Iinkxalabo zoKhuseleko kwiHCV
I-FDA isanda kukhupha isilumkiso sokukhusela ekusebenzisweni kwezilwanyana ezimbini zokugula zesifo se-hepatitis C kwizigulane ezinesifo esiphambili sesibindi (i- FDA link ). Iingcali ezichazweyo yi- Viekira Pak (https://www.viekira.com/about-viekira) kunye ne- Technivie (https://www.technivie.com) ngo-Abbvie. Zomibini zizinto zokudibanisa kunye zombini ziqulethe: i-paritaprevir, i-ombitasvir kunye ne-ritonavir (i-Technivie); ngelixa i-Viekira Pak iqulethe i-dasabuvir.
Zombili zisetyenziselwa ngokubambisana ne ribavirin. Ezi nkonzo ziye zanyango kakhulu zonyango lwe-hepatitis C ezi-1 kunye no-4 kunye namazinga okunyanga ngokubanzi ngaphezulu kwama-95%.
Nangona kunjalo, ukususela kwixesha lokuvunyelwa kwe-FDA, kuye kwaba nenani lamatyala enkcitho yokunciphisa isibindi ngexesha lokusetyenziswa klinikhi olubanzi lwala maqumrhu. Ngokutsho kwe-FDA (i- FDA link ), "ekubeni ukuvunyelwa kwe-Viekira Pak ngoDisemba 2014 kunye ne-Technivie ngoJulayi 2015, ubuncinane ama-26 amatyala ehlabathi jikelele angeniswe kwi-FDA ye-Advent Event Reporting System (FAERS) ayicingelwa ukuba mhlawumbi okanye mhlawumbi axhamene ne-Viekira Pak okanye Technivie. Kwimeko ezininzi, ukulimala kwesibindi kwenzeka ngaphakathi kweeveki ezi-1 ukuya kwezine zokuqala unyango. Ezinye zeemeko zenzeke kwizigulane apho la mayeza aphikisiwe okanye anganyanzelwanga. "Ukongezelela," AbbVie, amacandelo athatywayo okungaxhamliyo kunye nokungafezeki kwesibindi kwizigulana ezine-cirrhosis zesibindi ezithatha amayeza.
Ezinye zezi ziganeko zenza ukuba ukufakelwa kwesibindi okanye ukufa. Ezi ziphumo ezibi kakhulu zivakaliswe kwizigulane ezithatha iVikira Pak ezaba nobungqina be-cirrhosis eziphambili ngaphambi kokuqala unyango. "
I-FDA iphakamise ukuba ulwazi olongezelelweyo olulandelayo lunikwe izigulane kunye nabanikezeli benonophelo lwempilo kwilebula yeziyobisi:
- I-Viekira Pak ne-Technivie inokubangela ukulimala kakhulu kwesibindi, kubandakanywa nokungaphumeleli kwesibindi sokuphila, ikakhulu kwizigulane ezinezifo eziphezulu zesibindi.
- Ungayeki ukuthatha la mayeza ngaphandle kokuqala ukuthetha ngongcali lwezempilo. Ukuyeka ukwelashwa kwangaphambili kunokubangela ukunganyangeki kweziyobisi kwezinye iilpirit C.
- Xhumana nomncedisi wakho wezempilo unyango ngokukhawuleza ukuba uthatha i-Viekira Pak okanye i-Technivie kwaye ujonge nayiphi na le miqondiso kunye neempawu zeengxaki zesibindi:
o Ukukhathala
o Ubuthathaka
o Ukulahlekelwa ngumdla
o Ukuhluma nokuhlanza
o Amehlo aphuzi okanye ulusu
o Izitshixo ezikhanyayo
- Xoxa nayiphi na imibuzo okanye ukuxhalabisa ngeVikira Pak okanye iTynivivie kunye neengcali zezempilo.
- Ukufunda ngokucopheleleyo isigulane seMilisi eLawula iMithi ezayo kunye nemigomo yakho ye-Viekira Pak okanye ye-Technivie.
- Bika nayiphi na imiphumo emibi evela kwi-Viekira Pak okanye i-Technivie ukuya kwiinkonzo zonyango lwakho kunye neprogram ye-FDA MedWatch.
Kubalulekile ukuba uqaphele ukuba ezi ziganeko zenzeke malunga nezigulane ezinezifo eziphezulu. Kukho ubungqina obubonisa ubungqina kwizigulane ezininzi ezine-hepatitis C ezinezifo zesibindi. Ekugqibeleni, isizathu esona kunye nendlela yokulimala ihlala phantsi kophando.
Ukuba uthatha i-Viekira Pak okanye i-Technivie, okanye uceba ukuqala unyango, kufuneka uxoxe ngale ngxaki kunye nomboneleli wakho wezempilo.