natgillin/translations-raw huggingface dataset:
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.
Table 8: ‘Blood bilirubin increased' events observed in Asian patients from the phase 3 study HPC3005 versus the pooled phase 3 studies C208, C216 and HPC3007 receiving simeprevir or placebo in combination with peginterferon alfa and ribavirin (first 12 weeks of treatment) Blood bilirubin increased 
Tablica 8: Događaji ‘povišenog bilirubina u krvi' zabilježeni u bolesnika azijatskog porijekla iz ispitivanja faze 3 HPC3005 naspram objedinjenih ispitivanja faze 3 C208, C216 i HPC3007 koji su primali simeprevir ili placebo u kombinaciji s peginterferonom alfa i ribavirinom (prvih 12 tjedana liječenja) Povišen bilirubin u krvi
Description of selected adverse reactions 
Opis odabranih nuspojava Osip i pruritus
Simvastatin 40 mg simvastatin AUC 1.51 (1.32-1.73) ↑ simvastatin Cmax 1.46 (1.17-1.82) ↑ simvastatin Cmin not studied simvastatin acid AUC 1.88 (1.63-2.17) ↑ simvastatin acid Cmax 3.03 (2.49-3.69) ↑ simvastatin acid Cmin not studied 
Simvastatin 40 mg simvastatin AUC 1,51 (1,32-1,73) ↑ simvastatin Cmax 1,46 (1,17-1,82) ↑ simvastatin Cmin nije ispitano simvastatin acid AUC 1,88 (1,63-2,17) ↑ simvastatin acid Cmax 3,03 (2,49-3,69) ↑ simvastatin acid Cmin nije ispitano
Patients co-infected with HIV-1 
Bolesnici istovremeno inficirani HIVom-1
Mean (SE) change in HCV RNA at day 7/8 (log10 IU/mL) 
Srednja vrijednost promjene (standardna pogreška, engl. standard error, SE) HCV RNK na 7./8. dan (log10 IU/mL)
DXM AUC 1.08 (0.87-1.35) ↑ DXM Cmax 1.21 (0.93-1.57) ↑ DXM Cmin not studied dextrorphan AUC 1.09 (1.03-1.15) ↔ dextrorphan Cmax 1.03 (0.93-1.15) ↔ dextrorphan Cmin not studied 
DXM AUC 1,08 (0,87-1,35) ↑ DXM Cmax 1,21 (0,93-1,57) ↑ DXM Cmin nije ispitano dekstrorfan AUC 1,09 (1,03-1,15) ↔ dekstrorfan Cmax 1,03 (0,93-1,15) ↔ dekstrorfan Cmin nije ispitano
> 1.5 to ≤ 2.0 x ULN 15 (5.2%) 
> 1,5 do ≤ 2,0 x GGN 15 (5,2%)
Pre-treatment testing for NS3 Q80K polymorphism in patients infected with HCV genotype 1a OLYSIO in combination with sofosbuvir 
Ispitivanje na NS3 Q80K polimorfizam koje prethodi liječenju u bolesnika inficiranih HCV-om genotipa 1a
Atorvastatin 40 mg atorvastatin AUC 2.12 (1.72-2.62) ↑ atorvastatin Cmax 1.70 (1.42-2.04) ↑ atorvastatin Cmin not studied 2-OH-atorvastatin AUC 2.29 (2.08-2.52) ↑ 2-OH-atorvastatin Cmax 1.98 (1.70-2.31) ↑ 2-OH-atorvastatin Cmin not studied 
Atorvastatin 40 mg atorvastatin AUC 2,12 (1,72-2,62) ↑ atorvastatin Cmax 1,70 (1,42-2,04) ↑ atorvastatin Cmin nije ispitano 2-OH-atorvastatin AUC 2,29 (2,08-2,52) ↑ 2-OH-atorvastatin Cmax 1,98 (1,70-2,31) ↑ 2-OH-atorvastatin Cmin nije ispitano
Table 7: Treatment-emergent laboratory abnormalities observed at a higher incidence in patients receiving simeprevir in combination with peginterferon alfa and ribavirin (pooled phase 3 studies C208, C216 and HPC3007; first 12 weeks of treatments) 
Tablica 7: Poremećaji laboratorijskih nalaza koji su nastali tijekom liječenja uočeni u većoj incidenciji kod bolesnika koji su primali simeprevir u kombinaciji s peginterferonom alfa i ribavirinom (objedinjena ispitivanja faze 3 C208, C216 i HPC3007; tijekom prvih 12 tjedana liječenja) Laboratorijski parametar
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. 
F4); 78% imalo je HCV genotipe 1a od kojih je 45% nosilo Q80K na početku, i 22% je imalo HCV genotip 1b; 86% imalo je ne-CC IL28B alele (CT ili TT); 76% su bili bolesnici bez prethodnog odgovora na peginterferon alfa i ribavirin, te 24%
Table 13: Treatment outcome in HCV genotype 1 infected patients receiving 12 weeks simeprevir + sofosbuvir (studies HPC3017 and HPC3018) Treatment outcome 
Tablica 13: Ishod liječenja u bolesnika inficiranih HCV genotipom 1 koji su primali 12 tjedana simeprevir + sofosbuvir (ispitivanja HPC3017 i HPC3018)
- 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 
- 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
1 Viral relapse rates are calculated with a denominator of patients with undetectable (or unconfirmed detectable) HCV RNA at actual EOT. 
1 Stope virološkog relapsa izračunate su uz nazivnik koji predstavlja broj bolesnika s nedetektabilnom (ili nepotvrđenom detektabilnom) HCV RNK pri stvarnom kraju liječenja.
Treatment Outcome simeprevir + peginterferon + ribavirin N = 521 % (n/N) 
Ishod liječenja simeprevir + peginterferon + ribavirin N = 521 % (n/N)
Oral: midazolam AUC 1.45 (1.35-1.57) ↑ midazolam Cmax 1.31 (1.19-1.45) ↑ midazolam Cmin not studied 
Peroralno: midazolam AUC 1,45 (1,35-1,57) ↑ midazolam Cmax 1,31 (1,19-1,45) ↑ midazolam Cmin nije ispitano
100 mg patient individualised dose4 
Doza individualizirana prema bolesniku4
The most frequently reported adverse reactions (incidence ≥ 5% following 12 or 24 weeks of treatment) were rash, pruritus, constipation and photosensitivity reaction (see section 4.4). 
Najčešće prijavljene nuspojave (incidencija ≥ 5% nakon 12 ili 24 tjedna liječenja) bile su osip,
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. 
Provedene su analize radi istraživanja povezanosti između početnih NS3/4A supstitucija aminokiselina (polimorfizmi) koje se prirodno pojavljuju i ishoda liječenja.
Prior partial responders Prior null responders Viral relapse4 
Bolesnici s prethodnim djelomičnim odgovorom Bolesnici bez prethodnog odgovora Virološki relaps4
nelfinavir, nevirapine, ritonavir, saquinavir or tipranavir to treat HIV infection - atorvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin or simvastatin to lower cholesterol levels - ciclosporin, sirolimus or tacrolimus to lower immune response or prevent organ transplant failures - sildenafil or tadalafil to treat ‘pulmonary arterial hypertension' - midazolam or triazolam (when taken by mouth) to help you sleep or for anxiety 
- atorvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin ili simvastatin za snižavanje razine kolesterola - ciklosporin, sirolimus ili takrolimus za snižavanje imunološkog odgovora ili za sprječavanje neuspjeha kod transplantacije organa
How OLYSIO works 
Kako OLYSIO djeluje
The following side effects may happen with OLYSIO when used in combination with sofosbuvir: Common: may affect up to 1 in 10 people: - itching of the skin - skin rash* - constipation - being sensitive to sunlight (photosensitivity) - increased ‘bilirubin' levels in your blood (bilirubin is a pigment made by the liver). 
Sljedeće nuspojave mogu se javiti uz OLYSIO kada se uzima u kombinaciji sa sofosbuvirom: Često: mogu se javiti u do 1 na 10 osoba: - svrbež kože - kožni osip* - zatvor
It is not recommended to co-administer OLYSIO with cobicistat-containing medicinal products. 
Ne preporučuje se istovremeno primjenjivati OLYSIO s lijekovima koji sadrže kobicistat.
0.25 mg digoxin AUC 1.39 (1.16-1.67) ↑ digoxin Cmax 1.31 (1.14-1.51) ↑ digoxin Cmin not studied 
ANTIARITMICI Digoksin 0,25 mg digoksin AUC 1,39 (1,16-1,67) ↑ digoksin Cmax 1,31 (1,14-1,51) ↑ digoksin Cmin nije ispitano
Press edge of pocket 
Pritisnite rub džepića
NAME OF THE MEDICINAL PRODUCT OLYSIO 150 mg hard capsules 
NAZIV LIJEKA OLYSIO 150 mg tvrde kapsule
Ritonavir1 100 mg twice daily simeprevir AUC 7.18 (5.63-9.15) ↑ simeprevir Cmax 4.70 (3.84-5.76) ↑ simeprevir Cmin 14.35 (10.29-20.01) ↑ 
100 mg dva puta na dan simeprevir AUC 7,18 (5,63-9,15) ↑ simeprevir Cmax 4,70 (3,84-5,76) ↑ simeprevir Cmin 14,35 (10,29-20,01) ↑
Table 15: Treatment outcome in HCV genotype 1 infected patients with cirrhosis receiving 12 or 24 weeks simeprevir + sofosbuvir, with or without ribavirin (study HPC2002) Treatment outcome 
Tablica 15: Ishod liječenja u bolesnika inficirnaih HCV genotipom 1 s cirozom koji su primali 12 ili 24 tjedna simeprevir + sofosbuvir, s ili bez ribavirina (ispitivanje HPC2002)
ciclosporin AUC 1.19 (1.13-1.26) ↑ ciclosporin Cmax 1.16 (1.07-1.26) ↑ ciclosporin Cmin not studied simeprevir AUC 5.81 (3.56-9.48) ↑5 simeprevir Cmax 4.74 (3.12-7.18) ↑5 simeprevir Cmin not studied5 
ciklosporin AUC 1,19 (1,13-1,26) ↑ ciklosporin Cmax 1,16 (1,07-1,26) ↑ ciklosporin Cmin nije ispitano simeprevir AUC 5,81 (3,56-9,48) ↑5 simeprevir Cmax 4,74 (3,12-7,18) ↑5 simeprevir Cmin nije ispitano5
Prior relapsers Prior partial responders Prior null responders 
s prethodnim relapsom s prethodnim djelomičnim odgovorom bez prethodnog odgovora
Genotype 4, treatment-naïve or treatment-experienced2, with compensated cirrhosis or without cirrhosis patients without cirrhosis: 8 or 12 weeks SMV + sofosbuvir; patients with cirrhosis: 
Genotip 4, prethodno neliječeni ili prethodno liječeni 2, s kompenziranom cirozom ili bez ciroze bolesnici bez ciroze: 8 ili 12 tjedana SMV + sofosbuvir; bolesnici s cirozom: 12 tjedana SMV + sofosbuvir
Phase 3) 
3. stupanj
During the first 12 weeks of treatment, the most frequently reported adverse reactions (incidence ≥ 5%) were nausea, rash, pruritus, dyspnoea, blood bilirubin increase and photosensitivity reaction (see section 4.4). 
osip, pruritus, dispneja, povišen bilirubin u krvi i reakcije fotoosjetljivosti (vidjeti dio 4.4).
(CYP3A4 enzyme induction [etravirine or nevirapine] or inhibition [delavirdine]) 
Očekuju se promijenjene koncentracije simeprevira u plazmi. (indukcija enzima CYP3A4 [etravirin ili nevirapin] ili inhibicija [delavirdin])
Table 6: Treatment-emergent laboratory abnormalities in amylase and lipase in patients receiving 12 or 24 weeks of simeprevir in combination with sofosbuvir (12 weeks: pooled studies HPC2002, HPC3017 and HPC3018; 24 weeks: study HPC2002) Laboratory parameter WHO toxicity range1 12 weeks simeprevir + 
Tablica 6: Poremećaji laboratorijskih nalaza amilaze i lipaze koji su proizašli iz liječenja u bolesnika koji su primali 12 ili 24 tjedna simeprevir u kombinaciji sa sofosbuvirom (12 tjedana: objedinjena ispitivanja HPC2002, HPC3017 i HPC3018; 24 tjedna: ispitivanje HPC2002)
In study HPC2002, rash (grouped term) was reported in 10.7% of patients receiving 12 weeks of simeprevir and sofosbuvir without ribavirin versus 20.4% of patients receiving 12 weeks of simeprevir and sofosbuvir with ribavirin. 
U ispitivanju HPC2002, osip (grupni izraz) je bio prijavljen u 10,7% bolesnika koji su primali 12 tjedana simeprevira i sofosbuvira bez ribavirina naspram 20,4% bolesnika koji su primali 12 tjedana simeprevira i sofosbuvira s ribavirinom.
≥ 1.1 to ≤ 1.5 x ULN 13 (4.5%) 
≥ 1,1 do ≤ 1,5 x GGN 13 (4,5%)
800/100 mg once daily darunavir AUC 1.18 (1.11-1.25) ↑ darunavir Cmax 1.04 (0.99-1.10) ↔ darunavir Cmin 1.31 (1.13-1.52) ↑ ritonavir AUC 1.32 (1.25-1.40) ↑ ritonavir Cmax 1.23 (1.14-1.32) ↑ ritonavir Cmin 1.44 (1.30-1.61) ↑ simeprevir AUC 2.59 (2.15-3.11) ↑* simeprevir Cmax 1.79 (1.55-2.06) ↑* simeprevir Cmin 4.58 (3.54-5.92) ↑* 
800/100 mg jedanput na dan darunavir AUC 1,18 (1,11-1,25) ↑ darunavir Cmax 1,04 (0,99-1,10) ↔ darunavir Cmin 1,31 (1,13-1,52) ↑ ritonavir AUC 1,32 (1,25-1,40) ↑ ritonavir Cmax 1,23 (1,14-1,32) ↑ ritonavir Cmin 1,44 (1,30-1,61) ↑ simeprevir AUC 2,59 (2,15-3,11) ↑* simeprevir Cmax 1,79 (1,55-2,06) ↑* simeprevir Cmin 4,58 (3,54-5,92) ↑*
Female patients of childbearing potential and male patients with female partners of childbearing potential must use an effective form of contraception during treatment with ribavirin and after completion of ribavirin treatment for a duration as specified in the Summary of Product Characteristics for ribavirin. 
moraju koristiti učinkovitu metodu kontracepcije tijekom liječenja ribavirinom i nakon završetka liječenja ribavirinom toliko dugo koliko je navedeno u sažetku opisa svojstava lijeka za ribavirin.
The safety profile of OLYSIO 150 mg in combination with peginterferon alfa and ribavirin in a phase 3 study conducted in Asian patients in China and South-Korea is comparable to non-Asian patients from a pooled phase 3 population from global studies, except for higher frequencies for ‘blood bilirubin increased' events (see table 8). 
Sigurnosni profil lijeka OLYSIO 150 mg u kombinaciji s peginterferonom alfa i ribavirinom u ispitivanju faze 3 provedenom na bolesnicima azijatskog porijekla u Kini i Južnoj Koreji može se usporediti s onim u bolesnika koji nisu azijatskog porijekla iz objedinjenih globalnih ispitivanja faze 3,