I-Novel Drug Iyakwazi Ukwelapha Zonke Izintambo ezingu-6 emavikini angu-8
I-Mavyret (i-glecapravir, i-pibrentasvir) iyinzalo ehlanganisiwe yokuhlanganiswa kwezidakamizwa ezisetshenziswa ekwelapheni ukutheleleka okungapheli kwe- hepatitis C (HCV) . Izidakamizwa ezisetshenziselwa umsebenzi weMavyret ngokuvimbela amaprotheni amabili amabili okumele igciwane lidinga ukuliphindaphinda.
U-Mavyret wamukelwa ngo-Agasti 3, 2017 yi-US Food and Drug Administration ukusetshenziselwa abantu abadala 18 nangaphezulu. Ucwaningo lubonisa ukuthi izidakamizwa zingakwazi ukufeza amazinga okuphulukisa phakathi kwamaphesenti angu-92 namaphesenti angu-100 kuye ngokuthi i-HCV subtype, isibalo esincane kakhulu noma esingaphambene neminye imithi yokulwa namagciwane ngokuqondile (DAAs) okwamanje esetshenziswa ekwelapheni kwe-hepatitis C.
Ubuhle nobubi
UMavyret uyakwazi ukuphatha zonke izinhlobo ze-HCV eziyisithupha ( genotypes ) futhi zingasetshenziswa kokubili kubantu abangakaze bavezwe izidakamizwa ze-HCV nalabo abaye bahluleka ukwelashwa ngaphambilini. Ngaphezu kwalokho, lesi sidakamizwa singasetshenziswa kubantu abane- cirrhosis ehlawulisiwe (lapho isibindi sisasebenza khona).
U-Mavyret unenzuzo eyodwa ebalulekile ngaphezu kwezidakamizwa ezifanayo ngoba angaphatha ukutheleleka okungapheli kwesifo sofuba esibhedlela esingamaviki ayisishiyagalombili. Zonke ezinye izidakamizwa zidinga amasonto angu-12 angaphansi kwamagciwane asanda kuphathwa. Lokhu kuhlanganisa inhlanganisela ye-HCV yezidakamizwa e- Epclusa ephinde ivunyelwe kuwo wonke ama-genotypes ayisithupha.
Nokho, ngokungafani ne-Epclusa, i-Mavyret ayikwazi ukusetshenziselwa abantu abane-cirrhosis ekhulelwe (abanikazi babo abangekho ukusebenza).
Omunye umehluko oyinhloko uyinani . Nakuba izidakamizwa ezinjengo-Epclusa zithwala imali engama-dollar ayi-75,000 efundweni (noma i-$ 890 iphilisi ngalinye), uMavyret unikezwa ngamaRandi angu-26,400 kwi-course yamaviki angu-8 (noma i-$ 439 i-tablet ngayinye).
Ukuhlukana kwentengo kungahle kwanele ukukholisa abaqinisekisi bezempilo ukuba bandise ukwelashwa kubantu baseMelika abayizigidi ezingu-3.9 abangenwa yi-HCV, abaningi babo okufanele balinde kuze kube khona ukukhubazeka okubalulekile kwesibindi ngaphambi kokuba kutholakale ukwelashwa.
Ukubeka izincomo
Izinga eliphakanyisiwe likaMavyret lamathebulethi amathathu athathwa kanye ngosuku ngokudla.
Ithebhulethi ngayinye iqukethe ama-milligram angu-100 we-glecaprevir nama-milligram angu-40 we-pibrentasvir. Amaphilisi anemibala ephuzi, i-oblong-shaped, ifilimu-eboshwe, futhi ekhonjiswa nge "NXT" ngakolunye uhlangothi.
Ubude bokwelashwa buhluka nge-genotype ye-HCV, isipiliyoni sezokwelapha, nesimo sesibindi sesiguli, kanje:
- Ngaphambi kokungaphendulwa ngaphandle kwe-cirrhosis: amasonto ayisishiyagalombili
- Ngaphambi kokungaphendulwa nge-cirrhosis ekhokhelwa: amasonto angu-12
- Ngaphambilini waphathwa nge-HCV genotype 1, 2, 4, 5, no-6 ngaphandle kwe-cirrhosis: amasonto ayisishiyagalombili kuya kwangu-16 kuye ngokuthi ukwelashwa kwangaphambilini
- Iphethwe ngaphambilini nge-HCV genotypes 1, 2, 4, 5, no-6 nge-cirrhosis ekhokhelwa: amasonto angu-12 kuya kwangu-16 kuye ngokuthi ukwelashwa kwangaphambilini
- Ngaphambilini waphathwa nge-HCV genotype 3 noma ngaphandle kwe-cirrhosis: amasonto angu-16
Cishe amaphesenti angama-75 aseMelika ane-hepatitis C ane-genotype 1, okuyinto evelele kakhulu kodwa futhi eyinkimbinkimbi kunayo yonke yokwelapha. Ngokuphambene, amaphesenti angama-20 no-25 anama-genotype 2 no-3, kuyilapho kuphela okuncane okuncane kunama-genotypes 4, 5, noma ayisithupha.
Okuqhamuka uma udla imishanguzo
Ama-DAA asanda kuzalwa njengama-Mavyret anemiphumela emibi kakhulu kunezokwelapha zangaphambili, eziningi zazo zihlanganisa i- interferon ye- drug ( peginterferon ) ne- ribavirin . Imiphumela emibi kakhulu ehlobene noMavyret (eyenzeka ezingaphezu kwamaphesenti angaphezu kwamaphesenti amahlanu) kufaka:
- Izinwele
- Ukukhathala
- I-nausea
- Uhudo
Ngokuvamile, imiphumela emibi iphathekayo futhi ijwayele ukuthuthukisa ngokuhamba kwesikhathi. Eqinisweni, ucwaningo olungakafiki emakethe luphethe ngokuthi amaphesenti angaphansi kweyodwa kubantu eMavyret ayeke ukwelashwa ngenxa yemiphumela emibi engasabeki.
Ukusebenzisana kwezidakamizwa
Ukusetshenziswa kwemithi e-rifampin, esetshenziselwa ukwelapha isifo sofuba, iphikisana nokusetshenziswa noMavyret futhi kufanele ishiywe ngaphambi kokuqala ukwelashwa. Lezi zihlanganisa izidakamizwa ngamagama okuthiwa ama-Mycobutin, Rifater, Rifamate, Rimactane, Rifadin, no-Priftin.
Ezinye izidakamizwa ziyaziwa ukuthi zisebenzisana noMavyret futhi zingase zandise noma zinciphise ukuhlushwa kweMavyret egazini.
Okulandelayo akukhuthazwa ukuthi kusetshenziswe no-Mavyret:
- I-Carbamepazine, eyayisetshenziselwa ukwelashwa nokugula kwengqondo
- I-Ethinyl estradiol (estrogen) -ihambisana nemithi yokulawula ukubeletha
- Sustiva (efavirenz) esetshenziselwa ukwelashwa kwe-HIV
- I-Atorvastatin, i-lovastatin, ne-simvastatin esetshenziselwa ukwelapha i-cholesterol ephezulu
- Wort St. John's Wort
Ukukhubazeka kwesibindi
U-Mavyret uphikisana nokusetshenziswa kwabantu abanokukhubazeka kwesibindi (njengoba kulinganiswa ngamanothi we-Child-Pugh ka C) futhi akukhuthazwa kunoma ubani onokukhubazeka okulinganayo (Child-Pugh B).
Ukuhlolwa kokusebenza kwesibindi kunconywa ngaphambi kokuqala kokwelapha ukugwema izinkinga. Amaphuzu we-Child-Pugh nawo ayasiza ekunqumeni ubukhulu besifo sesibindi esekelwe ekuhlolweni kwegazi nokubuyekezwa kwezibonakaliso zezici.
Ukuvuselelwa kwe-Hepatitis B
I-Mavyret kufanele isetshenziswe ngokucophelela kubantu abane-hepatitis B ne-hepatitis C. I- virus ye-hepatitis B (i-HBV) iye yaziwa ukuthi iyasebenza noma ngokushesha ngemuva kokwelashwa. Ukuvuselelwa kungase kuhambisane nezimpawu ze-jaundice nokuvuvuka kwesibindi. Uma ukwelashwa kungavali ngokushesha, ukuvuselelwa kungaholela ekuhlulekeni kwesibindi ngisho nokufa.
Nakuba ukutheleleka kwe-HBV akuphikisana nokusetshenziswa kukaMavyret, kuzodinga ukuqapha ngokucophelela ama-enzyme yesibindi ukukhomba izimpawu zokuqala zokuvuselela.
Ekukhulelweni
Ngesikhathi uMavyret engathinteki ekukhulelweni, kunemininingwane encane yomtholampilo etholakalayo ukuhlola ingozi yangempela. Ngalokho kuthiwa, izifundo zezilwane ziye zabonisa ukuthi ukusetshenziswa kwe-glecaprevir ne-pibrentasvir ngesikhathi sokukhulelwa akuhlotshaniswa nokukhubazeka kwe-fetus, kufaka phakathi ukuvezwa ngesikhathi sokuncelisa.
Ukubonisana okhethekile kunconywa ukuba kungabi nje ukukala izinzuzo nezingozi zokwelapha kodwa ukusiza ukuthi ubone ukuthi ukwelashwa kuyindaba yokuphuthuma noma into engabambezeleka kuze kube yilapho sekulethwe.
Ukuvimbela ukukhulelwa ngenkathi ukwelashwa, imibhangqwana iyelulekwa ukuthi isebenzise okungenani izindlela ezimbili ezingekho ze-hormone zokuvimbela ukukhulelwa ngesikhathi nangaphezulu kwezinyanga eziyisithupha emva kokuphela kokugula. Njengoba ukulawulwa kwe-estrogen-based based is not recommended, khuluma nodokotela wakho ukuze ubone ukuthi ukubeletha komlomo kuphela kwe-progestin kungaba yindlela efanelekile.
> Imithombo:
> Abbie, Inc. "Amaphuzu avelele ekuchazeni ulwazi: amaphilisi e-Mavyret (glecaprevir ne-pibrentasvir) , okusetshenziselwa ngomlomo Ukwamukelwa kokuqala kwe-US: 2017." I-Chicago, i-Illinois; ibuyekeziwe ngo-December 2017.
> Foster, G .; I-Gane, E .; Asatryan, A. et al. "UKUQALA-3: ukuphepha nokusebenza kwe-glecaprevir / pibrentasvir uma kuqhathaniswa ne-sofosbuvir kanye ne-daclatasvir ezithombeni eziphethwe yi-HCV ye-HCV yesifo esine-3 ngaphandle kwe-cirrhosis." J Hepatol. 2017; 66 (I-Suppl 1): S33.
> Ukuphathwa Kwezokudla Nezidakamizwa zase-US. "I-FDA ivumela i-Mavyret nge-Hepatitis C." I-Silver Spring, e-Maryland; ikhishwe ngo-Agasti 3, 2017.