natgillin/translations-raw huggingface dataset:
Genotype 4d 0.60 Genotype 5a 
Genotip 3a Genotip 4a Genotip 4d Genotip 5a
Raltegravir (400 mg twice daily)/ sofosbuvir (400 mg once daily)d 
Raltegravir (400 mg dvaput na dan)/ sofosbuvir (400 mg jedanput na dan)d
Study 4063 was an open-label three-arm clinical study that evaluated 8, 12, and 24 weeks of treatment with ledipasvir/sofosbuvir in a total of 95 patients with genotype 1 (72%), 2 (22%), 4 (2%), 5 (1%), or 6 (2%) CHC and ESRD requiring dialysis: 45 treatment-naïve genotype 1 HCV-infected patients without cirrhosis received ledipasvir/sofosbuvir for 8 weeks; 31 treatment-experienced genotype 1 
Ispitivanje 4063 bilo je otvoreno kliničko ispitivanje s tri skupine ispitanika u kojem se procijenilo liječenje ledipasvirom/sofosbuvirom u trajanju od 8, 12 i 24 tjedna u ukupno 95 bolesnika s CHC-om uzrokovanim genotipom 1 (72 %), 2 (22 %), 4 (2 %), 5 (1 %) ili 6 (2 %) i s ESRD-om koji je zahtijevao dijalizu: 45 prethodno neliječenih bolesnika zaraženih HCV-om genotipa 1 bez ciroze primalo je ledipasvir/sofosbuvir tijekom 8 tjedana; 31 prethodno liječen bolesnik zaražen HCV-om genotipa 1 i prethodno neliječeni ili već liječeni bolesnici zaraženi HCV-om genotipa 2, 5 i 6 bez ciroze primali su ledipasvir/sofosbuvir tijekom 12 tjedana; a 19 bolesnika zaraženih HCV-om genotipa 1, 2 i 4 s kompenziranom cirozom primalo je ledipasvir/sofosbuvir tijekom 24 tjedna.
Treatment-naïve adults with or without cirrhosis - ION-1 (study 0102) - Genotype 1 ION-1 was a randomised, open-label study that evaluated 12 and 24 weeks of treatment with ledipasvir/sofosbuvir with or without ribavirin in 865 treatment-naïve patients with genotype 1 CHC including those with cirrhosis (randomised 1:1:1:1). 
Odrasli s cirozom ili bez nje koji prethodno nisu bili liječeni - ION-1 (ispitivanje 0102) - genotip 1 Ispitivanje ION-1 bilo je randomizirano, otvoreno ispitivanje kojim se procijenilo 12 i 24 tjedna liječenja ledipasvirom/sofosbuvirom s ribavirinom ili bez njega u 865 bolesnika s CHC-om uzrokovanim genotipom 1, uključujući one s cirozom (randomizirani u omjeru 1:1:1:1), koji prethodno nisu bili liječeni.
Patients without cirrhosis 89% (25/28) 
Bolesnici s cirozom 73% (16/22)
No significant effects on foetal development have been observed with ledipasvir or sofosbuvir in rats and rabbits. 
Nisu opaženi značajni učinci ledipasvira ili sofosbuvira na fetalni razvoj u štakora i kunića.
Rifapentine 
Rifapentin
Famotidine dosed simultaneously with Harvonid 
Famotidin primijenjen istovremeno s lijekom
Co-administration of such medicinal products is not recommended with Harvoni (see section 4.5). 
Ne preporučuje se istodobna primjena takvih lijekova s lijekom Harvoni (vidjeti dio 4.5).
8 weeks (n = 215) 
8 tjedana (n = 215)
No dose adjustment of Harvoni or efavirenz/ emtricitabine/ tenofovir disoproxil fumarate is required. 
Nije potrebna prilagodba doze lijeka Harvoni ili efavirenza/ emtricitabina/ tenofovirdizoproksilfumarata.
Table 4: Ribavirin dose modification guideline for co-administration with Harvoni in adults Laboratory values 
Tablica 4: Smjernica za prilagodbu doze ribavirina u odraslih kod istovremene primjene s lijekom Harvoni
No dose adjustment of Harvoni or methadone is required. 
Nije potrebna prilagodba doze lijeka Harvoni ili metadona.
Harvoni [Outer packaging only] 
16. PODACI NA BRAILLEOVOM PISMU Harvoni [samo vanjsko pakiranje]
Of the 670 treated patients, the median age was 59 years (range: 21 to 81 years); 77% of the patients were male; 91% were White; mean body mass index was 28 kg/m2 (range: 18 to 49 kg/m2); 94% and 6% had genotype 1 and 4 HCV infection, respectively; 78% of the patients failed a prior HCV therapy. 
Medijan dobi 670 liječenih bolesnika bio je 59 godina (raspon: od 21 do 81 godine); 77 % bolesnika bili su muškarci; 91 % bili su bijelci; srednja vrijednost indeksa tjelesne mase iznosila je 28 kg/m2 (raspon: od 18 do 49 kg/m2); 94 % imalo je infekciju HCV-om genotipa 1, a 6 % imalo je infekciju HCV-om genotipa 4; u 78 % bolesnika prethodna HCV terapija nije bila uspješna.
No dose adjustment of Harvoni or ciclosporin is required at initiation of co-administration. 
Nije potrebna prilagodba doze lijeka Harvoni ili ciklosporina na početku njihove istodobne primjene.
Age (years): median (range) Male gender 
Dob (godine): medijan (raspon) 56 (24-67) Muški spol
Table 15: Relapse rates for selected subgroups in study ION-2 LDV/SOF 
Tablica 15: Stope relapsa u odabranim podskupinama u ispitivanju ION-2 LDV/SOF
Use with moderate P-gp inducers 
Primjena s umjerenim induktorima P-glikoproteina
EC50 (K24G/N/R, M28A/G/T, Q30E/G/H/L/K/R/T, L31I/F/M/V, P32L, S38F, H58D, A92K/T, and Y93C/F/H/N/S for genotype 1a and L31I/F/M/V, P32L, P58D, A92K, and Y93C/H/N/S for genotype 1b HCV infection). 
Y93C/F/H/N/S za infekciju HCV-om genotipa 1a i L31I/F/M/V, P32L, P58D, A92K i Y93C/H/N/S za infekciju
Harvoni should not be administered concomitantly with other medicinal products containing sofosbuvir. 
4.4 Posebna upozorenja i mjere opreza pri uporabi Harvoni se ne smije primjenjivati istovremeno s drugim lijekovima koji sadrže sofosbuvir.
Cross-resistance 
Ukrižena rezistencija
- Harvoni (without ribavirin) for 12 weeks may be considered for patients deemed at low risk for clinical disease progression and who have subsequent retreatment options (see section 4.4). 
U bolesnika za koje se smatra da imaju niski rizik od progresije kliničke bolesti i koji imaju daljnje mogućnosti ponovnog liječenja može se razmotriti primjena lijeka Harvoni (bez ribavirina) tijekom 12 tjedana (vidjeti dio 4.4).
↔ Emtricitabine ↑ Tenofovir 
↑ Tenofovir
Table 10: Relapse rates by baseline characteristics in the ION-3 study, virological failure population* LDV/SOF 
Tablica 10: Stope relapsa prema početnim značajkama u ispitivanju ION-3, populacija s virološkim neuspjehom*
24% (4/17)e a These 4 non-cirrhotic relapsers all had baseline NS5A resistance-associated polymorphisms. 
Ova 4 bolesnika bez ciroze s relapsom imala su početne polimorfizme NS5A povezane s rezistencijom.
Harvoni is contraindicated with phenobarbital and phenytoin (see section 4.3). 
Harvoni je kontraindiciran s fenobarbitalom i fenitoinom (vidjeti dio 4.3).
b Patients with missing cirrhosis status were excluded from this subgroup analysis. 
b. Bolesnici bez podatka o statusu ciroze bili su isključeni iz analize ove podskupine.
Co-administration of Harvoni with tipranavir (ritonavir boosted) is expected to decrease the concentration of ledipasvir, leading to reduced therapeutic effect of Harvoni. 
Očekuje se da će istovremena primjena lijeka Harvoni s tipranavirom (pojačanim ritonavirom) smanjiti koncentraciju ledipasvira i tako dovesti do smanjenog terapijskog učinka lijeka Harvoni.
You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Harvoni. 
Nakon što počnete uzimati lijek Harvoni, možda ćete trebati pažljivije pratiti razinu glukoze u krvi i/ili prilagoditi lijek protiv šećerne bolesti.
12 weeks (n = 111) 
12 tjedana (n = 111)
- Harvoni (without ribavirin) for 12 weeks (in patients without cirrhosis) or 24 weeks (in patients with cirrhosis) may be considered for patients who are ineligible for or intolerant to ribavirin. 
- U bolesnika koji nisu pogodni za liječenje ribavirinom ili ga ne podnose može se razmotriti primjena lijeka Harvoni (bez ribavirina) tijekom 12 tjedana (u bolesnika bez ciroze) ili 24 tjedna (u bolesnika s cirozom).
No clinically relevant pharmacokinetic differences due to race have been identified for ledipasvir, sofosbuvir or GS-331007. 
Nisu utvrđene nikakve klinički važne razlike u farmakokinetici ledipasvira, sofosbuvira i GS-331007 zbog rase.
d 3/3 of these patients had cirrhosis. 
d. 3/3 bolesnika imalo je cirozu. e. 0/4 bolesnika imalo je cirozu.
If you have any questions about your medicines, please ask your doctor or pharmacist. 
Ako imate bilo kakvih pitanja o ovim lijekovima, obratite se svom liječniku ili ljekarniku.
c Patients with missing cirrhosis status were excluded from this subgroup analysis. 
c. Bolesnici bez podatka o statusu ciroze bili su isključeni iz analize ove podskupine.
ION-3 evaluated 8 weeks of treatment with ledipasvir/sofosbuvir with or without ribavirin and 12 weeks of treatment with ledipasvir/sofosbuvir in treatment-naïve non-cirrhotic patients with genotype 1 CHC. 
U ispitivanju ION-3 procjenjivalo se 8 tjedana liječenja ledipasvirom/sofosbuvirom s ribavirinom ili bez njega te 12 tjedana liječenja ledipasvirom/sofosbuvirom bolesnika s CHC-om uzrokovanim genotipom 1, bez ciroze, koji prethodno nisu bili liječeni.
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. 
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.
No dose adjustment of Harvoni or midazolam is required. 
Nije potrebna prilagodba doze lijeka Harvoni ili midazolama.
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate 
Jezgra tablete kopovidon laktoza hidrat celuloza, mikrokristalična karmelozanatrij, umrežena silicijev dioksid, koloidni bezvodni magnezijev stearat
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. 
Pročitajte sažetke opisa svojstava lijeka za tenofovirdizoproksilfumarat, emtricitabin/tenofovirdizoproksilfumarat ili elvitegravir/kobicistat/emtricitabin/tenofovirdizoproksilfumarat zbog preporuka o nadziranju funkcije bubrega.
Omeprazole dosed simultaneously with Harvoni 
Preporuka za istovremenu primjenu s lijekom Harvoni
Baseline HCV RNAa HCV RNA < 6 million IU/mL HCV RNA ≥ 6 million IU/mL 
HCV RNK < 6 milijuna IU/ml 2 % (2/121) HCV RNK > 6 milijuna IU/ml 10 % (9/92)
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. 
Ledipasvir i sofosbuvir supstrati su prijenosnika lijekova P-gp i BCRP, dok GS-331007 to nije.
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 
Norgestimat/etinilestradiol (norgestimat 0,180 mg/ 0,215 mg/ 0,25 mg/ etinilestradiol 0,025 mg)/ ledipasvir (90 mg jedanput na dan)d
Dosed simultaneouslyf 
Relapsb Ostaloc
Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ sofosbuvir (400 mg once daily)d 
Norgestimat/ etinilestradiol (norgestimat 0,180 mg/ 0,215 mg/ 0,25 mg/ etinilestradiol 0,025 mg)/ sofosbuvir (400 mg jedanput na dan)d
Other statins 
Drugi statini
Treatment-experienced patients had failed prior treatment with PEG-IFN + ribavirin ± an HCV protease inhibitor or sofosbuvir + ribavirin ± PEG-IFN. 
U bolesnika koji su prethodno bili liječeni, prethodno liječenje PEG-IFN + ribavirinom ± inhibitorom proteaze HCV-a ili sofosbuvirom + ribavirinom ± PEG-IFN bilo je neuspješno.
The median terminal half-lives of sofosbuvir and GS-331007 following administration of ledipasvir/sofosbuvir were 0.5 and 27 hours, respectively. 
Nakon primjene ledipasvira/sofosbuvira, medijan terminalnog poluvijeka sofosbuvira iznosio je 0,5 sati, a GS-331007 27 sati.
d Patients with missing cirrhosis status were excluded from this subgroup analysis. 
d. Bolesnici bez podatka o statusu ciroze bili su isključeni iz analize ove podskupine.
ANTIMYCOBACTERIALS Rifampicin (600 mg once daily)/ ledipasvir (90 mg single dose)d 
Rifampicin (600 mg jedanput na dan)/ ledipasvir (jedna doza od 90 mg)d
24 weeks (n = 217) 
24 tjedna (n = 217)
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; 
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).
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. 
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.
Rifampicin (600 mg once daily)/ sofosbuvir (400 mg single dose)d 
Rifampicin (600 mg jedanput na dan)/ sofosbuvir (400 mg jedna doza)d
No dose adjustment of Harvoni or tacrolimus is required at initiation of co-administration. 
Nije potrebna prilagodba doze lijeka Harvoni ili takrolimusa na početku njihove istodobne primjene.
Skin and subcutaneous tissue disorders: Common rash 
Poremećaji kože i potkožnog tkiva:
Abacavir/ lamivudine (600 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d 
Abakavir/ lamivudin (600 mg/ 300 mg jedanput na dan)/ ledipasvir (90 mg jedanput na dan)c/ sofosbuvir (400 mg jedanput na dan)c, d
Co-administration with such medicinal products is not recommended with Harvoni (see section 4.4). 
Ne preporučuje se istodobna primjena takvih lijekova s lijekom Harvoni (vidjeti dio 4.4).
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. 
+ ribavirin bile su sukladne poznatom sigurnosnom profilu kod liječenja ribavirinom, bez povećanja učestalosti ili težine očekivanih nuspojava.
This patient was subsequently retreated with ledipasvir/sofosbuvir + ribavirin for 24 weeks and achieved SVR following retreatment. 
+ ribavirinom tijekom 24 tjedna i postigao je SVR nakon ponovnog liječenja.
• rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis); • St. John's wort (herbal medicine used to treat depression); 
• rifampicin i rifabutin (antibiotici koji se primjenjuju za liječenje infekcija, uključujući tuberkulozu);
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. 
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.
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. 
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.
• fainting 
• nesvjesticu
Co-administration of Harvoni with rosuvastatin is contraindicated (see section 4.3). 
Istovremena primjena lijeka Harvoni s rosuvastatinom je kontraindicirana (vidjeti dio 4.3).
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. 
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.
No teratogenic effects were observed in rat and rabbit developmental toxicity studies with ledipasvir. 
Nisu bili opaženi teratogeni učinci ledipasvira u ispitivanjima njegove razvojne toksičnosti na štakorima i kunićima.
Harvoni is contraindicated with rifabutin (see section 4.3). 
Harvoni je kontraindiciran s rifabutinom (vidjeti dio 4.3).
virus. 
HIV-om)
↑ Dabigatran ↔ Ledipasvir 
↑ Lopinavir ↑ Ritonavir
Harvoni is contraindicated with carbamazepine (see section 4.3). 
Harvoni je kontraindiciran s karbamazepinom (vidjeti dio 4.3).
Breast-feeding Do not breast-feed during treatment with Harvoni. 
Nemojte dojiti tijekom liječenja lijekom Harvoni.
12 weeks (n = 214) 
12 tjedana (n = 214)
When given with elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate, Harvoni is expected to increase the concentration of tenofovir. 
Kad se daje s elvitegravirom/kobicistatom/ emtricitabinom/tenofovirdizoproksilfumaratom, očekuje se da će Harvoni povećati koncentraciju tenofovira.
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. 
U bolesnika s dekompenziranom cirozom i/ili onih poslije transplantacije jetre i koji su primali ledipasvir/sofosbuvir s ribavirinom, nisu otkrivene nove nuspojave.
Table 9: Response rates in study ION-3 LDV/SOF 
Tablica 9: Stope odgovora u ispitivanju ION-3 LDV/SOF
Tabulated list of adverse events 
Tablični popis nuspojava
Sofosbuvir ↓ Cmax 0.23 (0.19, 0.29) 
Sofosbuvir ↓ Cmax 0,23 (0,19; 0,29) ↓ AUC 0,28 (0,24; 0,32)
Relapseb 
Relapsb
Tacrolimus (5 mg single dose)/ sofosbuvir (400 mg single dose)h 
Takrolimus (jedna doza od 5 mg)/ sofosbuvir (jedna doza od 400 mg)h
Sofosbuvir ↑ Cmax 2.54 (1.87, 3.45) 
Sofosbuvir ↑ Cmax 2,54 (1,87; 3,45) ↑ AUC 4,53 (3,26; 6,30)
Gilead Sciences Ltd. Tel: + 44 (0) 8000 113700 
Tel: + 44 (0) 8000 113700
SVR Outcome for patients without SVR On-treatment virologic failure 
Ishod u bolesnika bez SVR
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). 
Farmakokinetika ledipasvira bila je ispitana u HCV-negativnih bolesnika s teškim oštećenjem jetre (CPT stadij C) nakon jedne doze od 90 mg ledipasvira.
When given with tenofovir disoproxil fumarate used in conjunction with atazanavir/ritonavir, Harvoni increased the concentration of tenofovir. 
Kad se daje s tenofovirdizoproksilfumaratom koji se primjenjivao zajedno s atazanavirom/ritonavirom, Harvoni će povećati koncentraciju tenofovira.
12 weeks (n = 217) 
12 tjedana (n = 217)
Table 12: Response rates in study ION-1 LDV/SOF 
Tablica 12: Stope odgovora u ispitivanju ION-1 LDV/SOF
Harvoni is contraindicated with rifampicin (see section 4.3). 
Harvoni je kontraindiciran s rifampicinom (vidjeti dio 4.3).
Cirrhosisd 
Ciklosporing
LDV/SOF 12 weeks (n = 335) 
LDV/SOF 12 tjedana (n = 335)
LDV/SOF 24 weeks (n = 109) 
LDV/SOF 24 tjedna (n = 109)
LDV/SOF+RBV 8 weeks (n = 216) 
LDV/SOF+RBV 8 tjedana (n = 216)
Patients with renal impairment 
Bolesnici bez ciroze
When given with lopinavir/ritonavir used in conjunction with tenofovir disoproxil fumarate, Harvoni is expected to increase the concentration of tenofovir. 
Kad se daje s lopinavirom/ritonavirom koji se primjenjivao zajedno s tenofovirdizoproksilfumaratom, očekuje se da će Harvoni povećati koncentraciju tenofovira.
LDV/SOF+RBV 8 weeks (n = 210) 
LDV/SOF+RBV 8 tjedana (n = 210)
Co-administration of Harvoni with rifapentine is expected to decrease the concentration of ledipasvir and sofosbuvir, leading to reduced therapeutic effect of Harvoni. 
Očekuje se da će istovremena primjena lijeka Harvoni s rifapentinom smanjiti koncentraciju ledipasvira i sofosbuvira i tako dovesti do smanjenog terapijskog učinka lijeka Harvoni.
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 
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
Genotype 1b 
Genotip 1a Genotip 1b
Table 14: Response rates in study ION-2 LDV/SOF 
Tablica 14: Stope odgovora u ispitivanju ION-2 LDV/SOF
LDV/SOF 8 weeks (n = 215) 
LDV/SOF 8 tjedana (n = 215)
Severe RI (eGFR 
Teško oštećenje bubrega (eGFR
When given with darunavir/ritonavir used in conjunction with tenofovir disoproxil fumarate, Harvoni increased the concentration of tenofovir. 
Kad se daje s darunavirom/ritonavirom koji se primjenjivao zajedno s tenofovirdizoproksilfumaratom, Harvoni će povećati koncentraciju tenofovira.
Ciclosporin (600 mg single dose)/ sofosbuvir (400 mg single dose)h 
Ciklosporin (jedna doza od 600 mg)/ sofosbuvir (jedna doza od 400 mg)h
LDV/SOF 24 weeks (n = 217) 
LDV/SOF 24 tjedna (n = 217)
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 
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
Concerning recommended regimens with different HCV genotypes, see section 4.2. 
Za preporučene režime kod različitih genotipova HCV-a, vidjeti dio 4.2. Za virološko i kliničko djelovanje na određeni genotip, vidjeti dio 5.1.
Co-administration of Harvoni with oxcarbazepine is expected to decrease the concentration of ledipasvir and sofosbuvir leading to reduced therapeutic effect of Harvoni. 
Očekuje se da će istovremena primjena lijeka Harvoni s okskarbazepinom smanjiti koncentraciju ledipasvira i sofosbuvira i tako dovesti do smanjenog terapijskog učinka lijeka Harvoni.
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. 
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.
Famotidine (40 mg single dose)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)c, d 
(jedna doza od 40 mg)/ ledipasvir (jedna doza od 90 mg)c/ sofosbuvir (jedna doza od 400 mg)c, d
IMMUNOSUPPRESSANTS Ciclosporing 
Inhibitori protonske pumpe
Abacavir ↔ Cmax 0.92 (0.87, 0.97) 
Abakavir ↔ Cmax 0,92 (0,87; 0,97) ↔ AUC 0,90 (0,85; 0,94)
↔ Dolutegravir ↔ Ledipasvir ↔ Sofosbuvir 
↔ Dolutegravir ↔ Ledipasvir ↔ Sofosbuvir ↔ GS-331007
Sofosbuvir ↑ Cmax 1.15 (0.88, 1.50) 
Sofosbuvir ↑ Cmax 1,15 (0,88; 1,50) ↔ AUC 1,11 (1,00; 1,24)
Vitamin K antagonists 
Antagonisti vitamina