Harvone ke tekanyo e tsitsitseng e kopantseng lithethefatsi tse sebelisoang ho phekola tšoaetso e sa foleng ea hepatitis C (HCV) . Meriana e 'meli e kenyang mosebetsi oa Harvoni (ledipasvir, sofosbuvir) ka ho thibela bobeli protheine (NS5A) le enzyme (RNA polymerase) e bohlokoa ho ts'oaetso ea kokoana-hloko.
Harvoni e ile ea amoheloa ka la 10 October, 2014, ke US Food and Drug Administration (FDA) e sebelisoang ho batho ba baholo lilemong tse 18 kapa ho feta ka tšoaetso ea genotypes 1 ea HCV, ho akarelletsa le ba nang le boloetse ba lefu lena .
Harvoni e amoheloa hore e sebelisoe ho bakuli ba neng ba sa phekoloe ("kalafo-naïve"), hammoho le ba nang le karabelo e sa lebelloang kapa e sa arabeleng kalafo ea pele ea HCV ("kalafo-phihlelo").
Harvone ke lithethefatsi tsa pele tsa HCV tse amohelehang ka FDA tse sa lokelang ho nkoa ka pegylated interferon (peg-interferon) kapa ribavirin (meriana e 'meli eo ka tloaelo e sebelisetsoang ho phekola HCV, eo ka bobeli e neng e na le litlaleho tse phahameng tsa chefo).
Ho tlalehoa hore Harvone e na le litefello tsa phekolo ea lipakeng tsa 94% le 99%, ha liteko tsa Phase II li tlalehile phekolo ea 100% ho bakuli ba kopanetsoeng le HIV le HCV.
Tekanyo
Letlapa le le leng (90mg / 400mg) le nkiloe letsatsi kapa leng le le leng ka lijo kapa ntle le lijo. Matlapa a Harvone a tšoantšitsoe ka taemane, a mebala ea ginger le filimi e nang le "GSI" e le ka lehlakoreng le leng "7985" ka lehlakoreng le leng.
Ho hlalosa Litlhahiso
Harvone e laeloa ho feta thupelo ea libeke tse 12 ho isa ho tse 24, ho latela litlhahiso tse latelang:
- Kalafo-naïve e nang le kapa e se nang li-cirrhosis: libeke tse 12
- Kalafo-e nang le phihlelo ntle le ho ruruha: libeke tse 12
- Kalafo-e nang le lefu la ho thatafala ha li-cirrhosis: libeke tse 24
Ho phaella moo, thupelo ea beke ea libeke tse 8 e ka nkoa e le bakuli ba nang le kalafo ba se nang li-cirrhosis ba nang le likokoana-hloko tsa HCV tse ka tlase ho limilione tse 6 / mL.
Liphello tse Tloaelehileng
Litla-morao tse tloaelehileng tse amanang le tšebeliso ea Harvone (e fumanoang ka 10% kapa tlaase ho bakuli) ke:
- Mokhathala
- Hlooho ea hlooho
Tse ling tsa litla-morao tse ka tlaase ho 10% li kenyelletsa ho nyefoloa, letšollo le ho hlobaela.
Litšebelisano le lithethefatsi
Lintlha tse latelang li lokela ho qojoa ha u sebelisa Harvone:
- Meriana e thibelang lefuba ea Rifampin: Mycobutin, Rifater, Rifamate, Rimactane, Rifadin, Priftin
- Li-Anticonvulsants: Tegretol, Dilantin, Trileptal, phenobarbital
- Aptivus (tipranavir / ritonavir) e sebelisetsoang phekolo ea HIV ea meriana ea lefuba
- Mokhoakho oa St. John's
Litlhaloso le likhokahano
Ha ho na lipelaelo tsa tšebeliso ea Harvone ho bakuli ba nang le mofuta oa HCV 1.
Leha ho le joalo, bakeng sa bakuli ba nang le HIV ba sebelisa lithethefatsi tsa tenofovir (ho akarelletsa le Viread, Truvada , Atripla, Complera, Stribild ), tlhokomelo e eketsehileng e lokela ho fanoa ka ho hlahloba litla-morao tse amanang le tenofovir, haholo-holo ho holofala ha liphio.
Li-antiacids li lokela ho nkoa ka nako e le 'ngoe lihora tse 4 pele ho kamora kapa ka morao ea Harvone dose, ha litekanyetso tsa proton pump inhibitors le H2 receptor inhibitors (aka H2 blockers) li ka' na tsa lokela ho fokotsoa e le ho thibela ho fokotseha ha ledipasvir.
Le hoja ho se ho hanyetsanoa ha tšebeliso ea Harvone nakong ea bokhachane, dintlha tsa kliniki e nyenyane ea motho e fumaneha. Leha ho le joalo, lithuto tsa liphoofolo ho sebelisoang habeli ledipasvir le sofosbuvir ha li bontšitse hore na ho na le phello efe ho ntlafatso ea fetallo.
Ho buisanoa ka litsebi tse khethehileng nakong ea bokhachane ho hlahloba hore na phekolo ea Harvone e potlakile hakae, ebang ke ho qala ka potlako kapa ho emela ho fihlela ha ho pepa.
Ho khothalletsoa hore basali bohle ba nang le lilemo tsa bana ba behe leihlo khoeli le khoeli bakeng sa bokhachane nakong ea phekolo. Ho boetse ho kgothaletswa hore mokuli le molekane oa hae oa banna ba fanoe bonyane mekhoa e 'meli e seng ea hormone ea thibelo ea bokhachane le hore e sebelisoe nakong ea phekolo le likhoeli tse tšeletseng hamorao.
Mohloli:
US Administration of Drug and Drug Administration (FDA). "FDA e amohela motsoako oa pele oa lithethefatsi ho alafa lefu la hepatitis C." Silver Spring, Maryland; tokomane ea khatiso e fanoeng ka la 10 October, 2014.