FrancophonIA/ELRC3.0 huggingface dataset:
English: The median age was 52 years (range: 26 to 72); 82% of the patients were male; 61% were white; 34% were black; 75% had genotype 1a HCV infection; 2% had genotype 4 infection; 76% had non-CC IL28B alleles (CT or TT); and 20% had compensated cirrhosis.
Croatian: Medijan dobi iznosio je 52 godine (raspon: od 26 do 72); 82 % bolesnika bili su muškarci; 61 % su bili bijelci; 34 % su bili crnci; 75 % ih je imalo infekciju HCV-om genotipa 1a; 2 % je imalo infekciju genotipa 4; 76 % je imalo ne-CC IL28B alele (CT ili TT); a 20 % je imalo kompenziranu cirozu.
English: No dose adjustment of Harvoni or midazolam is required.
Croatian: Nije potrebna prilagodba doze lijeka Harvoni ili midazolama.
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Croatian: Jezgra tablete kopovidon laktoza hidrat celuloza, mikrokristalična karmelozanatrij, umrežena silicijev dioksid, koloidni bezvodni magnezijev stearat
English: 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.
Croatian: Pročitajte sažetke opisa svojstava lijeka za tenofovirdizoproksilfumarat, emtricitabin/tenofovirdizoproksilfumarat ili elvitegravir/kobicistat/emtricitabin/tenofovirdizoproksilfumarat zbog preporuka o nadziranju funkcije bubrega.
English: Omeprazole dosed simultaneously with Harvoni
Croatian: Preporuka za istovremenu primjenu s lijekom Harvoni
English: Baseline HCV RNAa HCV RNA < 6 million IU/mL HCV RNA ≥ 6 million IU/mL
Croatian: HCV RNK < 6 milijuna IU/ml 2 % (2/121) HCV RNK > 6 milijuna IU/ml 10 % (9/92)
English: Potential for other medicinal products to affect Harvoni Ledipasvir and sofosbuvir are substrates of drug transporter P-gp and BCRP while GS-331007 is not.
Croatian: Ledipasvir i sofosbuvir supstrati su prijenosnika lijekova P-gp i BCRP, dok GS-331007 to nije.
English: ORAL CONTRACEPTIVES Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ ledipasvir (90 mg once daily)d
Croatian: Norgestimat/etinilestradiol (norgestimat 0,180 mg/ 0,215 mg/ 0,25 mg/ etinilestradiol 0,025 mg)/ ledipasvir (90 mg jedanput na dan)d
English: Dosed simultaneouslyf
Croatian: Relapsb Ostaloc
English: Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ sofosbuvir (400 mg once daily)d
Croatian: Norgestimat/ etinilestradiol (norgestimat 0,180 mg/ 0,215 mg/ 0,25 mg/ etinilestradiol 0,025 mg)/ sofosbuvir (400 mg jedanput na dan)d
English: Other statins
Croatian: Drugi statini
English: Treatment-experienced patients had failed prior treatment with PEG-IFN + ribavirin ± an HCV protease inhibitor or sofosbuvir + ribavirin ± PEG-IFN.
Croatian: U bolesnika koji su prethodno bili liječeni, prethodno liječenje PEG-IFN + ribavirinom ± inhibitorom proteaze HCV-a ili sofosbuvirom + ribavirinom ± PEG-IFN bilo je neuspješno.
English: The median terminal half-lives of sofosbuvir and GS-331007 following administration of ledipasvir/sofosbuvir were 0.5 and 27 hours, respectively.
Croatian: Nakon primjene ledipasvira/sofosbuvira, medijan terminalnog poluvijeka sofosbuvira iznosio je 0,5 sati, a GS-331007 27 sati.
English: d Patients with missing cirrhosis status were excluded from this subgroup analysis.
Croatian: d. Bolesnici bez podatka o statusu ciroze bili su isključeni iz analize ove podskupine.
English: ANTIMYCOBACTERIALS Rifampicin (600 mg once daily)/ ledipasvir (90 mg single dose)d
Croatian: Rifampicin (600 mg jedanput na dan)/ ledipasvir (jedna doza od 90 mg)d
English: 24 weeks (n = 217)
Croatian: 24 tjedna (n = 217)
English: Of the 95 total patients, at baseline, 20% of patients had cirrhosis, 22% were treatment experienced, 21% had received a kidney transplant, 92% were on hemodialysis, and 8% were on peritoneal dialysis;
Croatian: Od ukupno 95 bolesnika, na početku ispitivanja njih 20 % imalo je cirozu, 22 % bilo je prethodno liječeno, 21 % imalo je transplantiran bubreg, 92 % bilo je na hemodijalizi, a 8 % na peritonejskoj dijalizi; srednja vrijednost trajanja dijalize iznosila je 11,5 godina (raspon: od 0,2 do 43,0 godine).
English: Patients awaiting liver transplantation and post-liver transplant - SOLAR-1 and SOLAR-2 SOLAR-1 and SOLAR-2 were two open-label clinical studies that evaluated 12 and 24 weeks of treatment with ledipasvir/sofosbuvir in combination with ribavirin in genotype 1 and 4 HCV-infected patients who have undergone liver transplantation and/or who have decompensated liver disease.
Croatian: U dva otvorena klinička ispitivanja SOLAR-1 i SOLAR-2, procjenjivalo se 12-tjedno i 24-tjedno liječenje ledipasvirom/sofosbuvirom u kombinaciji s ribavirinom u bolesnika s infekcijom HCV-om genotipa 1 i 4, kojima je transplantirana jetra i/ili koji imaju dekompenziranu bolest jetre.
English: Rifampicin (600 mg once daily)/ sofosbuvir (400 mg single dose)d
Croatian: Rifampicin (600 mg jedanput na dan)/ sofosbuvir (400 mg jedna doza)d
English: No dose adjustment of Harvoni or tacrolimus is required at initiation of co-administration.
Croatian: Nije potrebna prilagodba doze lijeka Harvoni ili takrolimusa na početku njihove istodobne primjene.
English: Skin and subcutaneous tissue disorders: Common rash
Croatian: Poremećaji kože i potkožnog tkiva:
English: Abacavir/ lamivudine (600 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Croatian: Abakavir/ lamivudin (600 mg/ 300 mg jedanput na dan)/ ledipasvir (90 mg jedanput na dan)c/ sofosbuvir (400 mg jedanput na dan)c, d
English: Co-administration with such medicinal products is not recommended with Harvoni (see section 4.4).
Croatian: Ne preporučuje se istodobna primjena takvih lijekova s lijekom Harvoni (vidjeti dio 4.4).
English: When ledipasvir/sofosbuvir was studied with ribavirin, the most frequent adverse drug reactions to ledipasvir/sofosbuvir + ribavirin combination therapy were consistent with the known safety profile of ribavirin, without increasing the frequency or severity of the expected adverse drug reactions.
Croatian: + ribavirin bile su sukladne poznatom sigurnosnom profilu kod liječenja ribavirinom, bez povećanja učestalosti ili težine očekivanih nuspojava.
English: This patient was subsequently retreated with ledipasvir/sofosbuvir + ribavirin for 24 weeks and achieved SVR following retreatment.
Croatian: + ribavirinom tijekom 24 tjedna i postigao je SVR nakon ponovnog liječenja.
English: • rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis); • St. John's wort (herbal medicine used to treat depression);
Croatian: • rifampicin i rifabutin (antibiotici koji se primjenjuju za liječenje infekcija, uključujući tuberkulozu);
English: Previously treated adults with or without cirrhosis - ION-2 (study 0109) - Genotype 1 ION-2 was a randomised, open-label study that evaluated 12 and 24 weeks of treatment with ledipasvir/sofosbuvir with or without ribavirin (randomised 1:1:1:1) in genotype 1 HCV-infected patients with or without cirrhosis who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor.
Croatian: ION-2 bilo je randomizirano, otvoreno ispitivanje kojim se procijenilo 12 i 24 tjedna liječenja ledipasvirom/sofosbuvirom s ribavirinom ili bez njega u bolesnika (randomiziranih u omjeru 1:1:1:1) s cirozom ili bez nje zaraženih HCV-om genotipa 1 u kojih je prethodna terapija režimom na temelju interferona bila neuspješna, uključujući režime koji su sadržavali inhibitor proteaze HCV-a.
English: SVR was achieved in all 24 patients (n = 20 with L159F+C316N; n = 1 with L159F; and n = 3 with N142T) who had baseline variants associated with resistance to NS5B nucleoside inhibitors.
Croatian: Supstitucija S282T povezana s rezistencijom na sofosbuvir nije bila otkrivena populacijskim ili detaljnim sekvencioniranjem u početnoj NS5B sekvenci ni u jednog bolesnika u ispitivanjima faze 3, SVR je postignut u sva 24 bolesnika (n = 20 s L159F+C316N; n = 1 s L159F; i n = 3 s N142T) koji su na početku imali varijante povezane s rezistencijom na NS5B nukleozidne inhibitore.
English: • fainting
Croatian: • nesvjesticu
English: Co-administration of Harvoni with rosuvastatin is contraindicated (see section 4.3).
Croatian: Istovremena primjena lijeka Harvoni s rosuvastatinom je kontraindicirana (vidjeti dio 4.3).
English: ION-4 was an open-label clinical study that evaluated the safety and efficacy of 12 weeks of treatment with ledipasvir/sofosbuvir without ribavirin in HCV treatment-naïve and treatment-experienced patients with genotype 1 or 4 CHC who were co-infected with HIV-1.
Croatian: Ispitivanje ION-4 bilo je otvoreno kliničko ispitivanje kojim se procijenila sigurnost i djelotvornost liječenja ledipasvirom/sofosbuvirom bez ribavirina tijekom 12 tjedana u bolesnika s CHC-om uzrokovanim HCV-om genotipa 1 ili 4 te istovremeno zaraženih virusom HIV-1, koji prethodno nisu bili liječeni i koji su prethodno bili liječeni.
English: No teratogenic effects were observed in rat and rabbit developmental toxicity studies with ledipasvir.
Croatian: Nisu bili opaženi teratogeni učinci ledipasvira u ispitivanjima njegove razvojne toksičnosti na štakorima i kunićima.
English: Harvoni is contraindicated with rifabutin (see section 4.3).
Croatian: Harvoni je kontraindiciran s rifabutinom (vidjeti dio 4.3).
English: virus.
Croatian: HIV-om)
English: ↑ Dabigatran ↔ Ledipasvir
Croatian: ↑ Lopinavir ↑ Ritonavir
English: Harvoni is contraindicated with carbamazepine (see section 4.3).
Croatian: Harvoni je kontraindiciran s karbamazepinom (vidjeti dio 4.3).
English: Breast-feeding Do not breast-feed during treatment with Harvoni.
Croatian: Nemojte dojiti tijekom liječenja lijekom Harvoni.
English: 12 weeks (n = 214)
Croatian: 12 tjedana (n = 214)
English: When given with elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate, Harvoni is expected to increase the concentration of tenofovir.
Croatian: Kad se daje s elvitegravirom/kobicistatom/ emtricitabinom/tenofovirdizoproksilfumaratom, očekuje se da će Harvoni povećati koncentraciju tenofovira.
English: No new adverse drug reactions were detected among patients with decompensated cirrhosis and/or who were post-liver transplant and who received ledipasvir/sofosbuvir with ribavirin.
Croatian: U bolesnika s dekompenziranom cirozom i/ili onih poslije transplantacije jetre i koji su primali ledipasvir/sofosbuvir s ribavirinom, nisu otkrivene nove nuspojave.
English: Table 9: Response rates in study ION-3 LDV/SOF
Croatian: Tablica 9: Stope odgovora u ispitivanju ION-3 LDV/SOF
English: Tabulated list of adverse events
Croatian: Tablični popis nuspojava
English: Sofosbuvir ↓ Cmax 0.23 (0.19, 0.29)
Croatian: Sofosbuvir ↓ Cmax 0,23 (0,19; 0,29) ↓ AUC 0,28 (0,24; 0,32)
English: Relapseb
Croatian: Relapsb
English: Tacrolimus (5 mg single dose)/ sofosbuvir (400 mg single dose)h
Croatian: Takrolimus (jedna doza od 5 mg)/ sofosbuvir (jedna doza od 400 mg)h
English: Sofosbuvir ↑ Cmax 2.54 (1.87, 3.45)
Croatian: Sofosbuvir ↑ Cmax 2,54 (1,87; 3,45) ↑ AUC 4,53 (3,26; 6,30)
English: Gilead Sciences Ltd. Tel: + 44 (0) 8000 113700
Croatian: Tel: + 44 (0) 8000 113700
English: SVR Outcome for patients without SVR On-treatment virologic failure
Croatian: Ishod u bolesnika bez SVR
English: The pharmacokinetics of ledipasvir were studied with a single dose of 90 mg ledipasvir in HCV negative patients with severe hepatic impairment (CPT class C).
Croatian: Farmakokinetika ledipasvira bila je ispitana u HCV-negativnih bolesnika s teškim oštećenjem jetre (CPT stadij C) nakon jedne doze od 90 mg ledipasvira.
English: When given with tenofovir disoproxil fumarate used in conjunction with atazanavir/ritonavir, Harvoni increased the concentration of tenofovir.
Croatian: Kad se daje s tenofovirdizoproksilfumaratom koji se primjenjivao zajedno s atazanavirom/ritonavirom, Harvoni će povećati koncentraciju tenofovira.
English: 12 weeks (n = 217)
Croatian: 12 tjedana (n = 217)
English: Table 12: Response rates in study ION-1 LDV/SOF
Croatian: Tablica 12: Stope odgovora u ispitivanju ION-1 LDV/SOF
English: Harvoni is contraindicated with rifampicin (see section 4.3).
Croatian: Harvoni je kontraindiciran s rifampicinom (vidjeti dio 4.3).
English: Cirrhosisd
Croatian: Ciklosporing
English: LDV/SOF 12 weeks (n = 335)
Croatian: LDV/SOF 12 tjedana (n = 335)
English: LDV/SOF 24 weeks (n = 109)
Croatian: LDV/SOF 24 tjedna (n = 109)
English: LDV/SOF+RBV 8 weeks (n = 216)
Croatian: LDV/SOF+RBV 8 tjedana (n = 216)
English: Patients with renal impairment
Croatian: Bolesnici bez ciroze
English: When given with lopinavir/ritonavir used in conjunction with tenofovir disoproxil fumarate, Harvoni is expected to increase the concentration of tenofovir.
Croatian: Kad se daje s lopinavirom/ritonavirom koji se primjenjivao zajedno s tenofovirdizoproksilfumaratom, očekuje se da će Harvoni povećati koncentraciju tenofovira.
English: LDV/SOF+RBV 8 weeks (n = 210)
Croatian: LDV/SOF+RBV 8 tjedana (n = 210)
English: Co-administration of Harvoni with rifapentine is expected to decrease the concentration of ledipasvir and sofosbuvir, leading to reduced therapeutic effect of Harvoni.
Croatian: Očekuje se da će istovremena primjena lijeka Harvoni s rifapentinom smanjiti koncentraciju ledipasvira i sofosbuvira i tako dovesti do smanjenog terapijskog učinka lijeka Harvoni.
English: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate (150 mg/ 150 mg/ 200 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c
Croatian: Elvitegravir/ kobicistat/ emtricitabin/ tenofovirdizoproksilfumarat (150 mg/ 150 mg/ 200 mg/ 300 mg jedanput na dan)/ ledipasvir (90 mg jedanput na dan)c/ sofosbuvir (400 mg jedanput na dan)c
English: Genotype 1b
Croatian: Genotip 1a Genotip 1b
English: Table 14: Response rates in study ION-2 LDV/SOF
Croatian: Tablica 14: Stope odgovora u ispitivanju ION-2 LDV/SOF
English: LDV/SOF 8 weeks (n = 215)
Croatian: LDV/SOF 8 tjedana (n = 215)
English: Severe RI (eGFR
Croatian: Teško oštećenje bubrega (eGFR
English: When given with darunavir/ritonavir used in conjunction with tenofovir disoproxil fumarate, Harvoni increased the concentration of tenofovir.
Croatian: Kad se daje s darunavirom/ritonavirom koji se primjenjivao zajedno s tenofovirdizoproksilfumaratom, Harvoni će povećati koncentraciju tenofovira.
English: Ciclosporin (600 mg single dose)/ sofosbuvir (400 mg single dose)h
Croatian: Ciklosporin (jedna doza od 600 mg)/ sofosbuvir (jedna doza od 400 mg)h
English: LDV/SOF 24 weeks (n = 217)
Croatian: LDV/SOF 24 tjedna (n = 217)
English: Darunavir boosted with ritonavir (800 mg/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Croatian: Darunavir pojačan ritonavirom (800 mg/ 100 mg jedanput na dan) + emtricitabin/ tenofovirdizoproksilfumarat (200 mg/ 300 mg jedanput na dan)/ ledipasvir (90 mg jedanput na dan)c/ sofosbuvir (400 mg jedanput na dan)c, d
English: Concerning recommended regimens with different HCV genotypes, see section 4.2.
Croatian: Za preporučene režime kod različitih genotipova HCV-a, vidjeti dio 4.2. Za virološko i kliničko djelovanje na određeni genotip, vidjeti dio 5.1.
English: Co-administration of Harvoni with oxcarbazepine is expected to decrease the concentration of ledipasvir and sofosbuvir leading to reduced therapeutic effect of Harvoni.
Croatian: Očekuje se da će istovremena primjena lijeka Harvoni s okskarbazepinom smanjiti koncentraciju ledipasvira i sofosbuvira i tako dovesti do smanjenog terapijskog učinka lijeka Harvoni.
English: ERADICATE was an open-label study to evaluate 12 weeks of treatment with ledipasvir/sofosbuvir in 50 patients with genotype 1 CHC co-infected with HIV.
Croatian: Odrasli istovremeno zaraženi HCV/HIV-om - ERADICATE ERADICATE je bilo otvoreno ispitivanje kojim se procijenilo 12 tjedana liječenja ledipasvirom/sofosbuvirom u 50 bolesnika s CHC-om uzrokovanim genotipom 1 i istovremenom HIV-infekcijom.
English: Famotidine (40 mg single dose)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)c, d
Croatian: (jedna doza od 40 mg)/ ledipasvir (jedna doza od 90 mg)c/ sofosbuvir (jedna doza od 400 mg)c, d
English: IMMUNOSUPPRESSANTS Ciclosporing
Croatian: Inhibitori protonske pumpe
English: Abacavir ↔ Cmax 0.92 (0.87, 0.97)
Croatian: Abakavir ↔ Cmax 0,92 (0,87; 0,97) ↔ AUC 0,90 (0,85; 0,94)
English: ↔ Dolutegravir ↔ Ledipasvir ↔ Sofosbuvir
Croatian: ↔ Dolutegravir ↔ Ledipasvir ↔ Sofosbuvir ↔ GS-331007
English: Sofosbuvir ↑ Cmax 1.15 (0.88, 1.50)
Croatian: Sofosbuvir ↑ Cmax 1,15 (0,88; 1,50) ↔ AUC 1,11 (1,00; 1,24)
English: Vitamin K antagonists
Croatian: Antagonisti vitamina
English: Emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate (200 mg/ 25 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Croatian: Emtricitabin/ rilpivirin/ tenofovirdizoproksilfumarat (200 mg/ 25 mg/ 300 mg jedanput na dan)/ ledipasvir (90 mg jedanput na dan)c/ sofosbuvir (400 mg jedanput na dan)c, d
English: Atazanavir boosted with ritonavir (300 mg/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Croatian: Atazanavir pojačan ritonavirom (300 mg/ 100 mg jedanput na dan) + emtricitabin/ tenofovirdizoproksilfumarat (200 mg/ 300 mg jedanput na dan)/ ledipasvir (90 mg jedanput na dan)c/ sofosbuvir (400 mg jedanput na dan)c, d
English: LDV/SOF 12 weeks (n = 216)
Croatian: LDV/SOF 12 tjedana (n = 216)
English: Genotype
Croatian: Genotip
English: • light-headedness
Croatian: • ošamućenost
English: Sofosbuvir ↓ Cmax 0.52 (0.43, 0.62)
Croatian: Sofosbuvir ↓ Cmax 0,52 (0,43; 0,62) ↓ AUC 0,52 (0,46; 0,59) Cmin (NA)
English: Proton pump inhibitors Omeprazole (20 mg once daily)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)c
Croatian: Omeprazol (20 mg jedanput na dan)/ ledipasvir (jedna doza od 90 mg)c/ sofosbuvir (jedna doza od 400 mg)c
English: Close monitoring of INR is recommended with all vitamin K antagonists.
Croatian: Preporučuje se pomno praćenje međunarodnog normaliziranog omjera (INR) uz sve antagoniste vitamina K zbog promjena u funkciji jetre tijekom liječenja lijekom Harvoni.
English: Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV direct-acting antiviral treatment.
Croatian: Nakon uvođenja liječenja direktno djelujućim antivirusnim lijekovima, bolesnici s dijabetesom mogu imati bolju kontrolu glukoze u krvi, što može dovesti do simptomatske hipoglikemije.
English: Table 6: Adverse drug reactions identified with Harvoni Frequency
Croatian: Tablica 6: Nuspojave utvrđene uz Harvoni
English: Ledipasvir ↓ Cmax 0.89 (0.61, 1.30)
Croatian: Ledipasvir ↓ Cmax 0,89 (0,61; 1,30) ↓ AUC 0,96 (0,66; 1,39)
English: ↑ Pravastatin
Croatian: Nuspojava
English: CC
Croatian: K
English: Other effects that may be seen during treatment with Harvoni
Croatian: Mogućnost utjecaja drugih lijekova na Harvoni
English: GS-331007 ↑ Cmax 1.33 (1.22, 1.44)
Croatian: GS-331007 ↑ Cmax 1,33 (1,22; 1,44) ↑ AUC 1,44 (1,41; 1,48) ↑ Cmin 1,53 (1,47; 1,59)
English: LDV/SOF 12 weeks (n = 211)
Croatian: LDV/SOF 12 tjedana (n = 211)
English: Demographics and baseline characteristics were balanced across the two treatment groups.
Croatian: Dvije terapijske skupine bile su slične po demografskim i početnim značajkama.
English: GS-331007 ↔ Cmax 1.09 (0.99, 1.19)
Croatian: GS-331007 ↔ Cmax 1,09 (0,99; 1,19) ↔ AUC 1,02 (0,97; 1,08)
English: a One patient in the LDV/SOF 24-week treatment arms and one patient in the LDV/SOF+RBV 24-week treatment arm were prior treatment failures of a non-pegylated interferon-based regimen.
Croatian: Prethodno liječenje režimom na temelju nepegiliranog interferona bilo je neuspješno u jednog bolesnika u terapijskoj skupini liječenoj 24 tjedna LDV/SOF-om i jednog bolesnika u skupini liječenoj 24 tjedna LDV/SOF+RBV-om.
English: FibroTest-Determined Metavir scoreb F0-F1
Croatian: Metavir-rezultat određen FibroTestomb
English: Age (years): median (range) Male gender Race: Black/ African American White Genotype 1aa IL28CC genotype FibroTest-Determined Metavir scoreb F0-F1 F2 F3-F4 Not interpretable a Two patients in the LDV/SOF 12-week treatment arm, one patient in the LDV/SOF+RBV 12-week treatment arm, two patients in the LDV/SOF 24-week treatment arm, and two patients in the LDV/SOF+RBV 24-week treatment arm did not have a confirmed genotype 1 subtype.
Croatian: U dva bolesnika u terapijskoj skupini liječenoj 12 tjedana LDV/SOF-om, jednog bolesnika u skupini liječenoj 12 tjedana LDV/SOF + RBV-om, dva bolesnika u terapijskoj skupini liječenoj 24 tjedna LDV/SOF-om i dva bolesnika u terapijskoj skupini liječenoj 24 tjedna LDV/SOF+RBV-om nije bila potvrđena podvrsta genotipa 1. b. Rezultati FibroTesta koji nisu nedostajali bili su mapirani na Metavir-rezultate prema sljedećem: 0-0,31 = F0-F1; 0,32-0,58 = F2; 0,59-1,00 = F3-F4.
English: Harvoni is contraindicated with St. John's wort (see section 4.3).
Croatian: Harvoni je kontraindiciran s gospinom travom (vidjeti dio 4.3).
English: GS 331007 ↔ Cmax 1.15 (1.03, 1.27)
Croatian: GS 331007 ↔ Cmax 1,15 (1,03; 1,27) ↔ AUC 1,03 (0,95; 1,12) Cmin (NA)
English: • headache
Croatian: • glavobolja • umor
English: LDV/SOF 12 weeks (n = 214)
Croatian: LDV/SOF 12 tjedana (n = 214)
English: Sofosbuvir ↓ Cmax 0.97 (0.65, 1.43)
Croatian: Sofosbuvir ↓ Cmax 0,97 (0,65; 1,43) ↑ AUC 1,13 (0,81; 1,57)
English: HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS Raltegravir (400 mg twice daily)/ ledipasvir (90 mg once daily)d
Croatian: Raltegravir (400 mg dvaput na dan)/ ledipasvir (90 mg jedanput na dan)d
English: Of the 100 treated patients, the median age was 15 years (range: 12 to 17); 63% of the patients were female; 90% were White, 7% were Black, and 2% were Asian; 13% were Hispanic/Latino; mean weight was 61.3 kg (range: 33.0 to 126.0 kg); 55% had baseline HCV RNA levels greater than or equal to 800,000 IU/mL; 81% had genotype 1a HCV infection; 76% had non-CC IL28B alleles (CT or TT) and 1% had known cirrhosis.
Croatian: U 100 liječenih bolesnika medijan dobi bio je 15 godina (raspon: od 12 do 17); 63 % bolesnika bilo je ženskog spola; 90 % bolesnika bili su bijelci, 7 % crnci, a 2 % Azijci; 13 % bili su Hispano/Latinoamerikanci; srednja vrijednost tjelesne težine iznosila je 61,3 kg (raspon: od 33,0 do
English: ↑ Cmin 1.63 (1.45, 1.84) Ritonavir ↔ Cmax 0.86 (0.79, 0.93)
Croatian: Etinilestradiol ↑ Cmax 1,40 (1,18; 1,66) ↔ AUC 1,20 (1,04; 1,39) ↔ Cmin 0,98 (0,79; 1,22)
English: ↑ Cmin 1.39 (1.29, 1.51)
Croatian: Ledipasvir ↑ Cmax 1,45 (1,34; 1,56) ↑ AUC 1,39 (1,28; 1,49) ↑ Cmin 1,39 (1,29; 1,51)
English: Fertility
Croatian: Nizatidine
English: Tacrolimus
Croatian: Takrolimus
English: ACID REDUCING AGENTS
Croatian: LIJEKOVI KOJI SMANJUJU KISELOST
English: GS 331007 ↔ Cmax 1.04 (0.97, 1.11)
Croatian: GS 331007 ↔ Cmax 1,04 (0,97; 1,11) ↔ AUC 0,99 (0,94; 1,04) Cmin (NA)
English: Tel: + 420 910 871 986
Croatian: Česká republika Gilead Sciences s.r.o. Tel: + 420 910 871 986
English: ↑ Cmin 1.91 (1.76, 2.08) Sofosbuvir ↑ Cmax 1.33 (1.14, 1.56)
Croatian: Sofosbuvir ↑ Cmax 1,33 (1,14; 1,56) ↑ AUC 1,36 (1,21; 1,52)
English: Norelgestromin ↔ Cmax 1.07 (0.94, 1.22)
Croatian: Norelgestromin ↔ Cmax 1,07 (0,94; 1,22) ↔ AUC 1,06 (0,92; 1,21) ↔ Cmin 1,07 (0,89; 1,28)
English: GS-331007 ↓ Cmax 0.73 (0.65, 0.83)
Croatian: GS-331007 ↓ Cmax 0,73 (0,65; 0,83) ↔ AUC 1,04 (0,89; 1,22)
English: GS-331007 ↓ Cmax 0.60 (0.53, 0.69)
Croatian: GS-331007 ↓ Cmax 0,60 (0,53; 0,69) ↔ AUC 1,04 (0,90; 1,20)
English: Ledipasvir ↓ Cmax 0.80 (0.69, 0.93)
Croatian: Ledipasvir ↓ Cmax 0,80 (0,69; 0,93) ↔ AUC 0,89 (0,76; 1,06)
English: GS-331007 ↔ Cmax 1.13 (1.07, 1.20)
Croatian: GS-331007 ↔ Cmax 1,13 (1,07; 1,20) ↔ AUC 1,06 (1,01; 1,12)
English: Ledipasvir ↓ Cmax 0.83 (0.69, 1.00)
Croatian: Ledipasvir ↓ Cmax 0,83 (0,69; 1,00) ↔ AUC 0,98 (0,80; 1,20)
English: HCV protease inhibitor (ION-2).
Croatian: HIV ANTIVIRUSNI LIJEKOVI: INHIBITORI PROTEAZE HIV-A