FrancophonIA/ELRC3.0 huggingface dataset:
English: Simeprevir is extensively bound to plasma proteins ( 99.9%), primarily to albumin and, to a lesser extent, alfa-1-acid glycoprotein.
Maltese: Simeprevir jinrabat b'mod estensiv ma' proteini fil-plażma (> 99.9%), prinċipalment mal-albumina u, sa ċertu punt, ma' alfa-1-acid glycoprotein.
English: OLYSIO 150 mg capsules simeprevir
Maltese: OLYSIO 150 mg kapsuli ibsin simeprevir
English: OLYSIO 150 mg hard capsules
Maltese: OLYSIO 150 mg kapsuli ibsin
English: Frequency Category simeprevir + sofosbuvir simeprevir + peginterferon alfa + ribavirin N = 781
Maltese: Frekwenza simeprevir + sofosbuvir simeprevir + peginterferon alfa + ribavirin N = 781
English: OLYSIO is available in packs containing 7 capsules (1 blister) or 28 capsules (4 blisters).
Maltese: OLYSIO huwa disponibbli f'pakketti li jkun fihom 7 kapsuli (folja 1) jew 28 kapsula (4 folji).
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
Maltese: - carbamazepine, oxcarbazepine, phenobarbital jew phenytoin biex jiġu evitati aċċessjonijiet - astemizole jew terfenadine biex jiġu trattati allerġiji - itraconazole, fluconazole, ketoconazole, posaconazole jew voriconazole (meta jittieħdu mill ħalq jew jingħataw b'injezzjoni) biex jiġu ttrattati infezzjonijiet bil-fungi - rifabutin, rifampicin jew rifapentine biex jiġu ttrattati infezzjonijiet bħat-tuberkulożi - amlodipine, bepridil, diltiazem, felodipine, nicardipine, nifedipine, nisoldipine jew verapamil
English: 150 mg simeprevir 12 weeks % (n/N)
Maltese: 150 mg simeprevir 12-il ġimgħa % (n/N)
English: Simeprevir is not a clinically relevant inhibitor of cathepsin A enzyme activity.
Maltese: Simeprevir mhux impeditur klinikament rilevanti tal-attività enzimatika ta' cathepsin A.
English: Grade 1
Maltese: Hörgatúni 2
English: Amino acid substitutions at NS3 positions 43, 80, 122, 155, 156, and 168 reduced in vitro simeprevir activity.
Maltese: Sostituzzjonijiet ta' aċidi amminiċi fil-pożizzjonijiet ta' NS3 ta' 43, 80, 122, 155, 156 u 168 naqqsu l-attività ta' simeprevir in vitro.
English: Resistance in clinical studies
Maltese: Reżistenza fi studji kliniċi
English: Janssen-Cilag SpA, Via C. Janssen, Borgo San Michele, 04100 Latina, Italy
Maltese: Janssen, Borgo San Michele, 04100 Latina, L-Italja
English: OLYSIO is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients (see sections 4.2, 4.4 and 5.1).
Maltese: OLYSIO huwa indikat biex jingħata f'kombinazzjoni ma' prodotti mediċinali oħra, għat-trattament ta' epatite Ċ kronika (CHC) (chronic hepatitis C, CHC) f'pazjenti adulti (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: 24 weeks simeprevir + sofosbuvir
Maltese: 24 ġimgħa simeprevir + sofosbuvir
English: White gelatin capsule of approximately 22 mm in length, marked with “TMC435 150” in black ink.
Maltese: Kapsula bajda tal-ġelatina twila madwar 22 mm, immarkata b' "TMC435 150" b'linka sewda.
English: Janssen-Cilag GmbH Johnson & Johnson Platz 1 D-41470 Neuss Tel: +49 2137 955-955
Maltese: Janssen-Cilag GmbH Johnson & Johnson Platz 1 D-41470 Neuss
English: Variants carrying amino-acid substitutions conferring reduced susceptibility to NS5A inhibitors (L31F/V, Y93C/H), nucleoside polymerase inhibitors (S282T) and non-nucleoside polymerase inhibitors (C316N, M414I/L, P495A) remained susceptible to simeprevir in vitro.
Maltese: Varjanti li jġorru s-sostituzzjonijiet ta' aċidu amminiku li jġibu magħhom suxxetibilità mnaqqsa għal impedituri ta' NS5A (L31F/V, Y93C/H), impedituri nukleoside ta' polymerase (S282T) u impedituri mhux nukleoside ta' polimerase (C316N, M414I/L, P495A) baqgħu suxxetibbli għal simeprevir in vitro.
English: Table 21: SVR12 rates for selected subgroups (study HPC3007) simeprevir + peginterferon + ribavirin % (n/N)
Maltese: Rati ta' SVR12 għal sottogruppi magħżula (studju HPC3007) simeprevir + peginterferon + ribavirin % (n/N)
English: Simeprevir inhibits OATP1B1/3, P-gp and BCRP transporters.
Maltese: Simeprevir jimpedixxi t-trasportaturi OATP1B1/3, P-gp u BCRP.
English: The presence of 50% human serum reduced simeprevir replicon activity by 2.4-fold.
Maltese: Il-preżenza ta' 50% serum uman naqqas l-attività ta' replikon ta' simeprevir bi 2.4 darbiet.
English: Astemizole and terfenadine have the potential for cardiac arrhythmias.
Maltese: Astemizole u terfanadine għandhom il-potenzjal għal arritmiji kardijaċi.
English: Superior versus historical control rate (historical SVR rates of approved combination treatments of direct acting antivirals with peginterferon alfa and ribavirin).
Maltese: Rata ta' kontroll superjuri versus dik storika (rati storiċi approvati ta' SVR ta' kombinazzjonijiet approvati ta' trattamenti ta' antivirali li jaħdmu b'mod dirett flimkien ma' peginterferon alfa u ribavirin).
English: Janssen-Cilag SpA Via C. Janssen Borgo San Michele 04100 Latina Italy
Maltese: Janssen Borgo San Michele 04100 Latina L-Italja
English: In study C208, all patients received peginterferon alfa-2a; in study C216, 69% of the patients received peginterferon alfa-2a and 31% received peginterferon alfa-2b.
Maltese: Fl-istudju C208, ilpazjenti kollha rċivew peginterferon alfa-2a; fl-istudju C216, 69% tal-pazjenti rċivew peginterferon alfa-2a u 31% rċivew peginterferon alfa-2b.
English: Rash has been observed with OLYSIO combination treatment (see section 4.8).
Maltese: Ir-raxx ġie osservat b'OLYSIO fi trattament ikkombinat (ara sezzjoni 4.8).
English: Note, substitutions at NS3 position 43 and 156 associated with reduced simeprevir activity in vitro were not observed at
Maltese: Nota, sostituzzjonijiet ta' NS3 f'pożizzjoni 43 u 156 assoċjati ma' tnaqqis fl-attività ta' simeprevir in vitro ma ġewx osservati fi żmien ta' falliment.
English: Increase in sofosbuvir exposure observed in the pharmacokinetic substudy is not clinically relevant.
Maltese: Żieda fl-esponiment ta' sofosbuvir osservat fis-sottostudju farmakokinetiku mhux klinikament rilevanti.
English: 12 weeks SMV + peg-IFN-alfa + RBV, followed by 12 or 36 weeks peg-IFN-alfa + RBV control group: 48 weeks placebo + peg-IFN-alfa + RBV
Maltese: 12-il ġimgħa ta' SMV + peg-IFN-alfa + RBV, segwiti minn 12 jew 36 ġimgħa peg-IFN-alfa + RBV grupp ta' kontroll: 48 ġimgħa ta' plaċebo + peg-IFN-alfa + RBV
English: In these patients the SVR12 rates were 96%, 94%, 100% and 68%,
Maltese: F'dawn il-pazjenti r-rati ta' SVR kienu 96%. 94%, 100% u 68% rispettivament.
English: In a biochemical assay, simeprevir inhibited the proteolytic activity of recombinant genotype 1a and 1b HCV NS3/4A proteases, with median Ki values of 0.5 nM and 1.4 nM, respectively.
Maltese: F'analiżi bijokimika, simeprevir impedixxa l-attività proteolitika ta' ġenotip 1a u 1b ta' HCV NS3/4A proteases rikombinanti, b'valuri Ki medjani ta' 0.5 nM u 1.4 nM rispettivament.
English: Bepridil
Maltese: Azzjoni
English: Discontinuation of simeprevir due to ‘blood bilirubin increased' was rare (0.1%; n = 1).
Maltese: Il-waqfien ta' simeprevir minħabba ‘żieda fil-bilirubin fid-demm' kien rari (0.1%; n = 1).
English: Simeprevir is a specific inhibitor of the HCV NS3/4A serine protease, which is essential for viral replication.
Maltese: Simeprevir huwa impeditur speċifiku ta' HCV NS3/4A serine protease, li hu essenzjali għal replikazzjoni virali.
English: SVR: SVR12 for study HPC3007 and SVR24 for study C206.
Maltese: SVR: SVR12 għall-istudju HPC3007 u SVR24 għall-istudju C206. p < 0.001.
English: Discontinue peginterferon alfa and ribavirin
Maltese: Waqqaf peginterferon alfa u ribavirin
English: Pharmacotherapeutic group: Antivirals for systemic use, direct acting antivirals, ATC code: J05AE14.
Maltese: Antivirali għal użu sistemiku, antivirali li jaġixxi direttament, Kodiċi ATC:
English: Age (18-73 years) had no clinically meaningful effect on the pharmacokinetics of simeprevir based on a population pharmacokinetic analysis (n = 21, age above 65 years) of HCV infected patients treated with simeprevir.
Maltese: L-età (18-il sena73 sena) ma kellha l-ebda effett klinikament validu fuq il-farmakokinetiċi ta' simeprevir abbażi tal-analiżi farmakokinetika tal-popolazzjoni (n = 21, eta taħt 65 sena) ta' pazjenti infettati b'HCV trattati b' simeprevir.
English: Relapsers after prior interferon-based therapy.
Maltese: Irkadew wara terapija preċedenti abbażi ta' interferon.
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.
Maltese: Iżolati ta' ġenotip 1a u 1b b'linja bażi ta' polimorfiżmu ta' Q80K irriżulta f'FC medjan għal EC50 ta' simeprevir ta' 11 (N = 33) u 8.4 (N = 2) rispettivament.
English: Each hard capsule contains simeprevir sodium equivalent to 150 mg simeprevir.
Maltese: Kull kapsula iebsa fiha simeprevir sodium ekwivalenti għal 150 mg ta' simeprevir.
English: Refer to table 3 for treatment stopping rules based on HCV RNA levels at weeks 4, 12 and 24 for patients receiving treatment with OLYSIO, peginterferon alfa and ribavirin.
Maltese: Irreferi għal tabella 3 għal regoli marbuta ma' waqfien ta' trattament bażati fuq livelli ta' HCV RNA fil-ġimgħat 4, 12 u 24 għal pazjenti fuq trattament ta' OLYSIO, peginterferon alfa u ribavirin.
English: Chemistry Amylase
Maltese: Aluminium jew
English: Substitutions such as D168V or A, and R155K were usually associated with large reductions in susceptibility to simeprevir in vitro (FC in EC50 > 50), whereas other substitutions such as Q80K or R, S122R, and D168E displayed in vitro low level resistance (FC in EC50 between 2 and 50).
Maltese: Sostituzzjonijiet bħal D168V jew A, u R155K kienu ġeneralment assoċjati ma' tnaqqis kbir fis-suxxetibilità ta' simeprevir in vitro, (FC f'EC50 > 50), filwaqt li sostituzzjonijiet oħra bħal Q80K jew R, S122R, u D168E wrew reżistenza ta' livell baxx (FC f'EC50bejn 2 u 50).
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.
Maltese: Reazzjonijiet avversi ta' grad 3 jew 4 kienu rapportati fi 3.1% tal-pazjenti li rċevew simeprevir ma' peginterferon alfa u ribavirin kontra 0.5% ta' pazjenti li qed jirċievu plaċebo b'peginterferon alfa u ribavirin.
English: 12 weeks N = 286
Maltese: 12-il ġimgħa N = 286
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.
Maltese: Ġeno/sottotip ta' HCV u l-preżenza ta' polimorfiżmu ta' Q80K f'HCV tal-ġenotip 1a p < 0.001 imqabbel ma' kontroll storiku ta' peginterferon alfa u ribavirin.
English: 24 weeks OLYSIO + sofosbuvir or 12 weeks OLYSIO + sofosbuvir + ribavirin
Maltese: 24 ġimgħa OLYSIO + sofosbuvir jew 12-il ġimgħa OLYSIO + sofosbuvir + ribavirin
English: (OATP1B1 transporter and/or CYP3A4 enzyme
Maltese: (impediment tat-trasportatur OATP1B1/3 u/jew tal-enzima CYP3A4)
English: Johnson & Johnson România SRL Str. Tipografilor nr. 11-15
Maltese: Johnson & Johnson România SRL Str.
English: In vitro experiments with human liver microsomes indicated that simeprevir primarily undergoes oxidative metabolism by the hepatic CYP3A4 system.
Maltese: Esperimenti in vitro b'mikrosomi tal-fwied uman indikaw li simeprevir jiġi prinċipalment metabolizzat b'mod ossidattiv bis-sistema epatika ta' CYP3A4.
English: Eighty percent (28/35), 90% (18/20), 40% (4/10) and 49% (19/39) of simeprevir-treated treatment-naïve patients, prior relapsers, prior partial responders and prior null responders, respectively, had undetectable HCV RNA at week 4.
Maltese: Tmenin fil-mija (28/35), 90% (18/20), 40% (4/10) u 49% (19/39) ta' pazjenti trattati b'simeprevir li ma kinux kurati qabel, pazjenti li rkadew qabel, pazjenti li rrispondew b'mod parzjali qabel u li ma rrispondew xejn qabel, rispettivament, kellhom HCV RNA f'ġimgħa 4 li ma ġiex osservat.
English: Λεωφόρος Ειρήνης 56
Maltese: Kellem it-tabib tiegħek jekk qed tredda' qabel ma tieħu OLYSIO.
English: Other substitutions such as Q80G or L, S122G, N or T did not reduce simeprevir activity (FC in EC50 ≤ 2).
Maltese: Sostituzzjonijiet oħra bħal Q80G jew L, S122G, N jew T ma naqqsux l-attività ta' simeprevir (FC f'EC50 ≤ 2) in vitro.
English: The HCV RNA thresholds that trigger discontinuation of treatment (i.e., treatment stopping rules) are presented in table 3.
Maltese: Il-linji ta' riferiment ta' HCV RNA li jqanqlu l-waqfien ta' trattament (i.e., regoli ta' waqfien ta' trattament) hume preżentati f'tabella 3.
English: 75% had no cirrhosis (METAVIR fibrosis score F0-3) and 25% had cirrhosis (METAVIR fibrosis score F4); 78% had HCV genotype 1a of which 45% carried Q80K at baseline, and 22% had HCV genotype 1b; 86% had non-CC IL28B alleles (CT or TT); 76% were prior null responders to peginterferon alfa and ribavirin, and 24% were treatment-naïve.
Maltese: IU/ml; 75% ma kellhom l-ebda ċirrożi (punteġġ ta' fibrożi METAVIR F0-3) u 25% kellhom ċirrożi (punteġġ ta' fibrożi METAVIR F4); 78% kellhom HCV tal-ġenotip 1a li minnhom 45% kellhom Q80K fil-linja bażi, u 22% kellhom HCV tal-ġenotip 1b; 86% kellhom alleli IL28B mhux CC (CT jew TT); 76% ma kinux irrispondew għal trattament preċedenti b'peginterferon alfa u ribavirin, u 24% ma kinux ħadu trattament qabel.
English: Grade 3 rash or pruritus occurred in 0.5% and 0.1% of simeprevir-treated patients, respectively.
Maltese: Raxx jew ħakk ta' grad 3 seħħ f'0.5% u 0.1% ta' pazjenti trattati b'simeprevir, rispettivament.
English: placebo + peginterferon + ribavirin % (n/N)
Maltese: plaċebo + peginterferon + ribavirin % (n/N)
English: The interaction between simeprevir and the medicinal product was evaluated in a pharmacokinetic study in opioid-dependent adults on stable methadone maintenance therapy.
Maltese: L-interazzjoni bejn simeprevir u l-prodott mediċinali ġiet evalwata fi studju farmakokinetiku f'adulti dipendenti fuq lopijoidi fuq terapija ta' manteniment b'methadone stabbli.
English: It is not recommended to co-administer OLYSIO with delavirdine, etravirine or nevirapine.
Maltese: Mhux rakkomandat li OLYSIO jingħata flimkien ma' delavirdine, etravirine jew nevirapine.
English: In rodents, simeprevir elicited toxic effects in the liver, pancreas and gastrointestinal systems.
Maltese: Fil-firien, simeprevir qanqal effetti tossiċi fil-fwied, il-frixa u s-sistemi gastrointestinali.
English: Simeprevir does not affect CYP2C9, CYP2C19 or CYP2D6 in vivo.
Maltese: Simeprevir ma jaffettwax CYP2C9, CYP2C19 jew
English: Grade 2 and 3 adverse reactions were reported in 3.5% (n = 10) and 0.3% (n = 1) of patients, respectively, receiving 12 weeks simeprevir with sofosbuvir; no grade 4 adverse reactions were reported.
Maltese: Reazzjonijiet avversi ta' Grad 2 u 3 ġew irrappurtati fi 3.5% (n = 10) u 0.3% (n = 1) tal-pazjenti rispettivament, li kienu qed jirċievu 12-il ġimgħa ta' simeprevir ma' sofosbuvir; ma ġew irrappurtati l-ebda reazzjonijiet ta' grad 4.
English: Seventy-one percent (37/52), 93% (14/15), 80% (8/10) and 36% (10/28) of simeprevir-treated treatment-naïve patients, prior relapsers, prior partial responders and prior null responders had undetectable HCV RNA at week 4.
Maltese: Wieħed u sebgħin fil-mija (37/52), 93% (14/15), 80% (8/10) u 36% (10/28) ta' pazjenti li ngħataw simeprevir li ma kinux ngħataw kura qabel, li kienu rkadew qabel, li rrispondew b'mod parzjali qabel u li ma kienu rrispondew xejn kellhom HCV RNA li ma ġiex osservat f'ġimgħa 4.
English: Treatment regimen with sofosbuvir:
Maltese: Skeda ta' trattament b'sofosbuvir:
English: Laboratory parameter WHO toxicity range
Maltese: Parametru tallaboratorju
English: C-simeprevir to healthy subjects, on average 91% of the total radioactivity was recovered in faeces.
Maltese: C-simeprevir lil individwi b'saħħithom, medja ta' 91% tar-radjuattività totali kienet irkuprata fl-ippurgar.
English: Simeprevir in combination with sofosbuvir: pooled studies HPC2002, HPC3017 and HPC3018 (12 weeks) or study HPC2002 (24 weeks); simeprevir in combination with peginterferon alfa and ribavirin: pooled phase 3 studies C208, C216 and HPC3007 (first 12 weeks of treatments).
Maltese: Simeprevir flimkien ma' sofosbuvir: ġabra ta' studji HPC2002, HPC3017 u HPC3018 (12-il ġimgħa) jew l-istudju HPC2002 (24 ġimgħa); simeprevir flimkien ma' peginterferon alfa u ribavirin: ġabra ta' studji C208, C216 u HPC3007 (l-ewwel 12-il ġimgħa ta' trattamenti) tal-fażi 3.
English: In studies HPC3017 (OPTIMIST-1) and HPC3018 (OPTIMIST-2), patients received simeprevir + sofosbuvir for 8 weeks (HPC3017 only) or 12 weeks (HPC3017 and HPC3018) (see table 11).
Maltese: Fl-istudji HPC3017 (OPTIMIST-1) u HPC3018 (OPTIMIST-2), il-pazjenti irċivew simeprevir + sofosbuvir għal 8 ġimgħat (HPC3017 biss) jew 12-il ġimgħa (HPC3017 u HPC3018) (ara tabella 11).
English: Table 18: Studies conducted with simeprevir + peginterferon alfa + ribavirin: demographics
Maltese: Tabella 18: Studji li saru b'simeprevir + peginterferon alfa + ribavirin: demografika u
English: The proportion of simeprevir-treated patients with HCV RNA < 25 IU/ml detectable at week 4 was 14% (70/509); 67% achieved SVR12.
Maltese: Il-proporzjon ta' pazjenti trattati b'simeprevir b'RNA ta' HCV < 25 IU/ml li setgħet titkejjel f'ġimgħa 4 kien ta' 14% (70/509); 67% kisbu SVR12.
English: - milk thistle (a herbal medicine) for liver problems - St John's wort (Hypericum perforatum, a herbal medicine) for anxiety or depression - ledipasvir to treat hepatitis C infection - cobicistat to increase levels of some medicines used to treat HIV infection - atazanavir, darunavir, delavirdine, efavirenz, etravirine, fosamprenavir, indinavir, lopinavir,
Maltese: - ledipasvir biex jittratta infezzjoni tal-epatite C - cobicistat biex iżid il-livelli ta' xi mediċini wżati biex tiġi ttrattata infezzjoni tal-HIV - atazanavir, darunavir, delavirdine, efavirenz, etravirine, fosamprenavir, indinavir, lopinavir,
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).
Maltese: Ir-rati ta' SVR12 kienu statistikament b'mod sinifikanti ogħla għal pazjenti li kienu qed jirċievu simeprevir ma' peginterferon alfa-2a jew peginterferon alfa-2b u ribavirin (88% u 78%, rispettivament) meta mqabbla ma' pazjenti li kienu qed jirċievu plaċebo ma' peginterferon alfa-2a jew peginterferon alfa-2b u ribavirin (62% u 42% rispettivament) (studju C216).
English: The clinical relevance of this difference in viral breakthrough rates is
Maltese: Ir-rilevanza klinika ta' din id-differenza fir-rati ta' progress virali mhix
English: Table 21 shows the SVR rates for selected subgroups for study HPC3007.
Maltese: Tabella 21 turi r-rati ta' SVR għal sottogruppi magħżula għall-istudju HPC3007.
English: Patients with mild to moderate rashes should be monitored for possible progression of rash, including the development of mucosal signs or systemic symptoms.
Maltese: Pazjenti b'raxxijiet ħfief sa moderati għandhom jiġu sorveljati għal progressjoni possibbli ta' raxx, li jinkludi l-iżvilupp ta' sinjali jew sintomi sistemiċi.
English: - digoxin, disopyramide, flecainide, mexiletine, propafenone or quinidine (when taken by mouth)
Maltese: (Abacavir, Didanosine, Emtricitabine, Lamivudine, Stavudine, Zidovudine)
English: Simeprevir does not induce CYP1A2 or CYP3A4 in vitro.
Maltese: Simeprevir ma jissensibillax CYP1A2 jew CYP3A4 in vitro.
English: 1 12 weeks simeprevir + sofosbuvir N = 286 n (%)
Maltese: 12-il ġimgħa simeprevir + sofosbuvir N = 286 n (%)
English: The 167 enrolled patients had a median age of 57 years (range 27 to 70 years; with 5% above 65 years); 64% were male; 81% were White, 19% Black or African American, and 21% Hispanic; 37% had a BMI ≥ 30 kg/m2; the median baseline HCV RNA level was 6.7 log10 IU/ml;
Maltese: Il-167 pazjent irreġistrati kellhom medjan ta' età ta' 57 sena (firxa minn 27 sa 70 sena; b'5% aktar minn 65 sena); 64% kienu rġiel; 81% kienu Bojod, 19% kienu Suwed jew Amerikani Afrikani, u 21% kienu Ħispaniċi; 37% kellhom BMI ≥ 30 kg/m2; il-livell medjan ta' RNA ta' HCV fillinja bażi kien 6.7 log10
English: 24 weeks simeprevir + sofosbuvir N = 31 n (%)
Maltese: 24 ġimgħa simeprevir + sofosbuvir N = 31 n (%)
English: Antiretroviral - nucleoside or nucleotide reverse transcriptase inhibitors (N(t)RTIs) No dose adjustment is required.
Maltese: Antiretrovirali - impedituri nukleosidi jew nukleotidi ta' reverse transcriptase (N(t)RTIs) L-ebda aġġustament fiddoża mhu meħtieġ.
English: placebo + peginterferon alfa + ribavirin N = 397 n (%)
Maltese: plaċebo + peginterferon alfa + ribavirin N = 397 n (%)
English: In a pooled analysis of patients treated with 150 mg simeprevir in combination with peginterferon alfa and ribavirin who did not achieve SVR in the controlled phase 2 and phase 3 clinical studies (studies C205, C206, C208, C216, HPC3007), emerging amino acid substitutions at NS3 positions 80, 122, 155 and/or 168 were observed in 180 out of 197 (91%) patients.
Maltese: F'analiżi ta' riżultati miġbura minn pazjenti trattati b'150 mg simeprevir flimkien ma' peginterferon alfa u ribavirin li ma kisbux SVR fl-istudji kliniċi kkontrollati ta' fażi 2b u fażi 3 (studji C205, C206, C208, C216, HPC3007), is-sostituzzjonijiet ta' aċidi amminiċi li tfaċċaw fil-pożizzjonijiet ta' NS3 80, 122, 155 u/jew 168 kienu osservati f'180 mill-197 (91%) pazjent.
English: In vitro experiments with human Caco-2 cells indicated that simeprevir is a substrate of P-gp.
Maltese: Esperimenti in vitro b'ċelluli umani ta' Caco-2 kienu jindikaw li simeprevir huwa sottostrat ta' P-gp.
English: ul.
Maltese: U
English: Genotype 1a N = 116 % (n)
Maltese: N = 116 % (n)
English: Simeprevir is metabolised in the liver.
Maltese: Simeprevir huwa metabolizzat fil-fwied.
English: 2; the median baseline HCV RNA level was 6.01 log10 IU/ml; 37% had cirrhosis; 30% had HCV genotype 4a, and 56% HCV genotype 4c or 4d; 79% had non-CC IL28B alleles (CT or TT); 52% were treatment-naïve, and 48% were treatment-experienced.
Maltese: IU/ml; 37% kellhom ċirrożi; 30% kellhom HCV tal-ġenotip 4a, u 56% HCV tal-ġenotip 4c jew 4d; 79% kellhom alleli IL28B mhux CC (CT jew TT); 52% ma kinux ħadu trattament qabel, u 48% kienu ħadu trattament qabel.
English: As simeprevir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by
Maltese: Peress li simeprevir jingħaqad b'mod qawwi ma' proteini fil-plażma, huwa improbabbli li ser jitneħħa
English: The primary enzyme involved in the biotransformation of simeprevir is CYP3A4 (see section 5.2) and clinically relevant effects of other medicinal products on simeprevir pharmacokinetics via CYP3A4 may occur.
Maltese: Prodotti mediċinali li jaffettwaw l-esponiment ta' simeprevir L-enzima prinċipali involuta fil-bijotrasformazzjoni ta' simeprevir hi CYP3A4 (ara sezzjoni 5.2) u jistgħu jseħħu effetti klinikament rilevanti minn prodotti mediċinali oħra fuq il-farmakokinetiċi ta' simeprevir permezz ta' CYP3A4.
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%).
Maltese: Sitta u disgħin perċentwali ta' replikons ta' ġenotip 1 magħżula għal simeprevir ġarrew sostituzzjoni waħda jew multipla ta' aċidi amminiċi ta' protease ta' NS3 fil-pożizzjonijiet 43, 80, 155, 156 u/jew 168 b'sostituzzjonijiet fil-pożizzjoni NS3 ta' D168 tkun l-aktar waħda osservata (78%).
English: Genotype 1b N = 81 % (n)
Maltese: N = 81 % (n)