natgillin/translations-raw huggingface dataset:
Table 2: Recommended Maviret treatment duration for patients who failed prior therapy with peg-IFN + ribavirin +/- sofosbuvir, or sofosbuvir + ribavirin Genotype Recommended treatment duration No cirrhosis 
Tablica 2: Preporučeno trajanje liječenja lijekom Maviret u bolesnika koji nisu uspješno odgovorili na prethodnu terapiju kombinacijom peginterferon + ribavirin +/- sofosbuvir ili sofosbuvir + ribavirin
Co-administration is contraindicated (see section 4.3). 
Istodobna primjena je kontraindicirana (vidjeti dio 4.3).
(Inhibition of OATP1B1/3, P-gp, BCRP, CYP3A) 
(inhibicija OATP1B1/3, P-gp-a, BCRP-a, CYP3A)
Co-administration with atorvastatin and simvastatin is contraindicated (see section 4.3). 
Istodobna primjena s atorvastatinom i simvastatinom je kontraindicirana (vidjeti dio 4.3).
A 12-week treatment duration has been evaluated and is recommended in liver or kidney transplant recipients with or without cirrhosis (see section 5.1). 
U primatelja jetrenog ili bubrežnog presatka, s cirozom ili bez nje, ocijenjeno je i preporučuje se liječenje u trajanju od 12 tjedana (vidjeti dio 5.1).
ANTICOAGULANTS Dabigatran etexilate 150 mg single dose 
Dabigatraneteksilat jednokratna doza od 150 mg
↑ glecaprevir 
↑ glekaprevir
15 IU/mL (except for SURVEYOR-1 and SURVEYOR-2 which used the Roche COBAS TaqMan real-time reverse transcriptase-PCR (RT-PCR) assay v. 2.0 with an LLOQ of 25 IU/mL). 
AmpliPrep/COBAS Taqman HCV (verzija 2.0), čija je donja granica kvantifikacije (engl. lower limit of quantification, LLOQ) iznosila 15 IU/ml (osim u ispitivanjima SURVEYOR-1 i SURVEYOR-2, u kojima se koristio Roche COBAS TaqMan test reverzne transkriptaze-lančane reakcije polimerazom u stvarnom vremenu (engl. reverse transcriptase-PCR, RT-PCR), verzija 2.0, čiji je LLOQ iznosio
Adverse reactions observed in greater than or equal to 5% of subjects receiving Maviret for 12 weeks were headache (17%), fatigue (16%), nausea (8%) and pruritus (7%). 
Sveukupan sigurnosni profil u primatelja presadaka bio je usporediv s onim opaženim u ispitanika koji su sudjelovali u ispitivanjima faze 2 i 3. Nuspojave opažene u 5% ili više ispitanika koji su primali Maviret tijekom 12 tjedana bile su glavobolja (17%), umor (16%), mučnina (8%) i pruritus (7%).
ENDURANCE-1a Maviret for 8 weeks (n=351) or 12 weeks (n=352) SURVEYOR-1 Maviret for 8 weeks (n=34) 
Maviret tijekom 8 tjedana (n=351) ili 12 tjedana (n=352) SURVEYOR-1 Maviret tijekom 8 tjedana (n=34)
In TN or TE-PRS subjects with compensated cirrhosis who received the recommended duration, 97.0% (288/297) achieved SVR12 (among which 98.0% [192/196] of TN subjects achieved SVR12), while 0.7% (2/297) experienced on-treatment virologic failure and 1.0% (3/289) experienced posttreatment relapse. 
Među ispitanicima s kompenziranom cirozom koji prethodno nisu bili liječeni ili su prethodno bili liječeni PRS-om, a primali su lijek tijekom preporučenog razdoblja, njih 97,0% (288/297) postiglo je SVR12 (među kojima je SVR12 postiglo 98,0% [192/196] prethodno neliječenih ispitanika), dok je njih 0,7% (2/297) doživjelo virološki neuspjeh tijekom liječenja, a njih 1,0% (3/289) relaps nakon liječenja.
For other P-gp, BCRP, or OATP1B1/3 substrates, dose adjustment may be needed. 
Za specifične preporuke vezane za interakcije s osjetljivim supstratima P-gp-a, BCRP-a i OATP1B1/3 vidjeti Tablicu 3. Kod primjene drugih supstrata P-gp-a, BCRP-a ili OATP1B1/3 možda će biti potrebna prilagodba doze.
TN=treatment naïve, PRS-TE=treatment experienced (includes previous treatment that included pegIFN (or IFN), and/or RBV and/or sofosbuvir), PI=Protease Inhibitor, CKD=chronic kidney disease a. Included 33 subjects co-infected with HIV-1. 
PN=prethodno neliječeni, PRS-PL=prethodno liječeni (uključujući prethodno liječenje koje je uključivalo peginterferon (ili interferon) i/ili ribavirin i/ili sofosbuvir), KBB=kronična bubrežna bolest a.
norelgestromin ↑ norgestrel 
↑ EE ↑ norgestrel
If used, lovastatin should not exceed a dose of 20 mg/day and patients should be monitored. 
U slučaju primjene lovastatina, njegova doza ne smije biti veća do 20 mg/dan,
• dabigatran etexilate (to prevent blood clots) 
• dabigatraneteksilat (za sprječavanje krvnih ugrušaka)
10 mg once daily 
10 mg jedanput na dan
Among the 2 genotype 1-infected subjects who experienced virologic failure, one had treatmentemergent substitutions A156V in NS3 and Q30R/L31M/H58D in NS5A, and one had Q30R/H58D (while Y93N was present at baseline and post-treatment) in NS5A. 
Od 2 ispitanika s infekcijom genotipom 1 koja su doživjela virološki neuspjeh, u jednoga je tijekom liječenja došlo do supstitucije A156V u proteinu NS3 te supstitucije Q30R/L31M/H58D u proteinu NS5A, a u jednoga je došlo do supstitucije Q30R/H58D u proteinu NS5A (dok je na početku ispitivanja i nakon liječenja bila prisutna supstitucija Y93N).
In TE-PRS subjects without cirrhosis who received the recommended duration, 98.2% (215/219) achieved SVR12, while 0.5% (1/219) experienced on-treatment virologic failure and 1.4% (3/218) experienced post-treatment relapse. 
Među ispitanicima bez ciroze koji su prethodno bili liječeni PRS-om i koji su primali lijek tijekom preporučenog razdoblja, njih 98,2% (215/219) postiglo je SVR12, dok je njih 0,5% (1/219) doživjelo virološki neuspjeh tijekom liječenja, a njih 1,4% (3/218) relaps nakon liječenja.
Effect of baseline HCV amino acid polymorphisms on treatment response A pooled analysis of treatment-naïve and pegylated interferon, ribavirin and/or sofosbuvir treatmentexperienced subjects receiving Maviret in the Phase 2 and Phase 3 clinical studies was conducted to explore the association between baseline polymorphisms and treatment outcome and to describe substitutions seen upon virologic failure. 
Provedena je analiza objedinjenih podataka o prethodno neliječenim ispitanicima i ispitanicima prethodno liječenima pegiliranim interferonom, ribavirinom i/ili sofosbuvirom koji su u kliničkim ispitivanjima faze 2 i 3 primali Maviret, kako bi se istražila povezanost između polimorfizama prisutnih na početku ispitivanja i ishoda liječenja te opisale supstitucije primijećene nakon virološkog neuspjeha.
DAA=direct acting antiviral a. Effect of rifampicin on glecaprevir and pibrentasvir 24 hours after final rifampicin dose. 
Učinak rifampicina na glekaprevir i pibrentasvir 24 sata nakon posljednje doze rifampicina.
substitutions at these positions showed reductions in susceptibility to pibrentasvir. 
Određene kombinacije supstitucija u proteinu NS5A na navedenim položajima pokazale su smanjenu osjetljivost na pibrentasvir.
Each film-coated tablet contains 100 mg glecaprevir and 40 mg pibrentasvir. 
Jedna filmom obložena tableta sadrži 100 mg glekaprevira i 40 mg pibrentasvira.
The combination of Maviret with tacrolimus should be used with caution. 
Maviret u kombinaciji s takrolimusom treba
Pibrentasvir bioavailability when coadministered with glecaprevir is 3-fold of pibrentasvir alone. 
Bioraspoloživost pibrentasvira kod istodobne primjene s glekaprevirom 3 puta je veća nego kod samostalne primjene pibrentasvira.
This is due to liver function changes during treatment with Maviret. 
INR-a zbog promjena jetrene funkcije tijekom liječenja lijekom
Recommended treatment duration No cirrhosis 
Preporučeno trajanje liječenja
In a pooled analysis of treatment naïve patients without cirrhosis (including Phase 2 and 3 data) where SVR12 was assessed according to the presence of baseline A30K, a numerically lower SVR12 rate was achieved in patients with A30K treated for 8 weeks as compared to those treated for 12 weeks [78% (14/18) vs 93% (13/14)]. 
U objedinjenoj analizi prethodno neliječenih bolesnika bez ciroze (uključujući podatke iz ispitivanja faze 2 i faze 3) u kojih se SVR12 ocjenjivao prema prisutnosti A30K na početku ispitivanja, bolesnici s polimorfizmom A30K liječeni 8 tjedana postigli su brojčano nižu stopu SVR12 nego oni liječeni
Of the 280 subjects treated, the median age was 60 years (range: 34 to 88); 81.8% had HCV genotype 1, 10% had HCV genotype 2, 4.6% had HCV genotype 4, 0.4% had HCV genotype 5; 3.2% had HCV genotype 6; 60% were male; 9.6% were Black. 
Među 280 liječenih ispitanika, medijan dobi iznosio je 60 godina (raspon: 34 do 88); 81,8% imalo je HCV infekciju genotipa 1; 10 % imalo je HCV infekciju genotipa 2; 4,6% imalo je HCV infekciju genotipa 4; 0,4% imalo je HCV infekciju genotipa 5; 3,2% imalo je HCV infekciju genotipa 6; 60% bili su muškarci; 9,6% bili su crnci.
General disorders and administration site conditions Very common fatigue 
Opći poremećaji i reakcije na mjestu primjene Vrlo često umor
Maviret 100 mg/40 mg film-coated tablets glecaprevir/pibrentasvir 
Maviret 100 mg/40 mg filmom obložene tablete glekaprevir/pibrentasvir
• The active substances are glecaprevir and pibrentasvir. 
• Djelatne tvari su glekaprevir i pibrentasvir.
In vitro data indicate that the majority of the resistance-associated substitutions in NS5A at amino acid positions 24, 28, 30, 31, 58, 92, or 93 that confer resistance to ombitasvir, daclatasvir, ledipasvir, elbasvir, or velpatasvir remained susceptible to pibrentasvir. 
Podaci prikupljeni in vitro pokazuju da je većina supstitucija u proteinu NS5A na aminokiselinskim položajima 24, 28, 30, 31, 58, 92 ili 93 koje su povezane s rezistencijom na ombitasvir, daklatazvir,
P-gp and not excluded BCRP a. Median Tmax following single doses of glecaprevir and pibrentasvir in healthy subjects. 
Medijan Tmax nakon jednokratnih doza glekaprevira i pibrentasvira u zdravih ispitanika.
Serum HCV RNA values were measured during the clinical studies using the Roche COBAS AmpliPrep/COBAS Taqman HCV test (version 2.0) with a lower limit of quantification (LLOQ) of 
Serumske vrijednosti HCV RNK mjerile su se tijekom kliničkih ispitivanja testom Roche COBAS
Baseline polymorphisms in NS5A were detected in 26.8% (225/841), 79.8% (331/415), 22.1% (136/615), 49.7% (80/161), 12.9% (4/31), and 54.1% (20/37) of subjects with HCV genotype 1, 2, 3, 4, 5, and 6 infection, respectively. 
infekcijom genotipa 1, 79,8% (331/415) s genotipom 2, 22,1% (136/615) s genotipom 3, 49,7% (80/161) s genotipom 4, 12,9% (4/31) s genotipom 5 odnosno 54,1% (20/37) ispitanika s genotipom 6.
No re-treatment data is available for patients infected with genotypes 2, 3, 5 or 6. 
Za bolesnike zaražene virusom genotipa 2, 3,5 ili 6 nema dostupnih podataka o ponovnom liječenju.
Treatment-experienced with or without cirrhosis 
Prethodno liječeni ispitanici s cirozom ili bez nje
Among subjects with compensated cirrhosis, the overall SVR12 rate for GT3b infected subjects was 87.5% (7/8) [85.7% (6/7) for TN subjects and 100% (1/1) for TE-PRS subjects] and 100% (6/6) for GT3a infected subjects. 
Među ispitanicima s kompenziranom cirozom, ukupna stopa SVR12 za ispitanike s infekcijom genotipom 3b iznosila je 87,5% (7/8) [85,7% (6/7) za ispitanike koji prethodno nisu bili liječeni i
e. GT1, 4 from MAGELLAN-1 Part 1 - Maviret for 12 weeks (n=22); GT1, 4 from MAGELLAN-1 Part 2Maviret for 12 weeks (n=44) or 16 weeks (n=47). 
e. Ispitanici s genotipom 1 ili 4 iz 1. dijela ispitivanja MAGELLAN-1 - Maviret tijekom 12 tjedana (n=22); ispitanici s genotipom 1 ili 4 iz 2. dijela ispitivanja MAGELLAN-1 - Maviret tijekom 12 tjedana (n=44) ili 16 tjedana (n=47).
Among the 10 genotype 1-infected subjects with virologic failure, treatment-emergent NS3 substitutions V36A/M, R155K/T, A156G/T/V, or D168A/T were observed in 7 subjects. 
Među 10 ispitanika s infekcijom genotipom 1 koji su doživjeli virološki neuspjeh, u njih 7 opažene su supstitucije V36A/M, R155K/T, A156G/T/V ili D168A/T u proteinu NS3 koje su nastale tijekom liječenja.
Table 11: Pharmacokinetic properties of the components of Maviret in healthy adult subjects Glecaprevir 
Farmakokinetička svojstva sastavnica lijeka Maviret navedena su u Tablici 11. Tablica 11: Farmakokinetička svojstva sastavnica lijeka Maviret u zdravih odraslih ispitanika
Table 4: Adverse reactions identified with Maviret Frequency 
Tablica 4: Nuspojave utvrđene kod primjene lijeka Maviret Učestalost
Clinical Study in Renally Impaired Subjects 
Kliničko ispitivanje u ispitanika s oštećenjem funkcije bubrega
The safety assessment of Maviret in subjects treated for 8, 12 or 16 weeks with compensated liver disease (with or without cirrhosis) was based on registrational Phase 2 and 3 studies which evaluated approximately 2,300 subjects. 
koji su liječeni 8, 12 ili 16 tjedana temelji se na registracijskim ispitivanjima lijeka faze 2 i 3, u kojima je ocijenjeno približno 2300 ispitanika.
If you are not sure, talk to your doctor or pharmacist before taking Maviret. 
Ako dojite, obratite se svom liječniku prije nego uzmete Maviret.
Less than 0.1% of subjects treated with Maviret had serious adverse reactions (transient ischaemic attack). 
Ozbiljne nuspojave (prolazni cerebralni ishemijski napadaj) zabilježene su u manje od 0,1% ispitanika liječenih lijekom Maviret.
The median age was 14 years (range: 12 to 17); 79% had HCV genotype 1, 6% had HCV genotype 2, 9% had HCV genotype 3, 6% had HCV genotype 4; 55% were female; 11% were Black; 77% were HCV treatment-naïve; 23% were treatment-experienced to interferon; 4% had HIV-coinfection; none had cirrhosis; the mean weight was 59 kg (range: 32 to 109 kg). 
Medijan dobi iznosio je 14 godina (raspon: 12 do 17); njih 79% imalo je HCV infekciju genotipa 1, 6% imalo je HCV infekciju genotipa 2, 9% imalo je HCV infekciju genotipa 3, 6% imalo je HCV infekciju genotipa 4; 55% bile su žene; 11% bili su crnci; 77% prethodno nije primilo liječenje za HCV; 23% bilo je prethodno liječeno interferonom; 4% imalo je istodobnu HIV
Subjects with Genotype 1, 2, 4, 5, or 6 Infection with Cirrhosis who received 8 weeks of Maviret The safety and efficacy of Maviret given for 8 weeks in GT 1, 2, 4, 5 or 6 treatment naïve subjects with compensated cirrhosis was evaluated in a single-arm, open-label study (EXPEDITION-8). 
Sigurnost i djelotvornost lijeka Maviret koji se primjenjivao tijekom 8 tjedana u prethodno neliječenih ispitanika s genotipom 1, 2, 4, 5 ili 6 i kompenziranom cirozom jetre ocijenjene su u otvorenom ispitivanju s jednom skupinom (EXPEDITION-8).
Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir. 
Jedna tableta sadrži 100 mg glekaprevira i 40 mg pibrentasvira.
Glecaprevir and pibrentasvir AUC were similar with and without dialysis (≤ 18% difference) in dialysis-dependent non-HCV infected subjects. 
U ispitanika bez HCV infekcije ovisnih o dijalizi, vrijednosti AUC glekaprevira i pibrentasvira bile su slične neovisno o dijalizi (razlika od ≤ 18%).
• diabetes. 
• imate šećernu bolest.
Tacrolimus 1 mg single dose 
Takrolimus jednokratna doza od 1 mg
Glecaprevir and pibrentasvir AUC were increased ≤ 56% in non-HCV infected subjects with mild, moderate, severe, or end-stage renal impairment not on dialysis compared to subjects with normal renal function. 
U usporedbi s ispitanicima s normalnom bubrežnom funkcijom, vrijednosti AUC glekaprevira i pibrentasvira povećale su se za ≤ 56% u ispitanika bez HCV infekcije koji su imali blago, umjereno ili teško oštećenje bubrežne funkcije ili su bili u terminalnoj fazi bubrežne bolesti, a nisu bili na dijalizi.
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U
↔ glecaprevir ↔ pibrentasvir tacrolimus exposure is expected. 
Očekuje se porast izloženosti takrolimusu.
c. GT3 without cirrhosis from SURVEYOR-2 Parts 1 and 2 - Maviret for 8 weeks (n=29) or 12 weeks (n=54); GT3 without cirrhosis from SURVEYOR-2 Part 3 - Maviret for 12 weeks (n=22) or 16 weeks (n=22). 
c. Ispitanici s genotipom 3 bez ciroze iz 1. i 2. dijela ispitivanja SURVEYOR-2 - Maviret tijekom 8 tjedana (n=29) ili 12 tjedana (n=54); ispitanici s genotipom 3 bez ciroze iz 3. dijela ispitivanja SURVEYOR-2 - Maviret tijekom 12 tjedana (n=22) ili 16 tjedana (n=22).
ANTIMYCOBACTERIALS Rifampicin 
ANTIMIKOBAKTERIJSKI
Skin and subcutaneous tissue disorders Not known pruritus 
Poremećaji kože i potkožnog tkiva
(P-gp/BCRP inhibition) 
(inhibicija P-gp-a/BCRP-a)
• St. John's wort (Hypericum perforatum), (herbal remedy used for mild depression). 
• rifampicin (za liječenje infekcija) • gospinu travu (Hypericum perforatum) (biljni lijek za liječenje blage depresije)
A 16-week treatment duration should be considered in genotype 3-infected patients who are treatment experienced with peg-IFN + ribavirin +/sofosbuvir, or sofosbuvir + ribavirin. 
U bolesnika zaraženih genotipom 3 koji su prethodno liječeni kombinacijom peginterferon + ribavirin +/- sofosbuvir ili sofosbuvir + ribavirin treba razmotriti liječenje u trajanju od 16 tjedana.
Ciclosporin 400 mg single dose 
Ciklosporin jednokratna doza od 400 mg
Pravastatin 10 mg once daily 
Pravastatin 10 mg jedanput na dan
The ability to assess the impact of baseline polymorphisms in NS5A was limited among treatment-naïve subjects with cirrhosis and treatment-experienced subjects due to low prevalence of A30K (1.6%, 2/128) or Y93H (3.9%, 
U prethodno neliječenih ispitanika s cirozom te prethodno liječenih ispitanika mogućnost ocjene utjecaja polimorfizama NS5A na početku ispitivanja bila je ograničena zbog niske prevalencije A30K (1,6%,
All of the genotype 1-infected virologic failure subjects had one or more NS5A substitutions L/M28M/T/V, Q30E/G/H/K/L/R, L31M, P32 deletion, H58C/D, or Y93H at baseline, with additional treatment-emergent NS5A substitutions M28A/G, P29Q/R, Q30K, H58D, or Y93H observed in 7 of the subjects at the time of failure. 
U svih ispitanika s infekcijom genotipom 1 koji su doživjeli virološki neuspjeh je na početku ispitivanja bila prisutna jedna ili više supstitucija u proteinu NS5A: L/M28M/T/V, Q30E/G/H/K/L/R, L31M, delecija P32, H58C/D ili
↑ lovastatin acid 
↑ lovastatinska kiselina
d. GT3 with cirrhosis from SURVEYOR-2 Part 2 - Maviret for 12 weeks (n=24) or 16 weeks (n=4); GT3 with cirrhosis from SURVEYOR-2 Part 3 - Maviret for 12 weeks (n=40) or 16 weeks (n=47). 
d. Ispitanici s genotipom 3 i cirozom iz 2. dijela ispitivanja SURVEYOR-2 - Maviret tijekom 12 tjedana (n=24) ili 16 tjedana (n=4); ispitanici s genotipom 3 i cirozom iz 3. dijela ispitivanja SURVEYOR-2 - Maviret tijekom 12 tjedana (n=40) ili 16 tjedana (n=47).
(Inhibition of OATP1B1/3, P-gp, BCRP) 
(inhibicija OATP1B1/3, P-gp-a, BCRP-a)
Medicinal products that are strong P-gp and CYP3A inducers (e.g., rifampicin, carbamazepine, St. John's wort (Hypericum perforatum), phenobarbital, phenytoin, and primidone) could significantly decrease glecaprevir or pibrentasvir plasma concentrations and may lead to reduced therapeutic effect of Maviret or loss of virologic response. 
(Hypericum perforatum), fenobarbital, fenitoin i primidon) mogli bi značajno sniziti plazmatske koncentracije glekaprevira ili pibrentasvira te dovesti do smanjenja terapijskog učinka lijeka Maviret ili gubitka virološkog odgovora.
Liver or kidney transplant patients 
Bolesnici s jetrenim ili bubrežnim presatkom
Glecaprevir is affected to a lower extent by coadministration with pibrentasvir. 
Istodobna primjena s pibrentasvirom u manjoj mjeri utječe na glekaprevir.
(Inhibition of OATP1B1/3, BCRP) 
(inhibicija OATP1B1/3, BCRP-a)
SURVEYOR-2 Part 3 was an open-label study randomizing non-cirrhotic treatment-experienced subjects to 12- or 16-weeks of treatment; in addition, the study evaluated the efficacy of Maviret in subjects with compensated cirrhosis and genotype 3 infection in two dedicated treatment arms using 12-week (treatment-naïve only) and 16-week (treatmentexperienced only) durations. 
u ispitivanju se ocjenjivala djelotvornost lijeka Maviret u ispitanika s kompenziranom cirozom i infekcijom genotipom 3, podijeljenih u dvije skupine, od kojih je jedna liječena 12 tjedana (samo prethodno neliječeni ispitanici), a druga 16 tjedana (samo prethodno liječeni bolesnici).
Five of the 10 had combinations of V36M, Y56H, R155K/T, or D168A/E in NS3 at baseline and post-treatment. 
U 5 od tih 10 ispitanika su na početku ispitivanja i nakon liječenja bile prisutne kombinacije supstitucija V36M, Y56H, R155K/T ili D168A/E u proteinu NS3.
In subjects who are treatment-naïve (TN) or treatment-experienced to combinations of interferon, peginterferon, ribavirin and/or sofosbuvir (TE-PRS) who received the recommended duration, 97.5% (1,252/1,284) achieved SVR12 overall, while 0.3% (4/1,284) experienced on-treatment virologic failure and 0.9% (11/1,262) experienced post-treatment relapse. 
Među ispitanicima koji prethodno nisu bili liječeni ili su prethodno liječeni kombinacijama interferona, peginterferona, ribavirina i/ili sofosbuvira (PRS), a koji su primali lijek tijekom preporučenog razdoblja, sveukupno je njih 97,5% (1252/1284) postiglo SVR12, dok je njih 0,3%
Posology 
Prijenos
Asymptomatic serum ALT elevations (>5x ULN) were observed in 1 out of 70 healthy subjects following multiple doses of glecaprevir (700 mg or 800 mg) once daily for ≥ 7 days. 
Nakon primjene višestrukih doza glekaprevira (700 mg ili 800 mg) jedanput na dan tijekom ≥ 7 dana, u 1 od
Talk to your doctor before taking Maviret if you are breast-feeding. 
razgovarajte sa svojim liječnikom ili ljekarnikom prije nego uzmete Maviret.
Package leaflet: Information for the user Maviret 100 mg/40 mg film-coated tablets glecaprevir/pibrentasvir This medicine is subject to additional monitoring. 
Uputa o lijeku: Informacije za korisnika Maviret 100 mg/40 mg filmom obložene tablete glekaprevir/pibrentasvir
Outcome for subjects without SVR12 On-treatment VF 
Ishod u ispitanika bez SVR12 Virološki neuspjeh tijekom liječenja
Patients treated with vitamin K antagonists 
Kod primjene svih antagonista vitamina
↑ digoxin 
↑ digoksin
Substrate of transporter 
Supstrat prijenosnika
Treatment difference -1.2%; 95% confidence interval (-5.6% to 3.1%) Treatment difference -0.4%; 97.5% confidence interval (-5.4% to 4.6%) Outcome for subjects without SVR12 On-treatment VF Relapsea Otherb a. Relapse is defined as HCV RNA ≥ LLOQ after end-of-treatment response among those who completed treatment. 
interval pouzdanosti 97,5% (-5,4% do 4,6%) Ishod u ispitanika bez SVR12 Virološki neuspjeh tijekom liječenja
Studies in treatment-naïve and peginterferon (pegIFN), ribavirin (RBV) and/or sofosbuvir treatmentexperienced subjects with or without cirrhosis 
Ispitivanja u ispitanika s cirozom ili bez nje koji prethodno nisu bili liječeni i onih koji su prethodno liječeni peginterferonom (pegIFN), ribavirinom (RBV) i/ili sofosbuvirom
The most common adverse reactions in subjects with severe renal impairment were pruritus (17%) and fatigue (12%) in EXPEDITION-4 and pruritus (14.9%) in EXPEDITION-5. 
(12%) u ispitivanju EXPEDITION-4 te pruritus (14,9%) u ispitivanju EXPEDITION-5.
TN and PRS-TE subjects with cirrhosis GT1, 2, 4, 5, 6 EXPEDITION-1 Maviret for 12 weeks (n=146) GT3 
Ispitanici s cirozom koji su prethodno neliječeni i koji su prethodno liječeni peginterferonom (ili interferonom) i/ili ribavirinom i/ili sofosbuvirom GT1, 2, 4, 5, 6 EXPEDITION-1 Maviret tijekom 12 tjedana (n=146) GT3
The pharmacokinetic properties of the components of Maviret are provided in Table 11. 
iz kliničkih izolata prikazane su u Tablici 6.