natgillin/translations-raw huggingface dataset:
The dose of fluvastatin, lovastatin, or simvastatin should not exceed a daily dose of 20 mg when co-administered with ZEPATIER.
Pri istodobnoj primjeni s lijekom ZEPATIER, doza fluvastatina, lovastatina ili simvastatina ne smije biti viša od dnevne doze od 20 mg.
• EBR/GZR for 12 or 16 weeks (N=105 and respectively)
• EBR/GZR tijekom 12 ili 16 tjedana (N=105 odnosno 105)
(8-24 mg/2-6 mg once daily)/ grazoprevir (200 mg once daily)
(8-24 mg/2-6 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
How to store ZEPATIER
Kako čuvati ZEPATIER
• EBR* + GZR* + RBV† for 12 weeks (N=14)
• EBR*+GZR*+RBV tijekom 12 tjedana (N=14)
• EBR/GZR + RBV† for 12 or 16 weeks (N=104 and respectively)
• EBR/GZR+RBV tijekom 12 ili 16 tjedana (N=104 odnosno 106)
These changes are not clinically relevant; therefore, no dose adjustment of elbasvir/grazoprevir is recommended based on race/ethnicity (see section 4.4).
Te promjene nisu klinički značajne; stoga se ne preporučuje prilagođavati dozu elbasvira/grazoprevira na temelju rase/etničkog podrijetla (vidjeti dio 4.4).
Sevelamer carbonate (2,400 mg single dose)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
Sevelamer karbonat (2400 mg u jednokratnoj dozi)/elbasvir (50 mg u jednokratnoj dozi)/grazoprevir (100 mg u jednokratnoj dozi)
• EBR/GZR for 12 weeks (N=218)
• EBR/GZR tijekom 12 tjedana (N=218)
GT 1, 4, 6 TN with or without cirrhosis HCV/HIV-1 co-infection
GT 1, 4, 6 PN, s cirozom ili bez nje Istodobna HCV/HIV-1 infekcija
Proton pump inhibitors Pantoprazole (40 mg once daily)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
Inhibitori protonske pumpe Pantoprazol (40 mg jedanput na dan)/ elbasvir (50 mg u jednokratnoj dozi)/grazoprevir (100 mg u jednokratnoj dozi)
↔ R-Methadone AUC 1.09 (1.02, 1.17) Cmax 1.03 (0.96, 1.11)
↔ R-metadon AUC 1,09 (1,02; 1,17) Cmax 1,03 (0,96; 1,11)
Darunavir/ritonavir (600 mg twice daily)/ ritonavir (100 mg twice daily/ elbasvir (50 mg once daily)
Darunavir/ritonavir (600 mg dvaput na dan)/ritonavir (100 mg dvaput na dan)/elbasvir (50 jedanput na dan)
Among genotype 1binfected subjects, NS5A resistance-associated substitutions persisted at detectable levels in 100% (7/7) of subjects at follow-up week 12 and in 100% (3/3) of subjects with follow-up week 24 data.
Među ispitanicima s infekcijom genotipom 1b, supstitucije povezane s rezistencijom u NS5A bile su i dalje prisutne u mjerljivim količinama u 100% (7/7) ispitanika u 12. tjednu praćenja te u 100% (3/3) ispitanika u 24. tjednu praćenja.
Table 3: Adverse reactions identified with ZEPATIER Frequency
Tablica 3: Nuspojave zabilježene kod primjene lijeka ZEPATIER* Učestalost
Table 9: SVR in genotype 1b †-infected subjects Baseline Characteristics
Tablica 9: SVR u ispitanika s infekcijom genotipom 1b Početne značajke
• EBR/GZR* for 12 weeks (N=316)
• EBR/GZR* tijekom 12 tjedana (N=316)
• EBR/GZR for 12 weeks (N=201)
• EBR/GZR tijekom 12 tjedana (N=201)
Among genotype 1a-infected subjects, the median age was 54 years (range: 19 to 76); 71 % were male; 71 % were White; 22 % were Black or African American; 9% were Hispanic or Latino; 74% were treatment-naïve subjects; 26% were treatment-experienced subjects; mean body mass index was 27 kg/m2; 75 % had baseline HCV RNA levels greater than 800,000 IU/mL; 23 % had cirrhosis; 72% had non-C/C IL28B alleles (CT or TT); 30 % had HCV/HIV-1 co-infection.
Među ispitanicima s infekcijom genotipom 1a, medijan dobi iznosio je 54 godine (raspon: 19 do 76); 71% ispitanika bili su muškarci; 71% bili su bijelci; 22% bili su crnci ili Afroamerikanci; 9% bili su hispanoameričkog ili latinoameričkog podrijetla; 74% ispitanika prethodno nije bilo liječeno, dok je njih 26% prethodno primalo liječenje; srednja vrijednost indeksa tjelesne mase iznosila je 27 kg/m 75% ispitanika je na početku ispitivanja imalo vrijednost HCV RNK iznad 800 000 IU/ml; 23% imalo je cirozu; 72% imalo je alele IL28B koji nisu bili genotipa C/C (CT ili TT), a njih 30% imalo je istodobnu HCV/HIV-1 infekciju.
Among genotype 1b/1 other-infected subjects, the median age was 55 years (range: 22 to 82); 61% were male; 60 % were White; 20% were Black or African American; 6% were Hispanic or Latino; 82% were treatment-naïve subjects; 18% were treatment-experienced subjects; mean body mass index was 26 kg/m2; 64 % had baseline HCV RNA levels greater than 800,000 IU/mL; 22 % had cirrhosis; 71% had non-C/C IL28B alleles (CT or TT); 18 % had HCV/HIV-1 co-infection.
Među ispitanicima s infekcijom genotipom 1b/1 drugo, medijan dobi iznosio je 55 godina (raspon: 22 do 82); 61% ispitanika bili su muškarci; 60% bili su bijelci; 20% bili su crnci ili Afroamerikanci; 6% bili su hispanoameričkog ili latinoameričkog podrijetla; 82% ispitanika prethodno nije bilo liječeno, dok je njih 18% prethodno primalo liječenje; srednja vrijednost indeksa tjelesne mase iznosila je 26 kg/m2; 64% ispitanika je na početku ispitivanja imalo vrijednost HCV RNK iznad 800 000 IU/ml; 22% imalo je cirozu; 71% imalo je alele IL28B koji nisu bili genotipa C/C (CT ili TT), a njih 18% imalo je istodobnu HCV/HIV-1 infekciju.
Diabetics may experience improved glucose control potentially resulting in symptomatic hypoglycaemia, after initiating HCV direct acting antiviral (DAA) treatment.
Nakon uvođenja liječenja HCV infekcije direktno djelujućim antivirotikom (DAA), bolesnici s dijabetesom mogu imati bolju kontrolu glukoze u krvi, što može dovesti do simptomatske hipoglikemije.
These changes are not clinically relevant; therefore, no dose adjustment of elbasvir/grazoprevir is recommended based on sex (see section 4.4).
Te promjene nisu klinički značajne; stoga se ne preporučuje prilagođavati dozu elbasvira/grazoprevira na temelju spola (vidjeti dio 4.4).
Tenofovir disoproxil fumarate (300 mg once daily)/ elbasvir (50 mg once daily)
Tenofovirdizoproksilfumarat (300 mg jedanput na dan)/elbasvir (50 mg jedanput na dan)
†Reference sequences for NS5A at amino acid 31 are L (genotype 1a and genotype 1b) and M (genotype 4a and 4d).
Referentne sekvence za NS5A na aminokiselini 31 su L (genotip 1a i genotip 1b) i M (genotip 4a i 4d).
GT 1, 4, 6 TE with or without cirrhosis, and with or without HCV/HIV-1 co-infection
GT 1, 4, 6 PL, s cirozom ili bez nje te s istodobnom HCV/HIV-1 infekcijom ili bez nje
In population pharmacokinetic analyses, elbasvir and grazoprevir AUCs are estimated to be 50 % and 30 % higher, respectively, in females compared to males.
Prema populacijskim farmakokinetičkim analizama, procjenjuje se da je AUC elbasvira 50% veći, a AUC grazoprevira 30% veći u žena nego u muškaraca.
Among genotype 1a-infected subjects, NS3 resistance-associated substitutions persisted at detectable levels at follow-up week 24 in 31% (4/13) of subjects.
Među ispitanicima s infekcijom genotipom 1a, supstitucije povezane s rezistencijom u NS3 bile su i dalje prisutne u mjerljivim količinama u 31% (4/13) ispitanika u 24. tjednu praćenja.
• EBR* + GZR* for 12 weeks (N=122)
• EBR*+GZR* tijekom 12 tjedana (N=122)
In genotype 4 replicons, single NS3 substitutions D168A/V reduced grazoprevir antiviral activity by 110to 320-fold.
Kod replikona genotipa 4, pojedinačne supstitucije D168A/V u proteinu NS3 smanjile su antivirusnu aktivnost grazoprevira od 110 do 320 puta.
Table 11: SVR in genotype 4-infected subjects Baseline Characteristics
Tablica 11: SVR u ispitanika s infekcijom genotipom 4 Početne značajke
Lopinavir/ritonavir (400 mg twice daily)/ ritonavir (100 mg twice daily/ elbasvir (50 mg once daily)
Lopinavir/ritonavir (400 mg dvaput na dan)/ritonavir (100 mg dvaput na dan)/elbasvir (50 mg jedanput na dan)
Among genotype 1b-infected subjects, NS3 resistance-associated substitutions persisted at detectable levels at follow-up week 24 in 50% (1/2) of subjects.
Među ispitanicima s infekcijom genotipom 1b, supstitucije povezane s rezistencijom u NS3 bile su i dalje prisutne u mjerljivim količinama u 50% (1/2) ispitanika u 24. tjednu praćenja.
In genotype 1b replicons, single NS5A substitutions L31F and Y93H reduced elbasvir antiviral activity by 17-fold.
Kod replikona genotipa 1b, pojedinačne supstitucije L31F i Y93H u proteinu NS5A smanjile su antivirusnu aktivnost elbasvira 17 puta.
Among genotype 4-infected subjects, the median age was 51 years (range: 28 to 75); 66 % were male; 88 % were White; 8 % were Black or African American; 11% were Hispanic or Latino; 77% were treatment-naïve subjects; 23% were treatment-experienced subjects; mean body mass index was 25 kg/m2; 56 % had baseline HCV RNA levels greater than 800,000 IU/mL; 22 % had cirrhosis; 73% had non-C/C IL28B alleles (CT or TT); 40 % had HCV/HIV-1 co-infection.
Među ispitanicima s infekcijom genotipom 4, medijan dobi iznosio je 51 godinu (raspon: 28 do 75); 66% ispitanika bili su muškarci; 88% bili su bijelci; 8% bili su crnci ili Afroamerikanci; 11% bili su hispanoameričkog ili latinoameričkog podrijetla; 77% ispitanika prethodno nije bilo liječeno, dok je njih 23% prethodno liječeno; srednja vrijednost indeksa tjelesne mase iznosila je 25 kg/m ispitanika je na početku ispitivanja imalo vrijednost HCV RNK iznad 800 000 IU/ml; 22% imalo je cirozu; 73% imalo je alele IL28B koji nisu bili genotipa C/C (CT ili TT), a njih 40% imalo je istodobnu HCV/HIV-1 infekciju.
↔ Elbasvir AUC 1.66 (1.35, 2.05) Cmax 1.67 (1.36, 2.05) C24 1.82 (1.39, 2.39)
AUC 1,66 (1,35; 2,05) Cmax 1,67 (1,36; 2,05) C24 1,82 (1,39; 2,39)
Table 10: SVR in genotype 1a-infected subjects Baseline Characteristics
Tablica 10: SVR u ispitanika s infekcijom genotipom 1a Početne značajke
Raltegravir (400 mg single dose)/ elbasvir (50 mg single dose)
Raltegravir (400 mg u jednokratnoj dozi)/elbasvir (50 mg u jednokratnoj dozi)
↔ Buprenorphine AUC 0.98 (0.81, 1.19) Cmax 0.90 (0.76, 1.07)
↔ buprenorfin AUC 0,98 (0,81; 1,19) Cmax 0,90 (0,76; 1,07)
GT 1 TE with HCV protease inhibitor regimen
GT 1 PL režimom koji je uključivao inhibitor HCV proteaze s cirozom ili bez nje
(20-150 mg once daily)/ grazoprevir (200 mg once daily)
(20-150 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
For elbasvir, in HCV genotype 1a replicons, single NS5A substitutions Q30D/E/H/R, L31M/V and Y93C/H/N reduced elbasvir antiviral activity by 6- to 2,000-fold.
Kada je riječ o elbasviru, kod replikona HCV-a genotipa 1a, pojedinačne supstitucije Q30D/E/H/R, L31M/V i Y93C/H/N u proteinu NS5A smanjile su antivirusnu aktivnost elbasvira od 6 do 2000 puta.
Placebo-controlled study in which subjects were randomised in a 2:1 ratio to EBR/GZR for 12 weeks (ITG) or placebo for 12 weeks followed by open-label treatment with EBR/GZR for 12 weeks (DTG).
Placebom kontrolirano ispitivanje u kojem su ispitanici bili randomizirani u omjeru 2:1 za EBR/GZR tijekom 12 tjedana (skupina liječena odmah) ili placebo tijekom 12 tjedana, nakon čega je uslijedilo otvoreno 12-tjedno liječenje kombinacijom EBR/GZR (skupina s odgođenim liječenjem).
(300 mg once daily)/ ritonavir (100 mg once daily/ elbasvir (50 mg once daily)
(300 mg jedanput na dan)/ritonavir (100 mg jedanput na dan)/elbasvir (50 mg jedanput na dan)
(intestinal BCRP inhibition)
(inhibicija BCRP-a u crijevima)
↔ Elbasvir AUC 1.98 (1.84, 2.13) Cmax 1.95 (1.84, 2.07) C24 2.21 (1.98, 2.47)
AUC 1,98 (1,84; 2,13) Cmax 1,95 (1,84; 2,07) C24 2,21 (1,98; 2,47)
For grazoprevir, in HCV genotype 1a replicons, single NS3 substitutions D168A/E/G/S/V reduced grazoprevir antiviral activity by 2- to 81-fold.
Kada je riječ o grazopreviru, kod replikona HCV-a genotipa 1a, pojedinačne supstitucije D168A/E/G/S/V u proteinu NS3 smanjile su antivirusnu aktivnost grazoprevira od 2 do 81 puta.
(600 mg PO single dose)/ elbasvir (50 mg single dose)
(600 mg u jednokratnoj peroralnoj dozi)/elbasvir (50 mg u jednokratnoj dozi)
Expected: ↑ Dabigatran
Očekivano: ↑ dabigatran
Buprenorphine/naloxone (8 mg/2 mg single dose)/ elbasvir (50 mg single dose)
OPIOIDNA NADOMJESNA TERAPIJA Buprenorfin/nalokson (8 mg/2 mg u jednokratnoj dozi)/elbasvir (50 mg u jednokratnoj dozi)
↔ Mycophenolic acid AUC 0.95 (0.87, 1.03) Cmax 0.85 (0.67, 1.07)
↔ mikofenolatna kiselina AUC 0,95 (0,87; 1,03) Cmax 0,85 (0,67; 1,07)
The dose of rosuvastatin should not exceed a daily dose of 10 mg when co-administered with ZEPATIER.
Pri istodobnoj primjeni s lijekom ZEPATIER, doza rosuvastatina ne smije biti viša od dnevne doze od 10 mg.
↔ Prednisolone AUC 1.08 (1.01, 1.16) Cmax 1.04 (0.99, 1.09)
↔ prednizolon AUC 1,08 (1,01; 1,16) Cmax 1,04 (0,99; 1,09)
↔ R-Methadone AUC 1.03 (0.92, 1.15) Cmax 1.07 (0.95, 1.20) C24 1.10 (0.96, 1.26)
↔ R-metadon AUC 1,03 (0,92; 1,15) Cmax 1,07 (0,95; 1,20) C24 1,10 (0,96; 1,26)
↔ S-Methadone AUC 1.09 (0.94, 1.26) Cmax 1.09 (0.95, 1.25) C24 1.20 (0.98, 1.47)
↔ S-metadon AUC 1,09 (0,94; 1,26) Cmax 1,09 (0,95; 1,25) C24 1,20 (0,98; 1,47)
(OATP1B inhibition)
(inhibicija OATP1B)
GT 1, 3 TN with or without cirrhosis TE Null Responder with or without cirrhosis TN HCV/HIV1 co-infection without cirrhosis
GT 1, 3 PN, s cirozom ili bez nje PL bez odgovora na prethodno liječenje, s cirozom ili bez nje PN s istodobnom HCV/HIV-1 infekcijom, bez ciroze
Digoxin (0.25 mg single dose)/ elbasvir (50 mg once daily)
ANTIARITMICI Digoksin (0,25 mg u jednokratnoj dozi)/elbasvir (50 mg jedanput na dan)
↔ Buprenorphine AUC 0.98 (0.89, 1.08) Cmax 0.94 (0.82, 1.08) C24 0.98 (0.88, 1.09)
↔ buprenorfin AUC 0,98 (0,89; 1,08) Cmax 0,94 (0,82; 1,08) C24 0,98 (0,88; 1,09)
↔ Prednisone AUC 1.08 (1.00, 1.17) Cmax 1.05 (1.00, 1.10)
↔ prednizon AUC 1,08 (1,00; 1,17) Cmax 1,05 (1,00; 1,10)
In genotype 4 replicons, single NS5A substitutions L30S, M31V, and Y93H reduced elbasvir antiviral activity by 3to 23-fold.
Kod replikona genotipa 4, pojedinačne supstitucije L30S, M31V i Y93H u proteinu NS5A smanjile su antivirusnu aktivnost elbasvira od 3 do 23 puta.
↔ Emtricitabine AUC 1.07 (1.03, 1.10) Cmax 0.96 (0.90, 1.02) C24 1.19 (1.13, 1.25)
↔ emtricitabin AUC 1,07 (1,03; 1,10) Cmax 0,96 (0,90; 1,02) C24 1,19 (1,13; 1,25)
Ethinyl oestradiol (EE) / Levonorgestrel (LNG) (0.03 mg EE/
Etinilestradiol (EE) /levonorgestrel (LNG) (0,03 mg EE/0,15 mg LNG u jednokratnoj dozi)/elbasvir (50 mg jedanput na dan)
↔ Rilpivirine AUC 1.13 (1.07, 1.20) Cmax 1.07 (0.97, 1.17) C24 1.16 (1.09, 1.23)
↔ rilpivirin AUC 1,13 (1,07; 1,20) Cmax 1,07 (0,97; 1,17) C24 1,16 (1,09; 1,23)
↔ Elbasvir AUC 1.80 (1.41, 2.29) Cmax 1.29 (1.00, 1.66) C24 1.89 (1.37, 2.60)
AUC 1,80 (1,41; 2,29) Cmax 1,29 (1,00; 1,66) C24 1,89 (1,37; 2,60)
Grazoprevir is not a P-gp inhibitor based on in vitro data.
Prema podacima in vitro, grazoprevir nije inhibitor P-gp-a.
(CYP3A and OATP1B inhibition)
(inhibicija CYP3A i OATP1B)
Both relapsers had baseline HCV RNA >800,000 IU/mL Both subjects who failed to achieve SVR for reasons other than virologic failure had baseline HCV RNA <=800,000 IU/mL.
Oba ispitanika koja nisu uspjela postići SVR zbog nekog drugog razloga osim izostanka uspješnog virološkog odgovora imala su početnu vrijednost HCV RNK ≤ 800 000 IU/ml.
Rilpivirine (25 mg once daily)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Rilpivirin (25 mg jedanput na dan)/elbasvir (50 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
Close monitoring of INR is recommended with all vitamin K antagonists.
Preporučuje se pomno praćenje međunarodnog normaliziranog omjera (INR) uz sve antagoniste vitamina K zbog promjena u funkciji jetre tijekom liječenja lijekom ZEPATIER.
Pitavastatin (1 mg single dose)/ grazoprevir (200 mg once daily)
Pitavastatin (1 mg u jednokratnoj dozi)/grazoprevir (200 mg jedanput na dan)
Overall SVR Outcome for subjects without SVR On-treatment virologic failure Relapse Other SVR by cirrhosis status Non-cirrhotic Cirrhotic SVR by baseline HCV RNA <=800,000 IU/mL >800,000 IU/mL
SVR prema početnoj vrijednosti HCV RNK ≤ 800 000 IU/ml > 800 000 IU/ml
(400 mg PO once daily)/ grazoprevir (100 mg single dose)
(400 mg peroralno jedanput na dan)/grazoprevir (100 mg u jednokratnoj dozi)
EBR with GZR + RBV
SVR EBR s GZR-om EBR s GZR-om + RBV 12 tjedana
Rosuvastatin (10 mg single dose)/ grazoprevir (200 mg once daily)
Rosuvastatin (10 mg u jednokratnoj dozi)/grazoprevir (200 mg jedanput na dan)
↔ Elbasvir AUC 1.22 (1.06, 1.40) Cmax 1.41 (1.18, 1.68) C24 1.31 (1.12, 1.53)
AUC 1,22 (1,06; 1,40) Cmax 1,41 (1,18; 1,68) C24 1,31 (1,12; 1,53)
↔ Naloxone AUC 0.88 (0.76, 1.02) Cmax 0.85 (0.66, 1.09)
↔ nalokson AUC 0,88 (0,76; 1,02) Cmax 0,85 (0,66; 1,09)
Among genotype 1a-infected subjects, NS5A resistance-associated substitutions persisted at detectable levels at follow-up week 12 in 95% (35/37) of subjects and in 100% (9/9) of subjects with follow-up week 24 data.
Virusne populacije sa supstitucijama povezanima s rezistencijom u NS5A koje su nastale tijekom liječenja u pravilu su bile postojanije nego supstitucije povezane s rezistencijom u NS3. Među ispitanicima s infekcijom genotipom 1a, supstitucije povezane s rezistencijom u NS5A bile su i dalje prisutne u mjerljivim količinama u 95% (35/37) ispitanika u 12. tjednu praćenja te u 100% (9/9) ispitanika u 24. tjednu praćenja.
↔ Ciclosporin AUC 0.96 (0.90, 1.02) Cmax 0.90 (0.85, 0.97) C12 1.00 (0.92, 1.08)
↔ ciklosporin AUC 0,96 (0,90; 1,02) Cmax 0,90 (0,85; 0,97) C12 1,00 (0,92; 1,08)
Midazolam (2 mg single dose)/ grazoprevir (200 mg once daily)
Midazolam (2 mg u jednokratnoj dozi)/grazoprevir (200 mg jedanput na dan)
↔ Elbasvir AUC 1.17 (1.11, 1.24) Cmax 1.25 (1.16, 1.35) C24 1.04 (0.97, 1.12)
AUC 1,17 (1,11; 1,24) Cmax 1,25 (1,16; 1,35) C24 1,04 (0,97; 1,12)
Talk to your doctor before taking ZEPATIER if you are breast-feeding.
Ako dojite, obratite se svom liječniku prije nego uzmete ZEPATIER.
↔ Elbasvir AUC 1.22 (0.98, 1.52) Cmax 1.13 (0.87, 1.46) C24 1.22 (0.99, 1.51)
AUC 1,22 (0,98; 1,52) Cmax 1,13 (0,87; 1,46) C24 1,22 (0,99; 1,51)
(600 mg IV single dose)/ grazoprevir (200 mg single dose)
(600 mg u jednokratnoj i.v. dozi)/grazoprevir (200 mg u jednokratnoj dozi)
↔ Elbasvir AUC 1.09 (0.98, 1.21) Cmax 1.11 (0.99, 1.26) C24 0.96 (0.86, 1.08)
AUC 1,09 (0,98; 1,21) Cmax 1,11 (0,99; 1,26) C24 0,96 (0,86; 1,08)
Montelukast (10 mg single dose)/ grazoprevir (200 mg single dose)
ANTIASTMATICI Montelukast (10 mg u jednokratnoj dozi)/grazoprevir (200 mg u jednokratnoj dozi)
Rifampicin (600 mg IV single dose)/ elbasvir (50 mg single dose)
LIJEKOVI Rifampicin (600 mg u jednokratnoj i.v. dozi)/elbasvir (50 mg u jednokratnoj dozi)
(combination of OATP1B and CYP3A inhibition)
(kombinacija inhibicije OATP1B i CYP3A)
↔ Elbasvir AUC 1.05 (0.92, 1.18) Cmax 1.11 (0.98, 1.26) C24 1.03 (0.91, 1.17)
AUC 1,05 (0,92; 1,18) Cmax 1,11 (0,98; 1,26) C24 1,03 (0,91; 1,17)
(300 mg once daily)/elbasvir (50 mg once daily)/grazoprevir (100 mg once daily)
(300 mg jedanput na dan)/elbasvir (50 mg jedanput na dan)/grazoprevir (100 mg jedanput na dan)
Subjects without baseline NS5A polymorphisms, % (n/N)
Ispitanici bez polimorfizama NS5A na početku ispitivanja, % (n/N)
Subjects without baseline NS3 polymorphisms, % (n/N)
Ispitanici bez polimorfizama NS3 na početku ispitivanja, % (n/N)
(OATP1B inhibition and CYP3A induction)
(inhibicija OATP1B i indukcija CYP3A)
↔ Elbasvir AUC 1.13 (0.94, 1.37) Cmax 1.07 (0.88, 1.29) C24 1.22 (1.02, 1.45)
AUC 1,13 (0,94; 1,37) Cmax 1,07 (0,88; 1,29) C24 1,22 (1,02; 1,45)
↔ Elbasvir AUC 0.93 (0.82, 1.05) Cmax 0.88 (0.77, 1.00) C24 0.92 (0.18, 1.05)
AUC 0,93 (0,82; 1,05) Cmax 0,88 (0,77; 1,00) C24 0,92 (0,18; 1,05)
↔ Elbasvir AUC 1.05 (0.93, 1.18) Cmax 1.02 (0.92, 1.14) C24 1.03 (0.92, 1.17)
AUC 1,05 (0,93; 1,18) Cmax 1,02 (0,92; 1,14) C24 1,03 (0,92; 1,17)
(10 mg single dose)/ elbasvir (50 mg once daily) / grazoprevir (200 mg once daily)
(10 mg u jednokratnoj dozi)/elbasvir (50 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
The dose of atorvastatin should not exceed a daily dose of 20 mg when co-administered with ZEPATIER.
Pri istodobnoj primjeni s lijekom ZEPATIER, doza atorvastatina ne smije biti viša od dnevne doze od 20 mg.
Subjects were not excluded or discontinued from the trial based on a positive urine drug screen.
Pozitivan nalaz pretrage mokraće na drogu nije bio razlog za neuključivanje ispitanika u ispitivanje ili isključivanje iz njega.
↔ Elbasvir AUC 0.97 (0.90, 1.06) Cmax 0.99 (0.88, 1.10) C24 0.92 (0.83, 1.02)
AUC 0,97 (0,90; 1,06) Cmax 0,99 (0,88; 1,10) C24 0,92 (0,83; 1,02)
Subjects with baseline NS5A polymorphisms, % (n/N)
Ispitanici s polimorfizmima NS5A na početku ispitivanja, % (n/N)
(600 mg twice daily)/ ritonavir (100 mg twice daily/ grazoprevir (200 mg once daily)
(600 mg dvaput na dan)/ritonavir (100 mg dvaput na dan)/grazoprevir (200 mg jedanput na dan)
↔ Elbasvir AUC 1.17 (0.98, 1.39) Cmax 1.29 (1.06, 1.58) C24 1.21 (1.03, 1.43)
AUC 1,17 (0,98; 1,39) Cmax 1,29 (1,06; 1,58) C24 1,21 (1,03; 1,43)
(300 mg once daily)/ ritonavir (100 mg once daily/ grazoprevir (200 mg once daily)
(300 mg jedanput na dan)/ritonavir (100 mg jedanput na dan)/grazoprevir (200mg jedanput na dan)
↔ Elbasvir AUC 1.07 (1.00, 1.15) Cmax 1.07 (0.99, 1.16) C24 1.04 (0.98, 1.11)
AUC 1,07 (1,00; 1,15) Cmax 1,07 (0,99; 1,16) C24 1,04 (0,98; 1,11)
↔ Elbasvir AUC 0.92 (0.75, 1.14) Cmax 0.86 (0.71, 1.04) C24 0.87 (0.70, 1.09)
AUC 0,92 (0,75; 1,14) Cmax 0,86 (0,71; 1,04) C24 0,87 (0,70; 1,09)
(300 mg once daily)/ grazoprevir (200 mg once daily)
(300 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
(400 mg twice daily)/ ritonavir (100 mg twice daily/ grazoprevir (200 mg once daily)
(400 mg dvaput na dan)/ritonavir (100 mg dvaput na dan)/grazoprevir (200 mg jedanput na dan)
(400 mg twice daily)/ grazoprevir (200 mg once daily)
(400 mg dvaput na dan)/grazoprevir (200 mg jedanput na dan)
↔ Elbasvir AUC 0.81 (0.57, 1.17) Cmax 0.89 (0.61, 1.29) C24 0.80 (0.55, 1.16)
AUC 0,81 (0,57; 1,17) Cmax 0,89 (0,61; 1,29) C24 0,80 (0,55; 1,16)
• feeling very tired (fatigue)
• jaki umor (iscrpljenost)
Subjects with baseline NS3 polymorphisms, % (n/N)
Ispitanici s polimorfizmima NS3 na početku ispitivanja, % (n/N)
(due in part to OATP1B and CYP3A inhibition)
(dijelom zbog inhibicije OATP1B i CYP3A)
No clinically relevant change in exposure is represented by a horizontal arrow “↔”.
Vodoravna strelica "↔" znači da nije došlo do klinički značajne promjene izloženosti.
Ciclosporin (400 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Ciklosporin (400 mg u jednokratnoj dozi)/elbasvir (50 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
Haemodialysis does not remove elbasvir or grazoprevir.
Elbasvir i grazoprevir ne mogu se ukloniti hemodijalizom.
Mycophenolate mofetil (1,000 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Mofetilmikofenolat (1000 mg u jednokratnoj dozi)/elbasvir (50 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
↔ Elbasvir AUC 1.07 (1.00, 1.14) Cmax 1.07 (0.98, 1.16) C24 1.05 (0.97, 1.14)
AUC 1,07 (1,00; 1,14) Cmax 1,07 (0,98; 1,16) C24 1,05 (0,97; 1,14)
Tacrolimus (2 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Takrolimus (2 mg u jednokratnoj dozi)/elbasvir (50 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
↔ Elbasvir AUC 0.98 (0.93, 1.02) Cmax 0.97 (0.89, 1.05) C24 0.97 (0.92, 1.02)
AUC 0,98 (0,93; 1,02) Cmax 0,97 (0,89; 1,05) C24 0,97 (0,92; 1,02)
Overall prevalence of GT1a-infected subjects with baseline NS5A polymorphisms in the pooled analyses was
SVR prema prisutnosti polimorfizama NS5A povezanih s rezistencijom na početku ispitivanja Odsutni
Laboratory abnormalities
Laboratorijske vrijednosti
↔ Elbasvir AUC 0.98 (0.93, 1.04) Cmax 0.97 (0.89, 1.05) C24 0.98 (0.93, 1.03)
AUC 0,98 (0,93; 1,04) Cmax 0,97 (0,89; 1,05) C24 0,98 (0,93; 1,03)
(600 mg once daily)/ grazoprevir (200 mg once daily)
(600 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
(600 mg PO single dose)/ grazoprevir (200 mg once daily)
(600 mg u jednokratnoj peroralnoj dozi)/grazoprevir (200 mg jedanput na dan)
Sodium laurilsulfate Vitamin E polyethylene glycol succinate Copovidone
Jezgra tablete natrijev laurilsulfat vitamin E polietilenglikolsukcinat kopovidon hipromeloza mikrokristalična celuloza manitol laktoza hidrat umrežena karmelozanatrij natrijev klorid koloidni, bezvodni silicijev dioksid magnezijev stearat
Pravastatin (40 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Pravastatin (40 mg u jednokratnoj dozi)/elbasvir (50 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)