IHarvoni iyinambuzane echanekileyo yokudibanisa isilwanyana esisetyenziselwa unyango lwentsholongwane engapheliyo yesifo se- hepatitis C (HCV) . Amachiza amabini aquka iHarvoni (ledipasvir, sofosbuvir) isebenza ngokuthintela iiprotheyini (NS5A) kunye ne-enzyme (i-RNA polymerase) ibalulekile ekuphindaphindeni kwintsholongwane.
I-Harvoni yavunywa ngo-Oktobha 10, 2014, yi-US Food and Drug Administration (FDA) ukuba isebenzise kubantu abadala kweminyaka eyi-18 okanye ngaphezulu kunye ne-HCV ye-genotypes 1 isifo, kuquka abo abane- cirrhosis .
I-Harvoni ivunyiwe ukuba isetyenziswe ngaphambili kwiingxaki ze-HCV ("unyango-abanolwazi").
IHarvoni yiyesiqalo sokuqala se-HCV esivunyiweyo se-FDA esingafuneki ukuba sithathwe nge-interferon ye-pegylated (i-peg-interferon) okanye i-ribavirin (izidakamizi ezimbini ezisetyenziswa ngokuqhelekileyo kwi-HCV yonyango, kunye zombini eneziprofayili ezinobungozi obuphezulu).
I-Harvoni ibikwa ukuba inamazinga okunyanga phakathi kwama-94% kunye no-99%, ngelixa i-Phase II zilingo ziye zabika izinga lokuphilisa i-100% kwizigulana ezixhaswe nge-HIV kunye ne-HCV.
Isistim
Elinye ipilisi (90mg / 400mg) ithathwa imihla ngemihla kunye okanye ngaphandle kokutya. Iipilisi zeHarvoni ziyi-diamond enemibala, i-ginger-colored, kunye nefilimu-eboshwe, ene "GSI" emacaleni kwelinye icala kunye ne "7985" kwelinye.
Ukucetyiswa kweengcebiso
I-Harvoni imiselwe kwiikholeji zee-12 ukuya kwe-24, njengezi ngcebiso ezilandelayo:
- Unyango-naïve kunye okanye ngaphandle kwe-cirrhosis: iiveki ezili-12
- Unyango-owaziyo ngaphandle kwe-cirrhosis: iiveki ezili-12
- Unyango-owaziwayo nge-cirrhosis: iiveki ezingama-24
Ukongezelela, iikholeji zeeveki ezili-8 ziyakucingelwa izigulane zonyango ezingenayo i-cirrhosis ezine-HCV yegciwane le-virtual load of under 6 million copies / mL.
Iziphumo eziPhakathi
Iziphumo eziqhelekileyo ezimalunga nokusetyenziswa kweHarvoni (ezenzeka kwi-10% okanye ngaphantsi kwezigulane) zi:
- Ukukhathala
- Intloko
Ezinye iziphumo ezichaphazelekayo (ngaphantsi kwe-10%) ziquka i-nausea, isifo sohudo kunye nokulala.
Ukusebenzisana kweziyobisi
Oku kulandelayo kufuneka kuphetshwe xa usebenzisa iHarvoni:
- I-Rifampin-based based anti-tuberculosis amayeza: Mycobutin, Rifater, Rifamate, Rimactane, Rifadin, Priftin
- Anticonvulsants: Tegretol, Dilantin, Trileptal, phenobarbital
- I-Aptivus (tipranavir / ritonavir) isetyenziswe kwi-antiretroviral ye-HIV
- ISt John's Wort
Ukungqinelana nokuqwalasela
Akukho zichasiselo zokusetyenziswa kweHarvoni kwizigulane ezine-HCV genotype 1.
Nangona kunjalo, kwizigulane ezine- HIV zisebenzisa i-tenofovir (kuquka i-Viread, iTruvada, i-Atripla, i-Complera, iStribild ), kufuneka unakekelwe ngokunyamekela nayiphi na imiphumo echaphazelekayo ye-tenofovir, ngokukodwa ukuphazamiseka kwengqondo.
I-Antacids kufuneka ithathwe ngokwahlukileyo kwiiyure ezingama-4 ngaphambi okanye emva kwe-Harvoni dose, ngelixa i-proton pump inhibitors kunye ne-H2 receptor inhibitors (aka H2 blockers) zingadinga ukunciphisa ukwenzela ukunqanda ukunciphisa i-ledipasvir.
Nangona kungekho ukuphikisana nokusetyenziswa kweHarvoni ekukhulelweni, idatha encinci yekliniki yoluntu iyafumaneka. Nangona kunjalo, izifundo zezilwanyana ekusebenziseni zombini i-ledipasvir kunye ne-sofosbuvir azibonisi miphumo ekuphuculeni umtsalane.
Ukucebisana kwenzululwazi kunconywa ngexesha lokukhulelwa ukuvavanya ukukhawuleza kwe-Harvoni unyango, ngokukodwa ukuba uqale ngokukhawuleza okanye ulinde de emva kokunikezelwa.
Kunconywa ukuba bonke abafazi abaneminyaka engama-50 ubudala bahlolwe rhoqo ngenyanga ngokukhulelwa ngexesha loqeqesho. Kukwacetyiswa ukuba isigulane kunye nomlingani wakhe wesibini banikezelwe ubuncinane iindlela ezimbini ezingekho ze-hormonal zokukhulelwa kwezilwanyana kwaye zisetyenziswe ngexesha loqeqesho kunye neenyanga ezintandathu emva koko.
Umthombo:
US Administration and Drug Administration (FDA). "I-FDA iyavuma inxalenye yokuqala yezilwanyana ukunyanga i-hepatitis C." Silver Spring, eMaryn; ukukhutshwa kwenkcazelo ekhutshwa ngo-Oktobha 10, 2014.