natgillin/translations-raw huggingface dataset:
Compared to intake without food, administration of simeprevir with food to healthy subjects increased the AUC by 61% after a high-fat, high-caloric (928 kcal) and 69% after a normal caloric (533 kcal) breakfast, and delayed the absorption by 1 hour and 1.5 hours, respectively.
AUC za 61% nakon doručka s visokim udjelom masti i kalorija (928 kcal) i za 69% nakon doručka s normalom količinom kalorija (533 kcal), te je odgodila apsorpciju za 1 sat odnosno za 1,5 sati.
Concentrations of ledipasvir and simeprevir are increased when simeprevir is co-administered with ledipasvir.
Koncentracije ledipasvira i simeprevira su povišene kada se simeprevir primjenjuje istovremeno s ledipasvirom.
or amiodarone to treat irregular heart beat - clarithromycin, erythromycin (when taken by mouth or given by injection) or telithromycin to treat bacterial infections - warfarin and other similar medicines called vitamin K antagonists used to thin the blood.
- klaritromicin, eritromicin (kada se uzima kroz usta ili primjenjuje injekcijom) ili telitromicin za liječenje bakterijskih infekcija - varfarin i drugi slični lijekovi pod nazivom antagonisti vitamina
The persistence of simeprevir-resistant NS3 amino acid substitutions was assessed following treatment failure.
Ustrajnost supstitucija povezanih s rezistencijom Ustrajnost supstitucija aminokiselina NS3 proteaze koje uzrokuju rezistenciju na simeprevir bila je procijenjena nakon neuspjeha liječenja.
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 after end of treatment.
Tijekom primjene simeprevira s peginterferonom alfa i ribavirinom, povišenja razina konjugiranog i nekonjugiranog bilirubina općenito nisu bila povezana s povišenjem razine transaminaza u jetri i vratila su se na normalnu razinu nakon završetka liječenja.
Increased simeprevir concentrations may occur due to mild inhibition of CYP3A4 by amlodipine and moderate inhibition of CYP3A4 by diltiazem and verapamil.
Mogu se javiti povišene koncentracije simeprevira radi blage inhibicije CYP3A4 amlodipinom i umjerene inhibicije CYP3A4 diltiazemom i verapamilom.
Compared to healthy subjects with normal hepatic function, the mean steady-state AUC of simeprevir was 2.4-fold higher in non-HCV infected subjects with moderate hepatic impairment (Child-Pugh class B) and 5.2-fold higher in non-HCV infected subjects with severe hepatic impairment (Child-Pugh class C).
U usporedbi sa zdravim ispitanicima s normalnom funkcijom jetre, srednja vrijednost AUC-a simeprevira u stanju dinamičke ravnoteže bila je 2,4-puta viša u bolesnika koji nisu inficirani HCVom s umjerenim oštećenjem jetre (Child-Pugh stadij B) i 5,2-puta viša u bolesnika koji nisu inficirani
4 Body-weight based twice daily ribavirin dosing, according to the Summary of Product Characteristics of ribavirin.
4 Doziranje ribavirina dvaput dnevno na temelju tjelesne težine, prema sažetku opisa svojstava lijeka za ribavirin.
OLYSIO at the usual scheduled time.
prema uobičajenom rasporedu.
In 2% and 0.3% of the simeprevir-treated patients grade 3 or 4 ‘blood bilirubin increased' was reported, respectively (pooled phase 3 studies).
0,3% bolesnika liječenih simeprevirom bio je prijavljen ‘povišen bilirubin u krvi' stupnja 3 ili 4 (objedinjena ispitivanja faze 3).
MARKETING AUTHORISATION NUMBER(S) EU/1/14/924/001 (7 capsules)
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/924/001 (7 kapsula)
How to take OLYSIO
Kako uzimati OLYSIO
Proton pump inhibitors Omeprazole
Inhibitori protonske pumpe Omeprazol
Posaconazole
Posakonazol
ANTICONVULSANTS Carbamazepine Oxcarbazepine Phenobarbital Phenytoin
Karbamazepin Okskarbazepin Fenobarbital Fenitoin
> 5.0 x ULN
> 5,0 x GGN
Gastrointestinal disorders: very common nausea common constipation constipation constipation
Poremećaji probavnog sustava: vrlo često mučnina često konstipacija konstipacija konstipacija
Table 17: Studies conducted with simeprevir + peginterferon alfa + ribavirin: population and summary of study design
Tablica 17: Ispitivanja provedena sa simeprevirom + peginterferonom alfa + ribavirinom: populacija i sažetak dizajna ispitivanja
Plasma exposure of simeprevir in HCV infected patients was about 2- to 3-fold higher compared to that observed in healthy subjects.
Izloženost simepreviru u plazmi HCV-om inficiranih bolesnika bila je oko 2- do 3-puta viša u usporedbi s onom uočenom u zdravih ispitanika.
common rash*, pruritus*, photosensitivity reaction*
često osip*, pruritus*, reakcije fotoosjetljivosti*
HPC3018 (OPTIMIST-2; Phase 3)
HPC3018 (OPTIMIST-2; faza 3)
Refer also to the Summary of Product Characteristics of the medicinal products that are used in combination with OLYSIO.
Također pogledajte sažetak opisa svojstava lijeka za lijekove koji se koriste u kombinaciji s lijekom OLYSIO.
Study1
Ispitivanje1
Table 5: Adverse reactions identified with simeprevir in combination with sofosbuvir or simeprevir in combination with peginterferon alfa and ribavirin1
Tablica 5: Nuspojave identificirane kod primjene simeprevira u kombinaciji sa sofosbuvirom ili simeprevira u kombinaciji s peginterferonom alfa i ribavirinom1
Read the package leaflets for the other medicines used for treating your hepatitis C infection for side effects reported with these medicines.
U uputama o lijeku za druge lijekove koje koristite za liječenje infekcije hepatitisom C pročitajte o nuspojavama prijavljenim s tim lijekovima.
10 mg rosuvastatin AUC 2.81 (2.34-3.37) ↑ rosuvastatin Cmax 3.17 (2.57-3.91) ↑ rosuvastatin Cmin not studied
10 mg rosuvastatin AUC 2,81 (2,34-3,37) ↑ rosuvastatin Cmax 3,17 (2,57-3,91) ↑ rosuvastatin Cmin nije ispitano
No dose adjustment of OLYSIO is required in patients with mild hepatic impairment (Child-Pugh class A).
Prilagodba doze za lijek OLYSIO u bolesnika s blagim oštećenjem jetre (Child-Pugh stadij A) nije potrebna.
HPC3017 (OPTIMIST-1; Phase 3)
HPC3017 (OPTIMIST-1; faza 3)
without cirrhosis, who are co-infected with HIV
bez ciroze, koji su koinficirani HIV-om s cirozom, koji su koinficirani HIV-om
OLYSIO has no or negligible influence on the ability to drive and use machines.
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima OLYSIO ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Table 9: Antiviral activity of simeprevir 200 mg monotherapy (studies C201 and C202) Genotype
Tablica 9: Antivirusna aktivnost simeprevira od 200 mg u monoterapiji (ispitivanja C201 i C202)
Dosage adjustment or interruption of medicinal products used in combination with OLYSIO for the treatment of CHC
Prilagodbe doziranja ili prekid uzimanja lijekova koji se uzimaju u kombinaciji s lijekom OLYSIO za liječenje kroničnog hepatitisa C
The proportion of simeprevir-treated patients with HCV RNA < 25 IU/ml detectable at week 4 was 14% (70/509); 67% achieved SVR12.
Udio bolesnika liječenih simeprevirom s HCV RNK < 25 IU/ml koja je bila detektabilna u 4. tjednu bio je 14% (70/509); 67% postiglo je SVR12.
There were no grade 3 or 4 photosensitivity reactions reported and none of the patients discontinued treatment due to photosensitivity reactions.
4. stupnja i niti jedan bolesnik nije prekinuo liječenje zbog reakcija fotoosjetljivosti.
OLYSIO in combination with peginterferon alfa and ribavirin: HCV/HIV-1 co-infected patients should be treated for the same duration as HCV mono-infected patients, except for co-infected patients with cirrhosis who should receive 36 weeks of treatment with peginterferon alfa and ribavirin after completing 12 weeks of treatment with OLYSIO, peginterferon alfa and ribavirin (total treatment duration of 48 weeks).
OLYSIO u kombinaciji s peginterferonom alfa i ribavirinom: Bolesnike s koinfekcijom HCV-om i HIV-om-1 potrebno je liječiti jednako dugo kao i bolesnike samo s HCV infekcijom, osim koinficiranih bolesnika s cirozom, koji trebaju primiti liječenje peginterferonom alfa i ribavirinom tijekom 36 tjedana, nakon završetka liječenja lijekom OLYSIO, peginterferonom alfa i ribavirinom u trajanju od 12 tjedana (ukupno trajanje liječenja od 48 tjedana).
Antiretroviral - nucleoside or nucleotide reverse transcriptase inhibitors (N(t)RTIs) Tenofovir disoproxil fumarate
Antiretrovirusni - nukleozidni ili nukleotidni inhibitori reverzne transkriptaze (N(t)RTI-jevi)
Interim data from a phase 2 study in 11 HCV infected post-liver transplant patients.
Privremeni podaci iz ispitivanja faze 2 u 11 bolesnika nakon transplantacije jetre inficiranih HCV-om.
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.
Sedamdeset i jedan posto (37/52), 93% (14/15), 80% (8/10) i 36% (10/28) bolesnika liječenih simeprevirom koji prethodno nisu bili liječeni, prethodno su doživjeli relaps,
(OATP1B1/3, P-gp and CYP3A inhibition by ciclosporin)
(OATP1B1/3, P-gp i CYP3A inhibicija ciklosporinom)
In 32 out of 48 patients (67%) with emerging single D168V and in 34 out of 66 (52%) patients with emerging single R155K, the respective emerging variants were no longer detected at end of the studies.
U 32 od 48 bolesnika (67%) s nastalom samom D168V supstitucijom i u 34 od 66 (52%) bolesnika s nastalom samom R155K
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains simeprevir sodium equivalent to 150 mg of simeprevir.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tvrda kapsula sadrži simeprevirnatrij što odgovara 150 mg simeprevira.
S-warfarin AUC 1.04 (1.00-1.07) ↔ S-warfarin Cmax 1.00 (0.94-1.06) ↔ S-warfarin Cmin not studied
S-varfarin AUC 1,04 (1,00-1,07) ↔ S-varfarin Cmax 1,00 (0,94-1,06) ↔ S-varfarin Cmin nije ispitano
In dogs, simeprevir was associated with a reversible multifocal hepatocellular necrosis with associated increases in ALT, AST, alkaline phosphatase and/or bilirubin.
U pasa, simeprevir je bio povezan s reverzibilnom multifokalnom hepatocelularnom nekrozom s povezanim povišenjima ALT, AST,
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
The response rates for patients with cirrhosis (METAVIR score F4) receiving 12 or 24 weeks of simeprevir + sofosbuvir are shown in table 15.
Stope odgovora za bolesnike s cirozom (METAVIR skor F4) koji su primali 12 ili 24 tjedna simeprevir + sofosbuvir su prikazani u tablici 15.
Treatment week 24: ≥ 25 IU/ml1
24. tjedan liječenja: ≥ 25 IU/ml1
Elevations in direct and indirect bilirubin have been reported in patients treated with simeprevir and were mostly of mild or moderate severity.
Povišen bilirubin u krvi U bolesnika liječenih simeprevirom prijavljena su povišenja direktnog i indirektnog bilirubina i bila su većinom blage ili umjerene težine.
SVR12 without cirrhosis with cirrhosis
SVR12 bez ciroze s cirozom
Interim data from a phase 2 study in 9 HCV infected post-liver transplant patients.
Privremeni podaci iz ispitivanja faze 2 u 9 bolesnika nakon transplantacije jetre inficiranih HCV-om.
Intravenous: midazolam AUC 1.10 (0.95-1.26) ↑ midazolam Cmax 0.78 (0.52-1.17) ↓ midazolam Cmin not studied
Intravenski: midazolam AUC 1,10 (0,95-1,26) ↑ midazolam Cmax 0,78 (0,52-1,17) ↓ midazolam Cmin nije ispitano
Treatment week 12: ≥ 25 IU/ml1
12. tjedan liječenja: ≥ 25 IU/ml1
40 mg omeprazole AUC 1.21 (1.00-1.46) ↑ omeprazole Cmax 1.14 (0.93-1.39) ↑ omeprazole Cmin not studied
40 mg omeprazol AUC 1,21 (1,00-1,46) ↑ omeprazol Cmax 1,14 (0,93-1,39) ↑ omeprazol Cmin nije ispitano
Patients without cirrhosis N = 155 % (n/N)
Bolesnici bez ciroze N = 155 % (n/N)
Treatment-emergent laboratory abnormalities that were observed at a higher incidence in simeprevir-treated patients than in patients treated with placebo, peginterferon alfa and ribavirin are given in table 7.
Poremećaji laboratorijskih nalaza koji su proizašli tijekom liječenja te su uočeni s većom incidencijom u bolesnika liječenih simeprevirom nego u bolesnika liječenih placebom, peginterferonom alfa i ribavirinom prikazani su u tablici 7.
Frequency Category simeprevir + sofosbuvir simeprevir + peginterferon alfa + ribavirin N = 781
Učestalost simeprevir + sofosbuvir simeprevir + peginterferon alfa + ribavirin N = 781
Mild increased or decreased plasma concentrations of sirolimus may occur.
Mogu se javiti blago povišene ili snižene koncentracije sirolimusa u plazmi.
The planned total duration of HCV
Planirano ukupno trajanje
Table 23: Treatment outcome in HCV genotype 4 infected patients (study HPC3011) Treatment outcome
4. Tablica 23: Ishod liječenja u bolesnika inficiranih HCV genotipom 4 (ispitivanje HPC3011)
Alkaline phosphatase
Kemijski nalazi Alkalna fosfataza
> 1.5 to ≤ 3.0 x ULN 22 (7.7%)
> 1,5 do ≤ 3,0 x GGN 22 (7,7%)
24 weeks simeprevir + sofosbuvir
24 tjedna simeprevir + sofosbuvir
Grade 1
Stupanj 1
1 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).
1 Simeprevir u kombinaciji sa sofosbuvirom: objedinjena ispitivanja HPC2002, HPC3017 i HPC3018 (12 tjedana) ili ispitivanje HPC2002 (24 tjedna); simeprevir u kombinaciji s peginterferonom alfa i ribavirinom: objedinjena ispitivanja C208, C216 i HPC3007 faze 3 (prvih 12 tjedana liječenja).
(OATP1B1 inhibition by tacrolimus)
(OATP1B1 inhibicija takrolimusom)
Baseline polymorphisms at NS3 positions 43, 80, 122, 155, 156, and/or 168, associated with reduced simeprevir activity in vitro were generally uncommon (1.3%) in patients with HCV genotype 1 infection (n = 2,007; pooled phase 2 and phase 3 studies with simeprevir in combination with peginterferon alfa and ribavirin), with exception of the substitution Q80K in HCV genotype 1a patients which was seen 30% in patients with HCV genotype 1a and 0.5% in patients with HCV genotype 1b.
Početni polimorfizmi na položajima NS3 proteaze 43, 80, 122, 155, 156, i/ili 168, koji su povezani sa smanjenom aktivnošću simeprevira in vitro općenito su bile manje česte (1,3%) u bolesnika s infekcijom HCV genotipom 1 (n = 2007; objedinjena ispitivanja faze 2 i faze 3 sa simeprevirom u kombinaciji s peginterferonom alfa i ribavirinom), s iznimkom supstitucije Q80K u bolesnika s HCV genotipom 1a što je viđeno 30% u bolesnika s HCV genotipom 1a i 0,5% u bolesnika s HCV genotipom 1b.
ANALEPTIC Caffeine 150 mg caffeine AUC 1.26 (1.21-1.32) ↑ caffeine Cmax 1.12 (1.06-1.19) ↔ caffeine Cmin not studied
150 mg kofein AUC 1,26 (1,21-1,32) ↑ kofein Cmax 1,12 (1,06-1,19) ↔ kofein Cmin nije ispitano
What OLYSIO is - OLYSIO contains the active substance ‘simeprevir'.
- OLYSIO sadrži djelatnu tvar “simeprevir“.
Refer to the Summary of Product Characteristics for these co-administered medicinal products regarding their potential effect on the ability to drive and use machines.
Molimo pogledajte sažetak opisa svojstava lijeka za istodobno primijenjene lijekove vezano uz njihov potencijalni učinak na sposobnost upravljanja vozilima i rada sa strojevima.
If you forget to take OLYSIO - If it is more than 12 hours until your next dose, take the missed dose as soon as possible with food.
- Ukoliko do slijedeće doze ima više od 12 sati, uzmite zaboravljenu dozu što je prije moguće s hranom.
HORMONAL CONTRACEPTIVES Ethinylestradiol and norethindrone
Etinilestradiol i noretindron
H2-receptor antagonists Cimetidine
H2-receptora cimetidin nizatidin ranitidin
How to store OLYSIO
Kako čuvati OLYSIO
4 Includes relapsers, partial and null responders to prior treatment with peginterferon and ribavirin.
4 Uključuje bolesnike s relapsom, djelomičnim odgovorom ili bez odgovora na prethodno liječenje s peginterferonom i ribavirinom.
12 weeks SMV + peg-IFN-alfa + RBV, followed by 12 or 36 weeks peg-IFN-alfa + RBV3; control group: 48 weeks placebo + peg-IFN-alfa + RBV
36 tjedana peg-IFN-alfa + RBV3; kontrolna skupina: 48 tjedana placebo + peg-IFN-alfa + RBV
Includes one prior null responder who experienced relapse after SVR12, who was considered to have an HCV re-infection (based on phylogenetic analyses).
Uključuje jednog bolesnika koji prethodno nije odgovorio koji je doživio relaps nakon SVR12, za kojeg se smatralo da je imao reinfekciju HCV-om
≥ 1.1 to ≤ 1.5 x ULN 34 (11.9%)
≥ 1,1 do ≤ 1,5 x GGN 34 (11,9%)
Hepatobiliary disorders: common blood bilirubin increased* blood bilirubin increased* blood bilirubin increased* Skin and subcutaneous tissue disorders: very common rash*
Poremećaji jetre i žuči: često povišen bilirubin u krvi* povišen bilirubin u krvi* povišen bilirubin u krvi*
Prior partial responders Prior null responders Outcome for patients without SVR On-treatment failure Prior relapsers
Bolesnici bez prethodnog odgovora Ishod za bolesnike bez SVR
Simeprevir in combination with peginterferon alfa and ribavirin The safety profile of simeprevir in combination with peginterferon alfa and ribavirin in patients with HCV genotype 1 infection is based on the pooled data from the phase 2 studies and phase 3 studies C205, C206, C208, C216 and HPC3007 which included 924 patients who received simeprevir 150 mg once daily for 12 weeks and 540 patients who received placebo with peginterferon alfa and ribavirin.
Simeprevir u kombinaciji s peginterferonom alfa i ribavirinom Sigurnosni profil simeprevira u kombinaciji s peginterferonom alfa i ribavirinom u bolesnika s infekcijom HCV genotipa 1 temelji se na objedinjenim podacima iz ispitivanja faze 2 i ispitivanja faze 3 C205, C206, C208, C216 i HPC3007 koja su uključivala 924 bolesnika koji su primali simeprevir od 150 mg jedanput na dan tijekom 12 tjedana i 540 bolesnika koji su primali placebo s peginterferonom alfa i ribavirinom.
patients, with compensated cirrhosis or without cirrhosis
bolesnici, s kompenziranom cirozom ili bez ciroze
Caution is warranted and therapeutic drug monitoring for amiodarone and/or clinical monitoring (ECG etc.) when orally administered are recommended.
Režim liječenja koji ne sadrži sofosbuvir: Potreban je oprez i terapijsko praćenje lijeka za amiodaron i/ili kliničko praćenje (EKG itd.) kada je preporučena peroralna primijena.
Magnesium hydroxide Calcium carbonate
LIJEKOVI ZA PROBAVNI SUSTAV Antacidi aluminijev ili magnezijev hidroksid kalcijev karbonat
When taking OLYSIO combination treatment, tell your doctor if you have the following symptoms as they may be a sign of worsening liver problems: - notice yellowing of your skin or eyes - your urine is darker than normal - notice swelling of your stomach area.
- ako primijetite da su vam požutjeli koža ili oči - ako vam je mokraća tamnije boje od uobičajene - ako primijetite oticanje u području trbuha.
BMI ≥ 30 kg/m2
BMI ≥ 30 kg/m2 Početne razine HCV RNA
If you are not sure, talk to your doctor or pharmacist before taking OLYSIO.
obratite se svom liječniku ili ljekarniku prije nego što uzmete OLYSIO.
≥ 1.25 to ≤ 2.50 x ULN
≥ 1,25 do ≤ 2,50 x GGN
SVR12 rates for selected subgroups METAVIR fibrosis score F0-2 F3-4 F4 IL28B genotype CC CT TT HCV geno/subtype and presence of Q80K polymorphism in HCV genotype 1a Genotype 1a with Q80K without Q80K Genotype 1b
Stope SVR12 za odabrane podskupine METAVIR skor za fibrozu F0-2 F3-4 F4 IL28B genotip CC CT TT HCV geno/podtip i prisutnost Q80K polimorfizma u HCV genotipu 1a Genotip 1a s Q80K bez Q80K Genotip 1b
The safety profile of simeprevir in combination with sofosbuvir in patients with HCV genotype 1 infection with or without cirrhosis is based on pooled data from the phase 2 study HPC2002 and the phase 3 studies HPC3017 and HPC3018 which included 472 patients who received simeprevir with sofosbuvir without ribavirin (155, 286 and 31 patients received 8, 12 or 24 weeks of treatment, respectively) and 108 patients who received simeprevir with sofosbuvir and ribavirin (54 patients each received 12 or 24 weeks of treatment).
Sigurnosni profil simeprevira u kombinaciji sa sofosbuvirom u bolesnika s infekcijom HCV genotipa 1 s ili bez ciroze temelji se na objedinjenim podacima iz ispitivanja HPC2002 faze 2 i ispitivanja HPC3017 i HPC3018 faze 3 koja su uključivala 472 bolesnika koja su primala simeprevir sa sofosbuvirom bez ribavirina (155, 286 odnosno 31 bolesnik liječeni su 8, 12 odnosno 24 tjedna) i 108 bolesnika koji su primali simeprevir sa sofosbuvirom i ribavirinom (svaki od 54 bolesnika liječen je 12 ili 24 tjedna).
There are no virologic treatment stopping rules that apply to the combination of OLYSIO with sofosbuvir.
Ne postoje pravila za prekid virološkog liječenja koja su primjenjiva na kombinaciju lijeka OLYSIO
Treatment with OLYSIO should be initiated and monitored by a physician experienced in the management of CHC.
4.2 Doziranje i način primjene Liječenje lijekom OLYSIO mora započeti i pratiti liječnik s iskustvom u liječenju kroničnog hepatitisa
The response rates for patients with or without cirrhosis receiving 12 weeks of simeprevir + sofosbuvir are shown in table 13.
Stope odgovora za bolesnike s ili bez ciroze koji su primali 12 tjedana simeprevir + sofosbuvir prikazane su u tablici 13.
Increased plasma concentrations of pitavastatin and pravastatin are expected.
Očekuju se povišene koncentracije pitavastatina i pravastatina u plazmi.
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
Outcome for patients without SVR12 On-treatment failure Viral relapse2
Ishod za bolesnike bez SVR12 Neuspjeh tijekom liječenja Virološki relaps2
Table 2: Recommended treatment duration for OLYSIO combination therapy with peginterferon alfa and ribavirin1 in HCV genotype 1 or 4
Tablica 2: Preporučeno trajanje liječenja u kombiniranom liječenju lijekom OLYSIO i peginterferonom alfa i ribavirinom1 kod HCV genotipa 1 ili 4 Populacija bolesnika
The 63 enrolled patients had a median age of 51 years (range 24 to 68 years; with 2% above 65 years); 54% were male; 43% had a BMI ≥ 30 kg/m2; 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.
63 uključena bolesnika imalo je medijan dobi od 51 godine (raspon 24 do 68 godina; s 2% iznad 65 godina); 54% bili su muškarci; 43% imalo je BMI ≥ 30 kg/m2; medijan početne razine HCV RNA bila je 6,01 log10 IU/ml; 37% imalo je cirozu; 30% imalo je HCV genotip 4a, i 56% HCV genotip 4c ili 4d; 79% imalo je ne-CC IL28B alele (CT ili TT); 52% prethodno nisu bili liječeni, i 48% bili su prethodno liječeni.
≥ 1.1 to ≤ 1.5 x ULN
≥ 1,1 do ≤ 1,5 x GGN
In patients with HCV genotype 1a with a baseline Q80K amino acid substitution an emerging R155K substitution was observed most frequently at failure.
Q80K supstitucijom aminokiselina pri neuspjehu liječenja najčešće je bila uočena nastala R155K
> 3.0 to ≤ 5.0 x ULN 1 (0.3%)
> 3,0 do ≤ 5,0 x GGN 1 (0,3%)
3 To prior treatment with peginterferon alfa and ribavirin.
3 Na prethodno liječenje s peginterferonom alfa i ribavirinom.