natgillin/translations-raw huggingface dataset:
Following a single 400 mg oral dose of [14C]-sofosbuvir, mean total recovery of the dose was greater than 92%, consisting of approximately 80%, 14%, and 2.5% recovered in urine, faeces, and expired air, respectively. 
Po enkratnem 400-miligramskem peroralnem odmerku [14C]-sofosbuvirja je bil povprečni skupni delež odmerka, ki so ga izolirali, višji kot 92 %, pri čemer ga je bilo 80 % izoliranega v urinu, 14 % v blatu in 2,5 % v izdihanemu zraku.
The safety of tenofovir disoproxil fumarate in the setting of Harvoni and a pharmacokinetic enhancer has not been established. 
Varnost dizoproksiltenofovirata fumarata z zdravilom Harvoni in farmakokinetičnim ojačevalcem ni bila dokazana.
Contains lactose and sunset yellow FCF aluminium lake (E110). 
Vsebuje laktozo in barvilo sončno rumeno FCF (E110).
Women of childbearing potential / contraception in males and females When Harvoni is used in combination with ribavirin, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. 
Pri uporabi zdravila Harvoni v kombinaciji z ribavirinom je potrebna izjemna previdnost, da se prepreči nosečnost bolnic in partnerk bolnikov.
For hepatitis C virus (HCV) genotype-specific activity see sections 4.4 and 5.1. 
Za aktivnost, specifično za genotip virusa hepatitisa C (HCV), glejte poglavji 4.4 in 5.1. 4.2 Odmerjanje in način uporabe
Safety data are limited in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) and ESRD requiring haemodialysis. 
Podatki o varnosti so omejeni pri bolnikih s hudo ledvično okvaro (ocenjena stopnja glomerulne filtracije [eGFR] < 30 ml/min/1,73 m2) in ESRD, pri katerih je potrebna hemodializa.
Sofosbuvir had no effects on embryo-foetal viability or on fertility in rat and was not teratogenic in rat and rabbit development studies. 
Sofosbuvir pri podganah ni vplival na sposobnost preživetja zarodka ali ploda ali na sposobnost razmnoževanja in v študijah razvoja pri podganah in kuncih ni bil teratogen.
Table 11: Demographics and baseline characteristics in study ION-1 Patient disposition 
Preglednica 11: Demografske in izhodiščne značilnosti za študijo ION-1 Dispozicija bolnika
Use with HMG-CoA reductase inhibitors 
Uporaba z zaviralci reduktaze HMG-CoA
Harvoni contains sunset yellow FCF aluminium lake (E110) which can cause allergic reactions 
Zdravilo Harvoni vsebuje barvilo sončno rumeno FCF (E110), ki lahko povzroči alergijske reakcije
Patients with cirrhosis 
Bolniki s cirozo
• outer cartons containing 3 bottles of 28 (84) film-coated tablets. 
• škatle, ki vsebujejo 3 plastenke z 28 (84) filmsko obloženimi tabletami.
Table 8: Demographics and baseline characteristics in study ION-3 Patient disposition 
Preglednica 8: Demografske in izhodiščne značilnosti za študijo ION-3 Dispozicija bolnika
Medicinal products that are moderate P-gp inducers in the intestine (e.g. oxcarbazepine) may decrease ledipasvir and sofosbuvir plasma concentrations leading to reduced therapeutic effect of Harvoni. 
Zdravila, ki so zmerni induktorji P-gp v črevesju (npr. okskarbazepin), lahko zmanjšajo koncentracije ledipasvirja in sofosbuvirja v plazmi, kar zmanjša terapevtski učinek zdravila Harvoni.
Name and address of the manufacturer(s) responsible for batch release 
Ime in naslov proizvajalca (proizvajalcev), odgovornega (odgovornih) za sproščanje serij Gilead Sciences Ireland UC
What you need to know before you take Harvoni Do not take Harvoni 
Kaj morate vedeti, preden boste vzeli zdravilo Harvoni Kako jemati zdravilo Harvoni
The three Phase 3 studies included one study conducted in non-cirrhotic treatment-naïve patients (ION-3); one study in cirrhotic and non-cirrhotic treatment-naïve patients (ION-1); and one study in cirrhotic and non-cirrhotic patients who failed prior therapy with an interferon-based regimen, including regimens containing an 
Tri študije 3. faze so vključevale eno študijo, opravljeno pri predhodno nezdravljenih bolnikih brez ciroze (ION-3), eno študijo, opravljeno pri predhodno nezdravljenih bolnikih s cirozo in brez ciroze (ION-1) in eno študijo,
The efficacy of ledipasvir/sofosbuvir in genotype 5 and genotype 6 HCV-infected patients with decompensated cirrhosis and/or who are awaiting liver transplant or post-liver transplant has not been investigated. 
Učinkovitosti ledipasvirja/sofosbuvirja pri bolnikih, okuženih s HCV genotipa 5 in genotipa 6 z dekompenzirano cirozo, in/ali pri bolnikih, ki čakajo na presaditev jeter ali bolnikih po presaditvi jeter,
NS5A transient replicons Median (range)a 
Stabilni replikoni prehodni replikoni NS5A mediana (razpon)a
Adults with decompensated cirrhosis and/or who are awaiting liver transplant or post-liver transplant 
Odrasli z dekompenzirano cirozo in/ali bolniki, ki čakajo na presaditev jeter ali bolniki po presaditvi jeter
Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. 
Pri vseh živalskih vrstah, izpostavljenih ribavirinu, so dokazali pomembne teratogene in/ali embriocidne okvare.
The safety and efficacy of Harvoni in adolescents aged 12 to < 18 years is based on data from a Phase 2, open-label clinical study (Study 1116) that enrolled 100 patients with genotype 1 HCV infection who were treated with ledipasvir/sofosbuvir for 12 weeks. 
Varnost in učinkovitost zdravila Harvoni pri mladostnikih, starih od 12 do < 18 let, temelji na podatkih iz odprte klinične študije faze 2 (študija 1116), v katero je bilo vključenih 100 bolnikov z okužbo s HCV genotipa 1, ki so bili 12 tednov zdravljeni z ledipasvirjem/sofosbuvirjem.
Ledipasvir (90 mg once daily) 
Ledipasvir (90 mg enkrat na dan)
Harvoni + ribavirinA for 12 weeks (see section 5.1). 
Zdravilo Harvoni + ribavirinA 12 tednov (glejte poglavje 5.1).
Within each group, patients were randomized in a 1:1 ratio to receive ledipasvir/sofosbuvir + ribavirin for 12 or 24 weeks. 
Znotraj vsake skupine so bolnike randomizirali v razmerju 1 : 1 za prejemanje ledipasvirja/sofosbuvirja +
Once ribavirin has been withheld due to either a laboratory abnormality or clinical manifestation, an attempt may be made to restart ribavirin at 600 mg daily and further increase the dose to 800 mg daily. 
Če je bila uporaba ribavirina prekinjena zaradi nenormalnih laboratorijskih vrednosti ali klinične manifestacije, se lahko znova poskusi dajanje ribavirina v odmerku 600 mg na dan, nato pa se odmerek poveča na 800 mg na dan, vendar pa se povečanje odmerka ribavirina na prvotno določen odmerek ne priporoča (1.000 mg do 1.200 mg na dan).
Otherc 
Drugoc
Study 0154 was an open-label clinical study that evaluated the safety and efficacy of 12 weeks of treatment with ledipasvir/sofosbuvir in 18 genotype 1 HCV-infected patients with severe renal impairment not requiring dialysis. 
Študija 0154 je bila odprta klinična študija, v kateri so ocenjevali varnost in učinkovitost 12-tedenskega zdravljenja z ledipasvirjem/sofosbuvirjem pri 18 bolnikih, okuženih s HCV genotipa 1 s hudo ledvično okvaro, ki niso potrebovali dialize.
Table 6: Adverse drug reactions identified with Harvoni Frequency 
Preglednica 6: Neželeni učinki zdravila, identificirani pri zdravljenju z zdravilom Harvoni Pogostnost
IL28 genotype 
IL28 genotip CC
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of ledipasvir, sofosbuvir or Harvoni in pregnant women. 
Podatkov o uporabi ledipasvirja, sofosbuvirja ali zdravila Harvoni pri nosečnicah ni oziroma so omejeni (manj kot 300 izpostavljenih nosečnosti).
Proton pump inhibitors should not be taken before Harvoni. 
Zaviralcev protonske črpalke se ne sme uporabljati pred zdravilom Harvoni.
Body weight kg 
Telesna masa (kg)
Table 2: Guidance for ribavirin dosing when administered with Harvoni to patients with decompensated cirrhosis 
Preglednica 2: Navodila za odmerjanje ribavirina ob sočasnem dajanju zdravila Harvoni pri bolnikih z dekompenzirano cirozo
Potential for Harvoni to affect other medicinal products Ledipasvir is an in vitro inhibitor of drug transporter P-gp and breast cancer resistance protein (BCRP) and may increase intestinal absorption of co-administered substrates for these transporters. 
Ledipasvir je in vitro zaviralec prenašalca P-gp in proteina rezistence pri raku dojke (BCRP-breast cancer resistance protein) in lahko poveča absorpcijo sočasno uporabljenih substratov za te prenašalce v črevesju.
Following a single 90 mg oral dose of [14C]-ledipasvir, mean total recovery of the [14C]-radioactivity in faeces and urine was 87%, with most of the radioactive dose recovered from faeces (86%). 
Po enkratnem 90-miligramskem peroralnem odmerku [14C]-ledipasvirja je bil povprečni skupni delež [14C]-radioaktivnosti, ki so jo izolirali v blatu in urinu, 87 %, pri čemer so večino radioaktivnega odmerka izolirali v blatu (86 %).
Cases of severe bradycardia and heart block have been observed when Harvoni is used with amiodarone and/or other drugs that lower heart rate (see sections 4.4 and 4.5). 
Pri uporabi zdravila Harvoni z amiodaronom in/ali drugimi zdravili, ki upočasnjujejo srčni utrip, so opazili primere hude bradikardije in srčnega bloka (glejte poglavji 4.4 in 4.5).
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. 
Razlaga ni mogoča a. En bolnik v skupini 24-tedenskega zdravljenja z LDV/SOF in en bolnik v skupini 24-tedenskega zdravljenja z LDV/SOF+RBV sta doživela predhodni neuspeh zdravljenja z režimom zdravljenja na podlagi nepegiliranega interferona.
The safety of tenofovir disoproxil fumarate in the setting of Harvoni and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established. 
Varnost dizoproksiltenofovirata fumarata z zdravilom Harvoni in farmakokinetičnim ojačevalcem (npr. ritonavirjem ali kobicistatom) ni bila dokazana.
Co-administration with rosuvastatin (see section 4.5). 
Sočasno dajanje z rosuvastatinom (glejte poglavje 4.5).
The efficacy of ledipasvir/sofosbuvir in HCV infected adolescents aged 12 to < 18 years was evaluated in a Phase 2, open label clinical study that enrolled 100 patients with genotype 1 CHC (Study 1116). 
Pediatrična populacija Učinkovitost ledipasvirja/sofosbuvirja pri mladostnikih, okuženih s HCV, starih od 12 do < 18 let, je bila ovrednotena v odprti klinični študiji faze 2, v katero je bilo vključenih 100 bolnikov z okužbo s CHC genotipa 1 (študija 1116).
Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis (including decompensated cirrhosis) had no clinically relevant effect on the exposure to sofosbuvir and GS-331007. 
Analiza populacijske farmakokinetike pri bolnikih, okuženih s HCV, je pokazala, da ciroza (vključno z dekompenzirano cirozo) ni imela klinično pomembnega učinka na izpostavljenost sofosbuvirju in GS-331007.
Randomisation was stratified by the presence or absence of cirrhosis, HCV genotype (1a versus 1b) and response to prior HCV therapy (relapse/breakthrough versus non-response). 
Randomizacija je bila stratificirana glede na prisotnost ali odsotnost ciroze in genotip HCV (1a v primerjavi z 1b) in odziv na predhodno zdravljenje HCV (relaps/izbruh bolezni v primerjavi z neodzivom).
There are presently no data to support the effectiveness of retreatment of patients who have failed ledipasvir/sofosbuvir with a subsequent regimen that contains an NS5A inhibitor. 
Trenutno ni na voljo podatkov, ki bi podprli učinkovitost ponovnega zdravljenja z naknadnim režimom, ki vključuje zaviralca NS5A, pri bolnikih, pri katerih zdravljenje z ledipasvirjem/sofosbuvirjem ni bilo uspešno.
Of the 7 patients who failed to achieve SVR12, 3 relapsed, all had decompensated cirrhosis and were treated with ledipasvir/sofosbuvir + ribavirin for 12 weeks. 
Od 7 bolnikov, ki niso dosegli SVR12, so 3 doživeli relaps, vsi so imeli dekompenzirano cirozo in so z ledipasvirjem/sofosbuvirjem + ribavirinom bili zdravljeni
A Adults: weight based ribavirin (< 75 kg = 1,000 mg and ≥ 75 kg = 1,200 mg), administered orally in two divided doses with food. 
A Odrasli: ribavirin na osnovi telesne mase (< 75 kg = 1.000 mg in ≥ 75 kg = 1.200 mg), dan peroralno skupaj s hrano,
At the no observed effect level, AUC exposure to ledipasvir was approximately 7- and 3-fold, in males and females, respectively, the human exposure at the recommended clinical dose. 
Na ravni brez vidnega neželenega učinka je bila vrednost AUC izpostavljenosti ledipasvirju pri samcih približno 7-krat in pri samicah približno 3-krat višja od izpostavljenosti pri človeku pri priporočenem kliničnem odmerku.
In study ION-4, 13 HCV/HIV-1 co-infected patients with genotype 1, including 1 cirrhotic patient, who had failed a sofosbuvir + ribavirin regimen were enrolled; the SVR was 100% (13/13) after 12 weeks of treatment with ledipasvir/sofosbuvir. 
V študijo ION-4 so vključili 13 bolnikov s sočasnima okužbama HCV/HIV-1 genotipa 1, vključno z 1 bolnikom s cirozo, pri katerih režim s sofobuvirjem + ribavirinom ni bil uspešen; po 12 tednih zdravljenja z ledipasvirjem/sofobuvirjem je bil SVR 100 % (13/13).
No dose adjustment of Harvoni or atazanavir (ritonavir boosted) is required. 
Odmerka zdravila Harvoni ali atazanavirja (okrepljenega z ritonavirjem) ni treba prilagajati.
Male gender 
Moški spol
- 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. 
- O 12 tednih (pri bolnikih brez ciroze) ali 24 tednih (pri bolnikih s cirozo) zdravila Harvoni (brez ribavirina) je možno razmisliti pri bolnikih, pri katerih zdravljenje z ribavirinom ni primerno ali ga ne prenašajo.
H2-receptor antagonists may be administered simultaneously with or staggered from Harvoni at a dose that does not exceed doses comparable to famotidine 40 mg twice daily. 
Antagoniste receptorjev H2 se lahko uporablja sočasno z zdravilom Harvoni ali ločeno v odmerku, ki ne presega odmerkov,
Observed: 
Opažene:
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). 
Farmakokinetiko ledipasvirja so proučili z enkratnim 90-miligramskim odmerkom ledipasvirja pri bolnikih, negativnih za HCV, s hudo jetrno okvaro (stopnja C po CPT).
No clinically relevant pharmacokinetic differences due to race have been identified for ledipasvir, sofosbuvir or GS-331007. 
Klinično pomembnih farmakokinetičnih razlik zaradi rase za ledipasvir, sofosbuvir ali GS-331007 niso ugotovili.
therapy without cirrhosis, 26% (13/50) of patients were HIV antiretroviral naïve and 74% (37/50) of patients were receiving concomitant HIV antiretroviral therapy. 
Noben bolnik se predhodno ni zdravil zaradi HCV in noben ni imel ciroze, 26 % (13/50) bolnikov se predhodno ni zdravilo s protiretrovirusno terapijo proti HIV in 74 % (37/50) bolnikov je prejemalo sočasno protiretrovirusno terapijo proti HIV.
No clinically relevant pharmacokinetic differences due to gender have been identified for sofosbuvir or GS-331007. 
Klinično pomembnih farmakokinetičnih razlik zaradi spola za sofosbuvir in GS-331007 niso ugotovili.
If overdose occurs the patient must be monitored for evidence of toxicity. 
Pri bolnikih, ki so prejeli prevelik odmerek, je treba spremljati znake toksičnosti.
Decreases in haemoglobin to < 10 g/dL and < 8.5 g/dL during treatment were experienced by 39% and 13% of patients treated with ledipasvir/sofosbuvir with ribavirin, respectively. 
Zmanjšanje ravni hemoglobina na < 10 g/dl in < 8,5 g/dl med zdravljenjem so opazili pri 39 %
The concomitant use of amiodarone was limited through the clinical development of sofosbuvir. 
Med kliničnim razvojem sofosbuvirja je bila sočasna uporaba amiodarona omejena.
Sofosbuvir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo mouse micronucleus assays. 
Sofosbuvir v nizu raziskav in vitro ali in vivo ni bil genotoksičen, vključno z bakterijskim testom mutagenosti, testom kromosomske aberacije z uporabo limfocitov humane periferne krvi in in vivo v testu mikronukleusa pri miših.
Your doctor may need to give you a different medicine or adjust the dose of medicine you are taking. 
Vaš zdravnik vam bo morda moral predpisati drugo zdravilo ali prilagoditi odmerek zdravila, ki ga uporabljate.
Dose modification of ribavirin in adults taking 1,000-1,200 mg daily If Harvoni is used in combination with ribavirin and a patient has a serious adverse reaction potentially related to ribavirin, the ribavirin dose should be modified or discontinued, if appropriate, until the adverse reaction abates or decreases in severity. 
Če se zdravilo Harvoni uporablja v kombinaciji z ribavirinom in ima bolnik resne neželene učinke, ki so morebiti povezani z ribavirinom, je treba odmerek ribavirina prilagoditi ali ukiniti, kakor je ustrezno, dokler ni neželeni učinek odpravljen ali postane manj resen.
Ledipasvir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo rat micronucleus assays. 
Ledipasvir v nizu raziskav in vitro ali in vivo ni bil genotoksičen, vključno z bakterijskim testom mutagenosti, testom kromosomske aberacije z uporabo limfocitov humane periferne krvi in in vivo v testu mikronukleusa pri podganah.
These should be taken at the same time as Harvoni. 
Te je treba vzeti sočasno z zdravilom Harvoni.
Harvoni 90 mg/400 mg film-coated tablets 
IME ZDRAVILA Harvoni 90 mg/400 mg filmsko obložene tablete
Previously treated adults who have failed on sofosbuvir + ribavirin ± PEG-IFN The efficacy of ledipasvir/sofosbuvir in patients who had previously failed treatment with sofosbuvir + ribavirin ± PEG-IFN is supported by two clinical studies. 
Učinkovitost ledipasvirja/sofobuvirja pri bolnikih, pri katerih je bilo predhodno zdravljenje s sofobuvirjem + ribavirinom ± PEG-IFN neuspešno, so podprli z dvema kliničnima študijama.
Some medicines should not be taken with Harvoni. 
Nekaterih zdravil ne smete uporabljati sočasno z zdravilom Harvoni.
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. 
V študiji ION-3 so ocenjevali 8-tedensko zdravljenje z ledipasvirjem/sofosbuvirjem z ribavirinom ali brez njega in 12-tedensko zdravljenje z ledipasvirjem/sofosbuvirjem pri predhodno nezdravljenih bolnikih brez ciroze s CHC genotipa 1.
• carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures); • rosuvastatin (a medicine used to treat high cholesterol). 
• karbamazepin, fenobarbital in fenitoin (zdravila, ki se uporabljajo za zdravljenje epilepsije in preprečevanje epileptičnih napadov).
CPT Bc 
CPT Ac CPT Bc CPT Cc FCH
The sofosbuvir resistance-associated substitution S282T in NS5B was not detected in any virologic failure isolate from the Phase 3 studies. 
Substitucije S282T v polimerazi NS5B, povezane z odpornostjo na sofosbuvir, niso odkrili v nobenem od izolatov virološkega neuspeha v študijah 3. faze.
Among patients with decompensated liver disease (pre- and posttransplant), 4/16 (25%) patients with NS5A RAVs conferring > 100-fold resistance relapsed after 12 weeks treatment with ledipasvir/sofosbuvir + ribavirin compared to 7/120 (6%) in those without any baseline NS5A RAVs or RAVs conferring a fold-change of ≤ 100. 
Med bolniki z dekompenzirano jetrno boleznijo (pred presaditvijo in po njej) so 4 od 16 bolnikov (25 %) z RAV NS5A, ki so doprinesle k > 100-kratni spremembi dovzetnosti, po 12 tednih zdravljenja z ledipasvirjem/sofosbuvirjem + ribavirinom doživeli relaps v primerjavi s 7/120 bolnikov (6 %) brez izhodiščnih RAV NS5A ali RAV, ki so doprinesle k ≤ 100
Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents. 
Sočasna okužba z virusom HCV in virusom HBV (virus hepatitisa B) Med zdravljenjem ali po zdravljenju z zdravili z direktnim delovanjem na viruse so poročali o reaktivaciji virusa hepatitisa B (HBV), nekateri primeri so bili smrtni.
Safety data are limited in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) and end stage renal disease (ESRD) requiring dialysis. 
Podatki o varnosti so omejeni pri bolnikih s hudo ledvično okvaro (ocenjena stopnja glomerulne filtracije [eGFR-estimated glomerular filtration rate] < 30 ml/min/1,73 m2) in pri bolnikih z boleznijo ledvic v končni fazi (ESRD-end stage renal disease), zaradi katere je potrebna dializa.
White 
Belci
Study 0122 (ELECTRON-2) 6 25 0% (0/25) 
Študija 0122 (ELECTRON-2) 6 25 0 % (0/25) a. PZ: število predhodno zdravljenih bolnikov.
Ask your doctor for effective contraceptive method suitable for you. 
O načinu kontracepcije, ki je za vas najprimernejši, se posvetujte z zdravnikom.
• Get advice from a doctor or pharmacist if you take medicines used to treat stomach ulcers, heartburn or acid reflux. 
• Če jemljete zdravila, ki se uporabljajo za zdravljenje želodčnih razjed, zgage ali refluksa kisline, se posvetujte z zdravnikom ali farmacevtom.
12 weeks (n = 109) 
12 tednov (n = 109)
For the same treatment arm, patients with baseline NS5A RAVs conferring a fold-change of > 100, relapse occurred in 4/13 (31%), as compared to 3/95 (3%) in those without any baseline RAVs or RAVs conferring a fold-change of ≤ 100. 
V isti skupini se je pri bolnikih z izhodiščnimi RAV NS5A, ki so doprinesle k > 100-krat spremembi dovzetnosti, relaps pojavil pri 4 od 13 (31 %), v primerjavi s 3 od 95 (3 %) pri tistih brez izhodiščnih RAV ali RAV, ki so doprinesle k ≤ 100-kratni spremembi dovzetnosti.
Steady-state Cmax for ledipasvir, sofosbuvir and GS-331007 were 323, 618 and 707 ng/mL, respectively. 
Vrednosti Cmax v stanju dinamičnega ravnovesja za ledipasvir, sofosbuvir oz. GS-331007 so bile 323, 618 oz.
Harvoni contains the azo colouring agent sunset yellow FCF aluminium lake (E110), which may cause allergic reactions. 
Zdravilo Harvoni vsebuje azobarvilo sončno rumeno FCF (E110), ki lahko povzroči alergijske reakcije.
Cardiac arrhythmias 
Srčne aritmije
CPT Class C cirrhosis pre-transplant CPT Class B or C cirrhosis posttransplant 
Pred presaditvijo CPT B CPT C Po presaditvi
Median peak plasma concentration of GS-331007 was observed at 4 hours post-dose. 
GS-331007 v plazmi so opazili 4 ure po odmerku.
The group of NS5A RAVs that conferred > 100-fold shift and was observed in patients were the following substitutions in genotype 1a (M28A, Q30H/R/E, L31M/V/I, H58D, Y93H/N/C) or in genotype 1b (Y93H). 
Skupino RAV NS5A, ki je doprinesla k > 100-kratnemu premiku, in so jo opazili pri bolnikih, so bile naslednje substitucije v genotipu 1a (M28A, Q30H/R/E, L31M/V/I, H58D, Y93H/N/C) ali genotipu 1b (Y93H).
Following 12 weeks of treatment with ledipasvir/sofosbuvir with ribavirin in treatment-experienced patients with compensated cirrhosis (SIRIUS, n = 77), 8/8 patients with baseline NS5A RAVs conferring > 100-fold reduced susceptibility to ledipasvir achieved SVR12. 
Po 12 tednih zdravljenja z ledipasvirjem/sofosbuvirjem z ribavirinom pri predhodno zdravljenih bolnikih s kompenzirano cirozo (SIRIUS, n = 77) je 8/8 bolnikov z izhodiščnimi RAV NS5A, ki so doprinesle k > 100-kratni zmanjšani dovzetnosti za ledipasvir, doseglo SVR12.
SVR Outcome for patients without SVR On-treatment virologic failure 
Izid za bolnike brez SVR
Atazanavir concentrations are also increased, with a risk for an increase in bilirubin levels/icterus. 
obstaja tveganje za zvišanje ravni bilirubina/ikterusa.
• fainting 
• omedlevico
The median age was 56 years (range: 23 to 77); 74% of patients were male; 97% were white; 63% had genotype 1a HCV infection; 94% had non-CC IL28B alleles (CT or TT). 
Mediana starosti je bila 56 let (razpon: od 23 do 77); 74 % bolnikov je bilo moškega spola; 97 % jih je bilo belcev; 63 % jih je imelo okužbo HCV genotipa 1a; 94 % jih je imelo alele IL28B ne-CC (CT ali TT).