natgillin/translations-raw huggingface dataset:
It is therefore important that you also read the package leaflets that are provided with these other medicines before you start taking OLYSIO.
Stoga je važno da prije početka liječenja lijekom OLYSIO, također pročitate upute o lijeku koje su priložene uz te druge lijekove.
Body-weight based twice daily ribavirin dosing, according to the Summary of Product Characteristics of ribavirin.
Doziranje ribavirina dvaput dnevno na temelju tjelesne težine, prema sažetku opisa svojstava lijeka za ribavirin.
push the capsule through the foil, as
Nemojte pritiskati kapsulu preko središnjeg dijela džepića.
Caution is warranted and therapeutic drug monitoring for these antiarrhythmics and/or clinical monitoring (ECG etc.) when orally administered are recommended.
Nalaže se oprez i preporučuje se terapijsko praćenje za ove antiaritmike i/ili kliničko praćenje (EKG i dr.), kada se primjenjuju peroralno.
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.
Kod miševa, bili su prijavljena prekobrojna rebra i zakašnjele osifikacije pri 4-puta većim izloženostima u odnosu na one uočene u ljudi pri preporučenoj dozi od 150 mg jedanput na dan.
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).
Istovremena primjena lijeka OLYSIO s lijekovima koji se primarno metaboliziraju putem CYP3A4, može dovesti do povišenih koncentracija tih lijekova u plazmi (vidjeti tablicu 4).
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).
Održani virološki odgovor (engl. sustained virologic response, SVR) bio je primarna mjera ishoda u svim ispitivanjima i bio je definiran kao HCV RNA manja od donje granice kvantifikacije (engl. lower limit of quantification, LLOQ) detektabilne ili nedetektabilne 12 tjedana (SVR12) ili 24 tjedna (SVR24) nakon planiranog završetka liječenja (ispitivanja C206, C208, C212, C216, HPC2002, HPC3007 i HPC3011) ili nakon stvarnog završetka liječenja (ispitivanja HPC2014, HPC3017, HPC3018 i HPC3021) (LLOQ od 25 IU/ml i granica detekcije od 15 IU/ml, osim u ispitivanjima HPC2014 i HPC3021 gdje su LLOQ i granica detekcije bili 15 IU/ml).
Therefore, co-administration of OLYSIO with substances that moderately or strongly inhibit or induce CYP3A4 is not recommended.
Stoga se ne preporučuje istodobna primjena lijeka OLYSIO s tvarima koje umjereno ili snažno inhibiraju ili induciraju CYP3A4.
Disposal: Read the package leaflet.
Zbrinjavanje: Pročitajte uputu o lijeku.
Increased simeprevir concentrations may occur due to mild inhibition of CYP3A4 by amlodipine and moderate inhibition of CYP3A4 by
Mogu se javiti povišene koncentracije simeprevira radi blage inhibicije CYP3A4 amlodipinom i umjerene inhibicije CYP3A4
The presence of Q80K at baseline was associated with lower SVR rates in HCV genotype 1a patients treated with simeprevir in combination with peginterferon alfa and ribavirin (tables 19, 21, 22).
Prisutnost Q80K na početku bila je povezana s nižim stopama SVR u bolesnika s HCV genotipom 1a liječenih simeprevirom u kombinaciji s peginterferonom alfa i ribavirinom (tablice 19, 21, 22).
No dose adjustment of daclatasvir or OLYSIO is required.
Prilagodba doze za daklatasvir ili OLYSIO nije potrebna.
Hepatic decompensation and hepatic failure, including fatal cases, have been reported post-marketing in patients treated with OLYSIO in combination with peginterferon alfa and ribavirin and in combination with sofosbuvir.
Dekompenzacija i zatajenje jetre, uključujući smrtne slučajeve, prijavljeni su postmarketinški kod bolesnika liječenih lijekom OLYSIO u kombinaciji s peginterferonom alfa i ribavirinom, te u kombinaciji sa sofosbuvirom.
- 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,
- cisaprid za liječenje želučanih problema - sikavica (biljni lijek) za probleme s jetrom - gospina trava (Hypericum perforatum, biljni lijek) za tjeskobu ili depresiju - ledipasvir za liječenje infekcije hepatitisom C - kobicistat za povišenje razine nekih lijekova za liječenje HIV infekcije - atazanavir, darunavir, delavirdin, efavirenz, etravirin, fosamprenavir, indinavir, lopinavir,
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).
Istovremena primjena lijeka OLYSIO s umjerenim ili jakim inhibitorima CYP3A4 može značajno povisiti izloženost simepreviru u plazmi, dok istovremena primjena s umjerenim ili jakim induktorima CYP3A4 može značajno smanjiti izloženost simepreviru u plazmi i dovesti do gubitka djelotvornosti (vidjeti tablicu 4).
Plasma exposure of simeprevir (AUC) in HCV infected patients was about 2- to 3-fold higher compared to that observed in healthy subjects.
Izloženost simepreviru u plazmi (AUC) u bolesnika inficiranih HCVom bila je oko 2- do 3-puta viša u usporedbi s onom uočenom kod zdravih ispitanika.
A course of OLYSIO lasts for either 12 or 24 weeks but you may need to take the other medicines for longer, according to your doctor's instructions.
OLYSIO morate uzeti kao dio režima liječenja s drugim lijekovima za liječenje kronične infekcije hepatitisom C. Liječenje lijekom OLYSIO traje ili 12 ili 24 tjedna, ali druge lijekove ćete možda morati uzimati duže, ovisno o uputama Vašeg liječnika.
simvastatin acid AUC 1.88 (1.63-2.17) ↑ simvastatin acid Cmax 3.03 (2.49-3.69) ↑
simvastatin acid AUC 1,88 (1,63-2,17)  simvastatin acid Cmax 3,03 (2,49-3,69)  simvastatin acid Cmin nije ispitano
If you develop a rash during treatment, contact your doctor immediately.
Ako Vam se tijekom liječenja razvije osip, odmah se obratite svom liječniku.
In patients with HCV genotype 1a with a baseline Q80K amino acid substitution an emerging R155K substitution was observed most frequently at failure.
U bolesnika s HCV genotipom 1a s početnom Q80K supstitucijom aminokiselina pri neuspjehu liječenja najčešće je bila uočena nastala R155K
HCV geno/subtype and presence of Q80K polymorphism in HCV genotype 1a p < 0.001 compared to historical control of peginterferon alfa and ribavirin.
HCV geno/podtip i prisutnost Q80K polimorfizma u HCV genotipu 1a p < 0,001 u usporedbi s povijesnom kontrolom s peginterferonom alfa i ribavirinom.
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.
Nuspojave stupnja 3 ili 4 bile su prijavljene u 3,1% bolesnika koji su primali simeprevir s peginterferonom alfa i ribavirinom naspram 0,5% bolesnika koji su primali placebo s peginterferonom alfa i ribavirinom.
There are no clinical data on the use of OLYSIO in re-treating patients who have failed an HCV NS3-4A protease inhibitor-based therapy (see sections 5.1 and 5.3).
Ne postoje klinički podaci o primjeni lijeka OLYSIO u ponovljenom liječenju bolesnika kod kojih je terapija temeljena na NS3-4A inhibitorima proteaze HCV-a bila neuspješna (vidjeti dijelove 5.1 i 5.3).
Compared to healthy subjects with normal renal function (classified using the Modification of Diet in Renal Disease [MDRD] eGFR formula; eGFR ≥ 80 ml/min), the mean steady-state AUC of simeprevir was 1.62-fold higher (90% confidence interval: 0.73-3.6) in subjects with severe renal impairment (eGFR below 30 ml/min).
Modification of Diet in Renal Disease [MDRD]); eGFR ≥ 80 ml/min), srednja vrijednost AUC-a u stanju dinamičke ravnoteže simeprevira bila je za 1,62 puta viša (interval pouzdanosti 90%: 0,73-3,6) u ispitanika s teškim oštećenjem bubrega (eGFR ispod 30 ml/min).
Testing for the presence of the Q80K polymorphism in patients with HCV genotype 1a is strongly recommended when considering therapy with OLYSIO in combination with peginterferon alfa and ribavirin.
Ispitivanje na prisutnost polimorfizma Q80K u bolesnika s HCV genotipom 1a iznimno se preporučuje pri razmatranju liječenja s lijekom OLYSIO u kombinaciji s peginterferonom alfa i ribavirinom.
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).
Cjelokupna stopa SVR12 za bolesnike bez ciroze koji su primali 8 tjedana simeprevir + sofosbuvir bila je 83% (128/155); svi bolesnici koji nisu postigli SVR12 imali su virološki relaps (17%; 27/155).
Table 11: Studies conducted with simeprevir + sofosbuvir: population and summary of study design
Tablica 11: Ispitivanja provedena sa simeprevirom + sofosbuvirom: populacija i sažetak
In study HPC3017, patients without cirrhosis were enrolled; in study HPC3018, patients with cirrhosis
U ispitivanju HPC3017 bili su uključeni bolesnici bez ciroze; u ispitivanje HPC3018 bili su uključeni bolesnici s cirozom (tablica 12).
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.
Izolati genotipa 1a i 1b s početnim polimorfizmom Q80K rezultirali su s medijanom promjene EC50 simeprevira od 11 puta (N = 33) odnosno 8,4 puta (N = 2).
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).
Istovremena primjena lijeka OLYSIO s lijekovima supstratima za prijenos putem OATP1B1/3, P-gp-a i BCRP-a može rezultirati povišenjem koncentracija takvih lijekova u plazmi (vidjeti tablicu 4).
Table 5: Adverse reactions identified with simeprevir in combination with sofosbuvir or simeprevir in combination with peginterferon alfa and ribavirin
Tablica 5: Nuspojave identificirane kod primjene simeprevira u kombinaciji sa sofosbuvirom ili simeprevira u kombinaciji s peginterferonom alfa i ribavirinom
Elevations in direct and indirect bilirubin have been reported in patients treated with simeprevir and were mostly of mild or moderate severity.
U bolesnika liječenih simeprevirom prijavljena su povišenja direktnog i indirektnog bilirubina i bila su većinom blage ili umjerene težine.
In study HPC2002 (COSMOS), prior null responders with METAVIR fibrosis score F0-F2, or treatment-naïve and prior null responder patients with METAVIR fibrosis score F3-F4 and compensated liver disease received simeprevir + sofosbuvir, with or without ribavirin, for 12 or 24 weeks (see table 11).
U ispitivanju HPC2002 (COSMOS), bolesnici bez prethodnog odgovora s METAVIR skorom za fibrozu F0-F2, ili koji prethodno nisu bili liječeni i bolesnici bez prethodnog odgovora s METAVIR skorom za fibrozu F3-F4 i kompenziranom bolesti jetre su primali simeprevir + sofosbuvir, s ili bez ribavirina, tijekom 12 ili 24 tjedna (vidjeti tablicu 11).
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%).
Devedeset i šest posto replikona genotipa 1 odabranih simprevirom nosilo je jednu ili višestruku supstituciju aminokiselina na položajima NS3 proteaze 43, 80, 155, 156, i/ili 168, sa supstitucijama na položaju NS3 proteaze D168 što je bilo najčešće uočeno (78%).
The emerging NS3 amino acid substitutions were similar to those observed in patients who did not achieve SVR following treatment with simeprevir in combination with peginterferon alfa and ribavirin.
Nastale NS3 supstitucije aminokiselina bile su slične onima zabilježenim u bolesnika koji nisu postigli SVR nakon liječenja simeprevirom u kombinaciji s peginterferonom alfa i ribavirinom.
Simeprevir in combination with sofosbuvir
Simeprevir u kombinaciji sa sofosbuvirom
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).
Cjelokupna stopa SVR12 za bolesnike bez ciroze koji su primali 8 tjedana simeprevir + sofosbuvir bila je 75% (15/20); svi bolesnici koji nisu postigli SVR12 imalo je virološki relaps (25%; 5/20).
Janssen-Cilag SpA, Via C. Janssen, Borgo San Michele, 04100 Latina, Italy
Janssen, Borgo San Michele, 04100 Latina, Italija
Excipient of OLYSIO capsules
Pomoćna tvar u kapsulama lijeka OLYSIO
OLYSIO must not be administered as monotherapy and must be prescribed in combination with other medicinal products for the treatment of CHC.
OLYSIO se ne smije primijeniti kao monoterapija i i mora se propisati u kombinaciji s drugim lijekovima za liječenje kroničnog hepatitisa C.
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.
Nuspojave simeprevira u kombinaciji sa sofosbuvirom ili u kombinaciji s peginterferonom alfa i ribavirinom prijavljene u odraslih bolesnika s infekcijom HCV genotipa 1, popisane su u tablici 5.
- 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
- karbamazepin, okskarbazepin, fenobarbital ili fenitoin za sprječavanje napadaja - astemizol ili terfenadin za liječenje alergija - itrakonazol, flukonazol, ketokonazol, posakonazol ili vorikonazol (kada se uzimaju kroz usta ili se primjenjuju injekcijom) za liječenje gljivičnih infekcija - rifabutin, rifampicin ili rifapentin za liječenje infekcija poput tuberkuloze - amlodipin, bepridil, diltiazem, felodipin, nikardipin, nifedipin, nizoldipin ili verapamil (kada se uzimaju kroz usta) za sniženje krvnog tlaka - deksametazon (ako se primjenjuje injekcijom ili uzima kroz usta) za liječenje astme ili upala i
Monitoring of blood concentrations of tacrolimus is recommended.
Preporučuje se praćenje koncentracije takrolimusa u krvi.
It is not recommended to co-administer OLYSIO with astemizole or terfenadine.
Ne preporučuje se istovremeno primjenjivati OLYSIO s astemizolom ili terfenadinom.
The proportion of simeprevir-treated patients with HCV RNA < 25 IU/ml detectable at week 4 was 18% (47/259); 60% achieved SVR12.
Udio bolesnika liječenih simeprevirom s HCV RNK < 25 IU/ml detektabilnom u 4. tjednu bio je 18% (47/259); 60% postiglo je SVR12.
Photosensitivity reactions have been observed with OLYSIO combination treatment (see section 4.8).
Reakcije fotoosjeljivosti bile su uočene uz OLYSIO u kombiniranom liječenju (vidjeti dio 4.8).
OLYSIO must be used in combination with other medicinal products for the treatment of CHC (see section 5.1).
OLYSIO se mora koristiti u kombinaciji s drugim lijekovima za liječenje kroničnog hepatitisa C (vidjeti dio 5.1).
UAB "JOHNSON & JOHNSON" filiāle Latvijā Mūkusalas iela 101
UAB "JOHNSON & JOHNSON" filiāle Latvijā
In the pooled analysis of patients receiving 150 mg simeprevir in combination with peginterferon alfa and ribavirin in the controlled phase 2 and phase 3 studies, treatment-emergent simeprevir-resistance variants were no longer detectable in 90 out of 180 patients (50%) at the end of the studies after a median follow-up of 28 weeks (range 0-70 weeks).
U objedinjenoj analizi za bolesnike koji primaju 150 mg simeprevira u kombinaciji s peginterferonom alfa i ribavirinom u kontroliranim ispitivanjima faze 2 i faze 3, varijante rezistencije na simeprevir koje su se pojavile tijekom liječenja nisu više bile detektabilne u 90 od 180 bolesnika (50%) na kraju ispitivanja, nakon medijana praćenja od 28 tjedana (raspon 0-70 tjedana).
CBC III, Karadžičova 12 SK-821 08 Bratislava Tel: +421 232 408 400
Slovenská republika Johnson & Johnson s.r.o. CBC III, Karadžičova 12 SK-821 08 Bratislava Tel: +421 232 408 400
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).
Bolesnici s HCV genotipom 1a pretežno su imali nastalu samostalnu R155K supstituciju ili u kombinaciji sa supstitucijama aminokiselina na položajima NS3 proteaze 80, 122 i/ili 168, dok su bolesnici s HCV genotipom 1b imali najčešće nastalu D168V supstituciju (tablica 10).
Treatment-emergent laboratory abnormalities in amylase and lipase have been observed in patients treated with simeprevir in combination with sofosbuvir (table 6).
Poremećaji laboratorijskih nalaza amilaze i lipaze koji su proizašli iz liječenja zabilježeni su u bolesnika liječenih simeprevirom u kombinaciji sa sofosbuvirom (tablica 6).
Plasma concentrations of midazolam were not affected when administered intravenously as simeprevir does not inhibit hepatic CYP3A4.
Nije bilo utjecaja na koncentracije midazolama u plazmi kada se primjenjivao intravenski jer simeprevir ne inhibira jetreni CYP3A4.
Plasma Cmax and AUC of simeprevir were similar during co-administration of simeprevir with peginterferon alfa and ribavirin compared with administration of simeprevir alone.
Cmax i AUC simeprevira u plazmi bili su slični tijekom istovremene primjene simeprevira s peginterferonom alfa i ribavirinom u usporedbi sa primjenom samo simeprevira.
It is not recommended to co-administer OLYSIO with any HIV PI, with or without ritonavir.
Ne preporučuje se istovremeno primjenjivati OLYSIO s bilo kojim od inhibitora proteaze HIV-a sa ili bez ritonavira.
Discontinuation of simeprevir due to adverse reactions occurred in 0.9% of patients receiving simeprevir with peginterferon alfa and ribavirin.
Prekid primjene simeprevira zbog nuspojava dogodio se kod 0,9% bolesnika koji su primali simeprevir s peginterferonom alfa i ribavirinom.
Data from a 3-year follow-up study in patients who did not achieve SVR with simeprevir in combination with peginterferon alfa and ribavirin in a previous phase 2 or phase 3 study showed that in 86% (37/43) of these patients the emerging mutations at time of failure in the previous study were no longer detected after a median follow-up of 180 weeks (range 47-230 weeks) (study HPC3002).
Podaci iz 3-godišnjeg ispitivanja praćenja bolesnika koji u prethodnom ispitivanju faze 2 ili faze 3 nisu postigli SVR na simepreviru u kombinaciji s peginterferonom alfa i ribavirinom, pokazali su da u 86% (37/43) tih bolesnika mutacije nastale u vrijeme neuspjeha u prethodnom ispitivanju, više nije bilo moguće detektirati nakon medijana praćenja od 180 tjedana (raspon 47-230 tjedana)
Cases of bradycardia have been observed when OLYSIO is used in combination with sofosbuvir and concomitant amiodarone.
Slučajevi bradikardije zabilježeni su kada se lijek OLYSIO primjenjivao u kombinaciji sa sofosbuvirom te uz istodobnu primjenu amiodarona.
Respiratory, thoracic and mediastinal disorders: very common dyspnoea*
Poremećaji dišnog sustava, prsišta i sredoprsja: vrlo često dispneja*
Janssen-Cilag SpA Via C. Janssen Borgo San Michele 04100 Latina Italy
Janssen Borgo San Michele 04100 Latina Italija
A higher incidence of anaemia in patients with advanced fibrosis receiving simeprevir in combination with peginterferon alfa and ribavirin has been reported.
Bila je prijavljena veća incidencija anemije u bolesnika s uznapredovalom fibrozom koji su primali simeprevir u kombinaciji s peginterferonom alfa i ribavirinom.
Treatment with OLYSIO should be initiated and monitored by a physician experienced in the
Liječenje lijekom OLYSIO mora započeti i pratiti liječnik s iskustvom u liječenju kroničnog hepatitisa
8 or 12 weeks SMV + sofosbuvir
8 ili 12 tjedana SMV + sofosbuvir
Elimination of simeprevir occurs via biliary excretion.
Eliminacija simeprevira događa se putem ekskrecije žuči.
It is not recommended to co-administer OLYSIO with clarithromycin or telithromycin.
Ne preporučuje se istovremeno primjenjivati OLYSIO s klaritromicinom ili telitromicinom.
* darunavir/ritonavir + 50 mg simeprevir compared to
* darunavir/ritonavir + 50 mg simeprevira u usporedbi s monoterapijom simeprevirom od 150 mg.
Resistance to simeprevir was characterised in HCV genotype 1a and 1b replicon-containing cells.
Rezistencija na simeprevir bila je okarakterizirana kod stanica koje sadrže replikone HCV-a genotipa 1a i 1b.
Table 19: Treatment outcome in treatment-naïve HCV genotype 1 infected patients (pooled data studies C208 and C216)
Tablica 19: Ishod liječenja u bolesnika inficiranih HCV genotipom 1 koji prethodno nisu bili liječeni (objedinjeni podaci ispitivanja C208 i C216)
Grade 3 rash or pruritus occurred in 0.5% and 0.1% of simeprevir-treated patients, respectively.
Osip ili pruritus stupnja 3 pojavio se u 0,5% odnosno 0,1% bolesnika liječenih simeprevirom.
nelfinavir, nevirapine, ritonavir, saquinavir or tipranavir to treat HIV infection - atorvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin or simvastatin to lower cholesterol
nelfinavir, nevirapin, ritonavir, sakvinavir ili tipranavir za liječenje HIV infekcije - atorvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin ili simvastatin za snižavanje razine
Capsule content Sodium lauryl sulfate Magnesium stearate Colloidal anhydrous silica Croscarmellose sodium Lactose monohydrate
Sadržaj kapsule natrijev laurilsulfat magnezijev stearat silicijev dioksid, koloidni, bezvodni karmelozanatrij, umrežena laktoza hidrat
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.
U ispitivanju HPC3011 u bolesnika inficiranih HCV genotipom 4, 28 od 32 (88%) bolesnika koji nisu postigli SVR imali su nastale supstitucije aminokiselina na NS3 položajima 80, 122, 155, 156 i/ili 168 (uglavnom supstitucije na položajima 168; 24 od 32 [75%] bolesnika), slično nastajanju supstitucija aminokiselina koje su uočene u bolesnika inficiranih genotipom 1.
Patients with cirrhosis N = 103 % (n/N)
Bolesnici s cirozom N = 103 % (n/N)
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.
U biokemijskom testu simeprevir je inhibirao proteolitičku aktivnost rekombinantnih NS3/4A proteaza HCV-a genotipa 1a i 1b, s medijanom vrijednosti
While no change in the pharmacokinetics of warfarin is expected, close monitoring of INR is recommended with all vitamin K antagonists.
Iako se ne očekuje promjena farmakokinetike varfarina, preporučuje se pomno praćenje međunarodnog normaliziranog omjera (INR) sa svim antagonistima vitamina K zbog mogućih promjena u funkciji jetre tijekom liječenja lijekom OLYSIO.
Table 23: Treatment outcome in HCV genotype 4 infected patients (study HPC3011)
Tablica 23: Ishod liječenja u bolesnika inficiranih HCV genotipom 4 (ispitivanje HPC3011) Ishod liječenja