Gilead Epclusa Tau Pom Zoo Los Ntawm Asmeskas FDA Rau Siv Hauv Cov Menyuam ≥3 Xyoo!

Tsis ntev los no Gilead Sciences tau tshaj tawm tias Asmeskas Khoom Noj thiab Tshuaj Yeeb Tshuaj (FDA) tau pom zoo nthuav dav kev qhia menyuam yaus ntawm tus kab mob siab C tshuaj Epclusa (sofosbuvir/velpatasvir) kom suav nrog cov neeg mob menyuam yaus uas muaj kab mob siab C nyob rau hnub nyoog ≥3 xyoos, tsis hais HCV noob hom lossis qhov mob hnyav ntawm daim siab.

FDA tau pom zoo qhov ncauj qhov ncauj tshiab ntawm Epclusa (sofosbuvir/velpatasvir, 200mg/50mg, 150mg/37.5mg), uas tau tsim tshwj xeeb rau cov menyuam yaus uas tsis tuaj yeem nqos tau cov ntsiav tshuaj. Hais txog kev siv tshuaj, qhov pom zoo koob tshuaj Epclusa rau menyuam yaus hnub nyoog 3 xyoos yog ua raws lub cev hnyav thiab lub siab ua haujlwm.

Nws tsim nyog hais tias Epclusa tsuas yog cov protease inhibitor-free, pan-genotype HCV txoj kev kho mob tau pom zoo rau kev kho tus kab mob siab C rau cov neeg mob thaum muaj hnub nyoog 3 xyoos. Hauv Tebchaws Meskas, raws li xyoo 2018, kwv yees li 35-40 txhiab tus menyuam tau kis tus kabmob HCV, thiab qhov xwm txheej tau nce ntxiv. Kev sib kis ntawm niam-rau-menyuam yog feem ntau ua rau kis HCV hauv menyuam yaus. Txij xyoo 2009 txog 2017, kev sib kis ntawm niam-rau-menyuam tau nce 161%. Hauv cov poj niam uas muaj hnub nyoog muaj menyuam, kev siv tshuaj txhaj tshuaj yog lub hauv paus loj ntawm kev kis tus kab mob HCV.

Epclusa yog lub ntiaj teb' thawj qhov ncauj, yias-genotype, ib hom ntsiav tshuaj kab mob siab C kho ib zaug, ib hnub ib zaug rau tag nrho 6 yam genotypes (GT-1, -2, -3, -4, -5 , -6) Kho tus neeg mob siab hom C. Cov tshuaj no yog tsim los ntawm Gilead tus kab mob siab C lub hnub qub tshuaj Sovaldi (sofosbuvir) thiab lwm yam tshuaj tiv thaiv kab mob, velpatasvir. Ntawm lawv, sofosbuvir yog nucleoside analog polymerase inhibitor, thiab velpatasvir yog yias-genotype NS5A inhibitor. Nws yuav tsum tau taw qhia tias daim ntawv tshuaj Epclusa tau nrog lub thawv dub ceeb toom, qhia tias cov tshuaj muaj kev pheej hmoo rov kis tus kab mob siab B (HBV) hauv cov neeg mob uas muaj kab mob siab C/kab mob siab B (HCV/HBV).

Epclusa tau pom zoo rau kev lag luam thaum Lub Rau Hli 2016. Nrog rau qhov kev pom zoo zaum kawg no, cov tshuaj no haum rau menyuam yaus thiab cov neeg laus hnub nyoog ≥3 xyoos uas muaj tus kab mob HCV genotype 1-6 tus kab mob: (1) Epclusa monotherapy rau 12 lub lis piam, nrog rau cov neeg mob siab C cirrhosis lossis nrog mob siab them (tus menyuam-Pugh A); (2) Epclusa ua ke nrog ribavirin (RBV) rau 12 lub lis piam rau kev kho mob nrog decompensated cirrhosis (Child-Pugh Class B lossis C) cov neeg mob siab C.

Qhov kev pom zoo no yog ua raws cov ntaub ntawv los ntawm Phase II qhib-daim ntawv lo kuaj mob. Qhov kev sim cuv npe rau 41 tus menyuam hnub nyoog 3-6 xyoos uas tau kho nrog Epclusa rau 12 lub lis piam. Cov txiaj ntsig tau pom tias 12 lub lis piam tom qab kho tiav, raws li tus kab mob genotype, tus kab mob kho tus kab mob ntawm Epclusa 12-lub lim tiam kev tswj hwm (SVR12): 88% (28/32) rau hom 1 HCV kis thiab 50 rau hom 2 tus kab mob HCV% (3/6), 100% (2/2) ntawm hom 3 HCV tus kab mob, thiab 100% (1/1) ntawm hom 4 HCV kis. Ntawm 7 tus neeg mob tsis tau kho, txhua tus neeg mob tau nres kho tsis pub dhau 1-20 hnub tom qab pib kho.

Hauv txoj kev tshawb fawb no, kev nyab xeeb ntawm Epclusa hauv menyuam yaus hnub nyoog qis dua 3 txog 6 xyoos yog ib puag ncig zoo ib yam nrog cov txiaj ntsig ntawm cov neeg laus kuaj mob. Cov teeb meem ntuav thiab siv cov khoom lag luam (nto qaub ncaug tshuaj) tau tshwm sim hauv 15% thiab 10% ntawm cov neeg mob menyuam yaus, feem; cov kev tsis zoo no tau me me (Qib 1 lossis 2) thiab ua rau 5 tus menyuam (12%) txiav kev kho mob.

Dr. Merdad Parsey, Tus Thawj Saib Xyuas Kev Noj Qab Haus Huv ntawm Gilead, hais tias:" Gilead tseem mob siab rau txhawb nqa kev tshem tawm tus kab mob siab C (HCV). FDA qhov kev txiav txim siab niaj hnub no los nthuav kev kho rau cov menyuam muaj tus kab mob HCV sawv cev rau kev vam meej rau lub hom phiaj no. Qhov kev pom zoo no ntxiv cov pov thawj kho mob txhawm rau txhawb kev nyab xeeb thiab ua haujlwm tau zoo ntawm Epclusa hauv ntau cov neeg mob, suav nrog cov uas muaj kab mob hauv lub raum kawg thiab txhua theem ntawm fibrosis."

Gilead: cov khoom siv kab mob siab hom C thib 4, txhua qhov pom zoo rau npe hauv Suav teb

Gilead tau tsim plaub tiam ntawm cov khoom lag luam rau kab mob siab C, txhua tus tau pom zoo rau kev lag luam hauv Suav teb:

—— Nyob rau lub Cuaj Hli 25, 2017, Sovaldi (sofosbuvir, 400mg ntsiav tshuaj) tau pom zoo, suav nrog lwm yam tshuaj, rau kev kho mob puv-genotype (1-6) kab mob siab C kab mob rau cov neeg laus thiab cov hluas thaum muaj hnub nyoog 12-18. Qhov kev pom zoo no ua rau Sovaldi thawj qhov tshuaj tiv thaiv kab mob siab C raug lees paub los ntawm Gilead hauv Suav teb;

—— Nyob rau lub Tsib Hlis 30, 2018, Epclusa (sofosbuvir/velpatasvir, 400mg/100mg ntsiav tshuaj) tau pom zoo rau kev kho cov neeg laus nrog genotype 1-6, sib xyaw thiab tsis paub mob HCV ntev. Qhov kev pom zoo no tso cai rau Epclusa (Bingtongsha) dhau los ua Tuam Tshoj' thawj lub yias-gene HCV ib lub ntsiav tshuaj program.

—— Thaum Lub Kaum Ob Hlis 4, 2018, Harvoni (ledipasvir/sofosbuvir) tau pom zoo rau kev kho cov neeg laus uas muaj tus kab mob siab C (HCV) kis ntawm hom 1-6 thiab cov hluas hnub nyoog 12-18.

—— Thaum Lub Kaum Ob Hlis 18, 2019, Vosevi (sofosbuvir/velpatasvir/voxilaprevir, SOF/VEL/VOX, 400mg/100mg/100mg) tau pom zoo rau kev siv tshuaj tiv thaiv kab mob ncaj qha (DAA) kho uas ua tsis tiav thiab ua tsis tiav. Rov kho cov neeg laus uas muaj tus mob cirrhosis lossis tus kab mob siab C (HCV) kis tus kab mob cirrhosis.

Ntawm cov hais los saum toj no hais txog 4 hom kab mob siab C, Sovaldi feem ntau hu ua&"Jiyiyi &";, Harvoni feem ntau hu ua&"; Jiji tiam thib ob &", Epclusa yog feem ntau hu ua" Jiji peb tiam", thiab Vosevi feem ntau hu ua&"; Jiji plaub tiam &"; Ntawm lawv," Ji 4th tiam" Vosevi yog lub ntiaj teb' thawj zaug ib zaug ib hnub ntsiav tshuaj pom zoo raws li kev kho mob kho mob tshwj xeeb rau cov neeg mob siab mob siab C, thiab nws tseem yog qhov kawg ntawm Gilead's SOF-based HCV direct-acting antiviral (DAA) tshuaj yeeb rau .

Nws tsim nyog sau cia tias muaj lub npov dub ceeb toom txuas rau daim ntawv lo ntawm plaub lub tshuaj hauv Asmeskas, qhia tias cov tshuaj yuav ua rau muaj kev pheej hmoo rov tshwm sim ntawm tus kab mob siab hom B (HBV) hauv cov neeg mob uas muaj kab mob siab C/kab mob siab B (HCV/HBV) ) kev sib kis.