu iherezo ryibanze rya 'igipimo cyo guhindura indwara zikomeye cyangwa urupfu', washyizweho mbere yuko urubanza rurangira.

Ku ya 18 Gicurasi 2022, Ikinyamakuru gikomoka muri mikorobe & indwara zasohoye ibyavuye mu rubanza rwa mbere rwa VV116 mu barwayi banduye imiryango ya Ominroni.

Amakuru ava muri ubwo bushakashatsi bwerekanye ko abarwayi bafite ubwandu bwa omidron bakoresheje VV116 mugihe cyikizamini cya mbere cya acide cya mbere cyucle cyicle cyagize igihe cyo gusubira inyuma mu minsi 11,56, munsi yiminsi 11.13 mumatsinda 11.13 mumatsinda. Ubuyobozi bwa VV116 kubarwayi bafite ibimenyetso mugihe cyikigeragezo cyubushakashatsi (iminsi 2-10 yikizamini cya mbere cya acide. Ku bijyanye n'umutekano w'ibiyobyabwenge, nta ngaruka mbi zikomeye zagaragaye mu itsinda rya VV116.

ISOKO RY'IMAGA: Reba 4

Hariho ibigeragezo bitatu bikomeje kuvugwa kuri VV116, bibiri muri byo ni ibyiciro bya III byiga Cudique COVUTI - 19 (NCT05242042, NCT0582629). Ibindi bigeragezo bya Cyiza kugeza kuri Custom-19 ni byinshi mubantu benshi, byihutirwa, byimpumyi III ubuvuzi bwa III (Nct05279279235) gusuzuma imikorere n'umutekano wa VV116 ugereranije no kuvura bisanzwe. Nk'uko byatangajwe na Juniper, umurwayi wa mbere yiyandikishije kandi agafuzwa muri Werurwe 2022.

Isoko ISOKO: Clinicaltrials.gov

INGINGO:

[1] JINSHI bioch: Amatangazo ku mpera z'icyiciro cya PHAse III yanditseho imikorere ya VV116

[2] https://www.nejm.org/doi/upple/10.1056/nejmoa2208822/climiant XU, Hao Yin, Zhiren Fu, Hao Xing, Li li liw, Heyu Huang, Quan- . Inzitizi & Indwara 11: 1, urupapuro rwa 2636-2644.