Peb-Xyoo Qib III Cov Ntaub Ntawv Soj Ntsuam Ntawm GlaxoSmithKline Qhov Ob-hauv-ib qho Tshuaj Dovato (DTG / 3TC)

ViiV Kev Noj Qab Haus Huv yog kev tshawb nrhiav kab mob HIV / AIDS tshuaj thiab kev txhim kho tshuaj uas tswj los ntawm GlaxoSmithKline (GSK), Pfizer (Pfizer) thiab Shionogi (Shionogi). Tsis ntev los no, lub tuam txhab tshaj tawm 3-xyoo cov ntaub ntawv ntawm 2 theem III kev tshawb fawb (GEMINI 1& 2) ntawm cov tshuaj sib txuas Dovato (dolutegravir / lamivudine, DTG / 3TC, 50mg / 300mg) ntawm HIV Glasgow 2020 lub rooj sib tham.

Dovato ua tiav, ib zaug-ib-hnub, ib leeg-ntsiav tshuaj, ob-tshuaj noj tshuaj (2DR), suav nrog cov koob tshuaj dolutegravir (DTG, 50mg) thiab lamivudine (3TC, 300mg), uas nyob rau hauv: DTG yog tus kabmob HIV Kev sib xyaw cov saw hloov mus ua ke (INSTI) txwv tsis pub kis tus kabmob HIV los ntawm kev tiv thaiv DNA kis kabmob los ntawm kev txuam nrog cov khoom ntawm caj ces ntawm tib neeg lub cev tiv thaiv kab mob (T cell). 3TC yog nucleoside thim rov qab transcriptase inhibitor (NRTI). Nws feem ntau yog siv ua ke nrog lwm cov tshuaj tiv thaiv kev kho mob kom kho tus mob HIV.

Txog rau tam sim no, Dovato tau pom zoo: rau kev kho mob thawj zaug (kho kab-thawj tus kab mob) HIV-1 thiab rau kev tiv thaiv virological (kho kab mob thib ob) HIV-1 kis. Vim tias kev nce qib hauv kev kho, tam sim no cov neeg muaj mob HIV tuaj yeem cia siab tias yuav nyob ntev npaum li cov neeg zoo tib yam, tab sis cov neeg mob zoo li no tseem muaj txoj sia nyob mus ib txhis los tswj kev tiv thaiv mob virological. Dovato yog thawj qhov ua tiav, ib zaug-ib-hnub, ib-ntsiav tshuaj, ob-tshuaj noj tshuaj (2DR) pom zoo, uas tuaj yeem txo cov neeg kis rau ARV tshuaj los ntawm kev pib kho (kho thawj kab), thaum tswj hwm txheej txheem ib txwm peb Qhov ua tau zoo ntawm kev siv tshuaj thiab cov tshuaj tiv thaiv siab.

GEMINI-1 thiab GEMINI-2 cov kev tshawb fawb yog qhov rov ua dua, kev xaiv, ob qhov muag tsis pom kev, ntau qhov chaw, cov pab pawg sib tw, cov pab pawg tsis tau kawm qib III. Kwv yees li ntawm 1,400 tus neeg mob uas muaj kabmob HIV-1 kis tsawg dua 500,000 daim qauv / mL tau sau npe Kev Kho-tsis muaj tus kabmob HIV-1 cov neeg laus muaj mob, tsom mus soj ntsuam xyuas qhov 2-zaug ib hnub tshuaj (2DR, DTG / 3TC) piv rau tus qauv ua ntej -line 3-tshuaj noj tshuaj (3DR, dolutegravir thiab 2 nucleosides) ntawm HIV-1 Siv tau zoo thiab kev nyab xeeb ntawm kev thim rov qab transitorase inhibitor tenofovir disoproxil fumarate / emtricitabine [TDF / FTC], DTG + TDF / FTC). Lub hauv paus xaus yog qhov tsis muaj qhov tsis zoo ntawm qhov kev faib ua feem ntawm cov neeg mob uas ua tiav kev tiv thaiv kab mob (plasma HIV-1 RNA< 50="" daim="" ntawv="" ml)="" ntawm="" 48="" lub="" lim="" tiam="" ntawm="" kev="" kho="" mob.="" cov="" theem="" ob="" yog="" cov="" kev="" faib="" ua="" feem="" ntawm="" cov="" neeg="" mob="" txhawm="" rau="" tua="" lub="" lim="" tiam="" 24,="" lim="" tiam="" 96,="" thiab="" lub="" lim="" tiam="">

Peb lub xyoo cov ntaub ntawv tso tawm hauv lub rooj sib tham no tau qhia tias ntawm cov neeg mob HIV-1 cov neeg laus uas tau kho tshiab, 2DR (DTG / 3TC) txuas ntxiv qhia qhov tsis muaj qhov tsis zoo, piv nrog 3DR (DTG + TDF / FTC), hauv cov lus hais ntawm ua tau zoo. Muaj peev xwm tiv taus siab thiab sib piv cov kev nyab xeeb.

Tshwj xeeb, kev sib cais ntawm kev tshawb fawb ntawm ob qhov kev tshawb fawb pom tau tias nyob rau 144 lub lim tiam ntawm kev kho mob, hauv kev soj ntsuam kev sib tham-lub hom phiaj-rau-kho (ITT-E) cov neeg, 82% (584/716) ntawm 2DR kho pawg tau saib xyuas tus mob viralical suppression. (Plasma HIV-1 RNA< 50="" daim="" qauv="" ml),="" 3dr="" kho="" pawg="" yog="" 84%="" (599/717),="" thiab="" qhov="" ua="" tau="" pom="" tias="" tsis="" muaj="" qhov="" ua="" tsis="" tau="" zoo="" (kho="" qhov="" sib="" txawv:="" -1.8="" [95%="" ci:="" -5.8%,="" 2.1%]).="" txoj="" kev="" ntsuas="" nyab="" xeeb="" thiab="" thev="" taus="" thiab="" ua="" raws="" cov="" ntaub="" ntawv="" dhau="">

Ib qho ntxiv, 2DR cov kev pabcuam txuas ntxiv ua rau pom qhov muaj zog tiv thaiv kev tiv thaiv kev kho mob. Qhov feem pua ​​ntawm cov neeg mob uas lees paub tus mob thim rov qab (CVW) txhais los ntawm cov qauv qhia txog kev tshawb fawb yog 1.7% (12/716) hauv 2DR cov pawg tswj hwm thiab 1.3% (9/717) hauv 3DR regimen pawg. Tsis muaj leej twg ntawm cov neeg mob no qhia tias cov kev tsis taus hloov los ntawm kev kho mob. Ib tug tsis yog CVW tus neeg mob uas tau txais 2DR raws tu qauv tau tsim M184V thiab R263R / K tsis kam hloov ua ntej nres txoj kev tshawb no.

Qhov xwm txheej ntawm tag nrho cov xwm txheej tsis zoo (AE) zoo sib xws ntawm ob pawg, thiab qhov tshwm sim ntawm tshuaj tiv thaiv AEs hauv 2DR kho pawg tau qis dua qhov ntawd hauv pawg kho mob 3DR (20% [146/716] vs 27% [ Xyoo 192/717]. Hauv kev tshawb fawb, Muaj 4 tus neeg tuag (3/716 tus neeg hauv 2DR kho mob thiab 1/717 tus mob hauv 3DR kho pawg), txhua tus tau suav hais tias tsis cuam tshuam rau txoj kev kawm txog tshuaj kho qhov muag. qhia pom lub peev xwm rau kev ua haujlwm ntev txog pob txha thiab lub raum: Hloov pauv ntawm pob txha thiab lub raum kev ua haujlwm cim tom qab lub hauv paus, 2DR cov kev cai txuas ntxiv qhia tau zoo dua li 3DR cov kev tswj hwm kom txog rau thaum 144 lub lis piam.

Tus kws tshawb nrhiav tseem ceeb ntawm GEMINI kev tshawb fawb, Pedro Cahn, MD, tus xibfwb ntawm cov kabmob kis kabmob ntawm Tsev Kawm Ntawv University of Buenos Aires Lub Tsev Kawm Ntawv ntawm Tshuaj, hais tias:" Cov ntaub ntawv tshawb fawb ntev no tau lees tias DTG-based ob-tshuaj kev tswj hwm (2DR) ) yog cov lus qhia nyob hauv daim ntawv qhia txog kab mob HIV. Qhov chaw nyob. Piv nrog rau cov tshuaj muaj peb-cov tshuaj (3DR), 2DR kev tswj hwm tseem ua rau pom ntev mus ntev uas tsis muaj qhov ua tsis tau zoo, thiab nws cov txiaj ntsig tau dhau los ntawm kev tiv thaiv kab mob. Txawm hais tias qhov tshwm sim tag nrho ntawm cov kev tshwm sim tsis zoo hauv txhua pawg yog qhov zoo sib xws, 2DR txoj kev tswj hwm muaj tsawg dua qhov tsis zoo Cov kws kho mob cia siab tias ua pov thawj tias DTG-based 2DR tuaj yeem kho tus kab mob HIV-na adultve laus neeg mob ntev ntev. Tam sim no muaj pov thawj pom tias txoj haujlwm no muaj txiaj ntsig tiag."

Dovato tau pom zoo ua ntej los ntawm Asmeskas FDA thaum lub Plaub Hlis 2019 yog kev coj ua tiav rau cov neeg laus muaj tus mob HIV-1 (kho thawj kab) uas tsis tau txais kev kho mob (kev kho mob thaum ntxov). Tshwj xeeb: cov neeg laus HIV-1 uas tsis muaj keeb kwm ntawm kev kho mob ARV thiab tsis paub txog kev siv tshuaj tiv thaiv rau DTG lossis 3TC. Hauv xyoo 2019, Asmeskas Chaw Haujlwm Saib Xyuas Kev Noj Qab Haus Huv thiab Tib Neeg (DHHS)" Cov Neeg Loj thiab Kev Pab Cuam Tshuam Tshuaj Tiv Thaiv" suav nrog Dovato nyob rau hauv cov npe kab kho mob thawj zaug. Nov yog thawj zaug uas DHHS pom zoo kom ua 2-tshuaj noj tshuaj hauv kev kho thawj zaug.

Lub Yim Hli 2020, FDA tau pom zoo nthuav dav Dovato qhov kev pabcuam ua tiav rau kev kho mob rau tus neeg mob HIV-1 uas tau ua tiav kev tiv thaiv mob viav-voos (kho ob-kab), tshwj xeeb: ua tiav cov haujlwm kom tau txais Kev Tshuaj Tiv Thaiv Kab Mob (ARV) ruaj khov ) kev tswj hwm tau ua tiav kev tswj hwm voos (HIV-1 RNA< 50="" daim="" ntawv="" ml),="" tsis="" muaj="" keeb="" kwm="" ntawm="" kev="" kho="" mob="" tsis="" ua="" haujlwm,="" thiab="" tsis="" paub="" txog="" kev="" siv="" tshuaj="" tiv="" thaiv="" rau="" txhua="" ntu="" ntawm="" dovato.="" -1="" cov="" neeg="" muaj="" hnub="" nyoog="" kis="" mob,="" hloov="" lawv="" cov="" kev="" pabcuam="" arv="" tam="" sim="">

Hauv Tebchaws Europe thiab lwm lub tebchaws, Dovato tau pom zoo: rau kev kho thaum xub thawj (kho kab mob thib ib) thiab cov tshuaj tua kabmob (kho kab thib ob) HIV-1 kis, tshwj xeeb: hnub nyoog> Tsis pub muaj hnub nyoog 12 xyoos, hnyav ≥ 40 kg, tawm tsam integrase Tsis muaj cov paub lossis xav tias tsam cov neeg siv tshuaj tiv thaiv thiab cov laus muaj tus kabmob HIV-1 nrog tshuaj tiv thaiv lossis 3TC.

Dovato yuav ua rau cov neeg muaj mob HIV-1 txo cov tshuaj ARV uas lawv noj txhua hnub thaum tswj kev ua tau zoo thiab muaj tshuaj tiv thaiv kab mob siab, piv rau tenofovir cov tshuaj uas muaj tsawg kawg yog peb cov tshuaj. Cov tshuaj yuav pab cov neeg laus kis tus kabmob HIV-1 tswj hwm tus kabmob tsis tau txais tus kabmob thib peb.