natgillin/translations-raw huggingface dataset:
Safety data are limited in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2)and end stage renal disease (ESRD) requiring haemodialysis.
Podaci o sigurnosti primjene ograničeni su u bolesnika s teškim oštećenjem bubrega (procijenjena brzina glomerularne filtracije [eGFR] < 30 ml/min/1,73 m2) i završnim stadijem bolesti bubrega (engl. end stage renal disease, ESRD) koji zahtijeva hemodijalizu.
Effect on amiodarone, velpatasvir, and sofosbuvir concentrations unknown.
Učinci na koncentracije amiodarona, velpatasvira i sofosbuvira nisu poznati.
Three patients in the Epclusa + RBV 12 week group had baseline NS5B NI RAVs (N142T and L159F) and all three patients achieved SVR12.
Tri bolesnika u skupini koja je primala lijek Epclusa + RBV tijekom 12 tjedana na početku su imali varijante NS5B povezane s rezistencijom na nukleozidne inhibitore (N142T i L159F) te su sva tri bolesnika postigla SVR12.
Dolutegravir ↔ ↔ ↔ No dose adjustment of Epclusa or dolutegravir is required.
Dolutegravir ↔ ↔ ↔ Nije potrebna prilagodba doze lijeka Epclusa ili dolutegravira.
Table 15: Virologic outcome for patients with genotype 1 and 3 HCV infection in study ASTRAL-4
Tablica 15: Virološki ishod za bolesnike s genotipom 1 ili 3 HCV infekcije u ispitivanju ASTRAL-4.
Table 8: SVR12 in patients with or without baseline NS5A RAVs by HCV genotype (study ASTRAL-4)
Tablica 8: SVR12 u bolesnika sa ili bez početnog NS5A RAV-a prema genotipu HCV-a (ispitivanje ASTRAL-4)
Both patients had virus at baseline harboring NS5A RAVs.
Oba bolesnika imala su virus na početku ispitivanja koji je nosio NS5A RAV-ove.
CPT Class C cirrhosis pre-transplant CPT Class B or C post-transplant
CPT stadij B ili C nakon transplantacije
In vitro, slow metabolic turnover of velpatasvir by CYP2B6, CYP2C8 and CYP3A4 was observed.
In vitro je opažena spora metabolička izmjena velpatasvira putem CYP2B6, CYP2C8 i CYP3A4.
Of the 267 treated patients, the median age was 59 years (range: 40 to 73); 70% of the patients were male; 90% were White, 6% were Black; 42% had a baseline body mass index of at least 30 kg/m2.
Od 267 liječenih bolesnika, medijan dobi iznosio je 59 godina (raspon: 40 do 73); 70 % bolesnika bili su muškarci; 90 % bili su bijelci; 6 % bili su crnci; 42 % imali su početni indeks tjelesne mase od najmanje 30 kg/m2.
Medicinal products that are strong P-glycoprotein (P-gp) and/or strong cytochrome P450 (CYP) inducers (carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. John's wort).
Primjena s jakim induktorima P-gp-a i jakim induktorima CYP-a Lijekovi koji su jaki induktori P-glikoproteina (P-gp) i/ili jaki induktori citokroma P450 (CYP) (karbamazepin, fenobarbital, fenitoin, rifampicin, rifabutin i gospina trava).
Outcome for patients without SVR12 On-treatment virologic failure Relapsea
Ishod u bolesnika bez SVR12 Virološki neuspjeh uz liječenje Relapsa
Famotidine dosed simultaneously with Epclusad
Famotidin primijenjen u isto vrijeme s lijekom Epclusad
(Induction of P-gp and CYPs)
(Indukcija P-gp-a i CYP-ova)
The safety profile of Epclusa has been evaluated in one open-label study in which patients with CPT Class B cirrhosis received Epclusa for 12 weeks (n = 90), Epclusa + RBV for 12 weeks (n = 87) or Epclusa for 24 weeks (n = 90).
Sigurnosni profil lijeka Epclusa procijenjen je u otvorenom ispitivanju u kojem su bolesnici s cirozom CPT stadija B primali lijek Epclusa tijekom 12 tjedana (n = 90), lijek Epclusa + RBV tijekom
• St. John's wort (herbal medicine used to treat depression);
• gospinu travu (biljni lijek koji se primjenjuje za liječenje depresije);
Close monitoring is recommended if this medicinal product is administered with Epclusa (see sections 4.4 and 4.8).
Preporučuje se pažljivo praćenje ako se ovaj lijek primjenjuje s lijekom Epclusa (vidjeti dijelove 4.4 i
(n = 331), velpatasvir AUC0-24 and Cmax were 37% lower and 41% lower, respectively in HCV-infected patients.
U odnosu na one u zdravih ispitanika (n = 331), AUC0-24 i Cmax velpatasvira u bolesnika zaraženih HCV-om iznosile su 37 % manje odnosno 41 % manje.
No dose adjustment of Epclusa or ketoconazole is required.
Nije potrebna prilagodba doze lijeka Epclusa ili ketokonazola.
For ribavirin dose modifications, refer to the Summary of Product Characteristics of the medicinal product containing ribavirin.
Za modifikacije doze ribavirina vidjeti sažetak opis svojstava lijeka koji sadrži ribavirin.
Median velpatasvir EC50, nM (range)
Medijan EC50 velpatasvira, nM (raspon)
It is unknown whether sofosbuvir, metabolites of sofosbuvir or velpatasvir are excreted in human milk.
Nije poznato izlučuju li se sofosbuvir, njegovi metaboliti ili velpatasvir u majčino mlijeko.
No clinically relevant pharmacokinetic differences due to race or gender have been identified for sofosbuvir, GS-331007 or velpatasvir.
Nisu utvrđene nikakve klinički relevantne razlike u farmakokinetici sofosbuvira, GS-331007 ili velpatasvira kojima bi uzrok bila rasa ili spol.
Genotype 1b 11% (2/18) Genotype 3
Genotip 1b 11 % (2/18)
Co-administration of Epclusa with oxcarbazepine is expected to decrease the concentration of sofosbuvir and velpatasvir, leading to reduced therapeutic effect of Epclusa.
Očekuje se da će istodobna primjena lijeka Epclusa s okskarbazepinom smanjiti koncentraciju sofosbuvira i velpatasvira i tako dovesti do smanjenog terapijskog učinka lijeka Epclusa.
c Administered as Epclusa.
c. Primjenjuje se kao lijek Epclusa.
Interaction only studied with sofosbuvir Expected:
Interakcija ispitana samo sa sofosbuvirom
Medicinal products that are strong inducers of P-gp and/or strong inducers of CYP2B6, CYP2C8, or CYP3A4 (e.g. carbamazepine, phenobarbital and phenytoin, rifampicin, rifabutin and St. John's wort) may decrease plasma concentrations of sofosbuvir or velpatasvir leading to reduced therapeutic effect of sofosbuvir/velpatasvir.
Lijekovi koji su jaki induktori P-gp-a i/ili jaki induktori CYP2B6, CYP2C8 ili CYP3A4 (npr. karbamazepin, fenobarbital i fenitoin, rifampicin, rifabutin i gospina trava) mogu smanjiti koncentracije sofosbuvira ili velpatasvira u plazmi i tako dovesti do smanjenog terapijskog učinka sofosbuvira/velpatasvira.
• The active substances are sofosbuvir and velpatasvir.
• Djelatne tvari su sofosbuvir i velpatasvir.
Of the 2 genotype 3 virologic failure patients, one had NS5A RAV Y93H emerge at failure.
Od dva bolesnika s genotipom 3 kod kojih je došlo do virološkog neuspjeha, jedan je imao pojavu NS5A RAV-a Y93H pri neuspjehu.
Median sofosbuvir EC50, nM (range)
Medijan EC50 sofosbuvira, nM (raspon)
Velpatasvir is also a substrate of drug transporter OATP1B.
Velpatasvir je također supstrat prijenosnika lijeka OATP1B.
Epclusa + RBV 12 weeks (87) Epclusa 24 weeks (90)
Epclusa 12 tjedana (90) Epclusa + RBV 12 tjedana (87) Epclusa 24 tjedna (90)
The use of such medicinal products with Epclusa is contraindicated (see section 4.3).
Primjena takvih lijekova s lijekom Epclusa je kontraindicirana (vidjeti dio 4.3).
Outcome for patients without SVR12 Ontreatment virologic failure
Ishod u bolesnika bez SVR12 Virološki neuspjeh uz liječenje
Epclusa + ribavirin for 12 weeks a Includes patients co-infected with human immunodeficiency virus (HIV) and patients with recurrent HCV post-liver transplant (see section 4.4.
Uključuje bolesnike koji su istodobno zaraženi virusom humane imunodeficijencije (HIV) i bolesnike s rekurentnim HCV-om poslije transplantacije jetre (vidjeti dio 4.4.).
In vitro potential for sofosbuvir/velpatasvir drug-drug interactions Sofosbuvir and velpatasvir are substrates of drug transporters P-gp and BCRP while GS-331007 is not.
Sofosbuvir i velpatasvir supstrati su prijenosnika lijekova P-gp-a i BCRP-a, dok GS-331007 to nije.
No teratogenic effects were observed in the rat and rabbit developmental toxicity studies with sofosbuvir.
Nisu bili opaženi teratogeni učinci sofosbuvira u ispitivanjima njegove razvojne toksičnosti na štakorima i kunićima.
Demographics and baseline characteristics were balanced across the treatment groups.
Demografska slika i značajke na početku ispitivanja uravnotežene su između liječenih skupina.
Otherd a No patients with genotype 1 HCV had on-treatment virologic failure.
Nijedan bolesnik s infekcijom HCV-om genotipa 1 nije imao virološki neuspjeh tijekom liječenja.
Genotype 3 HCV-infected adults - ASTRAL-3 (study 1140) ASTRAL-3 was a randomised, open-label study that evaluated 12 weeks of treatment with Epclusa compared with 24 weeks of treatment with SOF+RBV in patients with genotype 3 HCV infection.
Odrasli zaraženi HCV-om genotipa 3 - ASTRAL-3 (ispitivanje 1140) ASTRAL-3 bilo je randomizirano, otvoreno ispitivanje u kojem se procjenjivalo 12 tjedana liječenja lijekom Epclusa u usporedbi s 24 tjedna liječenja sa SOF + RBV u bolesnika koji su imali infekciju HCV-om genotipa
Velpatasvir is a substrate of CYP2B6, CYP2C8, and CYP3A4 with slow turnover.
Velpatasvir je supstrat CYP2B6, CYP2C8 i CYP3A4 sa sporom metaboličkom izmjenom.
Co-administration of Epclusa with efavirenz-containing regimens is not recommended (see section 4.4).
Istodobna primjena lijeka Epclusa s režimima koji sadrže efavirenz se ne preporučuje (vidjeti dio 4.4).
Epclusa should not affect your ability to drive or use any tools or machinery.
Upravljanje vozilima i strojevima Lijek Epclusa ne bi trebao utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
f Bioequivalence/Equivalence boundary 80-125%.
f. Granica bioekvivalencija/ekvivalencije 80 %-125 %. g. Raspon u kojem nema farmakokinetičkih interakcija 50 %-200 %.
Ethinyl estradiol a Mean ratio (90% CI) of co-administered drug pharmacokinetics of study medicinal products alone or in combination.
Srednja vrijednost omjera (90 % CI) farmakokinetičkih parametara lijekova istodobno primijenjenih s jednim ispitivanim lijekom ili u kombinaciji s oba ispitivana lijeka.
Table 11 presents the SVR12 for the ASTRAL-2 study.
U tablici 11 predstavljen je SVR12 za ispitivanje ASTRAL-2.
Co-administration of Epclusa with rifapentine is expected to decrease the concentration of sofosbuvir and velpatasvir, leading to reduced therapeutic effect of
Očekuje se da će istodobna primjena lijeka Epclusa s rifapentinom smanjiti koncentraciju sofosbuvira i velpatasvira i tako dovesti do smanjenog terapijskog učinka lijeka Epclusa.
Table 12 presents the SVR12 for the ASTRAL-3 study.
U tablici 12 predstavljen je SVR12 za ispitivanje ASTRAL-3.
Genotype 2 HCV-infected adults - ASTRAL-2 (study 1139) ASTRAL-2 was a randomised, open-label study that evaluated 12 weeks of treatment with Epclusa compared with 12 weeks of treatment with SOF+RBV in patients with genotype 2 HCV infection.
Odrasli zaraženi HCV-om genotipa 2 - ASTRAL-2 (ispitivanje 1139) ASTRAL-2 bilo je randomizirano, otvoreno ispitivanje u kojem se procjenjivalo 12 tjedana liječenja lijekom Epclusa u usporedbi s 12 tjedna liječenja SOF+RBV u bolesnika koji su imali infekciju HCV-om genotipa
The pharmacokinetics of velpatasvir was studied with a single dose of 100 mg velpatasvir in HCV negative patients with severe renal impairment (eGFR < 30 mL/min by Cockcroft-Gault).
Farmakokinetika velpatasvira bila je ispitana u HCV-negativnih bolesnika s teškim oštećenjem bubrega (eGFR < 30 ml/min prema Cockcroft-Gaultu) nakon jedne doze od 100 mg velpatasvira.
Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ velpatasvir (100 mg once daily)d
Norgestimat/etinilestradiol (norgestimat 0,180 mg/0,215 mg/ 0,25 mg/etinilestradiol 0,025 mg)/velpatasvir (100 mg jedanput na dan)d
↔ ↔ ↔ Co-administration of Epclusa with efavirenz/ emtricitabine/ tenofovir disoproxil fumarate is expected to decrease the concentration of velpatasvir.
Efavirenz ↔ ↔ ↔ Očekuje se da će istodobna primjena lijeka Epclusa s efavirenzom/emtricitabinom/ tenofovirdizoproksilfumaratom smanjiti koncentracije velpatasvira.
Digoxin (0.25 mg single dose)f/ velpatasvir (100 mg single dose)
Digoksin (jedna doza od 0,25 mg)f/ velpatasvir (jedna doza od 100 mg)
HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Tenofovir disoproxil fumarate
ANTIVIRUSNI LIJEKOVI ZA HIV: INHIBITORI REVERZNE TRANSKRIPTAZE
100% (8/8)a
Genotip 2, 4 i 6 100 % (8/8)a
Epclusa is contraindicated with phenobarbital and phenytoin (see section 4.3).
Lijek Epclusa je kontraindiciran s fenobarbitalom i fenitoinom (vidjeti dio 4.3).
How to take Epclusa
Kako uzimati lijek Epclusa
Medicinal products that are moderate P-gp inducers and/or moderate CYP inducers (e.g. efavirenz, modafinil, oxcarbazepine or rifapentine) may decrease sofosbuvir or velpatasvir plasma concentration leading to reduced therapeutic effect of Epclusa.
Lijekovi koji su umjereni induktori P-gp-a i/ili umjereni induktori CYP-a (npr. efavirenz, modafinil, okskarbazepin ili rifapentin) mogu smanjiti koncentraciju sofosbuvira ili velpatasvira u plazmi i tako dovesti do smanjenog terapijskog učinka lijeka Epclusa.
Clinical studies in patients without cirrhosis and patients with compensated cirrhosis Genotype 1, 2, 4, 5 and 6 HCV-infected adults - ASTRAL-1 (study 1138) ASTRAL-1 was a randomised, double-blind, placebo-controlled study that evaluated 12 weeks of treatment with Epclusa compared with 12 weeks of placebo in patients with genotype 1, 2, 4, 5, or 6 HCV infection.
Klinička ispitivanja u bolesnika bez ciroze i bolesnika s kompenziranom cirozom Odrasli zaraženi HCV-om genotipa 1, 2, 4, 5 i 6 - ASTRAL-1 (ispitivanje 1138) ASTRAL-1 bilo je randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje za procjenu 12-tjednog liječenja lijekom Epclusa u usporedbi s 12 tjedana primanja placeba u bolesnika zaraženih HCV-om genotipa 1, 2, 4, 5 ili 6. Bolesnici zaraženi HCV-om genotipa 1, 2, 4 ili 6 randomizirani su u omjeru 5:1 za liječenje lijekom Epclusa tijekom 12 tjedana ili primanje placeba tijekom 12 tjedana.
Studies in patients without cirrhosis and patients with compensated cirrhosis In a pooled analysis of patients without cirrhosis or with compensated cirrhosis who received Epclusa for 12 weeks in three Phase 3 studies, 12 patients (2 with genotype 1 and 10 with genotype 3) qualified for resistance analysis due to virologic failure.
U objedinjenoj analizi bolesnika bez ciroze ili s kompenziranom cirozom koji su primili lijek Epclusa tijekom 12 tjedana u trima ispitivanjima faze 3, 12 bolesnika (dva s genotipom 1 i 10 s genotipom 3) kvalificiralo se za analizu rezistencije zbog virološkog neuspjeha.
Use with moderate P-gp inducers and/or moderate CYP inducers Medicinal products that are moderate P-gp and/or moderate CYP inducers (e.g. efavirenz, modafinil, oxcarbazepine or rifapentine) may decrease sofosbuvir or velpatasvir plasma concentrations leading to reduced therapeutic effect of Epclusa.
Primjena s umjerenim induktorima P-gp-a i/ili umjerenim induktorima CYP-a Lijekovi koji su umjereni induktori P-gp-a i/ili umjereni induktori CYP-a (npr. efavirenz, modafinil, okskarbazepin ili rifapentin) mogu smanjiti koncentracije sofosbuvira ili velpatasvira u plazmi što dovodi do smanjenog terapijskog učinka lijeka Epclusa.
ORAL CONTRACEPTIVES Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ sofosbuvir (400 mg once daily)d
Norgestimat/etinilestradiol (norgestimat 0,180 mg/0,215 mg/ 0,25 mg/etinilestradiol 0,025 mg)/sofosbuvir (400 mg jedanput na dan)d
Omeprazole dosed simultaneously with Epclusad
Omeprazol primijenjen u isto vrijeme s lijekom Epclusad
Following a single 100 mg oral dose of [14C]-velpatasvir, mean total recovery of the [14C]-radioactivity was 95%, consisting of approximately 94% and 0.4% recovered from the faeces and urine, respectively.
Nakon jedne peroralne doze od 100 mg [14C]-velpatasvira, srednja vrijednost ukupno otkrivene [14C]-radioaktivnosti bila je 95 % i sastojala se od približno 94 % one otkrivene u stolici i 0,4 % u mokraći.
No patients with genotype 2, 4 or 6 HCV infection experienced virologic failure.
Nijedan bolesnik s infekcijom HCV-om genotipa 2, 4 ili 6 nije imao virološki neuspjeh.
Studies in patients with decompensated cirrhosis
Ispitivanja u bolesnika s dekompenziranom cirozom
Genotypes 2 or 4
Genotip 3 Genotipi 2 ili 4 Ukupno
Velpatasvir AUC increases in a nearly dose proportional manner over the dose range of 25 mg to 150 mg. Sofosbuvir and GS-331007 AUCs are near dose-proportional over the dose range of 200 mg to 1,200 mg.
AUC sofosbuvira i GS-331007 bili su gotovo proporcionalni dozi u rasponu doza od 200 mg do 1200 mg.
Effect on velpatasvir exposure not studied.
Učinak na izloženost velpatasviru nije ispitan.
How to store Epclusa
Kako čuvati lijek Epclusa
No patients with genotype 2, 4, 5, or 6 HCV infection experienced virologic failure.
Nijedan bolesnik s infekcijom HCV-om genotipa 2, 4, 5 ili 6 nije imao virološki neuspjeh.
Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analogue triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator.
Sofosbuvir je nukleotidni predlijek iz kojeg unutarstaničnim metabolizmom nastaje farmakološki djelatan uridinu analogni trifosfat (GS-461203), koji se može ugraditi u
The median terminal half-lives of sofosbuvir and GS-331007 following administration of Epclusa were 0.5 and 25 hours, respectively.
Nakon primjene lijeka Epclusa, medijan terminalnog poluvijeka sofosbuvira iznosio je 0,5 sati, a GS-331007 25 sati.
(Inhibition of P-gp and CYPs)
(Inhibicija P-gp-a i CYP-ova)
Ketoconazole (200 mg twice daily)/ velpatasvir (100 mg single dose)d
Ketokonazol (200 mg dvaput na dan)/velpatasvir (jedna doza od 100 mg)d
 If you get any side effects tell your doctor.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika.
No dose adjustment of Epclusa or tacrolimus is required at initiation of co-administration.
Nije potrebna prilagodba doze lijeka Epclusa ili takrolimusa na početku istodobne primjene.
TN and TE with or without cirrhosis, with ESRD requiring dialysis
GS-US-342-4062 TN i TE, s cirozom ili bez nje, s ESRD-om koji je zahtijevao dijalizu
NARCOTIC ANALGESICS Methadone (Methadone maintenance therapy [30 to 130 mg daily])/ sofosbuvir (400 mg once daily)d
(terapija održavanja metadonom [30 do 130 mg na dan])/sofosbuvir (400 mg jedanput na dan)d
Effect of baseline HCV resistance-associated variants on treatment outcome Studies in patients without cirrhosis and patients with compensated cirrhosis Analyses were conducted to explore the association between pre-existing baseline NS5A RAVs and treatment outcome for patients without cirrhosis or with compensated cirrhosis in three Phase 3 clinical studies (ASTRAL-1, ASTRAL-2 and ASTRAL-3).
Provedene su analize kako bi se ispitala povezanost između postojećih početnih NS5A RAV-ova i ishoda liječenja u bolesnika bez ciroze ili s kompenziranom cirozom u trima kliničkim ispitivanjima faze 3 (ASTRAL-1, ASTRAL-2 i ASTRAL-3).
Tacrolimus (5 mg single dose)f/ sofosbuvir (400 mg single dose)d
Takrolimus (jedna doza od 5 mg)f/sofosbuvir (jedna doza od 400 mg)d
Patients with decompensated cirrhosis
Bolesnici s dekompenziranom cirozom
Of the 106 treated patients, the median age was 57 years (range: 25 to 72); 86% of the patients were male; 51% were white; 45% were black; 22% had a baseline body mass index ≥ 30 kg/m2; 19 patients (18%) had compensated cirrhosis; and 29% were treatment experienced.
Od 106 liječenih bolesnika, medijan dobi iznosio je 57 godina (raspon: 25 do 72); 86 % bolesnika bili su muškarci; 51 % bijelci, 45 % crnci; 22 % bolesnika imali su početni indeks tjelesne mase ≥ 30 kg/m2; 19 bolesnika (18 %) imalo je kompenziranu cirozu; i 29 % je prethodno liječeno.
Epclusa 12 Weeks
Epclusa 12 tjedana
Rifampicin (600 mg once daily)/ velpatasvir (100 mg single dose)
Rifampicin (600 mg jedanput na dan)/velpatasvir (jedna doza od 100 mg)
Pravastatin (40 mg single dose)/ velpatasvir (100 mg once daily)d
Pravastatin (jedna doza od 40 mg)/velpatasvir (100 mg jedanput na dan)d
Table 12: SVR12 in study ASTRAL-3 (HCV genotype 3)
Tablica 13: SVR12 u ispitivanju ASTRAL-3 (genotip 3 HCV-a)
Co-administration of such medicinal products with Epclusa is not recommended (see section 4.5).
Istodobna primjena takvih lijekova s lijekom Epclusa se ne preporučuje (vidjeti dio 4.5).
TN and TE, without cirrhosis or with compensated cirrhosis
Genotip 2 TN i TE, bez ciroze ili s kompenziranom cirozom
Refer to the tenofovir disoproxil fumarate-containing product's Summary of Product Characteristics for recommendations on renal monitoring (see section 4.4).
Preporuke o praćenju bubrežne funkcije pogledajte u sažetku opisa svojstava lijeka za lijekove koji sadrže tenofovirdizoproksilfumarat (vidjeti dio 4.4).
76% of the patients had non-CC IL28B alleles (CT or TT); 56% had baseline HCV RNA levels of at least 800,000 IU/mL, 55% were treatment-experienced; 90% and 95% of patients had CPT Class B
Nije bio uključen nijedan bolesnik s genotipom 5 HCV-a. 76 % bolesnika imali su ne-CC IL28B alele (CT ili TT); 56 % bolesnika imali su razine HCV RNK od najmanje 800.000 IU/ml, 55 % su bili prethodno liječeni; 90 % i 95 % bolesnika imali su cirozu CPT stadija B odnosno rezultat modela za završni stadij bolesti bubrega (engl.
Of the 740 treated patients, the median age was 56 years (range: 18 to 82); 60% of the patients were male; 79% were White, 9% were Black; 21% had a baseline body mass index of at least 30 kg/m2; the proportions of patients with genotype 1, 2, 4, 5, or 6 HCV infection were 53%, 17%, 19%, 5% and 7%, respectively; 69% had non-CC IL28B alleles (CT or TT); 74% had baseline HCV RNA levels of at least 800,000 IU/mL; 19% had compensated cirrhosis; and 32% were treatment-experienced.
Od 740 liječenih bolesnika, medijan dobi iznosio je 56 godina (raspon: 18 do 82); 60 % bolesnika bili su muškarci; 79 % bijelci, 9 % crnci; 21 % bolesnika imali su početni indeks tjelesne mase od najmanje 30 kg/m2; udio bolesnika s genotipom 1, 2, 4, 5 ili 6 HCV-a bio je 53 %, 17 %, 19 %, 5 % odnosno 7 %; 69 % su imali ne-CC IL28B alele (CT ili TT); 74 % bolesnika su imali početne razine HCV RNK od najmanje 800.000 IU/ml; 19 % je imalo kompenziranu cirozu; i 32 % je prethodno liječeno.
Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV direct-acting antiviral treatment.
Nakon uvođenja liječenja HCV infekcije direktno djelujućim antivirotikom, bolesnici s dijabetesom mogu imati bolju kontrolu glukoze u krvi, što može dovesti do simptomatske hipoglikemije.
Epclusa for 12 weeks
Epclusa tijekom 12 tjedana
It is important not to miss a dose of this medicine.
Ako ste zaboravili uzeti lijek Epclusa Važno je da ne propustite uzeti dozu ovog lijeka.
Epclusa is contraindicated with carbamazepine (see section 4.3).
Lijek Epclusa je kontraindiciran s karbamazepinom (vidjeti dio 4.3).,
Microcrystalline cellulose Croscarmellose sodium Magnesium stearate
Jezgra tablete kopovidon mikrokristalična celuloza umrežena karmelozanatrij magnezijev stearat
Patients were randomised in a 1:1 ratio to treatment with Epclusa for 12 weeks or SOF+RBV for 24 weeks.
Bolesnici su randomizirani u omjeru 1:1 za liječenje lijekom Epclusa tijekom 12 tjedana ili sa SOF + RBV tijekom 24 tjedana.
Recommendation concerning co-administration with Epclusa
Preporuka za istodobnu primjenu s lijekom Epclusa
Refer to tenofovir disoproxil fumarate, emtricitabine/tenofovir disoproxil fumarate, or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate Summary of Product Characteristics for recommendations on renal monitoring.
Pogledajte sažetak opisa svojstava lijeka za tenofovirdizoproksilfumarat, emtricitabin/tenofovirdizoproksilfumarat ili elvitegravir/kobicistat/emtricitabin/ tenofovirdizoproksilfumarat radi preporuka o praćenju bubrega.
ANTIMYCOBACTERIALS Rifampicin (600 mg once daily)/ sofosbuvir (400 mg single dose)d
Rifampicin (600 mg jedanput na dan)/sofosbuvir (jedna doza od 400 mg)d
No dose adjustment of Epclusa or pravastatin is required.
Nije potrebna prilagodba doze lijeka Epclusa ili pravastatina.
Epclusa is contraindicated with rifabutin (see section 4.3).
Lijek Epclusa je kontraindiciran s rifabutinom (vidjeti dio 4.3).