natgillin/translations-raw huggingface dataset:
Harvoni is contraindicated with phenobarbital and phenytoin (see section 4.3). 
Zdravilo Harvoni je kontraindicirano sfenobarbitalom in fenitoinom (glejte poglavje 4.3).
Dosed 1 hr After Dialysis 
1 uro po dializi
A total of 2 out of 100 patients (2%), both treatment- naïve, did not achieve SVR12 (due to loss to follow-up). 
Skupaj 2 od 100 bolnikov (2 %), oba predhodno nezdravljena,
24% (4/17)e a These 4 non-cirrhotic relapsers all had baseline NS5A resistance-associated polymorphisms. 
a. Ti 4 bolniki brez ciroze z relapsom so imeli izhodiščne z odpornostjo povezane polimorfizme NS5A.
The sofosbuvir resistance-associated substitution S282T was not detected in the baseline NS5B sequence of any patient in Phase 3 studies by population or deep sequencing. 
Substitucije S282T, povezane z odpornostjo na sofosbuvir, niso v izhodiščnem zaporedju NS5B odkrili pri nobenem bolniku v študijah 3. faze s karakterizacijo nukleotidnih sledi genoma ali karakterizacijo strukture genoma.
Following 12 weeks of treatment with ledipasvir/sofosbuvir (without ribavirin) in treatmentexperienced patients (arm 1 of ION-2 study) 4/4 patients with baseline NS5A RAVs conferring a ledipasvir fold-change of ≤ 100 achieved SVR. 
Po 12 tednih zdravljenja z ledipasvirjem/sofosbuvirjem (brez ribavirina) so SVR dosegli 4 od 4 bolnikov med predhodno zdravljenimi bolniki (skupina 1 v študiji ION-2) z izhodiščnimi RAV NS5A, ki so doprinesle k ≤ 100-krat spremembi dovzetnosti za ledipasvir.
Co-administration of Harvoni with tipranavir (ritonavir boosted) is expected to decrease the concentration of ledipasvir, leading to reduced therapeutic effect of Harvoni. 
Harvoni s tipranavirjem (okrepljenim z ritonavirjem) zmanjšalo koncentracijo ledipasvirja, kar bo povzročilo zmanjšan terapevtski učinek zdravila Harvoni.
No dose adjustment of Harvoni is required for patients with mild, moderate or severe hepatic impairment (Child-Pugh-Turcotte [CPT] class A, B or C) (see section 5.2). 
Pri bolnikih z blago, zmerno ali hudo jetrno okvaro (stopnja A, B ali C po Child-Pugh-Turcotteu
If you are not sure about taking any other medicines, talk to your doctor or pharmacist. 
Če ste v zvezi s katerimi drugimi zdravili negotovi, se posvetujte z zdravnikom ali farmacevtom.
Co-administration of such medicinal products is not recommended with Harvoni (see section 4.5). 
Sočasna uporaba teh zdravil z zdravilom Harvoni ni priporočljiva (glejte poglavje 4.5).
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. 
SOLAR-1 in SOLAR-2 sta bili dve odprti klinični študiji, v katerih so ocenili 12- in 24-tedensko zdravljenje z ledipasvirjem/sofosbuvirjem v kombinaciji z ribavirinom pri s HCV okuženih bolnikih z genotipoma 1 in 4, ki so imeli presaditev jeter in/ali imajo dekompenzirano jetrno bolezen.
Table 10: Relapse rates by baseline characteristics in the ION-3 study, virological failure population* LDV/SOF 
Preglednica 10: Stopnje relapsov glede na izhodiščne značilnosti v študiji ION-3, populacija bolnikov z virološkim neuspehom*
When given with tenofovir disoproxil fumarate used in conjunction with atazanavir/ritonavir, Harvoni increased the concentration of tenofovir. 
Pri sočasni uporabi z dizoproksiltenofoviratom fumaratom v povezavi z atazanavirjem/ritonavirjem je zdravilo Harvoni povečalo koncentracijo tenofovirja.
H2-receptor antagonists Famotidine (40 mg single dose)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)c, d 
Antagonisti receptorjev H2 Famotidin (40 mg enkratni odmerek)/ ledipasvir (90 mg enkratni odmerek)c/ sofosbuvir
If you take Harvoni you may get one or more of the side effects below: 
Če jemljete zdravilo Harvoni, boste morda dobili enega ali več spodaj navedenih neželenih učinkov: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov)
Outcome for patients without SVR On-treatment virologic failure Relapseb Otherc SVR rates for selected subgroups Patients with cirrhosis Previously treated patients with cirrhosis a 8 patients with genotype 4 HCV infection were enrolled in the study with 8/8 achieving SVR12. 
Bolniki s cirozo Predhodno zdravljeni bolniki s cirozo a. 8 bolnikov z okužbo HCV genotipa 4 je bilo vključenih v študijo, pri čemer jih je 8/8 doseglo SVR12.
Table 15 presents relapse rates with the 12-week regimens (with or without ribavirin) for selected subgroups (see also previous section “Effect of baseline HCV resistance-associated variants on treatment outcome”). 
za izbrane podskupine (glejte tudi prejšnje poglavje "Učinki izhodiščnih različic HCV, povezanih z odpornostjo, na izid zdravljenja").
24 weeks (n = 217) 
24 tednov (n = 217)
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). 
c. V analizo (s karakterizacijo strukture genoma) so bili vključeni polimorfizmi NS5A, povezani z odpornostjo, ki so doprinesli k > 2,5-kratni spremembi vrednosti EC50 (K24G/N/R, M28A/G/T, Q30E/G/H/L/K/R/T, L31I/F/M/V, P32L, S38F, H58D, A92K/T in Y93C/F/H/N/S za okužbo s HCV genotipa 1a in L31I/F/M/V, P32L, P58D, A92K in Y93C/H/N/S za okužbo s HCV genotipa 1b).
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. 
Mediana starost 670 zdravljenih bolnikov je bila 59 let (razpon: 21 do 81 let); 77 % bolnikov je bilo moškega spola; 91 % je bilo belcev; povprečni indeks telesne mase je bil 28 kg/m2 (razpon: 18 do 49 kg/m2);
Genotype 1b 
Genotip 1 Genotip 1b
Atazanavir ↔ Cmax 1.07 (1.00, 1.15) ↔ AUC 1.33 (1.25, 1.42) ↑ Cmin 1.75 (1.58, 1.93) 
↔ Cmax 1,07 (1,00; 1,15) ↔ AUC 1,33 (1,25; 1,42) ↑ Cmin 1,75 (1,58; 1,93)
The film-coated tablets are orange, diamond-shaped tablets debossed with “GSI” on one side and “7985” on the other side. 
»GSI« na eni in »7985« na drugi strani.
Orange, diamond-shaped, film-coated tablet of dimensions 19 mm x 10 mm, debossed with “GSI” on one side and “7985” on the other side. 
Oranžne, filmsko obložene tablete v obliki romba z merami 19 mm x 10 mm, z vtisnjeno oznako
Breast-feeding Do not breast-feed during treatment with Harvoni. 
Med zdravljenjem z zdravilom Harvoni ne smete dojiti.
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. 
Študija ION-2 je bila randomizirana, odprta študija, v kateri so ocenjevali 12- in 24-tedensko zdravljenje z ledipasvirjem/sofosbuvirjem z ribavirinom ali brez njega (randomizirane v razmerju 1:1:1:1) pri bolnikih, okuženih s HCV genotipa 1 s cirozo ali brez nje, pri katerih predhodno zdravljenje na podlagi interferona, vključno z režimi, ki so vključevali zaviralca proteaze HCV, ni bilo uspešno.
• rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis); • St. John's wort (herbal medicine used to treat depression); 
• rifampicin in rifabutin (antibiotika, ki se uporabljata za zdravljenje okužb, vključno s tuberkulozo),
12 weeks (n = 214) 
12 tednov (n = 214)
Table 9: Response rates in study ION-3 LDV/SOF 
Preglednica 9: Stopnje odziva v študiji ION-3 LDV/SOF
≥50 and mL/min/1. 
< 50 ml/min/
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 
Z ritonavirjem okrepljeni atazanavir (300 mg/ 100 mg enkrat na dan) + emtricitabin/ dizoproksiltenofovirat fumarat (200 mg/ 300 mg enkrat na dan)/ ledipasvir (90 mg enkrat na dan)c/
HCV protease inhibitor + PEG-IFN+RBV 
Zaviralec proteaze HCV +
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. 
Pri bolnikih z dekompenzirano cirozo in/ali po presaditvi jeter, ki so prejemali ledipasvir/sofosbuvir z ribavirinom niso opazili nobenih novih neželenih učinkov zdravila.
No target organs of toxicity were identified in rat and dog studies with ledipasvir at AUC exposures approximately 7 times the human exposure at the recommended clinical dose. 
V študijah ledipasvirja na podganah in psih z izpostavljenostjo AUC, ki je bila približno 7-krat večja od izpostavljenosti pri človeku pri priporočenem kliničnem odmerku, niso opredelili ciljnih organov za toksičnost.
LDV/SOF 24 weeks (n = 109) 
LDV/SOF 24 tednov (n = 109)
No dose adjustment of Harvoni or abacavir/ lamivudine is required. 
Odmerka zdravila Harvoni ali abakavirja/
Harvoni [Outer packaging only] 
PODATKI V BRAILLOVI PISAVI Harvoni [samo zunanja ovojnina]
Polyvinyl alcohol 
Etinilestradiol
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 s sočasno okužbo HCV/HIV - ERADICATE ERADICATE je bila odprta študija, v kateri so ocenjevali 12-tedensko zdravljenje z ledipasvirjem/sofosbuvirjem pri 50 bolnikih z okužbo CHC genotipa 1 in sočasno okužbo s HIV.
Co-administration of Harvoni with rifapentine is expected to decrease the concentration of ledipasvir and sofosbuvir, leading to reduced therapeutic effect of Harvoni. 
Harvoni z rifapentinom zmanjšalo koncentracije ledipasvirja in sofosbuvirja, kar bo povzročilo zmanjšan terapevtski učinek zdravila Harvoni.
Treatment-experienced patients had failed prior treatment with PEG-IFN + ribavirin ± an HCV protease inhibitor or sofosbuvir + ribavirin ± PEG-IFN. 
Pri predhodno zdravljenih bolnikih je bilo predhodno zdravljenje s PEG-IFN + ribavirinom ± zaviralcem proteaze
Genotype 6a 
15b genotip 6a
The following adverse drug reactions have been identified with Harvoni (Table 6). 
Pri uporabi zdravila Harvoni so ugotovili naslednje neželene učinke zdravila (preglednica 6).
Table 12: Response rates in study ION-1 LDV/SOF 
Preglednica 12: Stopnje odziva v študiji ION-1 LDV/SOF
Cirrhosisd 
Ciklosporin
Rifampicin (600 mg once daily)/ sofosbuvir (400 mg single dose)d 
Rifampicin (600 mg enkrat na dan)/ sofosbuvir
How to store Harvoni 
Shranjevanje zdravila Harvoni
Co-administration with such medicinal products is not recommended with Harvoni (see section 4.4). 
Sočasna uporaba teh zdravil z zdravilom Harvoni ni priporočljiva (glejte poglavje 4.4).
12 weeks (n = 217) 
12 tednov (n = 217)
Harvoni is contraindicated with carbamazepine (see section 4.3). 
Zdravilo Harvoni je kontraindicirano s karbamazepinom (glejte poglavje 4.3).
Sofosbuvir ↓ Cmax 0.52 (0.43, 0.62) 
Sofosbuvir ↓ Cmax 0,52 (0,43; 0,62) ↓ AUC 0,52 (0,46; 0,59)
Harvoni is contraindicated with rifabutin (see section 4.3). 
Zdravilo Harvoni je kontraindicirano z rifabutinom (glejte poglavje 4.3).
Other effects that may be seen during treatment with Harvoni 
Možni neželeni učinki Shranjevanje zdravila Harvoni
When given with lopinavir/ritonavir used in conjunction with tenofovir disoproxil fumarate, Harvoni is expected to increase the concentration of tenofovir. 
Pri sočasni uporabi z lopinavirjem/ritonavirjem v povezavi z dizoproksiltenofoviratom fumaratom se pričakuje, da zdravilo Harvoni poveča koncentracijo tenofovirja.
LDV/SOF+RBV 8 weeks (n = 216) 
LDV/SOF+RBV 8 tednov (n = 216)
LDV/SOF 12 weeks (n = 335) 
LDV/SOF 12 tednov (n = 335)
Impact of DAA therapy on drugs metabolized by the liver 
Vpliv zdravljenja z neposredno delujočim protivirusnim zdravilom na zdravila, ki se presnavljajo v jetrih
LDV/SOF+RBV 8 weeks (n = 210) 
LDV/SOF+RBV 8 tednov (n = 210)
Norelgestromin ↔ Cmax 1.02 (0.89, 1.16) 
Norelgestromin ↔ Cmax 1,02 (0,89; 1,16) ↔ AUC 1,03 (0,90; 1,18)
Starting dose of 600 mg, which can be titrated up to a maximum of 1,000/1,200 mg (1,000 mg for patients weighing < 75 kg and 1,200 mg for patients weighing ≥ 75 kg) if well tolerated. 
(1.000 mg pri bolnikih s telesno maso < 75 kg in 1.200 mg pri bolnikih s telesno maso ≥ 75 kg), če bolnik zdravilo dobro prenaša.
LDV/SOF 8 weeks (n = 215) 
LDV/SOF 8 tednov (n = 215)
When given with darunavir/ritonavir used in conjunction with tenofovir disoproxil fumarate, Harvoni increased the concentration of tenofovir. 
Pri sočasni uporabi z darunavirjem/ritonavirjem v povezavi z dizoproksiltenofoviratom fumaratom je zdravilo Harvoni povečalo koncentracijo tenofovirja.
The exposures to GS-331007 and ledipasvir were not altered in the presence of either meal type. 
Prisotnost nobene vrste obroka ni spremenila izpostavljenosti presnovku GS-331007 in ledipasvirju.
Recommendation concerning co-administration with Harvoni 
Priporočila glede sočasne uporabe z zdravilom Harvoni
Table 14: Response rates in study ION-2 LDV/SOF 
Preglednica 14: Stopnje odziva v študiji ION-2 LDV/SOF
Among post-transplant patients with compensated liver disease (SOLAR-1 and SOLAR-2 studies), no relapse occurred in patients with baseline NS5A RAVs (n = 23) following 12 weeks of treatment with ledipasvir/sofosbuvir + ribavirin. 
Po 12 tednih zdravljenja z ledipasvirjem/sofosbuvirjem + ribavirinom pri bolnikih s kompenzirano jetrno boleznijo po presaditvi (študiji SOLAR-1 in SOLAR-2) pri bolnikih z izhodiščnimi RAV NS5A (n = 23) ni prišlo do relapsa.
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 
0,215 mg/ 0,25 mg/ etinilestradiol 0,025 mg)/
Famotidine (40 mg single dose)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)c, d 
Famotidin (40 mg enkratni odmerek)/ ledipasvir (90 mg enkratni odmerek)c/ sofosbuvir
Reduced susceptibility to ledipasvir was associated with the primary NS5A substitution Y93H in both genotype 1a and 1b. 
Zmanjšana dovzetnost za ledipasvir je bila povezana s primarno substitucijo Y93H v polimerazi
Renal impairment No dose adjustment of Harvoni is required for patients with mild or moderate renal impairment. 
Ledvična okvara Pri bolnikih z blago ali zmerno ledvično okvaro odmerka zdravila Harvoni ni treba prilagajati.
However, the NS5B S282T substitution in combination with NS5A substitutions L31M, Y93H and Q30L were detected in one patient at failure following 8 weeks of treatment with ledipasvir/sofosbuvir from a Phase 2 study (LONESTAR). 
Vendar pa so pri enem bolniku ob neuspehu po 8-tedenskem zdravljenju z ledipasvirjem/sofosbuvirjem v študiji 2. faze (LONESTAR) odkrili substitucijo S282T v polimerazi NS5B v kombinaciji s substitucijami L31M, Y93H in Q30L v polimerazi NS5A.
Harvoni is contraindicated with rifampicin (see section 4.3). 
Zdravilo Harvoni je kontraindicirano z rifampicinom (glejte poglavje 4.3).
Emtricitabine ↔ Cmax 1.02 (0.98, 1.06) 
Emtricitabin ↔ Cmax 0,98 (0,94; 1,02)
LDV/SOF 24 weeks (n = 217) 
LDV/SOF 24 tednov (n = 217)
ANTICOAGULANTS Dabigatran etexilate 
ANTIKOAGULANTI
virus. 
bolnikov.
Hepatic impairment 
Huda ledvična okvara
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. 
Razlaga ni mogoča a. Dva bolnika v skupini 12-tedenskega zdravljenja z LDV/SOF, en bolnik v skupini 12-tedenskega zdravljenja z LDV/SOF+RBV, dva bolnika v skupini 24-tedenskega zdravljenja z LDV/SOF in dva bolnika v skupini 24-tedenskega zdravljenja z LDV/SOF+RBV niso imeli potrjenega podtipa genotipa 1. b. Nemanjkajoči rezultati FibroTest so kartirani v rezultate Metavir glede na: 0-0,31 = F0-F1; 0,32-0,58 = F2; 0,59
Darunavir ↔ Cmax 1.01 (0.96, 1.06) 
Darunavir ↔ Cmax 1,01 (0,96; 1,06) ↔ AUC 1,04 (0,99; 1,08)
Ciclosporin (600 mg single dose)/ sofosbuvir (400 mg single dose)h 
Ciklosporin (600 mg enkratni odmerek)/ sofosbuvir
Darunavir ↔ Cmax 1.02 (0.88, 1.19) 
↔ Cmax 1,02 (0,88; 1,19)
As Harvoni contains ledipasvir and sofosbuvir, any interactions that have been identified with these active substances individually may occur with Harvoni. 
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Zdravilo Harvoni vsebuje ledipasvir in sofosbuvir, zato se pri uporabi zdravila Harvoni lahko pojavijo katere koli interakcije, ki so jih opazili pri uporabi teh posameznih učinkovin.
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. 
Za priporočila o spremljanju ledvic glejte povzetke glavnih značilnosti zdravila za dizoproksiltenofovirat fumarat, emtricitabin/dizoproksiltenofovirat fumarat ali elvitegravir/kobicistat/emtricitabin/dizoproksiltenofovirat fumarat.
Dosed 1 hr Before Dialysis 
1 uro pred dializo
Cases of severe bradycardia and heart block have been observed when Harvoni is used with amiodarone with or without other drugs that lower heart rate. 
Pri uporabi zdravila Harvoni z amiodaronom, skupaj z drugimi zdravili, ki upočasnjujejo srčni utrip, ali brez njih, so opazili primere hude bradikardije in srčnega bloka.
↔ Cmin 1.12 (1.03, 1.21) Tenofovir ↔ Cmax 1.32 (1.25, 1.39) 
↔ Cmin 1,12 (1,03; 1,21) Tenofovir
Co-administration of Harvoni with oxcarbazepine is expected to decrease the concentration of ledipasvir and sofosbuvir leading to reduced therapeutic effect of Harvoni. 
Harvoni z okskarbazepinom zmanjšalo koncentracije ledipasvirja in sofosbuvirja, kar bo povzročilo zmanjšan terapevtski učinek zdravila Harvoni.
For the combination of tenofovir/emtricitabine + darunavir/ritonavir, please see below. 
darunavirja/ritonavirja glejte spodaj.
LDV/SOF 12 weeks (n = 216) 
LDV/SOF 12 tednov (n = 216)
No dose adjustment of Harvoni or emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate is required. 
rilpivirina/ dizoproksiltenofovirat fumarata ni treba prilagajati.
Raltegravir (400 mg twice daily)/ sofosbuvir (400 mg once daily)d 
Raltegravir (400 mg dvakrat na dan)/ ledipasvir (90 mg enkrat na dan)d
Proton pump inhibitors Omeprazole (20 mg once daily)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)c 
Omeprazol (20 mg enkrat na dan)/ ledipasvir (90 mg enkratni odmerek)c/ sofosbuvir
GS 331007 ↔ Cmax 1.15 (1.03, 1.27) 
GS 331007 ↔ Cmax 1,15 (1,03; 1,27) ↔ AUC 1,03 (0,95; 1,12)
Do not take it before Harvoni. 
Zdravila ne jemljite pred zdravilom Harvoni.
The pharmacokinetics of ledipasvir, sofosbuvir, and GS-331007 were studied in HCV-infected patients with ESRD requiring dialysis treated with ledipasvir/sofosbuvir (n=94) for 8, 12, or 24 weeks, and compared to patients without renal impairment in the ledipasvir/sofosbuvir Phase 2/3 trials. 
ESRD, zaradi katere so potrebovali dializo, zdravljenih z ledipasvirjem/sofosbuvirjem (n = 94) 8, 12 ali 24 tednov, in primerjali s farmakokinetiko pri bolnikih brez ledvične okvare v preskušanjih 2./3.
This patient was subsequently retreated with ledipasvir/sofosbuvir + ribavirin for 24 weeks and achieved SVR following retreatment. 
Ta bolnik se je nato 24 tednov ponovno zdravil z ledipasvirjem/sofosbivirjem +
Genotype 1b 0.004 Genotype 2a 
Genotip 1a Genotip 1b
↑ Cmin 1.53 (1.47, 1.59) 
↑ AUC 1,44 (1,41; 1,48) ↑ Cmin 1,53 (1,47; 1,59)
LDV/SOF 12 weeks (n = 211) 
LDV/SOF 12 tednov (n = 211)
NS 
V
Sofosbuvir ↓ Cmax 0.23 (0.19, 0.29) 
↓ Cmax 0,23 (0,19; 0,29)
LDV/SOF 12 weeks (n = 214) 
LDV/SOF 12 tednov (n = 214)
CPT C 
↔ AUC
GS-331007 ↔ Cmax 1.17 (1.12, 1.23) 
GS-331007 ↔ Cmax 1,17 (1,12; 1,23) ↔ AUC 1,31 (1,25; 1,36)
FibroTest-Determined Metavir scoreb F0-F1 
F0-F1 F2 F3-F4
↑ Cmin 1.63 (1.45, 1.84) Ritonavir ↔ Cmax 0.86 (0.79, 0.93) 
↑ Cmax 1,40 (1,18; 1,66) ↔ AUC 1,20 (1,04; 1,39) ↔ Cmin 0,98 (0,79; 1,22)
↔ Cmin 1.04 (0.98, 1.11) Tenofovir ↑ Cmax 1.79 (1.56, 2.04) 
↔ Cmin 1,04 (0,98; 1,11) Tenofovir
However, it is not recommended that ribavirin be increased to the originally assigned dose (1,000 mg to 1,200 mg daily). 
Prilagajanje odmerka ribavirina pri odraslih, ki jemljejo 1.000-1.200 mg na dan
GS 331007 ↔ Cmax 1.04 (0.97, 1.11) 
GS 331007 ↔ Cmax 1,04 (0,97; 1,11) ↔ AUC 0,99 (0,94; 1,04)
Sofosbuvir ↓ Cmax 0.64 (0.53, 0.77) 
Sofosbuvir ↓ Cmax 0,64 (0,53; 0,77) ↓ AUC 0,76 (0,63; 0,91)
Abacavir/ lamivudine (600 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d 
(600 mg/ 300 mg enkrat na dan)/ ledipasvir (90 mg enkrat na dan)c/ sofosbuvir
HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate (600 mg/ 200 mg/ 300 mg/ once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d 
100 mg enkrat na dan) + emtricitabin/ dizoproksiltenofovirat fumarat (200 mg/ 300 mg enkrat na dan)/ ledipasvir (90 mg enkrat na dan)c/
LDV/SOF+RBV 24-week treatment arm as both patients were infected with genotype 4 CHC. 
LDV/SOF+RBV sta bila izključena, ker sta bila okužena s CHC genotipa 4. b. Denominator za relaps je število bolnikov z RNA HCV < LLOQ ob zadnji oceni med zdravljenjem.
Prior HCV therapy 
Predhodno zdravljenje HCV
84 (3 bottles of 28) film-coated tablets. 
FARMACEVTSKA OBLIKA IN VSEBINA 28 filmsko obloženih tablet 84 (3 plastenke po 28) filmsko obloženih tablet
When given with elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate, Harvoni is expected to increase the concentration of tenofovir. 
emtricitabinom/ dizoproksiltenofovirat fumaratom se pričakuje, da bo zdravilo Harvoni povečalo koncentracijo tenofovirja.
HIV ANTIVIRAL AGENTS: HIV PROTEASE INHIBITORS Atazanavir boosted with ritonavir (300 mg/ 100 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d 
Z ritonavirjem okrepljeni atazanavir (300 mg/ 100 mg enkrat na dan)/ ledipasvir (90 mg enkrat na dan)c/ sofosbuvir
GS-331007 ↔ Cmax 1.00 (0.94, 1.07) 
GS-331007 ↔ Cmax 1,00 (0,94; 1,07) ↔ AUC 1,05 (1,01; 1,09)
↑ Cmin 1.59 (1.49, 1.70) Ledipasvir ↔ Cmax 1.11 (0.99, 1.24) 
↑ Cmax 1,64 (1,54; 1,74) ↑ AUC 1,50 (1,42; 1,59) ↑ Cmin 1,59 (1,49; 1,70)
Male 
Odmerjeno
↔ Cmin 1.07 (0.89, 1.28) Norgestrel ↔ Cmax 1.18 (0.99, 1.41) 
Norgestrel ↔ Cmax 1,03 (0,87; 1,23) ↔ AUC 0,99 (0,82; 1,20)
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/ dizoproksiltenofovirat fumarat (150 mg/ 150 mg/ 200 mg/
Package leaflet: Information for the user Harvoni 90 mg/400 mg film-coated tablets ledipasvir/sofosbuvir This medicine is subject to additional monitoring. 
Navodilo za uporabo Harvoni 90 mg/400 mg filmsko obložene tablete ledipasvir/sofosbuvir
Sofosbuvir ↔ Cmax 1.12 (0.88, 1.42) 
↔ Cmax 1,12 (0,88; 1,42)
↔ Cmin 1.12 (1.05, 1.20) Ledipasvir ↔ Cmax 1.10 (1.01, 1.19) 
Ledipasvir ↔ Cmax 1,10 (1,01; 1,19)
↑ Digoxin ↔ Ledipasvir 
Abakavir/ lamivudin
SVR Outcome for patients without SVR On-treatment virologic failure Relapsea Otherb SVR rates for selected subgroups Genotype Genotype 1a Genotype 1b Cirrhosis No 
Stabilni replikoni prehodni replikoni NS5B mediana (razpon)a genotip 1a genotip 1b genotip 2a genotip 2b
Titanium dioxide 
Norgestimat/ etinilestradiol
Excipients 
Emtricitabin
Atazanavir ↔ Cmax 1.07 (0.99, 1.14) 
Ledipasvir ↔ Cmax 1,11 (0,99; 1,24)
↔ Cmin 0.91 (0.83, 0.99) Emtricitabine ↔ Cmax 1.08 (0.97, 1.21) 
↓ Cmax 0,83 (0,69; 1,00) ↔ AUC 0,98 (0,80; 1,20)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING 
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI OZNAČEVANJE NA NALEPKI PLASTENKE IN ŠKATLI