natgillin/translations-raw huggingface dataset:
Caution is advised if co-administering Viekirax with medicinal products that are both moderate inhibitors of CYP3A4 and inhibitors of multiple transporters (P-gp, BCRP and/or OATP1B1/ OATP1B3). 
Previdnost je potrebna v primeru sočasne uporabe zdravila Viekirax z zdravili, ki so zmerni zaviralci CYP3A4 in zaviralci več prenašalcev (P-gp, BCRP in/ali
If parenteral midazolam is co-administered with Viekirax with or without dasabuvir, close clinical monitoring for respiratory depression and/or prolonged sedation should be exercised and dosage adjustment should be considered. 
Če se sočasno daje midazolam parenteralno in zdravilo Viekirax z dasabuvirjem ali brez njega, je potrebno natančno klinično spremljanje zaradi depresije dihanja in/ali sedacije.
Side effects when taking Viekirax with or without dasabuvir and with or without ribavirin: 
Neželeni učinki, ki se lahko pojavijo pri jemanju zdravila Viekirax z ali brez dasabuvirja in z ali brez ribavirina:
Viekirax + dasabuvir duloxetine 
Viekirax + dasabuvir duloksetin
Refer to the Summary of Product Characteristics of dasabuvir for its pharmacological properties. 
Za farmakološke lastnosti dasabuvirja glejte povzetek glavnih značilnosti zdravila z dasabuvirjem.
Pharmacokinetics of the combination of ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg, with dasabuvir 400 mg were evaluated in non-HCV infected subjects with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment. 
Farmakokinetiko kombinacije 25 mg ombitasvirja, 200 mg paritaprevirja in 100 mg ritonavirja s 400 mg dasabuvirja so ocenili pri preiskovancih brez okužbe z virusom hepatitisa C z blago (Child-Pugh A), zmerno (Child-Pugh B) in hudo (Child-Pugh C) okvaro jeter.
↔ ombitasvir/paritaprevir (based on the cross-study comparison) 
↔ ombitasvir/paritaprevir/(na podlagi primerjave med študijami)
RUBY-I; treatment-naïve or pegIFN + RBV experienced with or without cirrhosis who have severe renal impairment or end stage renal disease (ESRD) 
RUBY-I - še nezdravljeni ali zdravljeni s pegIFN + RBV z ali brez ciroze, ki imajo hudo okvaro ledvic ali končno ledvično odpoved Oblika: multicentrična, odprta
ANTIANGINA/ANTIARRYTHMICS Amiodarone 
KONTRACEPTIVI etinilestradiol/n orgestimat
treatment naïve: Viekirax without ribavirin or with weight-based ribavirin for 12 weeks pegIFN + RBV experienced: Viekirax with weight-based ribavirin for 12 weeks 
Zdravljenje: še nezdravljeni: zdravilo Viekirax brez ribavirina ali z ribavirinom, odvisnim od telesne mase, 12 tednov že zdravljeni s kombinacijo pegIFN + RBV: Viekirax z ribavirinom, odvisnim od telesne mase, 12 tednov
ALT elevations 
Zvišanja ALT
Upon completion of Viekirax and dasabuvir treatment, the appropriate dose and dosing frequency of tacrolimus should be guided by assessment of tacrolimus blood concentrations. 
Klinične opombe dasabuvirjem, je potrebno odmerek in pogostnost odmerjanja takrolimusa nadzirati s pomočjo ocene koncentracij takrolimusa v krvi.
Interactions between Viekirax with or without dasabuvir and other medicinal products 
Preglednica 2: Interakcije med zdravilom Viekirax (z dasabuvirjem ali brez njega) in drugimi zdravili
The activity of ombitasvir was attenuated 11- to 13-fold in the presence of 40% human plasma. 
V prisotnosti 40 % človeške plazme je aktivnost ombitasvirja oslabela za 11- do 13-krat.
Ciclosporin 100 mg dosed alone, 10 mg administered with Viekirax and 30 mg administered with Viekirax + dasabuvir. 
Odmerek 100 mg ciklosporina je bil uporabljen sam, odmerek 10 mg z zdravilom Viekirax in odmerek 30 mg z zdravilom Viekirax + dasabuvirjem.
The persistence of paritaprevir, ombitasvir, and dasabuvir resistance-associated amino acid substitutions in NS3, NS5A, and NS5B, respectively, was assessed in genotype 1a-infected subjects in Phase 2b trials. 
Trajnost aminokislinskih substitucij v NS3, NS5A oziroma NS5B, povezanih z odpornostjo proti paritaprevirju, ombitasvirju oziroma dasabuvirju, so ocenili pri preiskovancih, okuženih z genotipom 1a, v preskušanjih faze 2b.
Pharmacokinetics of the combination of ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg were not evaluated in subjects with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (ChildPugh C) hepatic impairment. 
Farmakokinetike kombinacije 25 mg ombitasvirja, 200 mg paritaprevirja in 100 mg ritonavirja niso ocenili pri preiskovancih z blago (Child-Pugh A), zmerno (Child-Pugh B) in hudo (Child-Pugh C) okvaro jeter.
Medicines you must not take with Viekirax Medicine or active substance 
Zdravila, ki jih ne smete jemati z zdravilom Viekirax
Transient increases in indirect bilirubin were observed at the highest doses of paritaprevir/ritonavir. 
Med uporabo največjih odmerkov paritaprevirja/ritonavirja so opažali prehodno zvišanje indirektnega bilirubina.
Viekirax and dasabuvir without ribavirin for 12 weeks 60 patients were randomized and treated, and 60/60 (100%) achieved SVR12. 
60 bolnikov je bilo randomiziranih in zdravljenih in 60/60 (100 %) jih je doseglo SRV12.
nordiazepam 
diazepam
• Itching. 
• driska.
Compared to the subjects with normal renal function, paritaprevir Cmax values were comparable, but AUC values were 19%, 33% and 45% higher in mild, moderate and severe renal impairment, respectively. 
Vrednosti Cmax paritaprevirja so bile v primerjavi z osebami z normalnim delovanjem ledvic primerljive, vrednosti AUC pa so bile pri bolnikih z blago okvaro ledvic 19 % večje, z zmerno okvaro ledvic 33 % večje in s hudo okvaro ledvic 45 % večje.
Mechanism: Increase in 
Mehanizem: Zavrtje
The direction of the arrow indicates the direction of the change in exposures (Cmax, and AUC) in paritaprevir, ombitasvir, dasabuvir and the co-administered medicinal product (↑ = increase (more than 20%), ↓ = decrease (of more than 20%), ↔ = no change or change less than 20%). 
dasabuvirju in sočasno uporabljenemu zdravilu (↑ = povečanje za več kot 20 %, ↓ = zmanjšanje za več kot
600 mg twice daily 
600 mg dvakrat na dan
Ritonavir plasma concentrations increased when renal function was reduced: Cmax and AUC values were 26% to 42% higher, 48% to 80% higher and 66% to 114% higher in subjects with mild, moderate and severe renal impairment, respectively. 
Cmax in AUC sta bili od 26 do 42 % večji pri bolnikih z blago okvaro ledvic, od 48 do 80 % večji pri bolnikih z zmerno okvaro ledvic ter od 66 do 114 % večji pri bolnikih s hudo okvaro ledvic.
ANGIOTENSIN RECEPTOR BLOCKER Valsartan 
ANTAGONISTI ANGIOTENZINA valsartan losartan kandesartan
In subjects with mild hepatic impairment, paritaprevir, ritonavir and ombitasvir mean Cmax and AUC values decreased by 29% to 48%, 34% to 38% and up to 8%, respectively, compared to subjects with normal hepatic function. 
Pri preiskovancih z blago okvaro jeter so bile v primerjavi s preiskovanci z normalnim delovanjem jeter vrednosti naslednje: povprečni Cmax in AUC paritaprevirja sta se zmanjšali za 29 do 48 %, ritonavirja za 34 do 38 % in ombitasvirja do 8 %.
Purpose of the medicine alprazolam, diazepam for anxiety, panic attacks and trouble sleeping ciclosporin, everolimus, sirolimus, tacrolimus to suppress the immune system cyclobenzaprine, carisoprodol for muscle spasms colchicine for patients whose kidney and liver function test are normal for treating gout attacks or familial Mediterranean fever digoxin, amlodipine, nifedipine, valsartan, diltiazem, verapamil, candesartan, losartan for heart problems or high blood pressure encorafenib for skin cancer furosemide for the build-up of too much fluid in the body hydrocodone for pain levothyroxine for thyroid problems rilpivirine, darunavir, atazanavir for HIV infection omeprazole, lansoprazole, esomeprazole for stomach ulcers and other stomach problems ibrutinib, imatinib for the treatment of some cancers of the blood fluvastatin, pitavastatin, pravastatin, rosuvastatin to lower blood cholesterol dabigatran to thin the blood fexofenadine for hay fever s-mephenytoin for epilepsy sulfasalazine for inflammatory bowel disease repaglinide for lowering blood sugar erythromycin for bacterial infections steroid or corticosteroid medicines (such as fluticasone) 
Namen uporabe zdravila alprazolam, diazepam pri tesnobi, napadih panike in težavah s spanjem ciklosporin, everolimus, sirolimus, takrolimus za zaviranje imunskega sistema ciklobenzaprin, karisoprodol pri mišičnih krčih kolhicin pri bolnikih, ki imajo normalne izvide ledvičnih in jetrnih testov pri protinu ali družinski mediteranski vročici digoksin, amlodipin, nifedipin, valsartan, diltiazem, verapamil, kandesartan, losartan pri težavah s srcem ali visokem krvnem tlaku enkorafenib pri kožnem raku furosemid pri prekomernem kopičenju tekočine v telesu hidrokodon proti bolečini levotiroksin pri težavah s ščitnico rilpivirin, darunavir, atazanavir pri okužbah z virusom HIV
Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported postmarketing in patients treated with Viekirax with and without dasabuvir and with and without ribavirin. 
Tveganje za dekompenzacijo jeter in okvaro jeter pri bolnikih s cirozo Pri bolnikih, ki so jih zdravili z zdravilom Viekirax z ali brez dasabuvirja in z ali brez ribavarina so po prihodu zdravila na trg poročali o dekompenzaciji jeter in okvari jeter, vključno s presaditvijo jeter ali smrtnimi izidi.
In Part 1a, SVR12 was achieved by 29/31 (93.5%) subjects on the 12-week arm (95% CI: 79.3%, 98.2%) and by 29/32 (90.6%) subjects on the 24-week arm (95% CI: 75.8% - 96.8%). 
98,2 %) in pri 29/32 (90,6 %) preiskovancih v 24-tedenski skupini (95 % CI: 75,8 % - 96,8 %).
Medicinal products transported by P-gp in the intestine While paritaprevir, ritonavir and dasabuvir are in vitro inhibitors of P-gp, no significant change was observed in the exposure of the P-gp substrate digoxin when administered with Viekirax and dasabuvir. 
Paritaprevir, ritonavir in dasabuvir in vitro sicer zavirajo P-gp, toda po uporabi z zdravilom Viekirax in dasabuvirjem se izpostavljenost substratu P-gp, digoksinu, ni spremenila.
In genotype 1a, substitutions M28T/V, Q30E/R, L31V, H58D, Y93C/H/N, and M28V + Q30R in HCV NS5A reduced susceptibility to ombitasvir. 
Pri genotipu 1a so substitucije M28T/V, Q30ER, L31V, H58D, Y93C/H/N in M28V + Q30R v genu
PEARL-II - genotype 1b, pegIFN+RBV-experienced, without cirrhosis 
PEARL-II - genotip 1b, že zdravljeni s pegIFN + RBV, brez ciroze
Dose normalized cyclosporine ratios are shown for interaction with Viekirax with or without dasabuvir. 
Za odmerek normalizirana razmerja ciklosporina so prikazana za medsebojno delovanje z zdravilom Viekirax z dasabuvirjem ali brez njega.
Overall SVR12 HCV genotype 1a HCV genotype 1b Outcome for subjects without SVR12 On-treatment VFa Relapse Otherb a. Confirmed HCV ≥ 25 IU/mL after HCV RNA < 25 IU/mL during treatment, confirmed 1 log10 IU/mL increase in 
Celotni SVR12 HCV genotip 1a HCV genotip 1b Izid pri preiskovancih brez SVR12 VN med zdravljenjema Recidiv Drugob a. Potrjen HCV ≥ 25 i.e./ml po HCV RNA < 25 i.e./ml med zdravljenjem, potrjeno povečanje HCV RNA za 1 log10 i.e./ml od najnižje točke, ali HCV RNA stalno ≥ 25 i.e./ml ob vsaj 6 tednih zdravljenja.
Viekirax, when co-administered with dasabuvir, combines three direct-acting antiviral medicinal products with distinct mechanisms of action and non-overlapping resistance profiles to target HCV at multiple steps in the viral lifecycle. 
Sočasna uporaba zdravila Viekirax z dasabuvirjem združuje tri direktno delujoča protivirusna zdravila z različnimi mehanizmi delovanja.
GT1b Arm A: Viekirax and dasabuvir + RBV Arm B: Viekirax and dasabuvir Treatment-naïve and peginterferon+ribavirin -experienced, with compensated cirrhosis 
GT1b Skupina A: Viekirax in dasabuvir+ RBV Skupina B: Viekirax in dasabuvir Še nezdravljeni in že zdravljeni peginterferonom + ribavirinom, s kompenzirano cirozo
You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medicines after starting Viekirax. 
Po začetku jemanja zdravila Viekirax morda potrebujete skrbno spremljanje ravni sladkorja v krvi in/ali prilagoditev zdravila za zdravljenje sladkorne bolezni.
THYROID HORMONES 
ŠČITNIČNI HORMONI
Viekirax with or without dasabuvir 
Viekirax z ali brez dasabuvirja
300 mg single dose 
Posamezni odmerek 300 mg
HCV Genotype 1a Viekirax and dasabuvir with RBV 
HCV Genotip 1a Viekirax in dasabuvir z RBV
paritaprevir recommended. 
- Navodilo shranite.
GT1 Arm A: Viekirax and dasabuvir + RBV Arm B: Placebo 
GT1 Skupina A: Viekirax in dasabuvir + RBV Skupina B: Placebo
Similarly, paritaprevir/ritonavir was not carcinogenic in a 2-year rat study up to the highest dosage tested (300 mg/30 mg/kg/day), resulting in paritaprevir AUC exposures approximately 8-fold higher than those in humans at 150 mg. 
Podobno paritaprevir/ritonavir nista bila kancerogena v 2-letni študiji na podganah vse do največjega testiranega odmerka (300 mg/30 mg/kg/dan), ob čemer je bila AUC izpostavljenost paritaprevirju približno 8-krat večja kot pri človeku ob uporabi 150 mg.
Paritaprevir /ritonavir was not carcinogenic in a 6-month transgenic mouse study up to the highest dosage tested (300 mg/30 mg/kg/day), resulting in paritaprevir AUC exposures approximately 38-fold higher than those in humans at the recommended dose of 150 mg. 
Paritaprevir/ritonavir v 6-mesečni študiji pri transgenskih miših nista bila kancerogena vse do največjega testiranega odmerka (300 mg/30 mg/kg/dan), ob čemer je bila AUC izpostavljenost paritaprevirju približno 38-krat večja od izpostavljenosti pri človeku, ob priporočenem odmerku 150 mg.
NA No dose adjustment required for diazepam; increase dose if clinically indicated. 
NP Prilagoditev odmerka diazepama ni potrebna; povečajte odmerek, če je klinično indicirano.
Table 2 provides the Least Squares Means Ratio (90% Confidence Interval) effect on concentration of Viekirax with or without dasabuvir and concomitant medicinal products. 
Preglednica 2 prikazuje vpliv na koncentracijo zdravila Viekirax (z dasabuvirjem ali brez njega) ter sočasno uporabljanih zdravil z razmerjem povprečij po metodi najmanjših kvadratov (90 % interval zaupanja).
Dose normalized tacrolimus ratios are shown for interaction with Viekirax with or without dasabuvir. 
Za odmerek normalizirana razmerja takrolimusa so prikazana za medsebojno delovanje z zdravilom Viekirax z dasabuvirjem ali brez njega.
pegIFN + RBVexperienced 
Zdravljeni s pegIFN + RBV
NA No dose adjustment is necessary for escitalopram. 
NP Prilagoditev odmerka escitaloprama ni potrebna.
Metabolism as well as biliary excretion of parent drug contribute to the elimination of paritaprevir. 
K odstranjevanju paritaprevirja pripomoreta presnova in biliarno izločanje matičnega zdravila.
Concomitant use with efavirenz is contraindicated (see section 4.3). 
Sočasna uporaba z efavirenzom je kontraindicirana (glejte poglavje 4.3).
A temporary suspension of pitavastatin/fluvastatin is recommended for the duration of treatment with Viekirax. 
Med zdravljenjem z zdravilom Viekirax je priporočljivo začasno opustiti suspenzijo pitavastatina/fluvastatina.
NA No dose adjustment required for cyclobenzaprine; increase dose if clinically indicated. 
Prilagoditev odmerka ciklobenzaprina ni potrebna; povečajte odmerek, če je klinično indicirano.
Mechanism: CYP3A4 and/or OATP1B inhibition by paritaprevir. 
CYP3A4 in/ali OATP1B s paritaprevirjem.
Viekirax and dasabuvir with/without ribavirin for 12 or 24 Weeks N = 200a 
Zdravilo Viekirax in dasabuvir z ali brez ribavirina 12 or 24 tednov N = 200a
Treated subjects (N = 22) had a median age of 54 years (range: 34 to 68); 41% were Black; 14% had compensated cirrhosis; 86% were HCV treatment-naïve; 14% had failed prior treatment with pegIFN/RBV; 68% had HCV genotype 1a infection. 
Mediana starosti zdravljenih preiskovancev (N = 22) je bila 54 let (razpon: od 34 do 68); 41 % je bilo črncev; 14 % jih je imelo kompenzirano cirozo; 86 % jih še ni bilo zdravljenih; 14 % jih je doživelo neuspeh predhodnega zdravljenja s pegIFN/RBV; 68 % jih je imelo okužbo HCV genotipa 1a.
CYP3A4 induction by phenobarbital. 
Indukcija CYP3A4 s fenobarbitalom.
SVR12 for genotype 1-infected peginterferon+ribavirin-experienced subjects in SAPPHIRE-II 
Preglednica 11: SVR12 pri preiskovancih, že zdravljenih s peginterferonom + ribavirinom, okuženih z genotipom 1, v preskušanju SAPPHIRE-II
2 mg single dose7 
Enkraten odmerek 2 mg 7
Mechanism: CYP3A4/OA TP1B inhibition 
CYP3A4/OAT P1B
Similarly, ombitasvir was not carcinogenic in a 2-year rat study up to the highest dose tested (30 mg per kg per day), resulting in ombitasvir exposures approximately 16-fold higher than those in humans at 25 mg. 
Podobno, ombitasvir ni bil kancerogen v 2-letni študiji pri podganah, vse do največjega testiranega odmerka (30 mg/kg/dan), ki je povzročil približno 16-krat večjo AUC izpostavljenost ombitasvirju, kot pri človeku pri 25 mg.
No dose adjustment of Viekirax is required in patients with mild hepatic impairment (Child-Pugh A). 
Bolnikom z blago okvaro jeter (Child-Pugh A) odmerka zdravila Viekirax ni treba prilagoditi.
Hepatic impairment 
Še nezdravljeni
Viekirax 12.5 mg / 75 mg / 50 mg film-coated tablets ombitasvir / paritaprevir / ritonavir 
Viekirax 12,5 mg/75 mg/50 mg filmsko obložene tablete ombitasvir/paritaprevir /ritonavir
Viekirax and dasabuvir + ribavirin 
Viekirax in dasabuvir + ribavirin
• Anaemia (low number of red blood cells) 
Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov • anemija (majhno število rdečih krvnih celic)
Ombitasvir and paritaprevir do not inhibit organic anion transporter (OAT1) in vivo and are not expected to inhibit organic cation transporters (OCT1 and OCT2), organic anion transporters (OAT3), or multidrug and toxin extrusion proteins (MATE1 and MATE2K) at clinically relevant concentrations. 
Prav tako ni pričakovati, da bi v klinično pomembnih koncentracijah zavirala prenašalce organskih kationov (OCT1 in OCT2 - organic cation transporters), prenašalec organskih anionov (OAT3) ali ekstruzijske beljakovine več zdravil in toksinov (MATE1 in MATE2K - multidrug and toxin extrusion proteins).
Geometric mean Cmax, AUC of multiple doses of Viekirax 150 mg/100 mg/25 mg once daily with dasabuvir 250 mg twice daily with food in healthy volunteers 
150 mg/100 mg/25 mg enkrat na dan in dasabuvirja 250 mg dvakrat na dan, s hrano, pri zdravih prostovoljcih.
Concomitant use is contraindicated (see section 4.3). 
Sočasna uporaba je kontraindicirana (glejte poglavje 4.3).
Mechanism: possibly due to UGT1A1 inhibition by paritaprevir, dasabuvir and ombitasvir and CYP3A4 inhibition by ritonavir 
Morda zavrtje UGT1A1 s paritaprevirjem, dasabuvirjem in ombitasvirjem ter zavrtje CYP3A4 z ritonavirjem.
Viekirax and dasabuvir in combination with ribavirin is recommended for 24 weeks in liver transplant recipients with genotype 1 HCV infection. 
Zdravilo Viekirax in dasabuvir sta skupaj z ribavirinom pri prejemnikih presajenih jeter, okuženih s HCV
NA Concomitant use of Viekirax with dasabuvir is contraindicated (see section 4.3). 
NP Sočasna uporaba z zdravilom Viekirax in dasabuvirjem je kontraindicirana (glejte poglavje 4.3).
Viekirax may be administered with or without dasabuvir. 
Zdravilo Viekirax se lahko uporablja z dasabuvirjem ali brez njega.
These medicines may be available without a prescription atorvastatin, lovastatin, simvastatin, lomitapide to lower blood cholesterol carbamazepine, phenytoin, phenobarbital for epilepsy cisapride for relieving certain stomach problems clarithromycin, fusidic acid, rifampicin, telithromycin for bacterial infections colchicine in patients who have severe problems with their liver or kidneys for treating gout attacks conivaptan for making the sodium levels in the blood normal efavirenz, etravirine, lopinavir/ritonavir, saquinavir, tipranavir, nevirapine, indinavir, cobicistat for HIV infection apalutamide,enzalutamide for prostate cancer ergotamine, dihydroergotamine for migraine headaches ergonovine, methylergometrine used in childbirth ethinyloestradiol-containing medicines such as those contained in most contraceptive pills and vaginal rings used for contraception for contraception itraconozole, ketoconozole, posaconazole, voriconazole for fungal infections midazolam, triazolam (when taken by mouth) for anxiety or trouble sleeping mitotane for symptoms of malignant tumours of the adrenal glands pimozide, lurasidone for schizophrenia quetiapine for schizophrenia, bipolar disorder and major depressive disorder quinidine for abnormal heart rhythms or malaria ranolazine for chronic angina (chest pain) 
Apalutamid, enzalutamid pri raku prostate ergotamin, dihidroergotamin pri migrenskih glavobolih ergonovin, metilergometrin uporaba pri porodu zdravila, ki vsebujejo etinilestradiol, kot je večina kontracepcijskih tablet in vaginalnih obročkov, ki se uporabljajo kot kontracepcija kontracepcija itrakonazol, ketokonazol, posakonazol, vorikonazol pri glivičnih okužbah midazolam, triazolam (če se jemlje skozi usta) pri občutku tesnobe ali težavah s spanjem mitotan pri simptomih malignih tumorjev nadledvičnih žlez pimozid, lurasidon pri shizofreniji kvetiapin pri shizofreniji, bipolarni motnji in veliki depresivni motnji kinidin pri nerednem srčnem utripu ali malariji ranolazin pri kronični angini pektoris (bolečine v prsnem košu)
Rilpivirine exposure is substantially increased (3-fold) when rilpivirine is given in combination with Viekirax and dasabuvir, with a consequent potential for QT-prolongation. 
Če je rilpivirin uporabljen v kombinaciji z zdravilom Viekirax in dasabuvirjem, se izpostavljenost rilpivirinu bistveno poveča (3-krat) in interval QT se lahko podaljša.
SVR12 for genotype 1b-infected peginterferon+ribavirin-experienced subjects in PEARL II 
Preglednica 12: SVR12 pri preiskovancih, že zdravljenih s peginterferonom + ribavirinom, okuženih z genotipom 1b, v preskušanju PEARL II
CORAL-I: treatment-naïve or pegIFN + RBV-experienced, at least 3 months post liver transplant or 12 months post renal transplant 
ugotovljenimi v preskušanjih 3. faze pri preiskovancih, okuženih samo s HCV. CORAL-I: še nezdravljeni ali že zdravljeni s pegIFN + RBV, vsaj 3 mesece po presaditvi jeter ali 12 mesecev po presaditvi ledvic
Mechanism: CYP3A4 induction by rifampicin. 
Mehanizem: Indukcija CYP3A4 z rifampicinom.
No dose adjustment needed for Viekirax. 
Odmerka zdravila Viekirax ni treba prilagoditi.
Although some cases had previous history of depression, psychiatric illness and/or substance abuse, a causal relation with Viekirax with or without dasabuvir treatment cannot be excluded. 
Čeprav so nekateri primeri vključevali predhodno zgodovino depresije, psihiatričnih bolezni in/ali zlorabe snovi,
Tacrolimus 2 mg was dosed alone, 0.5 mg administered with Viekirax and 2 mg was administered with Viekirax + dasabuvir. 
Odmerek 2 mg takrolimusa je bil uporabljen sam, odmerek 0,5 mg z zdravilom Viekirax in odmerek 2 mg z zdravilom Viekirax + dasabuvirjem.
Mechanism: OATP1B inhibition by paritaprevir and BCRP inhibition by paritaprevir, ritonavir or dasabuvir. 
OATP1B s paritaprevirjem in zavrtje BCRP s paritaprevirjem, ritonavirjem ali dasabuvirjem.
Medicinal products metabolised by glucuronidation (UGT1A1) Paritaprevir, ombitasvir and dasabuvir are inhibitors of UGT1A1. 
Paritaprevir, ombitasvir in dasabuvir zavirajo UGT1A1.
In the genotype 1b replicon, the activity of paritaprevir was reduced 76- and 159-and 337- fold by D168A, D168H, D168V, and D168Y respectively. 
V replikonu genotipa 1b so D168A, D168H, D168V in D168Y zmanjšale aktivnost paritaprevirja za 76-krat,159-krat oziroma 337-krat.
Viekirax and dasabuvir with or without RBV for 12 or 24 weeks 
Zdravljenje: zdravilo Viekirax in dasabuvir z ali brez RBV 12 ali 24 tednov