Ukukhathazeka kokuphepha kwe-HCV
I-FDA isanda kukhishwa isixwayiso sokuphepha ekusetshenzisweni kwezinyathelo ezimbili zokwelashwa kwesifo sohlobo lwe-hepatitis C ezigulini ezinezifo eziphezulu zesibindi (i- FDA link ). Ama-agent ahlotshaniswa yi- Viekira Pak (https://www.viekira.com/about-viekira) no- Technivie (https://www.technivie.com) ngo-Abbvie. Zombili lezi zindlela zokwelashwa ezihlangene futhi zombili ziqukethe: paritaprevir, ombitasvir ne-ritonavir (Technivie); kanti i-Viekira Pak iqukethe i-dasabuvir.
Zombili ziyasetshenziswa ngokuhlanganyela ne-ribavirin. Lawa ma-agent asebenze kahle kakhulu kwezokwelapha ze-hepatitis C ze-genotype 1 no-4 ngamazinga okuphulukisa ngokuvamile ngaphezu kwama-95%.
Kodwa-ke, kusukela ngesikhathi sokugunyazwa kwe-FDA, kuye kwaba nenani lamacala e-decompensation yesibindi phakathi kokusetshenziswa komtholampilo kwalezi zinhlanganisela. Ngokusho kwe-FDA (i- FDA link ), "njengoba izimvume ze-Viekira Pak ngoDisemba 2014 ne-Technivie ngoJulayi 2015, okungenani amacala angu-26 emhlabeni jikelele athunyelwe kwi-FDA Adverse Event Reporting System (FAERS) abhekwa njengokuthi mhlawumbe noma mhlawumbe axhumene ne-Viekira I-Pak noma i-Technivie. Ezimweni eziningi, ukulimala kwesibindi kwenzeka ngaphakathi kwamasonto angu-1 ukuya kwangu-4 okuqala ukwelashwa. Amanye amacala avela ezigulini ezazithinteka ngazo noma lezi zinqubo. "Ngaphezu kwalokho," u-AbbVie, amacala ahlonishwayo we-hepatic decompensation nokuhluleka kwesibindi kumagciwane ane-cirrhosis yesibindi esezansi ayethatha le mithi.
Ezinye zalezi zenzakalo zaholela ekufakweni kwesibindi noma ukufa. Lezi ziphumo ezibi kakhulu zabikwa ikakhulukazi ezigulini ezithatha i-Viekira Pak ezaba nobufakazi be-cirrhosis ephakeme ngisho nangaphambi kokuqala ukwelashwa nayo. "
I-FDA iphakamisa ulwazi olulandelayo olwengeziwe olunikezwa iziguli nabahlinzeki bempilo kwelebula lezidakamizwa:
- I-Viekira Pak ne-Technivie ingabangela ukulimala okukhulu kwesibindi, kufaka phakathi ukuhluleka kwesibindi sokusongela impilo, ikakhulukazi ezigulini ezinezifo ezinamandla zesibindi esiphezulu.
- Ungayeki ukuthatha lemithi ngaphandle kokuqala ukukhuluma nochwepheshe wezokunakekelwa kwezempilo. Ukuyeka ukwelashwa ekuqaleni kungabangela ukumelana nezidakamizwa kwezinye izifo ze-hepatitis C.
- Xhumana nochwepheshe wakho wokunakekelwa kwezempilo ngokushesha uma uthatha i-Viekira Pak noma i-Technivie bese uhlangabezana nanoma iyiphi yalezi zimpawu nezinkinga zezinkinga zesibindi:
o Ukukhathala
o Ubuthakathaka
o Ukulahlekelwa kwesifiso
o Ukucabangela nokuhlanza
o Amehlo aphuzi noma isikhumba
o Izitembu ezikhanyayo
- Xoxa nganoma yimiphi imibuzo noma ukukhathazeka mayelana ne-Viekira Pak noma i-Technivie nge-professional care yakho.
- Funda ngokucophelela Umhlahlandlela Wezokwelapha Ogulayo ohambisana nemigomo yakho ye-Viekira Pak noma ye-Technivie.
- Bika noma yimiphi imiphumela emibi evela ku-Viekira Pak noma i-Technivie kuya kuchwepheshe wakho wokunakekelwa kwezempilo kanye nohlelo lwe-FDA MedWatch.
Kubalulekile ukuthi uqaphele ukuthi lezi zimo zenzeke kuphela ezigulini ezinezifo eziphezulu. Kukhona okwamanje akukho bufakazi obukhombisa ukuthi kuyingozi ezigulini eziningi ezine-hepatitis C ezinezifo ezinobulunga obuncane ukuya ezilinganisweni. Okokugcina, isizathu esiqondile kanye nendlela yokulimala ehlala ngaphansi kophenyo.
Uma uthatha u-Viekira Pak noma i-Technivie, noma uhlela ukuqala noma ukwelapha, kufanele uxoxe ngalolu daba nomhlinzeki wakho wezempilo.