natgillin/translations-raw huggingface dataset:
When Epclusa is used in combination with ribavirin refer also to the Summary of Product Characteristics for ribavirin for patients with creatinine clearance < 50 mL/min (see section 5.2). 
Če se zdravilo Epclusa uporablja v kombinaciji z ribavirinom, glejte tudi povzetek glavnih značilnosti za ribavirin za bolnike z očistkom kreatinina < 50 ml/min (glejte poglavje 5.2).
The adverse events observed were consistent with expected clinical sequelae of decompensated liver disease, or the known toxicity profile of ribavirin for patients receiving Epclusa in combination with ribavirin. 
Opaženi neželeni učinki so bili skladni s pričakovanimi kliničnimi posledicami dekompenzirane bolezni jeter ali pa so bili v skladu z znanim toksikološkim profilom ribavirina za bolnike, ki so prejemali zdravilo Epclusa v kombinaciji z ribavirinom.
Interaction only studied with velpatasvir. 
Preučevane so bile samo interakcije z velpatasvirjem.
Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1). 
Zdravilo Epclusa je indicirano za zdravljenje kronične okužbe z virusom hepatitisa C (HCV) pri odraslih (glejte poglavja 4.2, 4.4 in 5.1).
SVR without Y93H 95% CI 
SVR brez Y93H 95 % IZ
Animal studies do not indicate harmful effects of sofosbuvir or velpatasvir on fertility. 
Študije na živalih ne kažejo škodljivih učinkov sofosbuvirja ali velpatasvirja na plodnost.
Co-administration of Epclusa with digoxin may increase the concentration of digoxin. 
Sočasno dajanje zdravila Epclusa z digoksinom lahko poveča koncentracijo digoksina.
The medicinal product interactions described are based on studies conducted with either sofosbuvir/velpatasvir or velpatasvir and sofosbuvir as individual agents, or are predicted medicinal product interactions that may occur with sofosbuvir/velpatasvir. 
Opisane interakcije med zdravili temeljijo na študijah, izvedenih z bodisi sofosbuvirjem/velpatasvirjem ali velpatasvirjem in sofosbuvirjem kot posameznimi učinkovinami ali so predvidene interakcije med zdravili, ki se lahko pojavijo s sofosbuvirjem/velpatasvirjem.
• fainting. 
• omedlevico.
In this setting, exposure of sofosbuvir metabolite GS331007 was 20-fold increased, exceeding levels where adverse reactions have been observed in preclinical trials. 
V teh pogojih se je izpostavljenost presnovku sofosbuvirja GS-331007 povečala za 20-krat, kar je preseglo ravni, pri katerih so v predkliničnih preskušanjih opazili neželene učinke.
Your doctor may need to closely monitor these other medicines you are taking and make adjustments after starting Epclusa. 
Zdravnik bo morda moral skrbno spremljati druga zdravila, ki jih jemljete, in po uvedbi zdravila Epclusa prilagoditi njihov odmerek.
This is due to liver function changes during treatment with Epclusa. 
Razlog za to so spremembe delovanja jeter pri zdravljenju z zdravilom Epclusa.
Velpatasvir is an inhibitor of drug transporter P-gp, BCRP, OATP1B1 and OATP1B3 and its involvement in drug interactions with these transporters is primarily limited to the process of absorption. 
Velpatasvir je zaviralec prenašalcev P-gp, BCRP, OATP1B1 in OATP1B3, njegovo sodelovanje pri medsebojnem delovanju s temi prenašalci pa je primarno omejeno na proces absorpcije.
If you are taking an antacid, take it at least 4 hours before or at least 4 hours after Epclusa. 
Če jemljete antacid, ga vzemite vsaj 4 ure pred zdravilom Epclusa ali najmanj 4 ure po tem.
Epclusa treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection. 
Zdravljenje z zdravilom Epclusa mora uvesti in nadzirati zdravnik z izkušnjami v obravnavi bolnikov z okužbo s HCV.
Haemodialysis is unlikely to result in significant removal of velpatasvir, since velpatasvir is highly bound to plasma protein. 
Ni verjetno, da bi hemodializa pomembno odstranila velpatasvir, saj se velpatasvir v veliki meri veže na beljakovine v plazmi.
Table 18: Effect of Varying Degrees of Renal Impairment on Exposures (AUC) of Sofosbuvir, GS-331007, and Velpatasvir Compared to Subjects with Normal Renal Function 
Preglednica 18: Učinek različnih stopenj ledvične okvare na izpostavljenosti (AUC) sofosbuvirju, GS-331007 in velpatasvirju v primerjavi z osebami z normalnim delovanjem ledvic
Of the 87 patients treated with Epclusa + RBV, 85 patients were included in the analysis of NS5A RAVs; 2 patients were excluded as they neither achieved SVR12 nor had virologic failure. 
87 bolnikov, ki so prejemali zdravljenje z zdravilom Epclusa + RBV, je bilo 85 bolnikov vključenih v analizo RAV NS5A; 2 bolnika sta bila izključena, ker nista dosegla niti SVR12 niti virološkega neuspeha.
All patients receiving Epclusa in combination with amiodarone with or without other medicinal products that lower heart rate should also be warned of the symptoms of bradycardia and heart block and should be advised to seek medical advice urgently should they experience them. 
Vse bolnike, ki prejemajo zdravilo Epclusa v kombinaciji z amiodaronom in drugimi zdravili, ki upočasnjujejo srčni utrip, ali brez njih, je treba prav tako opozoriti na simptome bradikardije in srčnega bloka ter jim svetovati, naj ob pojavu simptomov takoj poiščejo zdravniško pomoč.
The safety and efficacy of Epclusa in the treatment of HCV infection in patients who are post-liver transplant have not been assessed. 
Varnost in učinkovitost zdravila Epclusa pri zdravljenju bolnikov z okužbo z virusom HCV po presaditvi jeter nista bili ocenjeni.
c Data from various strains of full length NS5A replicons or chimeric NS5A replicons carrying full-length NS5A genes that contain L31 or M31 polymorphisms. 
c. Podatki iz različnih sevov replikonov NS5A polne dolžine ali himeričnih replikonov NS5A, ki prenašajo gene NS5A polne dolžine, ki vsebujejo polimorfizme L31 ali M31.
The safety and efficacy of Epclusa in children and adolescents aged less than 18 years have not yet been established. 
Pediatrična populacija Varnost in učinkovitost zdravila Epclusa pri otrocih in mladostnikih, starih manj kot 18 let, še nista bili dokazani.
The safety of Epclusa has been evaluated in a 12-week non-controlled study including 59 subjects with ESRD requiring dialysis (Study 4062). 
Varnost zdravila Epclusa so ovrednotili v 12-tedenski nenadzorovani študiji, v katero je bilo vključenih 59 bolnikov z ESRD, ki so potrebovali dializo (študija 4062).
No human data on the effect of Epclusa on fertility are available. 
Podatki o vplivu zdravila Epclusa na plodnost pri ljudeh niso na voljo.
After a single 400 mg oral dose of [14C]-sofosbuvir, GS-331007 accounted for approximately > 90% of total systemic exposure. 
Po enkratnem 400-miligramskem peroralnem odmerku [14C]-sofosbuvirja je GS-331007 prispeval približno > 90 % skupne sistemske izpostavljenosti.
Epclusa is sometimes used together with ribavirin. 
Zdravilo Epclusa se včasih uporablja skupaj z ribavirinom.
Velpatasvir Animal studies have shown a possible link to reproductive toxicity (see section 5.3). 
Študije na živalih so pokazale možno povezavo z reproduktivno toksičnostjo (glejte poglavje 5.3).
Velpatasvir is > 99.5% bound to human plasma proteins and binding is independent of drug concentration over the range of 0.09 µg/mL to 1.8 µg/mL. 
Velpatasvir se > 99,5-odstotno veže na humane beljakovine v plazmi, kar ni odvisno od koncentracije zdravila v razponu 0,09-1,8 μg/ml.
Table 16: Changes in CPT score parameters from baseline to week 12 and 24 post-treatment in patients achieving SVR12, ASTRAL-4 
Preglednica 16: Spremembe v rezultatih CPT od izhodišča do 12. tedna in 24. tedna po zdravljenju pri bolnikih, ki so dosegli SVR12, ASTRAL-4
Epclusa is a medicine that contains the active substances sofosbuvir and velpatasvir in a single tablet. 
Zdravilo Epclusa je zdravilo, ki vsebuje učinkovini sofosbuvir in velpatasvir v eni sami tableti.
• if you have had a liver transplant • have kidney problems or if you are on kidney dialysis, since Epclusa has not been fully tested in patients with some severe kidney problems; 
• imate težave z ledvicami ali se zdravite z ledvično dializo, saj učinkov zdravila Epclusa pri bolnikih s hudimi težavami z ledvicami niso v celoti preučili;
The presence of 40% human serum had no effect on the anti-HCV activity of sofosbuvir but reduced the anti-HCV activity of velpatasvir by 13-fold against genotype 1a HCV replicons. 
NA = podatkov ni na voljo Prisotnost 40-odstotnega humanega seruma ni vplivala na aktivnost sofosbuvirja proti HCV, je pa aktivnost velpatasvirja proti HCV zmanjšala za 13-krat proti replikonom HCV genotipa 1a.
• modafinil used to treat sleep disorders; 
• modafinil, ki se uporablja za zdravljenje motenj spanja;
These and other adverse events were reported at a similar frequency in placebo treated patients compared with Epclusa treated patients. 
O teh in drugih neželenih učinkih so s podobno pogostnostjo kot pri bolnikih, ki so se zdravili z zdravilom Epclusa, poročali pri bolnikih, ki so prejemali placebo.
AUC Cmin 
Aktiven Cmax AUC Cmin
SVR with Y93H 95% CI 
SVR z Y93H 95 % IZ
When co-administered with Epclusa, careful monitoring for statin adverse reactions should be undertaken and a reduced dose of statins should be considered if required. 
Pri sočasni uporabi z zdravilom Epclusa je treba skrbno spremljati neželene učinke statinov in razmisliti o zmanjšanem odmerku statinov, če je potrebno.
Famotidine dosed 12 hours prior to Epclusad 
Famotidin uporabljen 12 ur pred zdravilom Epclusad
It is not known whether sofosbuvir or velpatasvir, the two active substances of Epclusa, pass into human breast milk. 
Ni znano, ali sofosbuvir ali velpatasvir, dve učinkovini v zdravilu Epclusa, prehajata v materino mleko.
Available pharmacokinetic data in animals have shown excretion of velpatasvir and metabolites of sofosbuvir in milk. 
Razpoložljivi farmakokinetični podatki pri živalih kažejo na izločanje velpatasvirja in presnovkov sofosbuvirja v mleko.
Expected: 
Pričakovane:
However, a possible teratogenic effect was indicated in rabbits where an increase in total visceral malformations was seen in exposed animals at AUC exposures up to 0.7 fold the human exposure at recommended clinical dose. 
Vendar pa je bil indiciran morebiten teratogeni učinek pri kuncih, kjer je bilo pri izpostavljenih živalih z do 0,7-kratno izpostavljenostjo na podlagi AUC kot pri človeški izpostavljenosti pri priporočenem kliničnem odmerku opaženo zvečanje skupnih visceralnih malformacij.
These should be taken at least 4 hours before or 4 hours after Epclusa; 
Te je treba vzeti vsaj 4 ure pred uporabo zdravila Epclusa ali 4 ure po tem;
Randomisation was stratified by HCV genotype (1, 2, 3, 4, 5, 6 and indeterminate). 
Randomizacija je bila stratificirana po genotipu HCV (1, 2, 3, 4, 5, 6 in nedoločen).
Sofosbuvir was not a carcinogen in the 2-year mouse and rat carcinogenicity studies at GS-331007 exposures up to 15 and 9 times, respectively, higher than human exposure. 
Sofosbuvir ni bil karcinogen v 2-letnih študijah kancerogenosti pri miših in podganah ob izpostavljenostih GS-331007, ki so bile do 15-krat in 9-krat večje od izpostavljenosti pri človeku.
Compared to subjects with normal hepatic function velpatasvir total plasma exposure (AUCinf) was similar in patients with moderate or severe hepatic impairment. 
V primerjavi z bolniki z normalnim delovanjem jeter je bila skupna izpostavljenost velpatasvirju v plazmi (AUCinf) pri bolnikih z zmerno in hudo jetrno okvaro podobna.
Demographics and baseline characteristics were balanced across the treatment groups. 
Demografske in izhodiščne značilnosti so bile uravnotežene pri vseh skupinah zdravljenja.
• Your doctor can confirm that your treatment has worked and you are free of the hepatitis C 
• da lahko potrdi, da je bilo pri vas zdravljenje učinkovito in da ste brez virusa hepatitisa C. Otroci in mladostniki
Ethinyl estradiol a Mean ratio (90% CI) of co-administered drug pharmacokinetics of study medicinal products alone or in combination. 
Etinilestradiol a. Povprečno razmerje (90-odstotni IZ) farmakokinetike s sočasno uporabljenimi študijskimi zdravili posamezno ali v kombinaciji.
Overall 95% CI 
95 % IZ
Following a single 400 mg dose of sofosbuvir, a 4 hour haemodialysis removed 18% of administered dose. 
Po enkratnem 400-miligramskem odmerku sofosbuvirja se je s 4-urno hemodializo izločilo približno 18 % uporabljenega odmerka.
Epclusa has been shown to increase tenofovir exposure (P-gp-inhibition). 
Pokazalo se je, da zdravilo Epclusa poveča izpostavljenost tenofovirju (zaviranje P-gp).
Effect on rifampicin exposure not studied. 
Učinka na izpostavljenost rifampicinu niso preučevali.
Epclusa + ribavirin for 12 weeks a Includes patients co-infected with human immunodeficiency virus (HIV) and patients with recurrent HCV post-liver transplant (see section 4.4. 
Zdravilo Epclusa + ribavirin 12 tednov a. Vključno z bolniki, ki imajo sočasno okužbo z virusom človeške imunske pomanjkljivosti (HIV), in bolniki s ponovno okužbo s HCV po presaditvi jeter (glejte poglavje 4.4.
Velpatasvir is also a substrate of OATP1B. 
Velpatasvir je prav tako substrat prenašalca OATP1B.
If you accidentally take more than the recommended dose you should contact your doctor or nearest emergency department immediately for advice. 
Če ste vzeli večji odmerek zdravila Epclusa, kot bi smeli Če ste pomotoma vzeli večji odmerek od priporočenega, se takoj posvetujte z zdravnikom ali pojdite na najbližji oddelek nujne pomoči.
In biochemical assays, the ability of the active triphosphate of sofosbuvir (GS-461203) to inhibit recombinant NS5B polymerase from genotypes 1b, 2a, 3a and 4a expressing the S282T substitution was reduced compared to its ability to inhibit wild-type recombinant NS5B polymerase, as indicated by a 8.5- to 24-fold increase in the 50% inhibitory concentration (IC50). 
V biokemičnem testu se je sposobnost aktivnega trifosfata sofosbuvirja (GS-461203) za zaviranje rekombinantne polimeraze NS5B genotipov 1b, 2a, 3a in 4a z izraženo substitucijo S282T zmanjšala v primerjavi z njegovo sposobnostjo zaviranja rekombinantne polimeraze NS5B nemutiranih tipov virusa, kar se kaže z 8,5- do 24-kratnim povečanjem 50-odstotne inhibitorne koncentracije (IC50).
The proportions of patients with genotype 1, 2, 3, 4, 6 or indeterminate HCV infection were 42%, 12%, 27%, 7% , 3%, and 9%, respectively. 
Deleži bolnikov z genotipom 1, 2, 3, 4, 6 ali nedoločeno okužbo s HCV so bili 42 %, 12 %, 27 %, 7 % , 3 % oz. 9 %.
The ribavirin dose was weight-based (1,000 mg daily administered in two divided doses for patients < 75 kg and 1,200 mg for those ≥ 75 kg) and administered in two divided doses when used in combination with sofosbuvir in the ASTRAL-2 and ASTRAL-3 studies or in combination with Epclusa in the ASTRAL-4 study. 
Odmerek ribavirina je temeljil na telesni masi (1.000 mg dnevno v dveh razdeljenih odmerkih pri bolnikih s telesno maso < 75 kg in 1.200 mg pri bolnikih s telesno maso ≥ 75 kg) in so ga dajali v dveh razdeljenih odmerkih v kombinaciji s sofosbuvirjem v študijah ASTRAL-2 in ASTRAL-3 ali v kombinaciji z zdravilom Epclusa v študiji ASTRAL-4.
• If you notice within 18 hours of the time you usually take Epclusa, you must take the tablet as soon as possible. 
• Če se tega spomnite v roku 18 ur od takrat, ko običajno vzamete zdravilo Epclusa, morate tableto vzeti takoj, ko je mogoče.
TN = treatment-naïve patients; TE = treatment-experienced patients (including those who have failed a peginterferon alfa + ribavirin based regimen with or without an HCV protease inhibitor) 
PN = predhodno nezdravljeni bolniki PZ = predhodno zdravljeni bolniki (vključno s tistimi, pri katerih zdravljenje z režimom na osnovi peginterferona alfa + ribavirina z zaviralcem proteaze HCV ali brez njega ni bilo uspešno)
Serum HCV RNA values were measured during the clinical studies using the COBAS AmpliPrep/COBAS Taqman HCV test (version 2.0) with a lower limit of quantification (LLOQ) of 15 IU/mL. 
Med kliničnimi študijami so izmerili vrednosti RNK HCV v serumu s testom COBAS AmpliPrep/COBAS Taqman za virus HCV (različica 2.0), s spodnjo mejo kvantifikacije (LLOQ, lower limit of quantification) 15 i.e./ml.
In the ASTRAL-3 study, the Y93H RAV was detected at baseline in 9% of patients treated with Epclusa. 
V študiji ASTRAL-3 so RAV Y93H zabeležili ob izhodišču pri 9 % bolnikov, ki so prejemali zdravljenje z zdravilom Epclusa.
Another patient had virus with Y93H at baseline and virologic failure and also developed low levels (< 5%) of NS5B NI RAVs N142T and E237G at failure. 
Drugi bolnik je imel virus z Y93H ob izhodišču in v času virološkega neuspeha, pojavile pa so se tudi nizke ravni (< 5 %) RAV NI NS5B N142T in E237G ob neuspehu.
Afterwards, close monitoring and potential dose adjustment of ciclosporin may be required. 
Pozneje bo morda potrebno skrbno spremljanje in morebitno prilagajanje odmerka ciklosporina.
Epclusa should not affect your ability to drive or use any tools or machinery. 
Zdravilo Epclusa ne bi smelo vplivati na vašo sposobnost upravljanja vozil ali strojev.
The NS5B NI RAV S282T was not detected in the baseline NS5B sequence of any patient in Phase 3 studies. 
RAV NI NS5B S282T niso v izhodiščnem zaporedju NS5B odkrili pri nobenem bolniku v študijah 3. faze.
Elderly No dose adjustment is warranted for elderly patients (see section 5.2). 
Pri starejših bolnikih odmerka ni treba prilagajati (glejte poglavje 5.2).
Post-treatment Week 12 (N = 236), % (n/N) Decreased score (Improvement) 
12. teden po zdravljenju (N = 236), % (n/N) Nižji rezultat
Ribavirin dose adjustments were performed according to the ribavirin prescribing information. 
Prilagajanje odmerka ribavirina je bilo v skladu z informacijami za predpisovanje ribavirina.
The safety of tenofovir disoproxil fumarate in the setting of Epclusa and a pharmacokinetic enhancer has not been established. 
Varnost dizoproksiltenofovirijevega fumarata z zdravilom Epclusa in farmakokinetičnim ojačevalcem ni bila dokazana.
Velpatasvir had no adverse effects on mating and fertility. 
Velpatasvir nima neželenih učinkov na parjenje in plodnost.
d Data from a chimeric NS5A replicon carrying NS5A amino acids 9-184. 
d. Podatki iz himeričnega replikona NS5A, ki prenaša aminokisline NS5A 9-184.
See Table 3 for examples of interactions with sensitive substrates of P-gp (digoxin), BCRP (rosuvastatin), and OATP (pravastatin). 
Primere interakcij z občutljivimi substrati P-gp (digoksin), BCRP (rosuvastatin) in OATP (pravastatin) si oglejte v preglednici 3.
Table 2: Guidance for ribavirin dosing when administered with Epclusa to patients with decompensated cirrhosis 
Preglednica 2: Smernice za odmerjanje ribavirina v primeru dajanja skupaj z zdravilom Epclusa bolnikom z dekompenzirano cirozo
86% (6/7)c a n = 4 for genotype 2 and n = 4 for genotype 4. 
86 % (6/7)c a. n = 4 za genotip 2 in n = 4 za genotip 4 b. n = 4 za genotip 2 in n = 2 za genotip 4 c. n = 4 za genotip 2, n = 2 za genotip 4 in n = 1 za genotip 6
No clinically relevant pharmacokinetic differences due to race or gender have been identified for sofosbuvir, GS-331007 or velpatasvir. 
Klinično pomembnih farmakokinetičnih razlik zaradi rase ali spola za sofosbuvir, GS-331007 ali velpatasvir niso ugotovili.
• carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures). 
• karbamazepin, fenobarbital in fenitoin (zdravila, ki se uporabljajo za zdravljenje epilepsije in preprečevanje epileptičnih napadov).
No specific antidote is available for overdose with Epclusa. 
Specifični antidot za prevelik odmerek zdravila Epclusa ni na voljo.
Post-treatment Week 24 (N = 236), % (n/N) Decreased score (Improvement) 
24. teden po zdravljenju (N = 236), % (n/N) Nižji rezultat
SVR12 was achieved in all 77 patients who had baseline NS5B NI RAVs including N142T, L159F, E/N237G, C/M289L/I, L320F/I/V, V321A/I, and S282G+V321I. 
SVR12 je doseglo vseh 77 bolnikov z izhodiščnimi RAV NI NS5B, vključno z N142T, L159F, E/N237G, C/M289L/I, L320F/I/V, V321A/I in S282G+V321I.
Of the 1,035 patients treated with sofosbuvir/velpatasvir in the three Phase 3 clinical studies, 1,023 patients were included in the analysis of NS5A RAVs; 7 patients were excluded as they neither achieved sustained virologic response (SVR12) nor had virologic failure and 5 additional patients were excluded as NS5A gene sequencing failed. 
Od 1.035 bolnikov, ki so prejemali zdravljenje s sofosbuvirjem/velpatasvirjem v treh kliničnih študijah 3. faze, je bilo 1.023 bolnikov vključenih v analizo RAV NS5A; 7 bolnikov je bilo izključenih, ker niso dosegli niti trajnega virološkega odziva (sustained virological response - SVR12) niti virološkega neuspeha, 5 dodatnih bolnikov pa je bilo izključenih zaradi neuspešnega sekvenciranja gena NS5A.
• rifapentine (antibiotic used to treat infections, including tuberculosis); 
• rifapentin (antibiotik, ki se uporablja za zdravljenje okužb, vključno s tuberkulozo);
The median terminal half-life of velpatasvir following administration of Epclusa was approximately 15 hours. 
Mediani končni razpolovni čas za velpatasvir po uporabi zdravila Epclusa je bil približno 15 ur.
• proton pump inhibitors (such as omeprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole). 
• zaviralce protonske črpalke (kot so omeprazol, lansoprazol, rabeprazol, pantoprazol in esomeprazol).
The efficacy of Epclusa has not been assessed in patients who have previously failed treatment with other regimens that include an NS5A inhibitor. 
Učinkovitosti zdravila Epclusa niso ocenili pri bolnikih, pri katerih predhodno zdravljenje z drugimi režimi, ki so vključevali zaviralec NS5A, ni bilo uspešno.
Among the 87 patients who were treated with Epclusa + RBV for 12 weeks, decreases in haemoglobin to less than 10 g/dL and 8.5 g/dL during treatment were experienced by 23% and 7% patients, respectively. 
Od 87 bolnikov, ki so prejemali zdravljenje z zdravilom Epclusa + RBV 12 tednov, se je zmanjšanje ravni hemoglobina med zdravljenjem na manj kot 10 g/dl pojavilo pri 23 % bolnikov, zmanjšanje na manj kot 8,5 g/dl pa pri 7 % bolnikov.
One additional patient with genotype 3 HCV infection at baseline was reinfected with genotype 1a HCV at virologic failure and was excluded from the virological analysis. 
En dodaten bolnik z okužbo s HCV genotipa 3 ob izhodišču se je znova okužil s HCV genotipa 1a v času virološkega neuspeha in je bil izključen iz virološke analize.
Total (n = 328) 
Skupaj (n = 328)
• rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis); 
• rifampicin in rifabutin (antibiotika, ki se uporabljata za zdravljenje okužb, vključno s tuberkulozo);
The moderate or high fat meal did not alter GS-331007 AUC0-inf, but resulted in a 25% and 37% decrease in its Cmax, respectively. 
Obrok z zmerno ali visoko vsebnostjo maščobe ni vplival na vrednost AUC0-inf za GS-331007, vendar je povzročil zmanjšanje vrednosti Cmax, za 25 % in 37 %.
Potential for Epclusa to affect other medicinal products Velpatasvir is an inhibitor of drug transporter P-gp, breast cancer resistance protein (BCRP), organic anion-transporting polypeptide (OATP) 1B1 and OATP1B3. 
Možnost vpliva zdravila Epclusa na druga zdravila Velpatasvir je zaviralec prenašalca P-gp, proteina odpornosti pri raku dojke (BCRP, breast cancer resistance protein), transportnega polipeptida organskih anionov (OATP, organic anion-transporting polypeptide) 1B1 in OATP1B3.
Total (n = 78) 
Skupaj (n = 78)
The monohydroxylated and desmethylated velpatasvir were the metabolites identified in human plasma. 
Monohidroksilirani in demetilirani velpatasvir sta bila presnovka, ugotovljena v plazmi pri človeku.
The EC50 values of sofosbuvir and velpatasvir against clinical isolates are presented in Table 5. 
Vrednosti EC50 za sofosbuvir in velpatasvir proti kliničnim izolatom so prikazane v preglednici 5.
Co-administration of Epclusa with rosuvastatin increases the concentration of rosuvastatin, which is associated with increased risk of myopathy, including rhabdomyolysis. 
Sočasno dajanje zdravila Epclusa z rosuvastatinom lahko poveča koncentracijo rosuvastatina, kar je povezano z večjim tveganjem za miopatijo, vključno z rabdomiolizo.