amakuru

Uyu munsi, umushinwa wateje imbere ibiyobyabwenge bigenzurwa n’umwanya muto wa molekile, Zenotevir, uri ku kibaho. NEJM>. Ubu bushakashatsi bwatangajwe nyuma y’icyorezo cya COVID-19 n’icyorezo cyinjiye mu cyiciro gishya cy’icyorezo gisanzwe, kigaragaza inzira y’ubushakashatsi bw’amavuriro y’imiti yatangijwe mu gihe cy’icyorezo, kandi gitanga uburambe bwiza bwo kwemeza byihutirwa icyorezo cy’indwara zandura.

Ubwinshi bw'indwara ziterwa na virusi zandurira mu myanya y'ubuhumekero ni nini, harimo kwandura ibimenyetso simusiga, kwandura ibimenyetso (indwara zoroheje cyangwa zoroheje zidafite ibitaro), bikomeye (bisaba ibitaro), n'urupfu. Byaba byiza iyi ntera yo kwitegereza ivuriro ishobora gushyirwa mubigeragezo byo kwa muganga kugirango isuzume ibyiza by’imiti igabanya ubukana bwa virusi, ariko ku kibazo kigenda kigabanuka cyane mu gihe cy’icyorezo, ni ngombwa guhitamo icyerekezo cy’ibanze cy’ibanze no gusuzuma neza ingaruka z’imiti igabanya ubukana bwa virusi.

Intego z'ubushakashatsi ku miti igabanya ubukana bwa virusi zirashobora kugabanywa cyane mu kugabanya imfu, guteza imbere indwara zikomeye, kugabanya indwara zikomeye, kugabanya igihe cy'ibimenyetso no kwirinda kwandura. Mubyiciro bitandukanye byicyorezo, amavuriro yanyuma yatoranijwe akenshi aratandukanye cyane. Kugeza ubu, nta virusi ya Covid-19 yagaragaye ko ari nziza mu kugabanya imfu no guteza imbere indwara zikomeye.

Ku miti igabanya ubukana bwa COVID-19, Nematavir / Ritonavir yakoze EPIC-HR (NCT04960202) [1], EPIC-SR (NCT05011513) na EPIC-PEP (NCT05047601). Intego eshatu kwari ukugabanya indwara zikomeye, kugabanya igihe cyibimenyetso no kwirinda kwandura. Nematavir / ritonavir yerekanwe gusa na EPIC-HR kugirango igabanye uburwayi bukomeye, kandi nta gisubizo cyiza cyabonetse ku mpande ebyiri zanyuma.

Hamwe n’imihindagurikire y’icyorezo cya COVID-19 muri omicron no kwiyongera gukabije kw’inkingo, ikibazo cyo kohereza ibiro mu matsinda y’ibyago byinshi cyaragabanutse ku buryo bugaragara, kandi biragoye kubona ibisubizo byiza hifashishijwe igishushanyo mbonera gisa na EPIC-HR hamwe no kwimura ibiro nkiherezo. Kurugero, NEJM yasohoye ubushakashatsi bugereranya kuri VV116 na Nematavir / Ritonavir [2] bwerekana ko iyambere itameze nabi nyuma yanyuma mugihe cyigihe cyo gukira kwa muganga kubantu bakuze bafite Covid-19 yoroheje kandi yoroheje bafite ibyago byo gutera imbere. Nyamara, igeragezwa ryambere ryamavuriro ya VV116 ryakoresheje guhindura ibiro nkibisubizo by’inyigisho, kandi hamwe n’ihindagurika ryihuse ry’icyorezo, byari bigoye kureba umubare wari uteganijwe. Ubu bushakashatsi bwerekana ko uburyo bwo gusuzuma imikorere yubuvuzi bushya nibisobanuro byanyuma bigomba gukoreshwa nkigipimo cyo gusuzuma isuzuma ryabaye ikibazo cyingenzi cyubushakashatsi bwamavuriro mugihe habaye ihindagurika ryindwara byihuse, cyane cyane kugabanya umuvuduko wo guhindura ibiro.

Ikigeragezo cya Nematavir / Ritonavir EPIC-SR, cyafashe ibimenyetso 14 COVID-19 kandi bigakoresha igihe cyo gukemura ibimenyetso nkibiherezo, nabyo byatanze umusaruro mubi. Turashobora gukora hypotheses eshatu: 1. Ibipimo ngenderwaho byizewe, bivuze ko nematavir ntacyo ikora mugutezimbere ibimenyetso byubuvuzi bya COVID-19; 2. Ibiyobyabwenge bifite akamaro, ariko ibipimo byingirakamaro ntabwo byizewe; 3. Ibipimo ngenderwaho ntabwo byizewe, kandi ibiyobyabwenge nabyo ntacyo bikora muriki cyerekezo.

Mu gihe Ubushinwa bwigenga bushya bwa Covid-19 imiti igabanya ubukana bwa virusi ivuye muri laboratoire ikajya mu cyiciro cy’ibizamini by’amavuriro, duhura n’ikibazo gikomeye - kutagira ibipimo ngenderwaho by’isuzuma ry’amavuriro. Birazwi neza ko buri kintu cyingenzi cyibishushanyo mbonera by’amavuriro ari byo, kandi birashoboka kwerekana akamaro k'ibiyobyabwenge. Uburyo bwo gutekereza kuri ibyo bisubizo bibi byerekana niba ibiyobyabwenge byigenga by’Ubushinwa bishobora gutsinda.

Niba igihe cyo kubura ibimenyetso bya Covid-19 kitari iherezo ryiza ryo gusuzuma imiti igabanya ubukana bwa SARS-CoV-2, bivuze ko imiti yigenga y’Ubushinwa ishobora gukomeza gusuzuma no kugabanya uburemere kugira ngo yerekane ko ikora neza, kandi uyu muhanda w’ubushakashatsi n’iterambere uzarangira nyuma y’uko icyorezo kirangiye vuba kwandura isi ndetse n’ubudahangarwa bw’amatungo. Idirishya ryo kugera ku ntego zubushakashatsi bwamavuriro hamwe nuburemere bworoshye nkuko iherezo ryibanze rifunga.

Ku ya 18 Mutarama 2023, icyiciro cya 2-3 cy’amavuriro yo kuvura indwara yoroheje yoroheje kandi yoroheje ya coronavirus yanduye na Cenotevir yakozwe na Cao Bin n'abandi. yasohotse mu kinyamakuru cyitwa New England Journal of Medicine (NEJM) [3]. Ubushakashatsi bwabo bwerekana ubwenge bwuburyo bwo gutsinda ikibazo cyo gusuzuma imikorere yimiti ya virusi ya COVID-19 mugupima kwa muganga.

Iyi ivuriro, yanditswe ku mavuriro.gov ku ya 8 Kanama 2021 (NCT05506176), ni yo ya mbere igenzurwa na platbo yo mu cyiciro cya 3 ivuriro ry’abashinwa kavukire bashya barwanya COVID-19. Muri iki cyiciro 2-3-impumyi zibiri, ziteganijwe, zigenzurwa na platbo, abarwayi bafite COVID-19 yoroheje kandi yoroheje mugihe cyiminsi 3 itangiye bahabwa 1: 1 kubwa senotovir / ritonavir yo mu kanwa (750 mg / 100 mg) kabiri kumunsi cyangwa umwanya wiminsi 5. Iherezo ryibanze ryibanze ryigihe cyo gukemura ibimenyetso 11 byingenzi, ni ukuvuga gukira ibimenyetso byamaze iminsi 2 bitagarutse.

Duhereye kuri iyi ngingo, turashobora kubona iherezo ry '“ibimenyetso 11 byingenzi” byindwara zoroheje. Abashakashatsi ntibakoresheje ibimenyetso 14 bya COVID-19 byerekana ibizamini bya kliniki ya EPIC-SR, cyangwa ngo bakoreshe uburemere nkibintu byambere.

Abarwayi 1208 ni bo biyandikishije, 603 muri bo boherejwe mu itsinda rishinzwe kuvura senotevir na 605 mu itsinda rishinzwe kuvura ibibanza. Ibyavuye mu bushakashatsi byagaragaje ko mu barwayi ba MIT-1 bahawe imiti mu masaha 72 uhereye igihe batangiriye, igihe cyo gukemura ibimenyetso bya COVID-19 mu itsinda rya senotevir cyari kigufi cyane ugereranije n’itsinda rya placebo (amasaha 180.1 [95% CI, 162.1-201.6] ni amasaha 216.0 [95% CI, 203.4-228.1]; P = 0.006). Ku munsi wa 5 wo kwiyandikisha, kugabanya umutwaro wa virusi kuva kuri baseline byari byinshi mu itsinda rya senotevir kuruta mu itsinda rya placebo (bivuze itandukaniro [± SE], −1.51 ± 0.14 log10 kopi / ml; 95% CI, −1.79 kugeza kuri 1.24). Byongeye kandi, ibyavuye mu bushakashatsi mu bice byose byanyuma ndetse n’isesengura ry’abaturage mu matsinda byerekanaga ko zenotevir ishobora kugabanya igihe cy’ibimenyetso ku barwayi ba COVID-19. Ibisubizo byerekana neza ko Cenotevir ifite inyungu zikomeye muriki cyerekezo.

Igifite agaciro cyane muri ubu bushakashatsi nuko ifata ingingo nshya yo gusuzuma imikorere. Turashobora kubona kuva kumugereka wimpapuro ko abanditsi batanze umwanya utari muto kugirango berekane ubwizerwe bwiyi ndunduro, harimo guhuza ingamba zasubiwemo ibimenyetso 11 byingenzi, hamwe nibimenyetso 14. Abaturage bafite intege nke, cyane cyane abafite ibibazo by’ubuvuzi n’abafite umubyibuho ukabije, bungukirwa cyane n’ubushakashatsi. Ibi biremeza ko ubushakashatsi bwizewe buva mu mpande nyinshi, kandi bikerekana ko Cenotevir yavuye ku gaciro k’ubushakashatsi igera ku gaciro k’ubuvuzi. Isohora ry'ibyavuye muri ubu bushakashatsi bidufasha kubona intsinzi y'abashakashatsi b'Abashinwa kugira ngo bakemure mu buryo bwa gihanga ibibazo bizwi ku rwego mpuzamahanga. Hamwe niterambere ryibiyobyabwenge bishya mugihugu cyacu, byanze bikunze tuzahura nibindi bibazo bisa nkibishushanyo mbonera byamavuriro bigomba gucika mugihe kizaza.