natgillin/translations-raw huggingface dataset:
The safety assessment of Epclusa was based on pooled Phase 3 clinical study data from patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection (with or without compensated cirrhosis) including 1,035 patients who received Epclusa for 12 weeks.
Procjena sigurnosti primjene lijeka Epclusa temeljila se na objedinjenim podacima iz kliničkog ispitivanja faze 3 bolesnika s infekcijom HCV-a genotipa 1, 2, 3, 4, 5 ili 6 (sa ili bez kompenzirane ciroze) uključujući 1035 bolesnika koji su primali lijek Epclusa tijekom 12 tjedana.
Liver transplant patients
Bolesnici s transplantiranom jetrom
Based on the population pharmacokinetic analysis in HCV-infected patients, mean steady-state AUC0-24 for sofosbuvir (n = 982), GS-331007 (n = 1,428) and velpatasvir (n = 1,425) were 1,260, 13,970 and 2,970 ng•h/mL, respectively.
Na temelju analize populacijske farmakokinetike u HCV-om zaraženih bolesnika, srednji AUC0-24 u stanju dinamičke ravnoteže za sofosbuvir (n = 982), GS-331007 (n = 1428) i velpatasvir (n = 1425) bili su 1260, 13 970 odnosno 2970 ng•h/ml.
No teratogenic effects were observed in the mouse and rat developmental toxicity studies with velpatasvir at AUC exposures approximately 31- and 6-fold higher, respectively, than the human exposure at the recommended clinical dose.
Nisu opaženi teratogeni učinci u ispitivanjima razvojne toksičnosti s velpatasvirom na miševima i štakorima pri izloženostima AUC približno za 31 odnosno 6 puta većim od ljudske izloženosti pri preporučenoj kliničkoj dozi.
Renal impairment No dose adjustment of Epclusa is required for patients with mild or moderate renal impairment.
Ne preporučuje se prilagodba doze lijeka Epclusa u pacijenata s blagim ili umjerenim oštećenjem bubrega.
What you need to know before you take Epclusa Do not take Epclusa
Što morate znati prije nego počnete uzimati lijek Epclusa
Do not stop taking Epclusa
Nemojte prestati uzimati lijek Epclusa
Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis (including decompensated cirrhosis) had no clinically relevant effect on the exposure to velpatasvir (see section 4.2).
Analiza populacijske farmakokinetike u bolesnika zaraženih HCV-om pokazala je da ciroza (uključujući dekompenzirani cirozu) nije imala klinički relevantni učinak na izloženost velpatasviru (vidjeti dio 4.2).
Table 5: Activity of sofosbuvir and velpatasvir against transient replicons containing NS5A or NS5B from clinical isolates
Tablica 5: Djelotvornost sofosbuvira i velpatasvira protiv prolaznih replikona koji sadrže NS5A i NS5B iz kliničkih izolata Genotip replikona
Effect on ketoconazole exposure not studied.
Učinak na izloženost ketokonazolu nije ispitan.
Tablet core: Copovidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearate
Jezgra tablete: kopovidon, mikrokristalična celuloza, umrežena karmelozanatrij, magnezijev stearat
The pharmacokinetics of sofosbuvir, GS-331007, and velpatasvir were studied in HCV-infected patients with ESRD requiring dialysis treated with Epclusa (n=59) for 12 weeks, and compared to patients without renal impairment in the sofosbuvir/velpatasvir Phase 2/3 trials.
Farmakokinetika sofosbuvira, GS-331007 i velpatasvira ispitana je u bolesnika zaraženih HCV-om s ESRD-om koji je zahtijevao dijalizu liječenih lijekom Epclusa (n = 59) tijekom 12 tjedana, koji su uspoređeni s bolesnicima bez oštećenja bubrega u ispitivanjima sofosbuvira/velpatasvira faze 2/3.
Sofosbuvir and GS-331007 are not inhibitors of drug transporters P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 and OCT1.
Sofosbuvir i GS-331007 nisu inhibitori prijenosnika lijekova P-gp-a, BCRP-a, MRP2, BSEP-a, OATP1B1, OATP1B3, i OCT1.
Studies in patients with decompensated cirrhosis (CPT Class B) Analyses were conducted to explore the association between pre-existing baseline NS5A RAVs and treatment outcome for patients with decompensated cirrhosis in one Phase 3 study (ASTRAL-4).
Ispitivanja u bolesnika s dekompenziranom cirozom (CPT stadij B) Provedene su analize kako bi se ispitala povezanost između postojećih početnih NS5A RAV-ova i ishoda liječenja u bolesnika s kompenziranom cirozom u jednom ispitivanju faze 3 (ASTRAL-4).
If a dose of Epclusa is missed and it is within 18 hours of the normal time, patients should be instructed to take the tablet as soon as possible and then patients should take the next dose at the usual time.
Ako se propusti uzeti doza lijeka Epclusa, a još nije proteklo 18 sati od uobičajenog vremena uzimanja, bolesnike treba uputiti da uzmu tabletu čim prije i zatim uzmu sljedeću dozu u uobičajeno vrijeme.
c n = 4 for genotype 2, n = 2 for genotype 4 and n = 1 for genotype 6.
c. n = 4 za genotip 2, n = 2 za genotip 4 i n = 1 za genotip 6.
The median terminal half-life of velpatasvir following administration of Epclusa was approximately 15 hours.
Nakon primjene lijeka Epclusa, medijan terminalnog poluvijeka velpatasvira iznosio je približno 15 sati.
In vitro selection of HCV replicons with reduced susceptibility to velpatasvir was performed in cell culture for multiple genotypes including 1a, 1b, 2a, 3a, 4a, 5a and 6a.
In vitro odabir replikona HCV-a sa smanjenom osjetljivošću na velpatasvir proveden je u staničnoj kulturi za više genotipova uključujući 1a, 1b, 2a, 3a, 4a, 5a i 6a.
Epclusa 400 mg/100 mg film-coated tablets.
NAZIV LIJEKA Epclusa 400 mg/100 mg filmom obložene tablete.
Ribavirin Dose
Doza ribavirina
Velpatasvir had no adverse effects on behaviour, reproduction, or development of the offspring in the rat pre- and post-natal development study at AUC exposures approximately 5-fold higher than the human exposure at the recommended clinical dose.
Nije bilo štetnih učinaka velpatasvira na ponašanje, reprodukciju ili razvoj potomstva u ispitivanjima prenatalnog i postnatalnog razvoja u štakora pri AUC izloženostima približno za 5 puta većim od ljudske izloženosti pri preporučenoj kliničkoj dozi.
Among the patients who received treatment with Epclusa + RBV for 12 weeks, 29% (25/85) of patients had baseline virus with NS5A RAVs: 29% (19/66), 75% (3/4), 15% (2/13), and 50% (1/2) for patients with genotype 1, 2, 3 and 4 HCV, respectively.
Među bolesnicima koji su liječeni lijekom Epclusa + RBV tijekom 12 tjedana, 29 % (25/85) bolesnika imalo je početni virus s NS5A RAV-om: 29 % (19/66), 75 % (3/4), 15 % (2/13) i 50 % (1/2) za bolesnike s HCV-om genotipa 1, 2, 3 odnosno 4.
In one Phase 3 study in patients with decompensated cirrhosis who received Epclusa + RBV for 12 weeks, 3 patients (1 with genotype 1 and 2 with genotype 3) qualified for resistance analysis due to virologic failure.
U jednom ispitivanju faze 3 u pacijenata s dekompenziranom cirozom koji su primali lijek Epclusa + RBV tijekom 12 tjedana, tri bolesnika (jedan s genotipom 1 i dva s genotipom 3) kvalificirala su se za analizu rezistencije zbog virološkog neuspjeha.
Antacids e.g. Aluminium or magnesium hydroxide; calcium carbonate
Antacidi npr. aluminijev ili magnezijev hidroksid, kalcijev karbonat
Epclusa 24 weeks (n = 90)
Epclusa 24 tjedna (n = 90)
Treatmentexperienced (n = 71)
Prethodno liječeni bolesnici (n = 71)
Safety data are limited in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2) and ESRD requiring haemodialysis.
Podaci o sigurnosti primjene ograničeni su u bolesnika s teškim oštećenjem bubrega (eGFR < 30 ml/min/1,73 m2) i ESRD-om koji zahtijeva hemodijalizu.
Sofosbuvir and GS-331007 AUC0-24 and Cmax were similar in healthy adult subjects and patients with HCV infection.
AUC0-24 i Cmax sofosbuvira i GS-331007 bili su slični u zdravih odraslih ispitanika i bolesnika zaraženih HCV-om.
The single genotype 3 patient who had baseline NS5A RAVs and failed to achieve SVR12 had NS5A substitution Y93H at baseline; pharmacokinetic data from this patient was consistent with non-adherence to treatment.
Jedan bolesnika zaražen HCV-om genotipa 3 koji je imao početne NS5A RAV-ove i nije postigao SVR12 imao je NS5A supstituciju Y93H na početku; farmakokinetički podaci ovog bolesnika bili su konzistentni s nepridržavanjem liječenja.
d Other includes patients who did not achieve SVR12 and did not meet virologic failure criteria.
d. Ostalo uključuje bolesnike koji nisu postigli SVR12 i nisu zadovoljili kriterije virološkog neuspjeha.
Epclusa can be used in these patients with no dose adjustment when no other relevant treatment options are available (see section 4.4, 4.8, 5.1 and 5.2).
U tih se bolesnika Epclusa može primjenjivati bez prilagodbe doze kada nisu dostupne nikakve druge odgovarajuće mogućnosti liječenja (vidjeti dijelove 4.4, 4.8, 5.1 i 5.2).
Variants were selected at NS5A resistance associated positions 24, 28, 30, 31, 32, 58, 92 and 93.
Odabrane su varijante na mjestima povezanim s rezistencijom NS5A 24, 28, 30, 31, 32, 58, 92 i 93. Varijante povezane s rezistencijom (engl. resistance associated variants, RAVs) odabrane u dva ili više genotipa bile su F28S, L31I/V i Y93H.
Treatmentexperienced (n = 69)
Prethodno liječeni bolesnici (n = 69)
The efficacy of Epclusa was evaluated in three Phase 3 studies in patients with genotype 1 to 6 HCV infection with or without compensated cirrhosis, one Phase 3 study in patients with genotype 1 to 6 HCV infection with decompensated cirrhosis, one Phase 3 study in HCV/HIV-1 co-infected patients with genotype 1 to 6 HCV infection and one Phase 2 trial in patients with HCV infection and ESRD requiring dialysis, as summarised in Table 9.
Djelotvornost lijeka Epclusa procijenjena je u trima ispitivanjima faze 3 u bolesnika s infekcijom HCV-om genotipa 1 do 6 sa ili bez kompenzirane ciroze, u jednom ispitivanju faze 3 u bolesnika s infekcijom HCV-om genotipa 1 do 6 s dekompenziranom cirozom, jednom ispitivanju faze 3 u bolesnika s koinfekcijom virusima HCV/HIV-1 s HCV-om genotipa 1 do 6 i u jednom ispitivanju faze 2 u bolesnika s infekcijom HCV-om i s ESRD-om koji je zahtijevao dijalizu, što je sažeto prikazano u tablici 9.
Itraconazolee Voriconazolee Posaconazolee Isavuconazolee
Itrakonazole Vorikonazole Posakonazole Isavukonazole
Patients should be instructed that if vomiting occurs within 3 hours of dosing an additional tablet of Epclusa should be taken.
Bolesnike treba uputiti da uzmu dodatnu tabletu lijeka Epclusa ako povraćanje nastupi u roku od tri sata nakon uzimanja doze.
This may make Epclusa work less well.
To može oslabiti djelovanje lijeka Epclusa.
Each film-coated tablet contains 400 mg sofosbuvir and 100 mg velpatasvir.
Jedna filmom obložena tableta sadrži 400 mg sofosbuvira i 100 mg velpatasvira.
Epclusa 12 weeks (106)
Epclusa 12 tjedana (106)
At baseline, 29% of patients had cirrhosis, 22% were treatment experienced, 32% had received a kidney transplant, 92% were on haemodialysis, and 8% were on peritoneal dialysis; mean duration on dialysis was 7.3 years (range: 0 to 40 years).
Na početku ispitivanja, 29% bolesnika imalo je cirozu, 22% bilo je prethodno liječeno, 32% imalo je transplantiran bubreg, 92% bilo je na hemodijalizi, a 8% na peritonejskoj dijalizi; srednja vrijednost trajanja liječenja dijalizom iznosila je 7,3 godine (raspon: od 0 do 40 godina).
(Inhibition of P-gp)
(Inhibicija P-gp-a)
Table 9: Studies conducted with Epclusa in patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection
Tablica 9: Ispitivanja provedena s lijekom Epclusa u bolesnika s infekcijom HCV-om genotipa 1, 2, 3, 4, 5 i 6
Total (all GTs) (n = 624)
Ukupno (svi GT-i) (n = 624)
• a wide spread severe rash with peeling skin which may be accompanied by fever, flu like symptoms, blisters in the mouth, eyes, and/or genitals (Stevens Johnson syndrome).
simptomima nalik gripi, mjehurićima u ustima, na očima i/ili na genitalijama (Stevens
The pharmacokinetics of sofosbuvir was studied following 7-day dosing of 400 mg sofosbuvir in HCV-infected patients with moderate and severe hepatic impairment (CPT Class B and C).
Farmakokinetika sofosbuvira bila je ispitana nakon 7 dana doziranja 400 mg sofosbuvira u bolesnika zaraženih HCV-om s umjerenim i teškim oštećenjem jetre (CPT stadij B i C).
Epclusa 12 weeks (134) SOF+RBV 12 weeks (132)
Epclusa 12 tjedana (134) SOF+RBV 12 tjedana (132)
Genotype 2, 4, and 6 HCV-infected patients had a higher prevalence of NS5A RAVs (70%, 63% and 52%, respectively) compared to genotype 1 (23%), genotype 3 (16%), and genotype 5 (18%) HCV-infected patients.
Bolesnici s infekcijom HCV-om genotipa 2, 4 i 6 imali su veću prevalenciju NS5A RAV-ova (70 %, 63 % odnosno 52 %) u usporedbi s bolesnicima s infekcijom HCV-om genotipa 1 (23 %), genotipa 3 (16 %) i genotipa 5 (18 %).
• oxcarbazepine (medicine used to treat epilepsy and prevent seizures);
• okskarbazepin (lijek koji se primjenjuje za liječenje epilepsije i sprječavanje napadaja);
Table 7: SVR12 in patients with and without baseline Y93H, 1% Cut-off (Resistance Analysis Population Set) ASTRAL 3
Tablica 7: SVR12 u bolesnika sa ili bez početnog Y93H, 1 % granične vrijednosti (populacijski niz za analizu rezistencije) ASTRAL 3
Clinical monitoring, looking for signs of bleeding and anaemia, is recommended when dabigatran etexilate is co-administered with Epclusa.
Preporučuje se kliničko praćenje, kojim se traže znakovi krvarenja i anemije, kada se dabigatraneteksilat primjenjuje istodobno s lijekom Epclusa.
b n = 4 for genotype 2 and n = 2 for genotype 4.
b. n = 4 za genotip 2 i n = 2 za genotip 4
Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents.
Koinfekcija HCV-om/HBV-om (virusom hepatitisa B) Tijekom ili nakon liječenja direktno djelujućim antiviroticima, zabilježeni su slučajevi reaktivacije virusa hepatitisa B (HBV), neki od njih sa smrtnim ishodom.
Epclusa 12 weeks (277) SOF+RBV 24 weeks (275)
Epclusa 12 tjedana (277) SOF+RBV 24 tjedna (275)
Of the 2 genotype 1 virologic failure patients, one patient had virus with emergent NS5A RAV Y93N and the other patient had virus with emergent NS5A RAVs L31I/V and Y93H at virologic failure.
Od dva bolesnika s genotipom 1 kod kojih je došlo do virološkog neuspjeha, jedan bolesnik imao je virus s pojavom NS5A RAV-a Y93N dok je drugi imao virus s pojavom NS5A RAV-a L31I/V i Y93H pri virološkom neuspjehu.
Table 6: SVR12 in patients with or without baseline NS5A RAVs by HCV genotype (studies ASTRAL-1, ASTRAL-2 and ASTRAL-3)
Tablica 6: SVR12 u bolesnika sa ili bez početnog NS5A RAV-a prema genotipu HCV-a (ispitivanja ASTRAL-1, ASTRAL-2 i ASTRAL-3)
Safety and efficacy of Epclusa has not been assessed in patients with CPT Class C cirrhosis (see sections 4.8 and 5.1).
Sigurnost i djelotvornost lijeka Epclusa nije procijenjena u bolesnika s cirozom jetre CPT stadija C (vidjeti dijelove 4.8 i 5.1).
Epclusa has been shown to increase tenofovir exposure, especially when used together with an HIV regimen containing tenofovir disoproxil fumarate and a pharmacokinetic enhancer (ritonavir or cobicistat).
Upotreba s određenim antiretrovirusnim režimima za HIV Pokazalo se da Epclusa povećava izloženost tenofoviru, naročito kada se koristi zajedno s režimom za HIV koji sadrži tenofovirdizoproksilfumarat i farmakokinetički pojačivač (ritonavir ili kobicistat).
Epclusa 24 weeks
Epclusa 24 tjedna
The proportions of patients with genotype 1, 2, 3, 4, 6 or indeterminate HCV infection were 42%, 12%, 27%, 7% , 3%, and 9%, respectively.
Udjeli bolesnika s infekcijom HCV-om genotipa 1, 2, 3, 4, 6 odnosno neutvrđenim bili su 42%, 12%, 27%, 7%, 3% odnosno 9%.
The proportions of patients with genotype 1, 2, 3, 4 or 6 HCV were 78%, 4%, 15%, 3%, and < 1% (1 patient), respectively.
Udjeli bolesnika s genotipom 1, 2, 3, 4 ili 6 HCV-a bili su 78 %, 4 %, 15 %, 3 %, odnosno < 1 % (1 bolesnik).
The 50% effective concentration (EC50) values of sofosbuvir and velpatasvir against full-length or chimeric replicons encoding NS5B and NS5A sequences from the laboratory strains are presented in Table 4.
Vrijednosti 50 % učinkovite koncentracije (EC50) sofosbuvira i velpatasvira protiv replikona pune duljine ili kimeričkih replikona koji kodiraju sekvence NS5B i NS5A iz laboratorijskih sojeva navedene su u tablici 4. Vrijednosti EC50 sofosbuvira i velpatasvira protiv kliničkih izolata navedene su u tablici 5.
Patients receiving Epclusa concomitantly with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or with tenofovir disoproxil fumarate and a boosted HIV protease inhibitor should be monitored for tenofovir-associated adverse reactions.
Bolesnike koji primaju lijek Epclusa istodobno s elvitegravirom/kobicistatom/emtricitabinom/tenofovirdizoproksilfumaratom ili s tenofovirdizoproksilfumaratom i pojačanim inhibitorom HIV proteaze treba pratiti radi nuspojava povezanih s tenofovirom.
The frequency of the following side effects is not known (frequency cannot be estimated from the available data).
Ostale nuspojave koje se mogu uočiti tijekom liječenja sofosbuvirom: Učestalost sljedećih nuspojava nije poznata (učestalost se ne može procijeniti iz dostupnih podataka).
Total (all GTs) (n = 106)
Ukupno (svi GT-i) (n = 106)
Therefore, Epclusa should not be used during breast-feeding.
Stoga se lijek Epclusa ne bi trebao primjenjivati tijekom dojenja.
Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis (including decompensated cirrhosis) had no clinically relevant effect on the exposure to sofosbuvir and GS-331007.
Analiza populacijske farmakokinetike u bolesnika zaraženih HCV-om ukazuje na to da ciroza (uključujući dekompenzirani cirozu) nije imala klinički relevantni učinak na izloženost sofosbuviru i GS-331007.
Interaction only studied with velpatasvir.
Interakcije ispitana samo s velpatasvirom.
Table 15 presents the virologic outcome for patients with genotype 1 or 3 HCV infection in the ASTRAL-4 study.
U tablici 15 predstavljeni su virološki ishodi za bolesnike s genotipom 1 ili 3 HCV infekcije u ispitivanju ASTRAL-4.
Demographics and baseline characteristics were balanced across the two treatment groups.
Demografska slika i značajke na početku ispitivanja uravnotežene su između dviju liječenih skupina.
Velpatasvir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo rat micronucleus assays.
Velpatasvir nije bio genotoksičan u bateriji testova in vitro ili in vivo, uključujući test bakterijske mutagenosti, kromosomske aberacije na ljudskim limfocitima iz periferne krvi i in vivo mikronukleusni test u štakora.
Genotypes 2, 4, 5 or 6 Total
Genotipi 2, 4, 5 ili 6 Ukupno
Randomisation was stratified by HCV genotype (1, 2, 3, 4, 5, 6 and indeterminate).
Randomizacija je stratificirana prema genotipu (1, 2, 3, 4, 5, 6 i neutvrđeno) HCV-a.
• If you are sick (vomit) less than 3 hours after taking Epclusa, take another tablet.
• Ako povratite u razdoblju kraćem od 3 sata nakon uzimanja lijeka Epclusa, uzmite drugu tabletu.
With any baseline NS5A RAVs Without baseline NS5A RAVs
S bilo kojim početnim NS5A RAV-ovima Bez početnih NS5A
No patients with genotype 2 or 4 HCV infection in the Epclusa + RBV 12 weeks group experienced virologic failure.
Nijedan bolesnik s infekcijom HCV-om genotipa 2 ili 4 iz skupine koja je primala lijek Epclusa + RBV tijekom 12 tjedana nije imalo virološki neuspjeh.
After a single 100 mg dose of [14C]-velpatasvir in healthy subjects, the blood to plasma ratio of [14C]-radioactivity ranged between 0.52 and 0.67.
Nakon jedne doze od 100 mg [14C]-velpatasvira u zdravih ispitanika, omjer [14C]-radioaktivnosti u krvi u odnosu na plazmu kretao se u rasponu između 0,52 i 0,67.
The potential risks and benefits associated with co-administration of Epclusa with the fixed-dose combination tablet containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or tenofovir disoproxil fumarate given in conjunction with a boosted HIV protease inhibitor (e.g. atazanavir or darunavir) should be considered, particularly in patients at increased risk of renal dysfunction.
Potrebno je razmotriti moguće rizike i koristi povezane s istodobnom primjenom lijeka Epclusa s tabletom fiksne kombinacije koja sadrži elvitegravir/kobicistat/emtricitabin/ tenofovirdizoproksilfumarat ili tenofovirdizoproksilfumaratom danim zajedno s pojačanim inhibitorom HIV proteaze (npr. atazanavirom ili darunavirom), naročito kod bolesnika s povećanim rizikom od disfunkcije bubrega.
Epclusa + RBV 12 weeks
Epclusa + RBV 12 tjedana
In vitro resistance selection and cross-resistance studies indicate velpatasvir targets NS5A as its mode of action.
In vitro ispitivanja selekcije rezistencije i ukrižene rezistencije pokazuju da je velpatasvir po načinu djelovanja usmjeren na NS5A.
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of sofosbuvir, velpatasvir or Epclusa in pregnant women.
Nema podataka ili su podaci o primjeni sofosbuvira, velpatasvira ili lijeka Epclusa u trudnica ograničeni (manje od 300 trudnoća).
The NS5B NI RAV S282T was not detected in the baseline NS5B sequence of any patient in Phase 3 studies.
Varijanta NS5B S282T povezana s rezistencijom na nukleozidne inhibitore nije opažena u početnoj NS5B sekvenci u niti jednog bolesnika u ispitivanjima faze 3.
Velpatasvir solubility decreases as pH increases.
Topljivost velpatasvira smanjuje se s povećanjem pH.
Impact of DAA therapy on drugs metabolized by the liver The pharmacokinetics of drugs that are metabolized by the liver (e.g. immunosuppressive agents such as calcineurin inhibitors) may be impacted by changes in liver function during DAA therapy, related to clearance of HCV.
Na farmakokinetiku lijekova koji se metaboliziraju putem jetre (npr. imunosupresivi kao što su inhibitori kalcineurina) mogu utjecati promjene u funkciji jetre nastale tijekom terapije direktno djelujućim antiviroticima, a koje su povezane s klirensom HCV­a.
Film-coating Polyvinyl alcohol Titanium dioxide Polyethylene glycol Talc
Film ovojnica polivinilni alkohol titanijev dioksid polietilenglikol talk crveni željezov oksid
Clinical studies in patients with HCV/HIV-1 Co-infection - ASTRAL-5 (study 1202) ASTRAL-5 evaluated 12 weeks of treatment with Epclusa in patients with genotype 1, 2, 3, or 4 HCV infection who were co-infected with HIV-1 (HCV genotype 5 and 6 allowed, but no such patients were included).
Klinička ispitivanja u bolesnika s koinfekcijom virusima HCV/HIV-1 - ASTRAL-5 (ispitivanje 1202) U ispitivanju ASTRAL-5 procjenjivalo se 12 tjedana liječenja lijekom Epclusa u bolesnika zaraženih HCV-om genotipa 1, 2, 3 ili 4 koji su istodobno bili zaraženi virusom HIV-1 (HCV genotipa 5 i 6 bio je dopušten, ali nijedan bolesnik s genotipom 5 ili 6 HCV-a nije uključen u analizu).
If you have any questions about your medicines, please ask your doctor or pharmacist.
Ako imate bilo kakvih pitanja o lijekovima koje uzimate, molimo da se obratite svom liječniku ili ljekarniku.
cirrhosis and Model for End Stage Liver Disease (MELD) score ≤ 15 at baseline, respectively.
Model for End Stage Liver Disease, MELD) ≤ 15 na početku.
Following a single 400 mg oral dose of [14C]-sofosbuvir, mean total recovery of the [14C]-radioactivity was greater than 92%, consisting of approximately 80%, 14%, and 2.5% recovered in urine, faeces, and expired air, respectively.
Nakon jedne peroralne doze od 400 mg [14C]-sofosbuvira, srednja vrijednost ukupno otkrivene [14C]-radioaktivnosti bila je veća od 92 % i sastojala se od približno 80 % one otkrivene u mokraći, 14 % u stolici i 2,5 % u izdahnutom zraku.
SOF+RBV 24 weeks (n = 275)
SOF+RBV 24 tjedna (n = 275)
The pharmacokinetics of velpatasvir was studied with a single dose of 100 mg velpatasvir in HCV negative patients with moderate and severe hepatic impairment (CPT Class B and C).
Farmakokinetika velpatasvira bila je ispitana nakon jedne doze od 100 mg velpatasvira u HCV-negativnih bolesnika s umjerenim i teškim oštećenjem jetre (CPT stadij B i C).
Clinical studies in patients with decompensated cirrhosis - ASTRAL-4 (study 1137) ASTRAL-4 was a randomised, open-label study in patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection and CPT Class B cirrhosis.
Klinička ispitivanja u bolesnika s dekompenziranom cirozom- ASTRAL-4 (ispitivanje 1137) ASTRAL-4 bilo je randomizirano, otvoreno ispitivanje u bolesnika s genotipom 1, 2, 3, 4, 5 ili 6 HCV-a i cirozom CPT stadija B.
Epclusa + RBV 12 weeks (n = 87)
Epclusa + RBV 12 tjedana (n = 87)
SOF+RBV 12 weeks (n = 132)
SOF+RBV 12 tjedana (n = 132)