FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean absolute bioavailability of simeprevir following a single oral 150 mg dose of simeprevir in fed conditions is 62%.
Slovenian: Po zaužitju enkratnega 150 mg odmerka simeprevirja v stanju sitosti je povprečna absolutna biološka uporabnost simeprevirja 62%.
English: If other medicinal products used in combination with OLYSIO for the treatment of CHC are permanently discontinued for any reason, OLYSIO must also be discontinued.
Slovenian: Če je zaradi katerega koli vzroka treba prekiniti zdravljenje z zdravili, ki se uporabljajo za zdravljenje CHC v kombinaciji z zdravilom OLYSIO, je treba ukiniti tudi zdravilo OLYSIO.
English: Co-administration of OLYSIO with medicinal products that are substrates for OATP1B1/3, P-gp and BCRP transport may result in increased plasma concentrations of such medicinal products (see table 4).
Slovenian: Sočasna uporaba zdravila OLYSIO z zdravili, ki so substrati prenašalcev OATP1B1/3, P-gp in BCRP, lahko zveča koncentracijo teh zdravil v plazmi (glejte preglednico 4).
English: Superior versus historical control rate (historical SVR rates of approved combination treatments of direct acting antivirals with peginterferon alfa and ribavirin).
Slovenian: Superioren v primerjavi s predhodnimi kontrolami (predhodne stopnje SVR odobrene kombinacije zdravljenja z direktnim delovanjem na viruse s peginterferonom alfa in ribavirinom).
English: Supernumerary ribs and delayed ossification were reported in mice at 4-fold higher exposures than those observed in humans at the recommended dose of 150 mg once daily.
Slovenian: Pri miših so poročali o nadštevilčnih rebrih in zapozneli osifikaciji pri izpostavljenosti, ki je 4-krat presegala izpostavljenost, opaženo pri ljudeh pri uporabi priporočenega odmerka 150 mg enkrat na dan.
English: In dogs, simeprevir was associated with a reversible multifocal hepatocellular necrosis with associated increases in ALT, AST, alkaline phosphatase and/or bilirubin.
Slovenian: Pri psih je bil simeprevir povezan z reverzibilno multifokalno hepatocelularno nekrozo in s pridruženimi zvečanji koncentracij alanin-aminotransferaze (ALT), aspartat-aminotransferaze (AST), alkalne fosfataze in/ali bilirubina.
English: OLYSIO 150 mg capsules simeprevir
Slovenian: OLYSIO 150 mg kapsule simeprevir
English: SVR12 rates were statistically significantly higher for patients receiving simeprevir with peginterferon alfa-2a or peginterferon alfa-2b and ribavirin (88% and 78%, respectively) compared to patients receiving placebo with peginterferon alfa-2a or peginterferon alfa-2b and ribavirin (62% and 42%, respectively) (study C216).
Slovenian: Deleži bolnikov, ki so dosegli SVR12, so bili statistično značilno večji pri bolnikih, ki so prejemali simeprevir in peginterferon alfa-2a oziroma peginterferon alfa-2b ter ribavirin (88% oziroma 78%) v primerjavi s tovrstnimi deleži pri bolnikih, ki so prejemali placebo in peginterferon alfa-2a oziroma peginterferon alfa-2b ter ribavirin (62% oziroma 42%) (študija C216).
English: Eighty-eight percent (459/521) of the simeprevir-treated patients were eligible for a total treatment duration of 24 weeks; in these patients the SVR12 rate was 88%.
Slovenian: Oseminosemdeset odstotkov (459/521) bolnikov, ki so prejemali simeprevir, je bilo primernih za skupno trajanje zdravljenja 24 tednov, med temi bolniki jih je 88% doseglo SVR12.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking OLYSIO.
Slovenian: Če karkoli od zgoraj navedenega velja za vas (ali če o tem niste prepričani), se pred začetkom jemanja zdravila OLYSIO posvetujte z zdravnikom ali farmacevtom.
English: If you develop a photosensitivity reaction during treatment, contact your doctor immediately.
Slovenian: Če se pri vas med zdravljenjem pojavi fotosenzitivna reakcija, se nemudoma obrnite na svojega
English: The interaction between simeprevir and the medicinal product was evaluated in a pharmacokinetic substudy within a phase 2 study in 22 HCV infected patients.
Slovenian: Medsebojno delovanje med simeprevirjem in tem zdravilom so ocenjevali v farmakokinetični podštudiji v okviru študije faze 2 pri 22 bolnikih, okuženih s HCV.
English: In patients with HCV genotype 1a with a baseline Q80K amino acid substitution an emerging R155K substitution was observed most frequently at failure.
Slovenian: Pri bolnikih s HCV genotipa 1a, ki so imeli ob izhodišču substitucijo aminokislin Q80K, so ob neuspehu zdravljenja najpogosteje opažali pojav substitucije R155K.
English: The following side effects may happen with OLYSIO when used in combination with sofosbuvir: Common: may affect up to 1 in 10 people:
Slovenian: Pri jemanju zdravila OLYSIO skupaj s sofosbuvirjem se lahko pojavijo naslednji neželeni učinki: Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov:
English: When OLYSIO is used with ribavirin, please read the package leaflet for ribavirin for information regarding pregnancy.
Slovenian: Kadar jemljete zdravilo OLYSIO skupaj z ribavirinom preberite navodila o preprečevanju nosečnosti za ribavirin.
English: - you have ever taken any medicines to treat hepatitis C; - you have any other liver problems in addition to hepatitis C; - you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely; - you have had or are going to have an organ transplant.
Slovenian: P Pred začetkom jemanja zdravilo OLYSIO, se posvetujte z zdravnikom ali farmacevtom o vseh svojih boleznih, še zlasti če: - imate hepatitis C, ki ni ‘genotipa 1' ali ‘genotipa 4' - ste že jemali katero koli zdravilo za zdravljenje hepatitisa C - imate poleg hepatitisa C tudi druge težave z jetri - imate ali ste imeli okužbo z virusom hepatitisa B, ker vas bo zdravnik morda bolj skrbno spremljal - so vam presadili organ ali načrtujete presaditev organa
English: In vitro experiments show that simeprevir is a substrate for the drug transporters P-glycoprotein (P-gp), MRP2, OATP1B1/3 and OATP2B1.
Slovenian: Poskusi in vitro kažejo, da je simeprevir substrat prenašalcev zdravilnih učinkovin P-glikoproteina (P-gp), MRP2, OATP1B1/3 in OATP2B1.
English: Amino acid substitutions at NS3 positions 43, 80, 122, 155, 156, and 168 reduced in vitro simeprevir activity.
Slovenian: Substitucije aminokislin NS3 na položajih 43, 80, 122, 155, 156 in 168 so zmanjšale delovanje simeprevirja in vitro.
English: During administration of simeprevir with peginterferon alfa and ribavirin, the elevations in direct and indirect bilirubin were generally not associated with elevations in liver transaminases and normalised
Slovenian: Med jemanjem simeprevirja v kombinaciji s peginterferonom alfa in ribavirinom zvečanje direktnega in indirektnega bilirubina na splošno ni bilo povezano z zvečanjem koncentracije jetrnih transaminaz.
English: Note, substitutions at NS3 position 43 and 156 associated with reduced simeprevir activity in vitro were not observed at
Slovenian: Opozoriti velja na substituciji NS3 na položajih 43 in 156, ki sta in vitro zmanjšali aktivnost simeprevirja, pri bolnikih pa ju v času neuspeha zdravljenja niso opažali.
English: Co-administration of OLYSIO with ciclosporin is not recommended as this leads to significantly higher exposure of simeprevir (see section 4.5).
Slovenian: Sočasna uporaba zdravila OLYSIO s ciklosporinom ni priporočljiva, ker pomembno zveča izpostavljenost simeprevirju (glejte poglavje 4.5).
English: Adverse reactions of simeprevir in combination with sofosbuvir or in combination with peginterferon alfa and ribavirin reported in adult patients with HCV genotype 1 infection are listed in table 5.
Slovenian: Neželeni učinki simeprevirja v kombinaciji s sofosbuvirjem ali v kombinaciji s peginterferonom alfa in ribavirinom, o katerih so poročali pri odraslih bolnikih, okuženih s HCV genotipa 1, so navedeni v preglednici 5.
English: - carbamazepine, oxcarbazepine, phenobarbital or phenytoin to prevent seizures - astemizole or terfenadine to treat allergies - itraconazole, fluconazole, ketoconazole, posaconazole or voriconazole (when taken by mouth or given by injection) to treat fungal infections - rifabutin, rifampicin or rifapentine to treat infections like tuberculosis - amlodipine, bepridil, diltiazem, felodipine, nicardipine, nifedipine, nisoldipine or verapamil
Slovenian: - karbamazepin, okskarbazepin, fenobarbital ali fenitoin za preprečevanje epileptičnih napadov - astemizol ali terfenadin za zdravljenje alergij - itrakonazol, flukonazol, ketokonazol, posakonazol ali vorikonazol (če zdravilo zaužijete ali ga prejmete z injekcijo) za zdravljenje glivičnih okužb - rifabutin, rifampicin ali rifapentin za zdravljenje okužb, kot je tuberkuloza - amlodipin, bepridil, diltiazem, felodipin, nikardipin, nifedipin, nisoldipin ali verapamil (če zdravilo zaužijete) za znižanje krvnega tlaka - deksametazon (če zdravilo prejmete z injekcijo ali ga zaužijete) za zdravljenje astme,
English: Co-administration of OLYSIO with medicinal products that are primarily metabolised by CYP3A4 may result in increased plasma concentrations of such medicinal products (see table 4).
Slovenian: Sočasna uporaba zdravila OLYSIO z zdravili, ki se presnavljajo predvsem s CYP3A4, lahko zveča koncentracijo teh zdravil v plazmi (glejte preglednico 4).
English: There are limited data on the safety and efficacy of OLYSIO in patients older than 65 years.
Slovenian: Podatki o varnosti in učinkovitosti uporabe zdravila OLYSIO pri bolnikih, starejših od 65 let, so omejeni.
English: Grade 3 or 4 adverse reactions were reported in 3.1% of patients receiving simeprevir with peginterferon alfa and ribavirin versus 0.5% of patients receiving placebo with peginterferon alfa and ribavirin.
Slovenian: O neželenih učinkih stopnje 3 ali 4 so poročali pri 3,1% bolnikov, ki so prejemali simeprevir skupaj s peginterferonom alfa in z ribavirinom, v primerjavi z 0,5% pri bolnikih, ki so prejemali placebo skupaj s peginterferonom alfa in z ribavirinom.
English: Capsule content Sodium lauryl sulfate Magnesium stearate Colloidal anhydrous silica Croscarmellose sodium Lactose monohydrate
Slovenian: Vsebina kapsule natrijev lavrilsulfat magnezijev stearat koloidni brezvodni silicijev dioksid
English: 24 weeks simeprevir + sofosbuvir
Slovenian: 24 tednov simeprevir + sofosbuvir
English: The overall SVR12 rate for patients without cirrhosis receiving 8 weeks of simeprevir + sofosbuvir was 83% (128/155); all patients not achieving SVR12 had viral relapse (17%; 27/155).
Slovenian: Celokupna stopnja SVR12 za bolnike brez ciroze, ki so 8 tednov prejemali simeprevir + sofosbuvir, je bila 83% (128/155); pri vseh bolnikih, ki niso dosegli SVR12, se je bolezen ponovila (17%; 27/155).
English: When administered to lactating rats, simeprevir was detected in plasma of suckling rats likely due to excretion of simeprevir via milk.
Slovenian: Po odmerjanju doječim podganam so v plazmi dojenih podgan izmerili določeno koncentracijo simeprevirja, verjetno zaradi izločanja simprevirja v mleko.
English: Ninety-six percent of simeprevir-selected genotype 1 replicons carried one or multiple amino acid substitutions at NS3 protease positions 43, 80, 155, 156, and/or 168, with substitutions at NS3 position D168 being most frequently observed (78%).
Slovenian: Šestindevetdeset odstotkov replikonov genotipa 1, izbranih s simeprevirjem, je vključevalo eno ali več substitucij aminokislin proteaze NS3 na položajih 43, 80, 155, 156 in/ali 168, pri čemer so najbolj pogosto opažali substitucije NS3 na položaju D168 (78%).
English: Caution is warranted and clinical monitoring of patients is recommended when these calcium channel blockers are given orally.
Slovenian: Pri peroralnem dajanju teh zaviralcev kalcijevih kanalčkov, se priporoča klinično spremljanje bolnikov.
English: Simeprevir-resistant variants studied remained susceptible to representative HCV nucleoside and non-nucleoside polymerase inhibitors, and NS5A inhibitors.
Slovenian: Raziskovane, na simeprevir odporne variante virusa so ostale občutljive na predstavnike nukleozidnih in nenukleozidnih zaviralcev polimeraz ter na zaviralce NS5A.
English: Bepridil
Slovenian: prednizon
English: The recommended co-administered medicinal product(s) and treatment duration for OLYSIO combination therapy are provided in tables 1 and 2.
Slovenian: Priporočeno(a) zdravilo(a), ki se daje(jo) sočasno in trajanje zdravljenja s kombinirano terapijo z zdravilom OLYSIO je (so) opisano(i) v preglednicah1 in 2.
English: Amino acid substitutions at NS3 positions 80, 122, 155, and/or 168, associated with in vitro low level resistance to simeprevir when occurring alone, reduced simeprevir activity by more than 50-fold when present in combination.
Slovenian: Substitucije aminokislin NS3 na položajih 80, 122, 155 in/ali 168 povzročijo in vitro nizko stopnjo odpornosti na simeprevir, če so prisotne samostojno, v kombinaciji pa zmanjšajo delovanje simeprevirja za več kot 50-krat.
English: In study HPC2014 (OSIRIS), patients received simeprevir + sofosbuvir for 8 weeks (patients without cirrhosis) or 12 weeks (patients with or without cirrhosis) (see table 11).
Slovenian: V študiji HPC2014 (OSIRIS) so bolniki 8 tednov (bolniki brez ciroze) ali 12 tednov (bolniki s cirozo ali brez ciroze) prejemali simeprevir + sofosbuvir (glejte preglednico 11).
English: Co-administration of OLYSIO with moderate or strong inhibitors of CYP3A4 may significantly increase the plasma exposure of simeprevir, while co-administration with moderate or strong inducers of CYP3A4 may significantly reduce the plasma exposure of simeprevir and lead to loss of efficacy (see table 4).
Slovenian: Sočasna uporaba zdravila OLYSIO z zmernimi ali močnimi zaviralci CYP3A4 lahko bistveno poveča izpostavljenost simeprevirju v plazmi, medtem ko lahko sočasna uporaba zmernih ali močnih induktorjev CYP3A4 bistveno zmanjša izpostavljenost simeprevirju v plazmi in zmanjša njegovo učinkovitost (glejte preglednico 4).
English: Cases are potentially life threatening, therefore amiodarone should only be used in patients on OLYSIO combination treatment with sofosbuvir when other alternative antiarrhythmic treatments are
Slovenian: Ti pojavi so lahko življensko nevarni, zato se pri bolnikih, ki prejemajo zdravilo OLYSIO v kombinaciji sofosbuvirjem, lahko amidaron uporablja le kadar so druga antiaritmična zdravila kontraindicirana ali jih bolnik ne prenaša.
English: Discontinuation of simeprevir due to rash or pruritus occurred in 0.8% and 0.1% of simeprevir-treated patients, compared to 0.3% and 0% of placebo-treated patients, respectively.
Slovenian: Do prekinitve zdravljenja s simeprevirjem zaradi izpuščaja ali srbenja je prišlo pri 0,8% in 0,1% bolnikov, ki so se zdravili s simeprevirjem, v primerjavi z 0,3% in
English: The overall SVR12 rate for patients without cirrhosis receiving 8 weeks of simeprevir + sofosbuvir was 75% (15/20); all patients not achieving SVR12 had viral relapse (25%; 5/20).
Slovenian: Celokupna stopnja SVR12 za bolnike brez ciroze, ki so 8 tednov prejemali simeprevir + sofosbuvir, je bila 75% (15/20); pri vseh bolnikih, ki niso dosegli SVR12, se je bolezen ponovila (25%; 5/20).
English: Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin.
Slovenian: Pri vseh živalskih vrstah, ki so bile izpostavljene ribavirinu, so dokazali pomembne teratogene in/ali embriocidne učinke tega zdravila.
English: When administered to lactating rats, simeprevir was detected in plasma of suckling rats likely due to excretion of simeprevir via milk (see section 5.3).
Slovenian: Po odmerjanju doječim podganam so v plazmi dojenih podgan izmerili določeno koncentracijo simeprevirja, verjetno zaradi izločanja simprevirja v mleko (glejte poglavje 5.3).
English: One patient in the 12-week treatment group (0.3%) and none of the patients in the 24-week treatment group discontinued treatment due to adverse reactions.
Slovenian: V 12-tedenski skupini je zaradi neželenih učinkov zdravljenje prekinil 1 bolnik (0,3%), v 24-tedenski skupini pa zdravljenja ni prekinil noben bolnik.
English: Resistance to simeprevir was characterised in HCV genotype 1a and 1b replicon-containing cells.
Slovenian: Odpornost na simeprevir so ovrednotili v celicah, ki so vsebovale replikon HCV z genotipom 1a in 1b.
English: ≥ 1.1 to ≤ 1.5 x ULN 34 (11.9%)
Slovenian: > 3,0 to ≤ 5,0 x ZMN 1 (0,3%)
English: Table 1: Recommended treatment duration for OLYSIO combination therapy with sofosbuvir with or without ribavirin in patients with HCV genotype 1 or 4 Patient population
Slovenian: Preglednica 1: Priporočeno trajanje zdravljenja z zdravilom OLYSIO v kombinaciji s sofosbuvirjem in ribavirinom ali brez ribavirina pri bolnikih s HCV genotipa 1 ali 4 Populacija bolnikov
English: Sustained virologic response (SVR) was the primary endpoint in all studies and was defined as HCV RNA less than the lower limit of quantification (LLOQ) detectable or undetectable 12 weeks (SVR12) or 24 weeks (SVR24) after the planned end of treatment (studies C206, C208, C212, C216, HPC2002, HPC3007 and HPC3011) or after the actual end of treatment (studies HPC2014, HPC3017, HPC3018 and HPC3021) (LLOQ of 25 IU/ml and limit of detection of 15 IU/ml, except in studies HPC2014 and HPC3021 where LLOQ and limit of detection were 15 IU/ml).
Slovenian: Trajni virološki odziv (SVR- sustained virologic response) je bil primarni opazovani dogodek v vseh študijah, opredeljen kot koncentracija HCV RNK manj kot spodnja meja kvantifikacije (LLOQ-lower limit of quantification), zaznavna ali nezaznavna 12 tednov (SVR12) ali 24 tednov (SVR24) po načrtovanem zaključku zdravljenja (študije C206, C208, C212, C216, HPC2002, HPC3007 in HPC3011) ali po dejanskem zaključku zdravljenja (študije HPC2014, HPC3017, HPC3018 in HPC3021) (LLOQ 25 i.e./ml in meja zaznavnosti 15 i.e./ml, razen v študijah HPC2014 in HPC302, kjer sta bili LLOQ in meja zaznavnosti 15 i.e./ml).
English: If you have any further questions about any of these medicines, ask your doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja o katerem koli od teh zdravil, se posvetujte z zdravnikom ali farmacevtom.
English: Simeprevir in combination with peginterferon alfa and ribavirin The efficacy of simeprevir in combination with peginterferon alfa and ribavirin was evaluated in patients with HCV genotype 1 or 4 infection, with or without HIV-1 co-infection, who were treatment-naïve or treatment-experienced (following prior interferon-based therapy) (tables 17 and
Slovenian: Simeprevir v kombinaciji s peginterferonom alfa in ribavirinom Učinkovitost simeprevirja v kombinaciji s peginterferonom alfa in ribavirinom so ocenjevali pri bolnikih z okužbo s HCV genotipa 1 ali 4, z ali brez sočasne okužbe s HIV-1, ki še niso bili zdravljeni ali pa so zdravljenje že prejemali (po predhodnem zdravljenju na osnovi interferona) (preglednici 17 in
English: Simeprevir in combination with sofosbuvir
Slovenian: Simeprevir v kombinaciji s sofosbuvirjem
English: 24 weeks OLYSIO + sofosbuvir or 12 weeks OLYSIO + sofosbuvir + ribavirin
Slovenian: 24 tednov OLYSIO + sofosbuvir ali 12 tednov OLYSIO + sofosbuvir + ribavirin
English: OLYSIO in combination with peginterferon alfa-2b In the clinical studies, patients randomised to simeprevir in combination with peginterferon alfa-2b and ribavirin obtained numerically lower SVR12 rates and also experienced viral breakthrough and viral relapse more frequently than those treated with simeprevir in combination with peginterferon alfa-2a and ribavirin (see section 5.1).
Slovenian: Uporaba zdravila OLYSIO v kombinaciji s peginterferonom alfa-2b Bolniki, ki so bili v kliničnih študijah randomiziranih na simeprevir v kombinaciji s peginterferonom alfa-2b in ribavirinom so imeli številčno manjšo pogostnost doseganja SVR12, pogostejši virusni preboj in pogostejšo ponovitev bolezni v primerjavi z bolniki, ki so se zdravili s simeprevirjem v kombinaciji s peginterferonom alfa-2a in ribavirinom (glejte poglavje 5.1).
English: Effect of baseline HCV polymorphisms on treatment response Analyses were conducted to explore the association between naturally-occurring baseline NS3/4A amino acid substitutions (polymorphisms) and treatment outcome.
Slovenian: Vpliv prisotnosti polimorfizma virusa hepatitis C ob izhodišču na odziv na zdravljenje Analizirali so podatke, da bi raziskali povezavo med naravnimi substitucijami aminokislin NS3/4A, ki so prisotne že ob izhodišču (kar je polimorfizem), in izidom zdravljenja.
English: Data from a phase 2 study in 9 HCV infected post-liver transplant patients.
Slovenian: Podatki iz študije faze 2 pri 9 bolnikih s presaditvijo jeter, okuženih s HCV.
English: 1 12 weeks simeprevir + sofosbuvir N = 286 n (%)
Slovenian: 12 tednov simeprevir + sofosbuvir N = 286 n (%)
English: Treatment stopping rules for HCV therapy were used to ensure that patients with inadequate on-treatment virologic response discontinued treatment in a timely manner.
Slovenian: Za pravočasno ukinitev zdravljenja s HCV so pri bolnikih z nezadostnim virološkim odzivom uporabili smernice za ukinitev zdravljenja s HCV.
English: OLYSIO 150 mg hard capsules
Slovenian: OLYSIO 150 mg trde kapsule
English: In study HPC3011 in HCV genotype 4 infected patients, 28 of 32 (88%) patients who did not achieve SVR had emerging amino acid substitutions at NS3 positions 80, 122, 155, 156 and/or 168 (mainly substitutions at position 168; 24 out of 32 [75%] patients), similar to the emerging amino acid substitutions observed in genotype 1 infected patients.
Slovenian: V študiji HPC3011, pri bolnikih, okuženih s HCV genotipa 4, je pri 28 od 32 bolnikov (88%), ki niso dosegli SVR, prišlo do substitucije aminokislin NS3 na položajih 80, 122, 155, 156 in/ali 168 (predvsem substitucije na položaju 168; pri 24 od 32 [75%] bolnikov), podobno kot pri substituciji aminokislin, opaženi pri bolnikih, okuženih z genotipom 1.
English: It is not recommended to co-administer OLYSIO with astemizole or terfenadine.
Slovenian: Sočasna uporaba zdravila OLYSIO z astemizolom ali s terfenadinom ni priporočljiva.
English: 24 weeks simeprevir + sofosbuvir N = 31 n (%)
Slovenian: 24 tednov simeprevir + sofosbuvir N = 31 n (%)
English: Table 14: Treatment outcome in HCV genotype 1 infected patients without cirrhosis receiving 12 weeks simeprevir + sofosbuvir, with or without ribavirin simeprevir + sofosbuvir + ribavirin N = 43 % (n/N)
Slovenian: Preglednica 14: Izid zdravljenja bolnikov, okuženih s HCV genotipa 1, brez ciroze, ki so 12 tednov prejemali simeprevir + sofosbuvir, z ribavirinom ali brez ribavirina simeprevir + sofosbuvir + ribavirin N = 43 % (n/N)
English: HCV geno/subtype and presence of Q80K polymorphism in HCV genotype 1a p < 0.001 compared to historical control of peginterferon alfa and ribavirin.
Slovenian: HCV geno/podtip in prisotnost polimorfizma Q80K HCV genotipa 1a p < 0,001 v primerjavi z zgodovinskimi kontrolami, za uporabo peginterferona alfa in ribavirina.
English: Carcinogenicity studies with
Slovenian: Študij karcinogenosti simeprevirja niso
English: Simeprevir is metabolised in the liver.
Slovenian: Simeprevir se presnavlja v jetrih.
English: Genotype 1a and 1b isolates with a baseline Q80K polymorphism resulted in median FC in simeprevir EC50 of 11 (N = 33) and 8.4 (N = 2), respectively.
Slovenian: Pri izolatih genotipa 1a in 1b z izhodiščnim polimorfizmom Q80K je prišlo do mediano 11-kratnega (N = 33) oziroma 8,4-kratnega (N = 2) povečanja EC50 simeprevirja.
English: All patients with or without cirrhosis receiving 12 weeks of simeprevir + sofosbuvir achieved SVR12 (table 16).
Slovenian: Vsi bolniki s cirozo ali brez ciroze, ki so 12 tednov prejemali simeprevir + sofosbuvir, so dosegli SVR12
English: Patients with HCV genotype 1a predominantly had emerging R155K alone or in combination with amino acid substitutions at NS3 positions 80, 122 and/or 168, while patients with HCV genotype 1b had most often an emerging D168V substitution (table 10).
Slovenian: Pri bolnikih s HCV genotipa 1a je večinoma prišlo do substitucije R155K samostojno ali v kombinaciji s substitucijami aminokislin NS3 na položajih 80, 122 in/ali 168, medtem ko je pri bolnikih s HCV genotipa 1b najpogosteje prišlo do substitucije D168V (preglednica 10).