natgillin/translations-raw huggingface dataset:
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) ↑ 
Ritonavir1 100 mg dvakrát denne simeprevir AUC 7,18 (5,63-9,15)
2 Relapsers after prior interferon-based therapy. 
2 Pacienti s recidívou v minulosti na liečbe s interferónom.
How to take OLYSIO 
Čo je OLYSIO
> 2.5 to ≤ 5.0 x ULN 
2,5 až ≤ 5,0 x ULN
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). 
detekovateľná alebo nedetegovateľná 12 týždňov (SVR12) alebo 24 týždňov (SVR24) po plánovanom ukončení liečby (štúdie C206, C208, C212, C216, HPC2002, HPC3007 a HPC3011) alebo po skutočnom ukončení liečby (štúdia HPC2014, HPC3017, HPC3018 a HPC3021)
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). 
pozíciách 80, 122 a/alebo 168, zatiaľ čo pacienti s HCV genotypu 1b mali najčastejšie vznikajúcu substitúciu D168V (tabuľka 10).
0.25 mg digoxin AUC 1.39 (1.16-1.67) ↑ digoxin Cmax 1.31 (1.14-1.51) ↑ digoxin Cmin not studied 
0,25 mg digoxín AUC 1,39 (1,16-1,67)
In HCV genotype 1a infected patients with cirrhosis, testing for the presence of the NS3 Q80K polymorphism may be considered prior to initiation of therapy with OLYSIO in combination with sofosbuvir (see section 5.1). 
U pacientov infikovaných HCV genotypu 1a s cirhózou sa môže zvážiť testovanie na prítomnosť polymorfizmu Q80K pred začatím liečby OLYSIOM v kombinácii so sofosbuvirom (pozri časť 5.1).
If adverse reactions, potentially related to the medicinal products that are used in combination with OLYSIO for the treatment of CHC, require dosage adjustment or interruption of the medicinal product(s), refer to the instructions outlined in the respective Summary of Product Characteristics for these medicinal products. 
Ak je z dôvodu nežiaducich reakcií, potenciálne súvisiacich s liekmi užívanými v kombinácii s OLYSIOM na liečbu CHC, potrebná úprava dávky alebo prerušenie liečby liekom (liekmi),
Simeprevir in combination with peginterferon alfa and ribavirin The efficacy of simeprevir in combination with peginterferon alfa and ribavirin was evaluated in patients with HCV genotype 1 or 4 infection, with or without HIV-1 co-infection, who were treatment-naïve or treatment-experienced (following prior interferon-based therapy) (tables 17 and 
Účinnosť simepreviru v kombinácii s peginterferónom alfa a ribavirínom bola hodnotená u pacientov infikovaných HCV genotypu 1 alebo 4, ktorí boli alebo neboli koinfikovaní HIV-1, a ktorí boli
Viral relapse3 
Virologická recidíva3
Erythromycin 500 mg three times a day erythromycin AUC 1.90 (1.53-2.36) ↑ erythromycin Cmax 1.59 (1.23-2.05) ↑ erythromycin Cmin 3.08 (2.54-3.73) ↑ simeprevir AUC 7.47 (6.41-8.70) ↑ simeprevir Cmax 4.53 (3.91-5.25) ↑ simeprevir Cmin 12.74 (10.19-15.93) ↑ 
Erytromycín 500 mg trikrát denne erytromycín AUC 1,90 (1,53-2,36) ↑ erytromycín Cmax 1,59 (1,23-2,05)
(strong CYP3A4 induction) 
(silná indukcia CYP3A4)
No dose adjustment of OLYSIO is required in patients with mild hepatic impairment (Child-Pugh class A). 
U pacientov s ľahkou poruchou funkcie pečene (Childova-Pughova trieda A) sa nevyžaduje úprava dávky OLYSIA.
Ledipasvir 30 mg once daily ledipasvir AUC 1.92 (1.77-2.07) ↑ ledipasvir Cmax 1.81 (1.69-2.94) ↑ ledipasvir Cmin not studied simeprevir AUC 2.69 (2.44-2.96) ↑ simeprevir Cmax 2.61 (2.34-2.86) ↑ simeprevir Cmin not studied 
Ledipasvir 30 mg jedenkrát denne ledipasvir AUC 1,92 (1,77-2,07) ↑ ledipasvir Cmax 1,81 (1,69-2,94)
All grades Grade 3 
Stupeň 3 Stupeň 4
simeprevir + sofosbuvir 
+ sofosbuvir
Tabulated list of adverse reactions 
Súhrn nežiaducich reakcií v tabuľkách
Lovastatin 
Omeprazol
Viral relapse2 
Virologická recidíva2
(OATP1B1/3 transporter and/or CYP3A4 enzyme inhibition) 
(inhibícia transportéra OATP1B1/3 a/alebo enzýmu CYP3A4)
It is not recommended to co-administer OLYSIO with these anticonvulsants as co-administration may result in loss of therapeutic effect of OLYSIO. 
Súbežné podávanie OLYSIA s týmito antikonvulzívami sa neodporúča, pretože súbežné podávanie môže viesť k strate terapeutického účinku
Table 20: Treatment outcome in treatment-experienced1 HCV genotype 1 infected patients 
Tabuľka 22: Výsledok liečby u pacientov infikovaných HCV genotypu 1 koinfikovaných
> 1.5 to ≤ 2.5 x ULN 
1,5 až ≤ 2,5 x ULN
N = 7 % (n/N) 
7 % (n/N)
When considering OLYSIO combination treatment with peginterferon alfa and ribavirin in HCV genotype 1a patients, patients should be tested for the presence of virus with the NS3 Q80K polymorphism before starting treatment (see section 4.4). 
1 Keď sa zvažuje liečba OLYSIOM v kombinácii s peginterferónom alfa a ribavirínom u pacientov s HCV genotypu 1a, pred začiatkom liečby sa má uskutočniť testovanie na polymorfizmus NS3 Q80K (pozri časť 4.4).
Press edge of pocket 
Stlačte okraj vrecka
It is not recommended to co-administer OLYSIO with systemic dexamethasone as co-administration may result in loss of therapeutic effect of OLYSIO. 
Súbežné podávanie OLYSIA so systémovým dexametazónom sa neodporúča, pretože súbežné podávanie môže viesť k strate terapeutického účinku
(OATP1B1 transporter and/or CYP3A4 enzyme inhibition) 
(inhibícia transportéra OATP1B1 a/alebo enzýmu CYP3A4)
Genotype 1, treatment-naïve patients, with compensated cirrhosis or without cirrhosis 
Genotyp 1, „naivní“ pacienti, s kompenzovanou cirhózou alebo bez cirhózy
Intravenous: midazolam AUC 1.10 (0.95-1.26) ↑ midazolam Cmax 0.78 (0.52-1.17) ↓ midazolam Cmin not studied 
Intravenózny: midazolam AUC 1,10 (0,95-1,26)
> 2.0 to ≤ 5.0 x ULN 13 (4.5%) 
2,0 až ≤ 5,0 x ULN 13 (4,5
10 mg rosuvastatin AUC 2.81 (2.34-3.37) ↑ rosuvastatin Cmax 3.17 (2.57-3.91) ↑ rosuvastatin Cmin not studied 
↑ rosuvastatín Cmax 3,17 (2,57-3,91)
CC 
C.
> 1.5 to ≤ 2.0 x ULN 15 (5.2%) 
2,0 x ULN 15 (5,2
(intestinal CYP3A4 enzyme and P-gp transporter inhibition) 
(inhibícia črevného enzýmu CYP3A4 a transportéra P-gp)
HPC3011 N = 107 
HPC3011
Oral: midazolam AUC 1.45 (1.35-1.57) ↑ midazolam Cmax 1.31 (1.19-1.45) ↑ midazolam Cmin not studied 
Perorálny: midazolam AUC 1,45 (1,35-1,57)
Altered plasma concentrations of simeprevir are expected. 
Očakáva sa zmena plazmatickej koncentrácie simepreviru.
It is not recommended to co-administer OLYSIO with rifabutin or rifapentine as co-administration may result in loss of therapeutic effect of OLYSIO. 
Súbežné podávanie OLYSIA s rifabutínom alebo rifapentínom sa neodporúča, pretože súbežné podávanie môže viesť k strate terapeutického účinku
* darunavir/ritonavir + 50 mg simeprevir compared to 150 mg simeprevir alone. 
+ simeprevir 50 mg v porovnaní so samotným simeprevirom 150 mg.
3 To prior treatment with peginterferon alfa and ribavirin. 
Na predchádzajúcu liečbu peginterferónom alfa a ribavirínom.
The adverse reactions are listed by system organ class (SOC) and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000). 
1/100 až < 1/10), menej časté (≥
Table 14: Treatment outcome in HCV genotype 1 infected patients without cirrhosis receiving 12 weeks simeprevir + sofosbuvir, with or without ribavirin (study HPC2002) Treatment outcome simeprevir + sofosbuvir N = 21 % (n/N) 
Tabuľka 14: Výsledok liečby u pacientov infikovaných HCV genotypu 1 bez cirhózy, ktorí dostávali 12 týždňov simeprevir + sofosbuvir, s ribavirínom alebo bez ribavirínu (štúdia HPC2002)
GLUCOCORTICOIDS Dexamethasone (systemic) 
Dexametazón (podávaný systémovo)
40 mg omeprazole AUC 1.21 (1.00-1.46) ↑ omeprazole Cmax 1.14 (0.93-1.39) ↑ omeprazole Cmin not studied 
↑ omeprazol Cmax 1,14 (0,93-1,39)
If a dose of OLYSIO is missed, and the patient notices within 12 hours of the usual dosing time, the patient should take the missed dose of OLYSIO with food as soon as possible and then take the next dose of OLYSIO at the regularly scheduled time. 
pacient má užiť vynechanú dávku lieku OLYSIO čím skôr spolu s jedlom, a potom pokračovať v užívaní ďalšej dávky lieku OLYSIO vo zvyčajnom čase.
Patients with mild to moderate rashes should be monitored for possible progression of rash, including the development of mucosal signs or systemic symptoms. 
U pacientov s miernymi až stredne závažnými vyrážkami sa má sledovať možná progresia vyrážky,
Seventy-seven percent (200/259) of simeprevir-treated patients had undetectable HCV RNA at week 4; in these patients the SVR12 rate was 87%. 
%. 77 % (200/259) pacientov liečených simeprevirom malo nedetekovateľnú HCV RNA v 4. týždni; u týchto pacientov bol podiel
1 Includes relapsers, partial and null reponders to prior treatment with interferon (pegylated or non-pegylated), with or without ribavirin, and interferon-intolerant patients. 
(pegylovaným alebo nepegylovaným), s ribavirínom alebo bez ribavirínu, a pacientov s intoleranciou na interferón.
Table 18: Studies conducted with simeprevir + peginterferon alfa + ribavirin: demographics and baseline characteristics Pooled C208 and C216 N = 785 
Tabuľka 18: Štúdie vykonané so simeprevirom + peginterferónom alfa + ribavirín: demografické údaje a východiskové charakteristiky
Simeprevir in combination with sofosbuvir: ‘Blood bilirubin increased' was reported in 1.0% of patients receiving 12 weeks of treatment compared to 3.2% in patients receiving 24 weeks of treatment (all grades). 
Simeprevir v kombinácii so sofosbuvirom: „Zvýšená hladina bilirubínu v krvi“ bola hlásená u 1,0 %
NAME OF THE MEDICINAL PRODUCT OLYSIO 150 mg capsules simeprevir 
NÁZOV LIEKU OLYSIO 150 mg kapsuly simeprevir
Study HPC3007: includes 5 simeprevir-treated patients who experienced relapse after SVR12. 
zahŕňa 5 pacientov liečených simeprevirom, u ktorých došlo k recidíve po SVR12.
Therefore, co-administration of OLYSIO with substances that moderately or strongly inhibit or induce CYP3A4 is not recommended. 
ktoré stredne silno alebo silno inhibujú alebo indukujú CYP3A4, neodporúča.
(studies HPC3007 and C206) Treatment Outcome 
C216 a HPC3007 (prvých 12 týždňov liečby).
It is not recommended to co-administer OLYSIO with efavirenz as co-administration may result in loss of therapeutic effect of OLYSIO. 
Súbežné podávanie OLYSIA s efavirenzom sa neodporúča, pretože súbežné podávanie môže viesť k strate terapeutického účinku
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 Cmin nesledovala sa dextrorfan AUC 1,09 (1,03-1,15)
Table 3: Treatment stopping rules in patients receiving OLYSIO in combination with peginterferon alfa and ribavirin with inadequate on-treatment virologic response 
v kombinácii s peginterferónom alfa a ribavirínom a s nedostatočnou virologickou odpoveďou počas liečby
Prior partial responders Prior null responders Outcome for patients without SVR On-treatment failure Prior relapsers 
pacienti s recidívou v minulosti čiastoční respondenti v minulosti nuloví respondenti v minulosti
HCV geno/subtype and presence of baseline Q80K polymorphism in HCV genotype 1a Genotype 1a with Q80K without Q80K Genotype 1b 
HCV geno/subtyp a prítomnosť východiskového polymorfizmu Q80K u HCV genotypu 1a HCV genotyp 1a s Q80K HCV genotyp 1b
What OLYSIO is - OLYSIO contains the active substance ‘simeprevir'. 
- OLYSIO obsahuje liečivo „simeprevir“.
(OATP1B1/3, BCRP transporter inhibition) 
(inhibícia transportéra OATP1B1/3, BCRP)
HCV geno/subtype and presence of baseline Q80K polymorphism in HCV genotype 1a HCV genotype 1a with Q80K 
HCV geno/subtyp a prítomnosť polymorfizmu Q80K u HCV genotypu 1a
Genotype 4, treatment-naïve or treatment-experienced4 
Genotyp 1, t „naivní“ pacienti alebo pacienti po predchádzajúcej liečbe 4,
Decreased plasma concentrations of simeprevir are expected. 
Očakáva sa zníženie plazmatickej koncentrácie simepreviru.
It is not recommended to co-administer OLYSIO with rifampicin as co-administration may result in loss of therapeutic effect of OLYSIO. 
Súbežné podávanie OLYSIA s rifampicínom sa neodporúča, pretože súbežné podávanie môže viesť k strate terapeutického účinku
HMG CO-A REDUCTASE INHIBITORS Rosuvastatin 
INHIBÍTORY REDUKTÁZY
Significantly increased plasma concentrations of simeprevir are expected. 
Očakáva sa významné zvýšenie plazmatickej koncentrácie simepreviru.
1 Viral relapse rates are calculated with a denominator of patients with undetectable (or unconfirmed detectable) HCV RNA at actual EOT. 
Podiely virologickej recidívy sú vypočítané s denominátorom pacientov s nedetekovateľnou (alebo nepotvrdenou detekovateľnou)
The 40 enrolled patients had a median age of 51 years (range 29 to 69 years; with 5% above 65 years); 73% were male; 18% had a BMI ≥ 30 kg/m2; the median baseline HCV RNA level was 6.35 log10 IU/ml; 18% had cirrhosis; 25% had HCV genotype 4a, and 73% HCV genotype 4d; 85% 
% malo BMI ≥ 30 kg/m2; medián východiskovej hladiny HCV RNA bol 6,35 log10 IU/ml; 18 % malo cirhózu; 25 % malo HCV genotypu 4a a 73 % HCV genotypu 4d; 85 % malo non-CC
Increased plasma concentrations of lovastatin are expected. 
Očakáva sa zvýšenie plazmatickej koncentrácie lovastatínu.
(OATP1B1/3 transporter inhibition) 
(inhibícia transportéra OATP1B1/3)
No dose adjustment of OLYSIO is required in patients with mild or moderate renal impairment. 
OLYSIO sa neodporúča u pacientov so stredne závažnou alebo závažnou poruchou funkcie pečene
- digoxin, disopyramide, flecainide, mexiletine, propafenone or quinidine (when taken by mouth) 
- digoxín, disopyramid, flekainid, mexiletín, propafenón alebo chinidín (keď sa užíva cez ústa) alebo amiodarón na liečbu nepravidelného tlkotu srdca - klaritromycín, erytromycín (keď sa užíva cez ústa alebo sa podáva injekčne) alebo telitromycín na liečbu bakteriálnych infekcií
Magnesium hydroxide Calcium carbonate 
Hydroxid hlinitý alebo horečnatý Uhličitan vápenatý
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; 
167 zaregistrovaných pacientov malo medián veku 57 rokov (v rozmedzí od 27 do 70 rokov, s 5 % nad 65 rokov); 64 % boli muži; 81 % boli belosi,
HPC3007 N = 393 
HPC3007.
NAME OF THE MEDICINAL PRODUCT OLYSIO 150 mg hard capsules simeprevir 
NÁZOV LIEKU OLYSIO 150 mg tvrdé kapsuly simeprevir
0.035 mg once daily/ 1 mg once daily ethinylestradiol AUC 1.12 (1.05-1.20) ↔ ethinylestradiol Cmax 1.18 (1.09-1.27) ↑ ethinylestradiol Cmin 1.00 (0.89-1.13) ↔ norethindrone AUC 1.15 (1.08-1.22) ↔ norethindrone Cmax 1.06 (0.99-1.14) ↔ norethindrone Cmin 1.24 (1.13-1.35) ↑ 
0,035 mg jedenkrát denne/1 mg jedenkrát denne etinylestradiol AUC 1,12 (1,05-1,20)
Increased plasma concentrations of simeprevir are expected. 
Očakáva sa zvýšenie plazmatickej koncentrácie simepreviru.
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 
Cmin nesledoval sa kyselina simvastatínová AUC 1,88 (1,63-2,17)↑ kyselina simvastatínová
Pitavastatin Pravastatin 
Pitavastatín Pravastatín
N = 10 % (n/N) 
40 % (n/N)
Rilpivirine 25 mg once daily rilpivirine AUC 1.12 (1.05-1.19) ↔ rilpivirine Cmax 1.04 (0.95-1.13) ↔ rilpivirine Cmin 1.25 (1.16-1.35) ↑ simeprevir AUC 1.06 (0.94-1.19) ↔ simeprevir Cmax 1.10 (0.97-1.26) ↑ simeprevir Cmin 0.96 (0.83-1.11) ↔ 
Rilpivirín 25 mg jedenkrát denne rilpivirín AUC 1,12 (1,05-1,19)
OLYSIO is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh class B or C) (see sections 4.2, 4.8 and 5.2). 
B alebo C) (pozri časti 4.2, 4.8 a 5.2).
STIMULANTS Methylphenidate 
INHIBÍTORY FOSFODIESTERÁZY
The proportion of simeprevir-treated patients with HCV RNA < 25 IU/ml detectable at week 4 was 18% (47/259); 60% achieved SVR12. 
Podiel pacientov liečených simeprevirom s detekovateľnou HCV RNA < 25 IU/ml v 4. týždni bol 18
This is particularly significant if these are accompanied by either of the following symptoms: - feel sick (nauseous), are sick (vomit) or lose your appetite - confusion. 
Je to obzvlášť dôležité, ak sú sprevádzané niektorými z nasledovných príznakov
Treatment with OLYSIO must be initiated in combination with peginterferon alfa + ribavirin and administered for 12 weeks and then followed by an additional 12 weeks of peginterferon alfa + ribavirin. 
12 týždňov, potom má nasledovať ďalších 12 týždňov liečby peginterferónom alfa + ribavirínom.
Chemistry 
LIEKY
Rash 
RTIs)
4 Viral relapse rates are calculated with a denominator of patients with undetectable HCV RNA at EOT and with at least one follow-up HCV RNA assessment. 
HCV RNA na EOT a s najmenej jedným následným hodnotením HCV RNA.
OLYSIO is not recommended for patients with moderate or severe hepatic impairment (Child-Pugh class B or C) (see sections 4.4 and 5.2). 
OLYSIO sa neodporúča pacientom so stredne závažnou alebo závažnou poruchou funkcie pečene (Childova-Pughova trieda
Treatment with OLYSIO must be initiated in combination with peginterferon alfa + ribavirin and administered for 12 weeks and then followed by an additional 36 weeks of peginterferon alfa and + ribavirin. 
12 týždňov, potom má nasledovať ďalších 36 týždňov liečby peginterferónom alfa + ribavirínom.
(strong CYP3A4 enzyme inhibition) 
(silná inhibícia enzýmu CYP3A4)
1 When considering OLYSIO combination treatment with peginterferon alfa and ribavirin in HCV genotype 1a patients, 
s peginterferónom alfa a ribavirínom u pacientov s HCV genotypu 1 alebo 4 Populácia pacientov
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). 
týždňov) alebo štúdia HPC2002 (24 týždňov); simeprevir v kombinácii s peginterferónom alfa a ribavirínom: zlúčené štúdie fázy 3 C208,
Includes 
ALEBO
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. 
%) s vyskytujúcou sa jedinou D168V a u 34 zo 66 (52
simeprevir % (n/N) 
% (n/N)
Genotype 1, treatment-experienced4 
Virologická recidíva4
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. 
%) u pacientov infikovaných HCV genotypu 1 (n = 2007; v zlúčených štúdiách fazy 2 a 3 so simeprevirom v kombinácii s peginterferónom alfa a ribavirínom), s výnimkou substitúcie Q80K u pacientov s HCV genotypu 1a, ktorá bola pozorovaná u 30 % pacientov s HCV genotypu 1a a 0,5
Prior treatment history treatment-naïve treatment-experienced2 
„naivní“ pacienti po predchádzajúcej liečbe2
HCV genotype 1b 
HCV genotyp 1a s Q80K
400 mg twice a day raltegravir AUC 1.08 (0.85-1.38) ↑ raltegravir Cmax 1.03 (0.78-1.36) ↔ raltegravir Cmin 1.14 (0.97-1.36) ↑ simeprevir AUC 0.89 (0.81-0.98) ↔ simeprevir Cmax 0.93 (0.85-1.02) ↔ simeprevir Cmin 0.86 (0.75-0.98) ↓ 
400 mg dvakrát denne raltegravir AUC 1,08 (0,85-1,38)
WHO toxicity range1 
Rozsah toxicity podľa
Elevations in direct and indirect bilirubin have been reported in patients treated with simeprevir and were mostly of mild or moderate severity. 
U pacientov liečených simeprevirom bolo hlásené zvýšenie hladiny priameho a nepriameho bilirubínu,
Genotype 4, treatment-naïve or treatment-experienced2, with compensated cirrhosis or without cirrhosis 
Genotyp 4, „naivní“ pacienti alebo pacienti po predchádzajúcej liečbe4, s kompenzovanou cirhózou alebo bez cirhózy
The planned total duration of HCV 
Všetky genotypy HCV
1 Superior versus historical control rate (historical SVR rates of approved combination treatments of direct acting antivirals with peginterferon alfa and ribavirin). 
Genotyp 1a s Q80K bez Q80K Genotyp 1b 1 Superior oproti historickej miere kontroly (miera historickej SVR schválenej kombinovanej liečby priamo účinkujúcich antivirotík s peginterferónom alfa and ribavirínom).
Outcome for patients without SVR12 On-treatment failure Viral relapse2 
Výsledok u pacientov bez SVR12
ANTIDEPRESSANTS Escitalopram 10 mg once daily escitalopram AUC 1.00 (0.97-1.03) ↔ escitalopram Cmax 1.03 (0.99-1.07) ↔ escitalopram Cmin 1.00 (0.95-1.05) ↔ simeprevir AUC 0.75 (0.68-0.83) ↓ simeprevir Cmax 0.80 (0.71-0.89) ↓ simeprevir Cmin 0.68 (0.59-0.79) ↓ 
ANTIDEPRESÍVA Escitalopram 10 mg jedenkrát denne escitalopram AUC 1,00 (0,97-1,03)
The proportion of simeprevir-treated patients with HCV RNA < 25 IU/ml detectable at week 4 was 14% (70/509); 67% achieved SVR12. 
HCV RNA v 4. týždni; u týchto pacientov bol podiel SVR12 90 %. Podiel pacientov liečených simeprevirom s detekovateľnou HCV RNA < 25 IU/ml v 4. týždni bol 14
(intestinal CYP3A4 enzyme inhibition) 
(inhibícia enzýmu CYP3A4)
- 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 
- karbamazepín, oxkarbazepín, fenobarbital alebo fenytoín na prevenciu epileptických záchvatov - astemizol alebo terfenadín na liečbu alergií
The response rates for patients with or without cirrhosis receiving 12 weeks of simeprevir + sofosbuvir are shown in table 13. 
Miera odpovede pacientov s cirhózou alebo bez cirhózy, ktorí dostávali 12 týždňov simeprevir
Simeprevir in combination with peginterferon alfa and ribavirin There were no differences in haemoglobin, neutrophils or platelets between both treatment groups. 
Medzi oboma liečebnými skupinami sa nezaznamenali žiadne rozdiely v hladine hemoglobínu, neutrofilov alebo krvných doštičiek.
Consult the Summary of Product Characteristics of the co-prescribed medicinal products before starting therapy with OLYSIO. 
Pred začatím liečby OLYSIOM si treba pozrieť súhrn charakteristických vlastností súbežne predpísaných liekov.
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 
Cmin nesledovala sa simeprevir AUC 5,81 (3,56-9,48)
Genotype 1a1 N = 116 % (n) 
Genotyp 1 (N =
Genotype 1, prior relapsers2, with compensated cirrhosis or without cirrhosis 
1, pacienti s recidívou v minulosti2, s kompenzovanou cirhózou alebo bez cirhózy
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. 
- warfarín a iné podobné lieky, ktoré sa nazývajú antagonisty vitamínu K, ktoré sa používajú na riedenie krvi.
600 mg once daily efavirenz AUC 0.90 (0.85-0.95) ↔ efavirenz Cmax 0.97 (0.89-1.06) ↔ efavirenz Cmin 0.87 (0.81-0.93) ↔ simeprevir AUC 0.29 (0.26-0.33) ↓ simeprevir Cmax 0.49 (0.44-0.54) ↓ simeprevir Cmin 0.09 (0.08-0.12) ↓ 
600 mg jedenkrát denne efavirenz AUC 0,90 (0,85-0,95)