natgillin/translations-raw huggingface dataset:
That risk is even higher if ribavirin is used as part of the HCV treatment. 
To tveganje je še večje, če se kot del HCV zdravljenja
• Do not take any other medicine that contains sofosbuvir, one of the active substances in Harvoni. 
• Ne jemljite nobenih drugih zdravil, ki vsebujejo sofosbuvir, ki je ena od zdravilnih učinkovin v zdravilu Harvoni.
Metavir score F0-F3 96% (53/55) CPT A 
Rezultat Metavir F0-F3 96 % (53/55) CPT Ab
Harvoni is not recommended for use in children and adolescents under 18 years of age because the safety and efficacy have not been established in this population. 
Uporaba zdravila Harvonise ne priporoča pri otrocih in mladostnikih, starih manj kot 18 let, saj varnost in učinkovitost pri tej populaciji nista bili dokazani.
HCV RNA < 6 million IU/mL HCV RNA ≥ 6 million IU/mL 
HCV RNA < 6 milijonov i.e./ml HCV RNA ≥ 6 milijonov i.e./ml
Genotype 2, 3, 4, 5 and 6 
Genotip 2, 3, 4, 5 in 6
Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare 
Neželeni učinki so po pogostnosti opredeljeni kot sledi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000) ali zelo redki (< 1/10.000).
Harvoni (administered alone or in combination with ribavirin) has no or negligible influence on the ability to drive and use machines. 
Zdravilo Harvoni (uporabljeno samo ali v kombinaciji z ribavirinom) nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
a. Mean ratio (90% CI) of co-administered drug pharmacokinetics of study medicinal products alone or in combination. 
a. Povprečno razmerje (90-odstotni IZ) farmakokinetike s sočasno uporabljenimi študijskimi zdravili posamezno ali v kombinaciji.
d. 3/3 of these patients had cirrhosis. 
d. 3 od teh 3 bolnikov so imeli cirozo.
Patients awaiting liver transplantation and post-liver transplant - SOLAR-1 
Bolniki, ki čakajo na presaditev jeter in bolniki po presaditvi jeter - SOLAR-1
If the starting dose is not well-tolerated, the dose should be reduced as clinically indicated based on haemoglobin levels. 
Če bolnik začetnega odmerka ne prenaša dobro, je treba odmerek zmanjšati, kot je klinično indicirano, na podlagi vrednosti hemoglobina.
a. TE: number of treatment-experienced patients. 
a. PZ: število predhodno zdravljenih bolnikov.
MARKETING AUTHORISATION NUMBER(S) EU/1/14/958/001 28 film-coated tablets EU/1/14/958/002 84 (3 bottles of 28) film-coated tablets 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/958/001 28 filmsko obloženih tablet EU/1/14/958/002 84 (3 plastenke po 28) filmsko obloženih tablet
The safety and efficacy of sofosbuvir have not been established in patients with severe renal impairment or ESRD. 
Varnosti in učinkovitost sofosbuvirja niso ocenili pri bolnikih s hudo ledvično okvaro ali ESRD.
Age (years): median (range) Male gender 
Starost (v letih): mediana (razpon) Moški spol
INFORMATION IN BRAILLE Harvoni [Outer packaging only] 
PODATKI V BRAILLOVI PISAVI Harvoni [samo zunanja ovojnina]
(Inhibition of drug transporters OATP and BCRP) 
(zaviranje prenašalcev OATP in BCRP)
Atazanavir concentrations are also increased, with a risk for an increase in bilirubin levels/icterus. 
Povišane so tudi koncentracije atazanavirja, obstaja tveganje za zvišanje ravni bilirubina/ikterusa.
What Harvoni is and what it is used for What you need to know before you take Harvoni How to take Harvoni 
Kaj je zdravilo Harvoni in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Harvoni Kako jemati zdravilo Harvoni
The European Medicines Agency has deferred the obligation to submit the results of studies with ledipasvir/sofosbuvir in one or more subsets of the paediatric population in the treatment of chronic hepatitis C (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z ledipasvirjem/sofosbuvirjem za eno ali več podskupin pediatrične populacije za zdravljenje kroničnega hepatitisa C (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Each film-coated tablet contains 156.8 mg of lactose (as monohydrate) and 261 micrograms of sunset yellow FCF aluminium lake. 
Ena filmsko obložena tableta vsebuje 156,8 mg laktoze (v obliki monohidrata) in 261 mikrogramov barvila sončno rumeno FCF aluminium lake.
Warnings and precautions Your doctor will know if any of the following conditions apply to you. 
Zdravnik bo vedel, če se katero koli od naslednjih stanj nanaša na vas.
Mean ratio (90% confidence interval) for AUC, Cmax, Cmin a, b 
(90-odstotni interval zaupanja) za AUC, Cmax,
Pharmacotherapeutic group: Direct-acting antiviral, ATC code: J05AX65 
Farmakoterapevtska skupina: zdravilo z direktnim delovanjem na viruse; oznaka ATC: J05AX65 Mehanizem delovanja
• rosuvastatin (a medicine used to treat high cholesterol). 
• rosuvastatin (zdravilo, ki se uporablja za zdravljenje visokih ravni holesterola).
Cimetidine e 
Cimetidine Nizatidin e
Age (years): median (range) 
Starost (v letih): mediana (razpon)
Famotidine dosed 12 hours prior to Harvonid 
Famotidin uporabljen 12 ur pred zdravilom Harvoni d
The presence of 40% human serum had no effect on the anti-HCV activity of sofosbuvir but reduced the anti-HCV activity of ledipasvir by 12-fold against genotype 1a HCV replicons. 
40 % humanega seruma ni vplivala na aktivnost sofosbuvirja proti HCV, je pa aktivnost ledipasvirja proti HCV zmanjšala za 12-krat proti replikonom HCV genotipa 1a.
The safety and efficacy of Harvoni in children and adolescents aged less than 18 years have not yet been established. 
Varnost in učinkovitost zdravila Harvoni pri otrocih in mladostnikih, starih manj kot 18 let, še nista bili dokazani.
No clinically relevant differences in ledipasvir pharmacokinetics were observed between healthy subjects and patients with severe renal impairment. 
Klinično pomembnih razlik v farmakokinetiki ledipasvirja med zdravimi osebami in bolniki s hudo ledvično okvaro niso opazili.
Harvoni is a medicine that contains the active substances ledipasvir and sofosbuvir in a single tablet. 
Zdravilo Harvoni je zdravilo, ki vsebuje zdravilni učinkovini ledipasvir in sofosbuvir v eni sami tableti.
Seven patient populations are being evaluated (patients with decompensated cirrhosis [CPT B and C] pre-transplant; post-transplant, no cirrhosis; post-transplant CPT A; post-transplant CPT B; post-transplant CPT C; post-transplant fibrosing cholestatic hepatitis [FCH]). 
Ocenjuje se sedem populacij bolnikov (bolniki z dekompenzirano cirozo [CPT B in C] pred presaditvijo; po presaditvi, brez ciroze; CPT A po presaditvi; CPT B po presaditvi; CPT C po presaditvi; fibrozni holestatski hepatitis po presaditvi [FCH]).
Harvoni + ribavirin for 12 weeks or 
Zdravilo Harvoni + ribavirin 12 tednov ali
• statins used to treat high cholesterol. 
• statini, ki se uporabljajo za zdravljenje visoke ravni holesterola.
The efficacy of Harvoni (ledipasvir [LDV]/sofosbuvir [SOF]) was evaluated in three open-label Phase 3 studies with data available for a total of 1,950 patients with genotype 1 CHC. 
Učinkovitost zdravila Harvoni (ledipasvir [LDV]/sofosbuvir [SOF]) so ocenili v treh odprtih študijah 3. faze, pri čemer so podatki na voljo za skupaj 1.950 bolnikov s CHC genotipa 1.
In order to evaluate the recurrence of hepatocellular carcinoma associated with Harvoni, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol. 
Da bi lahko ugotovili ponovitev hepatocelularnega karcinoma, povezanega z zdravilom Harvoni, mora imetnik dovoljenja za promet z zdravilom izvesti in predložiti rezultate prospektivne študije varnosti s podatki, ugotovljenimi v kohortah natančno določenih skupin bolnikov, dogovorjenih v protokolu.
- Harvoni for 8 weeks may be considered in previously untreated genotype 1-infected patients (see section 5.1, ION-3 study). 
- O 8 tednih zdravila Harvoni je možno razmisliti pri predhodno nezdravljenih bolnikih, okuženih z genotipom 1 (glejte poglavje 5.1, študija ION-3).
Although adverse events, including serious adverse events, occurred more frequently in this study compared to studies that excluded decompensated patients and/or patients who were post-liver transplantation, the adverse events observed were those expected as clinical sequelae of advanced liver disease and/or transplantation or were consistent with the known safety profile of ribavirin (see section 5.1 for details of this study). 
Čeprav so se neželeni učinki, vključno z resnimi neželenimi učinki, v teh študijah pojavili pogosteje kot v študijah, ki so izključile dekompenzirane bolnike in/ali bolnike po presaditvi jeter, so bili opaženi učinki pričakovani kot klinična posledica napredovale bolezni jeter in/ali presadtive ali pa so bili skladni z znanim profilom varnosti zdravljenja z ribavirinom (za podrobnosti te študije glejte poglavje 5.1).
Harvoni contains lactose monohydrate. 
Zdravilo Harvoni vsebuje laktozo monohidrat.
The use of Harvoni in children and adolescents has not yet been studied. 
Uporabe zdravila Harvoni pri otrocih in mladostnikih niso preučili.
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. 
Ženske v rodni dobi/kontracepcija pri moških in ženskah Pri uporabi zdravila Harvoni v kombinaciji z ribavirinom je potrebna izjemna previdnost, da se prepreči nosečnost bolnic in partnerk bolnikov.
In clinical studies - Genotype 2, 3, 4, 5 and 6 
V kliničnih študijah - genotip 2, 3, 4, 5 in 6
a. Six patients (1 in the 12-week, 5 in the 24-week treatment group) with HCV RNA < LLOQ at last measurement prior to transplant, were transplanted prior to SVR12 and were excluded from SVR12 and relapse analyses. 
a. Pri šestih bolnikih (1 v 12-tedenski, 5 v 24-tedenski skupini zdravljenja) z vrednostjo RNA HCV < LLOQ ob zadnjem merjenju pred presaditvijo so opravili presaditev pred SVR12 in so jih izključili iz analiz SVR12 ter relapsa.
Sofosbuvir is approximately 61-65% bound to human plasma proteins and the binding is independent of drug concentration over the range of 1 μg/mL to 20 μg/mL. 
Vezava sofosbuvirja na humane beljakovine v plazmi je približno 61- do 65-odstotna, ni pa odvisna od koncentracije zdravila v razponu od 1 μg/ml do 20 μg/ml.
• tenofovir disoproxil fumarate or any medicine containing tenofovir disoproxil fumarate, used to treat HIV infection; 
• dizoproksiltenofovirat fumarat ali katero koli zdravilo, ki vsebuje dizoproksiltenofovirat fumarat, ki se uporablja za zdravljenje okužbe s HIV,
SVR rates for selected subgroups Genotype Genotype 1a Genotype 1b Cirrhosis No c c 
Stopnje SVR za izbrane podskupine Genotip Genotip 1a Genotip 1b Ciroza Ne
f. One patient who achieved a viral load < LLOQ at end of treatment had missing baseline NS5A data and was excluded from the analysis. 
f. En bolnik, ki je dosegel virusno obremenitev < LLOQ ob koncu zdravljenja, ni imel izhodiščnih podatkov za NS5A in je bil iz analize izključen.
• kidney problems, since Harvoni has not been fully tested in patients with severe kidney problems; 
• težave z ledvicami, saj učinkov zdravila Harvoni pri bolnikih s hudimi težavami z ledvicami niso v celoti preučili;
ANTICONVULSANTS Carbamazepine Phenobarbital Phenytoin 
ANTIKONVULZANTI Karbamazepin Fenobarbital Fenitoin
Clinical efficacy and safety in genotype 2, 3, 4, 5 and 6 (see also section 4.4) Ledipasvir/sofosbuvir has been evaluated for the treatment of non-genotype 1 infection in small Phase 2 studies, as summarised below. 
Klinična učinkovitost in varnost pri genotipu 2, 3, 4, 5 in 6 (glejte tudi poglavje 4.4) Ledipasvir/sofosbuvir so ovrednotili za zdravljenje okužb, razen z genotipom 1, v majhnih študijah 2. faze, kot je povzeto spodaj.
The improvement in CPT scores observed was driven largely by improvements in total bilirubin and albumin. 
Izboljšanje rezultatov CPT je bilo večinoma posledica izboljšanja skupne ravni bilirubina in albumina.
HCV/HIV co-infected adults - ERADICATE 
Odrasli s sočasno okužbo HCV/HIV - ERADICATE
• Obligation to conduct post-authorisation measures 
Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet
Table 1: Recommended treatment duration for Harvoni and the recommended use of co-administered ribavirin for certain subgroups 
Preglednica 1: Priporočeno trajanje zdravljenja za zdravilo Harvoni in priporočena uporaba sočasno dajanega ribavirina za nekatere podskupine Populacija bolnikov*
In patients with decompensated cirrhosis, ribavirin should be administered at a starting dose of 600 mg given in a divided daily dose. 
Pri bolnikih z dekompenzirano cirozo je treba ribavirin dajati z začetnim odmerkom 600 mg v razdeljenih dnevnih odmerkih.
• Tell your doctor if you are lactose intolerant or intolerant to other sugars. 
• Povejte zdravniku, če ne prenašate laktoze ali katerega drugega sladkorja.
Serum HCV RNA values were measured during the clinical studies using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System. 
Vrednosti RNA HCV v serumu so izmerili med kliničnimi študijami s testom COBAS TaqMan za virus HCV (različica 2.0), za uporabo s sistemom
Unchanged ledipasvir excreted in faeces accounted for a mean of 70% of the administered dose and the oxidative metabolite M19 accounted for 2.2% of the dose. 
Nespremenjeni ledipasvir, ki se je izločil v blatu, je predstavljal povprečno 70 % uporabljenega odmerka, oksidativni presnovek M19 pa je predstavljal 2,2 %
It is not known whether ledipasvir or sofosbuvir, the two active substances of Harvoni, pass into human breast milk. 
Ni znano, ali ledipasvir ali sofosbuvir, dve zdravilni učinkovini v zdravilu Harvoni, prehajata v materino mleko.
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 »GSI« na eni in »7985« na drugi strani.
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. 
Možnost vpliva zdravila Harvoni na druga zdravila 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.
d. Metavir score = 4 or Ishak score ≥ 5 by liver biopsy, or FibroTest score of > 0.75 and (APRI) of > 2. 
d. Rezultat Metavir = 4 ali rezultat Ishak ≥ 5 s pomočjo biopsije jeter ali rezultat FibroTest > 0,75 in (APRI) > 2.
e. 0/4 of these patients had cirrhosis. 
e. 0 od teh 4 bolnikov ni imel ciroze.
If the starting dose is well-tolerated, the dose can be titrated up to a maximum of 1,000-1,200 mg daily (1,000 mg for patients weighing < 75 kg and 1,200 mg for patients weighing ≥ 75 kg). 
Če bolnik začetni odmerek dobro prenaša, ga je mogoče povečevati do največ 1.000-1.200 mg na dan (1.000 mg za bolnike s telesno maso < 75 kg in 1.200 mg za bolnike s telesno maso ≥ 75 kg).
If you are lactose intolerant, or if you have been told that you have an intolerance to other sugars, talk to your doctor before taking this medicine. 
Če ne prenašate laktoze ali če so vam povedali, da ne prenašate nekaterih sladkorjev, se posvetujte z zdravnikom, preden uporabite to zdravilo.
The EC50 values of ledipasvir and sofosbuvir against full-length or chimeric replicons encoding NS5A and NS5B sequences from clinical isolates are detailed in Table 5. 
Vrednosti EC50 za ledipasvir in sofosbuvir proti replikonom polne dolžine ali himeričnim replikonom, ki kodirajo zaporedje NS5A in NS5B iz kliničnih izolatov, so prikazane v preglednici 5.
• The active substances are ledipasvir and sofosbuvir. 
• Zdravilni učinkovini sta ledipasvir in sofosbuvir.
Patients with decompensated cirrhosis, irrespective of transplant status 
Bolniki z dekompenzirano cirozo ne glede na presaditev
In repeat dose toxicology studies in rat and dog, high doses of the 1:1 diastereomeric mixture caused adverse liver (dog) and heart (rat) effects and gastrointestinal reactions (dog). 
V študijah toksičnosti pri ponavljajočih odmerkih pri podganah in psih so veliki odmerki diastereomeričnih mešanic v razmerju 1:1 povzročili neželene učinke na jetra (psi) in srce (podgane)
In patients with ESRD, relative to patients with normal renal function, sofosbuvir AUC0-inf was 28% higher when sofosbuvir was dosed 1 hour before haemodialysis compared with 60% higher when sofosbuvir was dosed 1 hour after haemodialysis. 
Pri bolnikih z ESRD je bila v primerjavi z bolniki z normalnim delovanjem ledvic vrednost AUC0-inf sofosbuvirja za 28 % višja pri odmerjanju sofosbuvirja 1 uro pred hemodializo v primerjavi s 60 % višjo vrednostjo pri odmerjanju sofosbuvirja 1 uro po hemodializi.
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 % oziroma 13 % bolnikov, zdravljenih z ledipasvirjem/sofosbuvirjem z ribavirinom.
b. Non-missing FibroTest results are mapped to Metavir scores according to: 0-0.31 = F0-F1; 0.32-0.58 = F2; 0.59-1.00 = F3-F4. 
b. Nemanjkajoči rezultati FibroTest so kartirani v rezultate Metavir glede na: 0-0,31 = F0-F1; 0,32-0,58 = F2; 0,591,00 = F3-F4.
Table 5: Activity of ledipasvir and sofosbuvir against chimeric replicons Genotype replicons 
Preglednica 5: Aktivnost ledipasvirja in sofosbuvirja proti himeričnim replikonom
a. HCV RNA values were determined using the Roche TaqMan Assay; a patient's HCV RNA may vary from visit to visit. 
a. Vrednosti HCV RNA so bile ugotovljene s pomočjo testa Roche TaqMan; vrednost HCV RNA bolnika se lahko med obiski razlikuje.
Patients in the latter treatment arm received placebo (for ledipasvir/sofosbuvir and ribavirin) during the first 12 weeks, followed by active blinded therapy during the subsequent 12 weeks. 
Bolniki v slednji skupini zdravljenja so prejemali placebo (za ledipasvir/sofosbuvir in ribavirin) v prvih 12 tednih, potem pa slepo zdravljenje z zdravilno učinkovino v naslednjih 12 tednih.
Post-baseline NS5A and NS5B deep sequencing data (assay cut off of 1%) were available for 37/37 and 36/37 patients, respectively. 
Zaporedja NS5A in NS5B po izhodišču s podatki karakterizacije strukture genoma (deep sequencing) (mejna vrednost testa 1 %) so bila na voljo za 37 od 37 oz. 36 od 37 bolnikov.
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 + ribavirinom in je po ponovnem zdravljenju dosegel SVR.
↔ GS-331007 (Induction of P-gp) 
↔ GS-331007 (indukcija P-gp)
• Do not take any of these medicines with Harvoni: 
• Z zdravilom Harvoni ne jemljite nobenega od naslednjih zdravil:
The AUC0-inf of GS-331007 in patients with ESRD administered with sofosbuvir 1 hour before or 1 hour after haemodialysis was at least 10-fold and 20-fold higher, respectively. 
Vrednost AUC0-inf GS-331007 pri bolnikih z ESRD pri dajanju sofosbuvirja 1 uro pred hemodializo je bila vsaj 10-krat večja, 1 uro po hemodializi pa vsaj 20-krat večja.
Harvoni is indicated for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4 and 
Zdravilo Harvoni je indicirano za zdravljenje kroničnega hepatitisa C (CHC-chronic hepatitis C) pri odraslih (glejte poglavja 4.2, 4.4 in 5.1).
Sofosbuvir and GS-331007 are not inhibitors of drug transporters P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3, OCT1 and GS-331007 is not an inhibitor of OAT1, OCT2 and MATE1. 
Sofosbuvir in GS-331007 nista zaviralca prenašalcev P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3, OCT1 in GS-331007 ni zaviralec OAT1, OCT2 in MATE1.
Among patients with a baseline HCV RNA < 6 million IU/mL, the SVR was 97% (119/123) with 8-week treatment of ledipasvir/sofosbuvir and 96% (126/131) with 12-week treatment of ledipasvir/sofosbuvir. 
Med bolniki z ravnijo HCV RNA ob izhodišču < 6 millijonov i.e./ml je bil SVR 97 % (119/123) z 8-tedenskim zdravljenjem z ledipasvirjem/sofosbuvirjem in 96 % (126/131) z 12-tedenskim zdravljenjem z ledipasvirjem/sofosbuvirjem.
Use with potent P-gp inducers 
Uporaba z močnimi induktorji P-gp
What Harvoni looks like and contents of the pack The film-coated tablets are orange, diamond-shaped tablets debossed with “GSI” on one side and “7985” on the other side. 
Izgled zdravila Harvoni in vsebina pakiranja Filmsko obložene tablete so oranžne tablete v obliki romba, z vtisnjeno oznako »GSI« na eni in »7985« na drugi strani.
Of the remaining 154 patients, a total of 149 achieved SVR12 across both treatment groups; 96% (74/77) of patients in the ledipasvir/sofosbuvir with ribavirin 12-week group and 97% (75/77) of patients in the ledipasvir/sofosbuvir 24-week group. 
Od ostalih 154 bolnikov jih je skupno 149 doseglo SVR12 v obeh skupinah zdravljenja; 96 % (74/77) v skupini bolnikov z 12-tedenskim zdravljenjem z ledipasvirjem/sofosbuvirjem z ribavirinom in 97 % (75/77) v skupini bolnikov s 24-tedenskim zdravljenjem z ledipasvirjem/sofosbuvirjem.
Relative to healthy subjects (n = 191), ledipasvir AUC0-24 and Cmax were 24% lower and 32% lower, respectively, in HCV-infected patients. 
V primerjavi z zdravimi osebami (n = 191) sta bili vrednosti AUC0-24 in Cmax za ledipasvir pri bolnikih, okuženih s HCV, za 24 % oz. 32 % manjši.
Not interpretable a. One patient in the LDV/SOF 8-week treatment arm did not have a confirmed genotype 1 subtype. 
Razlaga ni mogoča a. En bolnik v skupini 8-tedenskega zdravljenja z LDV/SOF ni imel potrjenega podtipa genotipa 1.
A conservative 24 weeks of therapy is advised in all treatment-experienced genotype 3 patients and those treatment-naïve genotype 3 patients with cirrhosis (see section 4.2). 
Konzervativno 24-tedensko zdravljenje je priporočljivo pri vseh predhodno zdravljenih bolnikih z genotipom 3 in pri predhodno nezdravljenih bolnikih z genotipom 3 s cirozo (glejte poglavje 4.2).
All 5 patients who did not achieve SVR12 relapsed after having end-of-treatment response (see section “Resistance” - “In clinical studies” above). 
Pri vseh 5 bolnikih, ki niso dosegli SVR12, je prišlo po odzivu ob koncu zdravljenja do relapsa (glejte zgornje poglavje
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 NS5A v obeh genotipih 1a in 1b.
In patients without decompensated cirrhosis requiring the addition of ribavirin to their treatment regimen (see Table 1), the daily dose of ribavirin is weight based (< 75 kg = 1,000 mg and ≥ 75 kg = 1,200 mg) and administered orally in two divided doses with food. 
Pri bolnikih brez dekompenzirane ciroze, pri katerih je treba k režimu zdravljenja dodajati ribavirin (glejte preglednico 1), temelji dnevni odmerek ribavirina na telesni masi (< 75 kg = 1.000 mg in ≥ 75 kg = 1.200 mg) in se daje peroralno v dveh razdeljenih odmerkih s hrano.
• If you are allergic to ledipasvir, sofosbuvir or any of the other ingredients of this medicine 
• če ste alergični na ledipasvir, sofosbuvir ali katero koli sestavino tega zdravila (navedeno v poglavju 6 tega navodila).
Table 14: Response rates in study ION-4 
Preglednica 14: Stopnje odziva v študiji ION-4