I-Novel iDrug ekwazi ukujongana nayo yonke iintlobo ze-6 kwiiveki ezi-8
I-Mavyret (glecapravir, pibrentasvir) yinyango edibeneyo isilwanyana esisetyenziselwa unyango lwe- hepatitis C (HCV) . Iziyobisi ezisetyenziselwa umsebenzi waseMavyret ngokuthintela iiprotheni ezimbini ezifunekayo ukuba igqithise.
UMavyret wavunywa ngo-Agasti 3, 2017 yi-US Food and Drug Administration ukusetyenziswa kubantu abadala 18 nangaphezulu. Uphando lubonisa ukuba izidakamizwa ziyakwazi ukuphumeza amazinga okunyanga phakathi kwama-92 ekhulwini kunye neepesenti ezingama-100 kuxhomekeke kwi-subtype ye-HCV, umlinganiselo ophantsi okanye ophantsi ngokuhambelanayo namanye ama -anti-virus (DAAs) asebenza ngokuthe ngqo esetyenziswa kwi-hepatitis C unyango.
Okuhle nokubi
U-Mavyret uyakwazi ukuphatha zonke iintlobo ze-HCV ezintandathu (i- genotype ) kwaye zingasetyenziselwa kubini abantu abangazange bavezwe kwiidakamizwa ze-HCV kunye nalabo abaye balahleka unyango ngaphambili. Ngaphezu koko, isilwanyana singasetyenziselwa abantu abane- cirrhosis ehlawulwe (apho isibindi sisasebenza).
U-Mavyret unenzuzo enye ebalulekileyo kwizidakamizwa ezifanayo kuba unokuphatha ukusuleleka kwe-hepatitis C engapheliyo kwiiveki ezisibhozo. Zonke ezinye iziyobisi zidinga iiveki ezingaphantsi kwe-12 kwizigulane ezandululweyo. Oku kubandakanya inhlanganisela yeHCV ye-Epclusa evunyiwe nayo yonke i-genotypes ezintandathu.
Nangona kunjalo, ngokungafani ne-Epclusa, i-Mavyret ayikwazi ukusetyenziswa kubantu abane-cirrhosis ekhutshelweyo (i-livers yayo ayisasebenzi).
Omnye ummangaleli oyintloko yintengo . Nangona izidakamizwa ezinjenge-Epclusa zithwala ixabiso lemali elingaphantsi kwama-$ 75,000 kwiiklasi eziyi-12 (okanye i-$ 890 ngepilisi), i-Mavyret inikwe i-$ 26,400 kwiikholeji zeeveki ezisibhozo (okanye i-$ 439 nganye kwi-tablet).
Ulwahluko lwamaxabiso lunokwaneleyo ukuqinisekisa abaqinisekisi bempilo ukwandisa unyango kwi-3.9 yezigidi zabantu baseMerika abanesifo esiphelele kwi-HCV, eninzi kubo kufuneka balinde de kubekho ukukhubazeka kwesibindi esikhulu ngaphambi kokuba kuvunywe unyango.
Ukucetyiswa kweengcebiso
Imilinganiselo ephakanyisiweyo kaMavyret yile macwecwe amathathu athathwe kanye ngosuku ngokutya.
Ithebhulethi nganye iqukethe ii-milligram ze-glecaprevir kunye ne-40 milligrams ze-pibrentasvir. Iipilisi zincinki, zenziwe nge-oblong-shaped, i-film-coated, kwaye ikhutshwe nge "NXT" kwelinye icala.
Ubude bonyango buhluka ngohlobo lwe-HCV, amava oonyango, kunye nesimo sesibindi sesigulane, ngale ndlela:
- Ngaphambili ayengathatyathwa ngaphandle kwe-cirrhosis: iiveki ezisibhozo
- Ngaphambili ayengathatyathwa nge-cirrhosis ehlawulwe: iiveki ezili-12
- Ngaphambilini waphathwa nge-HCV i-genotypes 1, 2, 4, 5, no-6 engenayo i-cirrhosis: iiveki ezisibhozo ukuya kwe-16 kuxhomekeke kwonyango langaphambili
- Ngaphambilini waphathwa nge-HCV i-genotype 1, 2, 4, 5, no-6 kunye ne-cirrhosis ehlawulwayo: iiveki ezili-12 ukuya kwe-16 kuxhomekeke kunyango lwangaphambili
- Ukuphathwa kwangaphambili nge-HCV genotype 3 kunye okanye ngaphandle kwe-cirrhosis: iiveki ezili-16
Phantse iipesenti ezingama-75 zamaMerika ezine-hepatitis C zine-genotype 1, eyona nto ixhaphakileyo kodwa yona kunzima kakhulu ukuyiphatha. Ngokwahlukileyo, phakathi kwama-20 ukuya kuma-25 ekhulwini anama-genotype 2 kunye no-3, ngelixa iincinane zincinci zineentlobo ze-genotypes 4, 5, okanye 6.
Imiphumela
Ama-DAA atsha ngokutsha njenge-Mavyret aneziphumo ezincinci ezimbalwa kunezonyango zangaphambili, ezininzi zazo zibandakanya i- intergyon epgyon ( peginterferon ) kunye ne- ribavirin . Imiphumo echaphazelekayo echaphazelekayo enxulumene noMavyret (eyenzeka ngaphezu kweepesenti ezingamahlanu kwezigulane) zibandakanya:
- Intloko
- Ukukhathala
- I sizathu
- Uhudo
Ngokuqhelekileyo, iziphumo ezilawulwayo zilawulwa kwaye zivame ukuphucula ngaphezulu kwexesha. Enyanisweni, uphando lwangaphambili lweemarike luphelile ukuba ngaphantsi kwepesenti yabantu baseMavyret bayeka unyango ngenxa yeempembelelo ezingabandezelekayo.
Ukusebenzisana kweziyobisi
Ukusetyenziswa kwamachiza ase-rifampin, asetyenziswa ngokusesikweni ekuphatheni isifo sofuba, aphikisana nokusetyenziswa kunye noMavyret kwaye kufuneka apheliswe ngaphambi kokuqala unyango. Ezi ziquka iziyobisi ngamagama e-brand Mycobutin, Rifater, Rifamate, Rimactane, Rifadin, kunye ne-Priftin.
Ezinye iziyobisi ziyaziwa ukuba zisebenzisana noMavyret kwaye zinokunyusa okanye ukunciphisa uxinzelelo lweMavyret egazini.
Ezi zilandelayo azikhuthazwa ukuba zisebenzise kunye noMavyret:
- I-Carbamepazine, esetyenziselwa ukuphazamisa ukuphazamiseka kwengxaki kunye nengxaki yokuguquguquka kwengqondo
- I-Ethinyl estradiol (estrogen) -kuqukumbela ukulawulwa kwamayeza
- Sustiva (efavirenz) esetyenziswe kwi-HIV yonyango
- I-Atorvastatin, i-lovastatin, ne-simvastatin esetyenziselwa ukuphatha i-cholesterol ephezulu
- ISt John's Wort
Ukukhubazeka kwesibindi
U-Mavyret uyaphikiswa ukusetyenziswa kwabantu abanokukhubazeka kwesibindi (njengoko kulinganiswa ngumlinganiselo we-Child-Pugh ka-C) kwaye akucebisekanga nabani na abanokukhubazeka okulinganayo (Child-Pugh B).
Ukuhlolwa kokusebenza kwesibindi kunconywe ngaphambi kokuqala kweyeza ukuphepha iingxaki. Umdlalo we-Child-Pugh uphinde uxhamle ekuqaliseni ubunzima besifo sesibindi esekelwe kwiimvavanyo zegazi kunye nokuhlaziywa kweempawu zampawu.
I-Hepatitis B kwakhona
U-Mavyret kufuneka asetyenziswe ngokulumkileyo kubantu abane-hepatitis B kunye ne-hepatitis C. I- virus ye-hepatitis B (i-HBV) yaziwa ngokuba yasebenza ngexesha okanye emva kwangoko unyango. Ukusebenza kwakhona kungahamba kunye neempawu zesifo se-jaundice nesibindi sokuvuvukala kwesibindi. Ukuba unyango aluzange lubekwe ngokukhawuleza, ukuvuselelwa kwakhona kunokukhokelela ekuphumelelweni kwesibindi kunye nokufa.
Nangona ukusuleleka kwe-HBV akuchasani nokusetyenziswa kwe-Mavyret, kuya kufuna ukuba i-enzyme yesibindi ihlolisise ngakumbi ukuba ibone iimpawu zokuqala zokuqalisa.
Ukukhulelwa
Nangona i-Mavyret ingaphikiswanga ngokukhulelwa, kukho idatha encinci yeklinikhi yoluntu ekhoyo ukuvavanya ingozi. Xa kuthethwa ukuba, izifundo zezilwanyana ziye zabonisa ukuba ukusetyenziswa kwe-glecaprevir kunye ne-pibrentasvir ngexesha lokukhulelwa akudibaniswanga nokungaqhelekanga komntwana, kuquka ukuvezwa ngexesha lokuncelisa.
Ukucebisana kwenzululwazi kunconywa ukuba kungekhona nje ukulinganisela iingenelo kunye neengozi zonyango kodwa kuncedise ukuba ngaba unyango luyimeko yokuphuthuma okanye into enokulibaziseka emva kokuhanjiswa kweenkonzo.
Ukuthintela ukukhulelwa ngexesha lotyando, izibini zincetyiswa ukuba zisebenzise ubuncinane iindlela ezimbini ezingekho-hormonal zokukhulelwa kwangoko ngexesha leenyanga ezintandathu emva kokugqitywa kweyeza. Ekubeni ulawulo lwe-estrogen-based based birth control is not recommended, uthetha nogqirha wakho ukuba ubone ukuba ukukhulelwa komlomo kuphela kweprogesin kuyindlela efanelekileyo.
> Imithombo:
> Abbie, Inc. "Iimbonakaliso zokuLawulwa kolwazi : Amacwecwe e-Mavyret (glecaprevir kunye ne-pibrentasvir) , ngokusetyenziswa komlomo Iimvume zokuqala zase-US: 2017." Chicago, Illinois; kuhlaziywa ngoDisemba 2017.
> Foster, G .; Gane, E. Asatryan, A. et al. "UKUPHATHISWA-3: ukhuseleko kunye nokusebenza kwe-glecaprevir / pibrentasvir xa kuthelekiswa ne-sofosbuvir kunye ne-daclatasvir kwii-HIV ze-HCV zonyango ezine-3 ezinegciwane ezikhulelwe ngaphandle kwe-cirrhosis." J Hepatol. 2017; 66 (iSiza 1): S33.
> Ulawulo lweZiko lokuTya kunye neDrug. "I-FDA iyavuma i-Mavyret nge-Hepatitis C." Silver Spring, eMaryn; kukhutshwa ngo-Agasti 3, 2017.