Harvoni waa daroogo isku dhafan oo loo isticmaalo daaweynta infakshanka cagaarshow C (HCV) ee joogtada ah. Labada daroogo oo ka kooban Harvoni (ledipasvir, sofosbuvir) ayaa shaqeynaya iyada oo la xakameynayo protein (NS5A) iyo enzym (RNA polymerase) oo muhiim u ah soo-saarka fayraska.
Harvoni waxaa la ansixiyey Oktoobar 10-keedii, 2014, Maamulka Maraykanka ee Cuntada iyo Maandooriyaha (FDA) ee loogu talagalay isticmaalka dadka qaangaarka ah 18 sano ama ka weyn HCV genotypes 1 cudur, oo ay ku jiraan kuwa qaba cirrhosis .
Harvoni waxaa loo ogolaaday isticmaalka bukaanka hore loo daaweyn ("treatment-naïve"), iyo sidoo kale kuwa qaba qayb ka mid ah ama aan wax laga qabanin daaweynta hore ee HCV ("daaweyn-khibrad").
Harvoni waa daawada ugu horreysa ee daawada HCV ee loo yaqaan 'FDA-approved' oo aan u baahnayn in la qaado labadaba interferon pegylated interferon (peg-interferon) ama ribavirin (laba dawo oo caadi ahaan loo isticmaalo daaweynta isku dhafka HCV, labaduba waxay leeyihiin profiles sarreysa).
Harvoni waxaa lagu soo waramayaa in ay daaweynayso heerarka u dhexeeya 94% ilaa 99%, halka Iskeelka Phase II ay soo saartay boqolkiiba 100% daaweynta bukaan-socodka ee lagu sameeyay HIV iyo HCV.
Qiyaasta
Hal kiniin (90mg / 400mg) ayaa maalin walba la qaataa ama aan lahayn cunto. Kiniiniyada Harvoni waa dheeman, qaababka quruxda leh, iyo filimka, oo leh "GSI" oo ka kooban hal dhinac iyo "7985" dhinaca kale.
Soo-jeedinta Talooyinka
Harvoni waxaa lagu qoraa koorso 12 ilaa 24 toddobaad ah, sida soo socota talooyinka soo socda:
- Daaweyn-nala soo baxa ama aan lahayn cirrhosis: 12 toddobaad
- Daaweyn-khibrad la'aan aan lahayn cirrhosis: 12 toddobaad
- Daaweynta-khibrad leh cirrhosis: 24 toddobaad
Intaa waxa dheer, koorso 8 asbuuc ah ayaa loo tixgelin karaa daaweynta-naeef bukaanka ah oo aan lahayn cirrhosis oo leh hargab fayras oo HCV ah oo ka yar 6 milyan oo nuqul / mL.
Saameynada Caadiga ah
Waxyeellooyinka ugu badan ee la xiriira isticmaalka Harvoni (oo ku dhaca 10% ama ka yar bukaanada) waa:
- Daal
- Madax xanuun
Dhibaatooyinka kale ee suurtagalka ah (ka yar 10%) waxaa ku jira lallab, shuban, iyo hurdo la'aan.
Isdhexgalka daroogada
Kuwa soo socda waa in laga fogaadaa marka la isticmaalayo Harvoni:
- Dawooyinka anti-tuberculosis ku salaysan Rifampin: Mycobutin, Rifater, Rifamate, Rimactane, Rifadin, Priftin
- Anticonvulsants: Tegretol, Dilantin, Trileptal, phenobarbital
- Aptivus (tipranavir / ritonavir) oo loo isticmaalo daaweynta antiretroviral ee HIV
- St. John Wort
Khilaafaadka iyo Tixgelinnada
Ma jiraan wax iska hor imaad ah isticmaalka Harvoni ee bukaanada qaba HCV genotype 1.
Si kastaba ha noqotee, bukaanka HIV qaba isticmaalka tenofovir daawada (oo ay ku jiraan Viread, Truvada , Atripla, Complera, Stribild ), daryeel dheeraad ah waa in la siiyaa kormeerka waxyeellooyinka waxyeellada ee tenofovir, gaar ahaan kelyaha (kelyaha).
Daawooyinka waa in si gooni ah loo qaataa 4 saacadood ka hor ama ka dib qiyaasta Harvoni, halka qiyaasta daawada sunta difaaca iyo H2 soo-qaboojiyeyaasha (aka H2 blockers) ay u baahan karaan in la yareeyo si looga hortago in la yareeyo nuugista ledipasvir.
Inkastoo aysan jirin wax khilaaf ah oo loo isticmaalo isticmaalka Harvoni ee uurka, macluumaadka bukaan-socodka yar ee bani-aadamka ayaa la heli karaa. Si kastaba ha noqotee, daraasaadka xayawaanka ee isticmaalka labada ledipasvir iyo sofosbuvir labaduba ma muujin wax saameyn ah u yeeshay horumarinta uurjiifka.
La-talin takhasus gaar ah ayaa lagula taliyaa inta lagu jiro uurka si loo qiimeeyo degdegga daaweynta Harvoni, gaar ahaan haddii si degdeg ah loo bilaabo ama u sugto illaa dhalashada ka dib.
Waxaa lagu talinayaa in dhammaan haweenka ku jira da'da ilmo-dhalista la kormeero bil kasta uurka inta lagu jiro muddada daaweynta. Waxaa sidoo kale lagu talinayaa in bukaanku iyo ragga ragga ah la siiyo ugu yaraan laba hab-hormoon oo aan ahayn hormoonin iyo in loo isticmaalo muddada daweynta iyo lix bilood kadib.
Xigasho:
Maamulka Cuntada iyo Dawooyinka Maraykanka (FDA). "FDA waxay ogolaatay daawada isku dhafan ee koowaad si loo daaweeyo cagaarshow C." Silver Spring, Maryland; war-saxaafadeed uu soo saaray 10-kii October, 2014.