Tivicay PD (dotegravir dispersible tablets) yog yuav tau txais kev pom zoo hauv EU: kho cov neeg mob ≥ 4 lub lis piam thiab kg 3 kg!

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) thiab Pfizer thiab Shionogi. Tsis ntev los no, lub tuam txhab tshaj tawm tias Pawg Neeg Saib Xyuas Kev Noj Tshuaj hauv Tebchaws Europe (EMA) rau Cov Khoom Siv Tshuaj rau Cov Neeg Siv (CHMP) tau tshaj tawm cov lus pom zoo hais tias Tivicay 5mg dispersible ntsiav tshuaj (dolutegravir, dispersible ntsiav tshuaj rau lub qhov ncauj tawm) tau txais kev pom zoo. Cov tshuaj ib hnub ib zaug, tsim nyog rau kev sib xyaw nrog lwm cov tshuaj tiv thaiv kab mob, rau kev kho mob hnub nyoog ≥ 4 lub lis piam, hnyav ≥ 3 kg, tsis muaj kev kho yav dhau los (kev kho mob-naive) lossis tau txais kev kho mob (kev paub txog-kev kho mob), tab sis Cov Menyuam muaj HIV- 1 tus kab mob uas tsis tau txais cov kab mob sib kis transferase inhibitor txoj kev kho (INSTI-naive, INSTI). Ib qho ntxiv, CHMP cov lus pom zoo rau kev soj ntsuam tseem suav nrog kev hloov kho cov tshuaj tswv yim ntawm Tivicay (10mg, 25mg, 50mg) cov tshuaj yeeb yaj kiab rau cov menyuam yaus HIV-1 hnub nyoog ≥6 xyoo thiab hnyav ≥14 kg. Qhov no yuav pom zoo nrog Lub Koom Haum Ntiaj Teb Kev Noj Qab Haus Huv. (LEEJ TWG) Qhov ntsuas qhov hnyav yog xwm yeem.

CHMP cov tswv yim yuav muab xa mus rau European Commission (EC) rau kev tshuaj xyuas, uas yuav tsum ua qhov kev txiav txim siab zaum kawg li ntawm ob lub hlis tom ntej no. Hais txog kev cai Asmeskas, Tivicay PD (dotegravir dispersible tablets) tau pom zoo los ntawm FDA rau lub Rau Hli xyoo no rau cov kab mob HIV-1 cov menyuam yaus uas muaj hnub nyoog ≥4 lis, hnyav ≥3 kg, kho tshiab lossis kho tab sis INSTI nyuam qhuav kho 者 群。 Ntxiv rau, FDA kuj pom zoo nthuav dav cov cim ntawm Tivicay 50mg zaj duab xis-coated rau cov kab mob HIV rau cov menyuam muaj kabmob kis tus kabmob weigh20 kg.

Nws yog tsim nyog teev tias Tivicay PD yog thawj dolutegravir ntawm dispersible ntsiav tshuaj tsim qauv pom zoo los ntawm FDA. Nyob rau tib lub sijhawm, dolutegravir tseem yog thawj cov tshuaj tiv thaiv kev puas tsuaj uas tuaj yeem siv los ua cov ntsiav tshuaj tawg rau kev tshem tawm qhov ncauj rau kev kho mob ntawm cov menyuam muaj hnub nyoog ≥ 4 lub lis piam thiab hnyav ≥ 3 kg.

Hauv Tebchaws Meskas thiab European Union, dolutegravir tau pom zoo yav tas los siv rau cov menyuam yaus ≥ 6 xyoo thiab hnyav ≥ 30 kg. Los ntawm kev muab cov qauv tsim nyog rau cov hnub nyoog rau cov hluas, nws yuav nthuav dav ntawm dolutegravir thiab nws yuav pab tau qhov sib txawv nruab nrab ntawm cov kev xaiv kho mob HIV rau cov neeg laus thiab menyuam.

Hauv Suav Teb, dolutegravir (Dolutegravir Sodium ntsiav tshuaj, lub npe lag luam: Tevikai) tau txais daim ntawv tso npe rau daim ntawv tso npe rau lub Kaum Ob Hlis 30, 2015. Cov tshuaj no tsim nyog rau: ua ke nrog lwm cov tshuaj tiv thaiv kev kho mob rau tib neeg cov tshuaj tiv thaiv kab mob HIV (HIV) cov neeg laus thiab menyuam yaus. dhau 12 xyoos.

Kab mob HIV tseem nyob thoob ntiaj teb, thiab cov menyuam yaus kis tus kabmob HIV ntau dua. Cov ntaub ntawv zaum kawg qhia tau hais tias 1.7 lab cov menyuam yaus tau kis tus kabmob HIV, thiab feem ntau ntawm cov neeg tuag uas muaj kabmob AIDS rau cov menyuam tseem muaj nyob rau thawj 5 xyoos tomqab yug los. Rau cov menyuam yaus, cov teeb meem tseem ceeb, xws li txuas ntxiv leej niam mus rau menyuam, muaj kev kuaj HIV, pib qeeb ntawm kev kho, thiab tsis muaj qhov zoo txog kev txiav txim siab tshuaj tiv thaiv kab mob.

CHMP cov tswv yim zoo yog txiav txim siab los ntawm cov ntaub ntawv los ntawm kev kawm P1093 txuas ntxiv thiab ODYSSEY (PENTA20) txoj kev kawm. Cov kev tshawb fawb no tau ua haujlwm koom tes nrog International Pediatric Research Network (IMPAACT thiab PENTA-ID) hauv cov menyuam mos, menyuam yaus thiab tub ntxhais hluas muaj tus kabmob HIV-1 hnub nyoog qis dua 4 lub lis piam mus txog 18 xyoo. Cov ntaub ntawv qhia tias muaj kev nyab xeeb, ua haujlwm tau zoo, thiab cov khw muag tshuaj ntawm Tivicay thiab Tivicay cov ntsiav tshuaj hauv cov menyuam yaus sib piv rau cov neeg mob hauv cov neeg laus noj dolutegravir. Hauv 24 lub lim tiam ntawm kev kho mob, 62% ntawm cov menyuam yaus mob kho nrog Tivicay thiab Tivicay PD muaj kev tiv thaiv kab mob kis tsis tau (tus kab mob HIV tsis nyob hauv ntshav); nyob rau ntawm 48 lub lim tiam ntawm kev kho mob, 69% ntawm cov menyuam yaus mob lub nra qhov muag tsis paub txog. Feem ntau, cov kws kho mob hauv cov menyuam yaus muaj cov qib siab dua ntawm cov hlwb (CD4 hlwb) uas pab lub cev tua kab mob.

Deborah Waterhouse, CEO ntawm ViiV Kho Mob, hais tias: “Kev tshawb fawb hauv chaw kho mob hauv cov menyuam yaus yog qhov nyuaj. Tsuas yog nrog kev txhawb nqa ntawm peb cov neeg mob siab tshawb nrhiav peb tuaj yeem ncav cuag lub sijhawm ntawd. Qhov kev xav zoo ntawm CHMP yog rau cov neeg hluas. Kev nthuav dav kev siv cov dolutegravir hauv nruab nrab qhib kev vim tias cov ntsiav tshuaj tuaj yeem sib kis hauv dej, ua rau nws yooj yim rau menyuam yaus noj tshuaj."

Amanda Ely, CEO ntawm Koomhaum Pabcuam HIV Rau Cov Menyuam (CHIVA), tau hais tias: “Xyoo tsis ntev los no, cov kabmob HIV tshiab peb pom nyob hauv menyuam yaus tau poob qis, uas ua pov thawj rau ntau qhov kev koom tes thiab kev siv zog los ntawm ntau tus neeg koom nrog thoob plaws ntiaj teb. Txawm li cas los xij, cov menyuam yaus Txoj kev loj hlob thiab muaj ntawm tus qauv tsim phooj ywg poob qab cov neeg laus. Nrog kev txhawb nqa kom ua raws li kev kho mob kom tau txais txiaj ntsig, kev kuaj mob sai sai thiab kev siv tshuaj yeeb yog qhov tseem ceeb rau kev muaj sia nyob ntawm 1.8 lab cov menyuam yaus muaj tus kabmob HIV thoob ntiaj teb."