natgillin/translations-raw huggingface dataset:
Efavirenz (600 mg once daily)/ elbasvir (50 mg once daily) 
Efavirenz (600 mg jedanput na dan)/elbasvir (50 mg jedanput na dan)
HIV ANTIVIRAL AGENTS: NON-NUCLEOSIDE HIV REVERSE TRANSCRIPTASE INHIBITORS 
ANTIVIROTICI ZA LIJEČENJE INFEKCIJE HIV-om: NENUKLEOZIDNI INHIBITORI HIV REVERZNE TRANSKRIPTAZE
In genotype 1b replicons, single NS3 substitutions F43S, A156S/T/V, and D168A/G/V reduced grazoprevir antiviral activity by 3- to 375-fold. 
Kod replikona genotipa 1b, pojedinačne supstitucije F43S, A156S/T/V i D168A/G/V u proteinu NS3 smanjile su antivirusnu aktivnost grazoprevira od 3 do 375 puta.
HBV AND HIV ANTIVIRAL AGENTS: NUCLEOS(T)IDE REVERSE TRANSCRIPTASE INHIBITORS 
ANTIVIROTICI ZA LIJEČENJE INFEKCIJE HBV-om I HIV-om: NUKLEOZIDNI/NUKLEOTIDNI INHIBITORI REVERZNE TRANSKRIPTAZE
Cirrhotic 
Ciroza
Elbasvir was given to rats and rabbits without eliciting adverse effects on embryofetal or post natal development at up to the highest doses tested (approximately 9- and 17-fold above human exposure in rats and rabbits, respectively). 
Nisu zapaženi štetni učinci na embriofetalni ni postnatalni razvoj kada se elbasvir primjenjivao štakorima ili kunićima u dozama sve do najviših ispitivanih doza (kojima se u štakora i kunića postiže izloženost približno 9 puta odnosno 17 puta veća od one koja se postiže u ljudi).
Based on in vitro data, a potential for GZR to inhibit BSEP cannot be excluded. 
Prema podacima in vitro ne može se isključiti mogućnost da grazoprevir inhibira BSEP (pumpa za izbacivanje žučnih soli, engl. bile salt export pump).
The incidence of late ALT elevations was not affected by treatment duration. 
Trajanje liječenja nije utjecalo na incidenciju kasnog nastupa povišenja vrijednosti ALT-a.
Co-administration of inducers of CYP3A or P-gp with ZEPATIER is contraindicated because it may decrease elbasvir and grazoprevir plasma concentrations, which may lead to reduced therapeutic effect of ZEPATIER (see sections 4.3 and 4.4). 
Istodobna primjena induktora CYP3A ili P-gp-a s lijekom ZEPATIER je kontraindicirana jer bi mogla sniziti koncentracije elbasvira i grazoprevira u plazmi, što bi moglo smanjiti terapijski učinak lijeka ZEPATIER (vidjeti dijelove 4.3 i 4.4).
↑ Tacrolimus AUC 1.43 (1.24, 1.64) Cmax 0.60 (0.52, 0.69) C12 1.70 (1.49, 1.94) 
↑ takrolimus AUC 1,43 (1,24; 1,64) Cmax 0,60 (0,52; 0,69) C12 1,70 (1,49; 1,94)
The concomitant use of ZEPATIER and strong CYP3A inhibitors increases elbasvir and grazoprevir concentrations, and co-administration is not recommended (see section 4.5). 
Istodobna primjena lijeka ZEPATIER i snažnih inhibitora CYP3A povisuje koncentracije elbasvira i grazoprevira i stoga se ne preporučuje (vidjeti dio 4.5).
Co-administration of ZEPATIER and CYP3A or P-gp inducers is contraindicated because it may significantly decrease elbasvir and grazoprevir plasma concentrations and may lead to a reduced therapeutic effect of ZEPATIER (see sections 4.3, 4.5 and 5.2). 
Istodobna primjena lijeka ZEPATIER i induktora CYP3A ili P-gp-a je kontraindicirana jer može značajno sniziti koncentracije elbasvira i grazoprevira u plazmi te oslabiti terapijski učinak lijeka ZEPATIER (vidjeti dijelove 4.3, 4.5 i 5.2).
↔ Digoxin AUC 1.11 (1.02, 1.22) Cmax 1.47 (1.25, 1.73) 
↔ digoksin AUC 1,11 (1,02; 1,22) Cmax 1,47 (1,25; 1,73)
Treatment outcomes in genotype 1a-infected subjects treated with elbasvir/grazoprevir for 12 weeks or elbasvir/grazoprevir with ribavirin for 16 weeks are presented in Table 10. 
Ishodi liječenja u ispitanika s infekcijom genotipom 1a liječenih elbasvirom/grazoprevirom tijekom 12 tjedana ili elbasvirom/grazoprevirom u kombinaciji s ribavirinom tijekom 16 tjedana prikazani su u Tablici 10.
*Reference sequences for NS5A at amino acid 28 are M (genotype 1a) and L (genotype 1b and genotype 4a and 4d). 
*Referentne sekvence za NS5A na aminokiselini 28 su M (genotip 1a) i L (genotip 1b i genotip 4a i 4d).
‡Reference sequences for NS5A at amino acid 58 are H (genotype 1a) and P (genotype 1b and genotype 4a and 4d). 
Referentne sekvence za NS5A na aminokiselini 58 su H (genotip 1a) i P (genotip 1b i genotip 4a i 4d).
GT 1, 4, 6 TN with or without cirrhosis 
GT 1, 4, 6 PN, s cirozom ili bez nje
No circulating metabolites of either elbasvir or grazoprevir were detected in human plasma. 
U ljudskoj plazmi nisu pronađeni cirkulirajući metaboliti ni elbasvira ni grazoprevira.
Placebo-controlled study in which subjects were randomised in a 3:1 ratio to: EBR/GZR for 12 weeks (immediate treatment group [ITG]) or placebo for 12 weeks followed by open-label treatment with EBR/GZR for 12 weeks (deferred treatment group (DTG)). 
Placebom kontrolirano ispitivanje u kojem su ispitanici bili randomizirani u omjeru 3:1 za: EBR/GZR tijekom 12 tjedana (skupina liječena odmah) ili placebo tijekom 12 tjedana, nakon čega je uslijedilo otvoreno 12-tjedno liječenje EBR/GZR (skupina s odgođenim liječenjem).
KINASE INHIBITOR 
INHIBITOR KINAZE Sunitinib
GT 1, 4, 6 TN with or without cirrhosis Opiate agonist therapy 
GT 1, 4, 6 PN, s cirozom ili bez nje Liječenje opijatnim agonistima
These changes are not clinically relevant; therefore, no dose adjustment of elbasvir/grazoprevir is recommended based on age (see sections 4.2 and 4.4). 
Te promjene nisu klinički značajne; stoga se ne preporučuje prilagođavati dozu elbasvira/grazoprevira na temelju dobi (vidjeti dijelove 4.2 i 4.4).
Iron oxide yellow (E172) Iron oxide red (E172) Iron oxide black (E172) Carnauba wax 
Film ovojnica laktoza hidrat hipromeloza titanijev dioksid triacetin željezov oksid, žuti (E172) željezov oksid, crveni (E172) željezov oksid, crni (E172) karnauba vosak
ACID REDUCING AGENTS H2-receptor antagonists Famotidine (20 mg single dose)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose) 
LIJEKOVI ZA SNIŽAVANJE KISELOSTI Antagonisti H2 receptora Famotidin (20 mg u jednokratnoj dozi)/elbasvir (50 mg u jednokratnoj dozi)/grazoprevir (100 mg u jednokratnoj dozi)
↔ Cobicistat AUC 1.49 (1.42, 1.57) Cmax 1.39 (1.29, 1.50) 
↔ kobicistat AUC 1,49 (1,42; 1,57) Cmax 1,39 (1,29; 1,50)
Co-administration of ZEPATIER with strong CYP3A inhibitors increases elbasvir and grazoprevir plasma concentrations, and co-administration is not recommended (see Table 2 and section 4.4). 
Istodobna primjena lijeka ZEPATIER sa snažnim inhibitorima CYP3A povisuje koncentracije elbasvira i grazoprevira u plazmi i stoga se ne preporučuje (vidjeti Tablicu 2 i dio 4.4).
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)