natgillin/translations-raw huggingface dataset:
The response rates for patients with or without cirrhosis receiving 12 weeks of simeprevir + sofosbuvir are shown in
Stope odgovora za bolesnike s ili bez ciroze koji su primali 12 tjedana simeprevir + sofosbuvir
Refer to the Summary of Product Characteristics for these co-administered medicinal products regarding their potential effect on the ability to drive and use
Molimo pogledajte sažetak opisa svojstava lijeka za istodobno primijenjene lijekove vezano uz njihov potencijalni učinak na sposobnost upravljanja vozilima i rada sa strojevima.
Most of the rash and pruritus events in simeprevir-treated patients were of mild or moderate severity
U bolesnika liječenih simeprevirom većina slučajeva pojave osipa i pruritusa bilo je blage ili umjerene
24 weeks simeprevir + sofosbuvir
simeprevir + sofosbuvir
The safety profile of simeprevir in combination with peginterferon alfa and ribavirin is comparable between HCV genotype 1 infected patients with and without HIV-1 co-infection.
Sigurnosni profil simeprevira u kombinaciji s peginterferonom alfa i ribavirinom usporediv je između bolesnika inficiranih HCV genotipom 1 sa ili bez koinfekcije HIVom-1.
Johnson & Johnson România SRL Str. Tipografilor nr. 11-15
Johnson & Johnson România SRL Str.
In study HPC2002, increased bilirubin was reported in 0% of patients receiving 12 weeks of simeprevir and sofosbuvir without ribavirin versus 9.3% of patients receiving 12 weeks of simeprevir and sofosbuvir with ribavirin.
U ispitivanju HPC2002, povišen bilirubin bio je prijavljen u 0% bolesnika koji su 12 tjedana primali simeprevir i sofosbuvir bez ribavirina naspram 9,3% bolesnika koji su 12 tjedana primali simeprevir i sofosbuvir s ribavirinom.
HCV genotype 1 subtype-specific patterns of simeprevir treatment-emergent amino acid substitutions were observed in patients not achieving SVR.
Obrasci supstitucija aminokiselina, specifični za podtip HCV genotipa 1, koji su proizašli iz liječenja simeprevirom bili su uočeni u bolesnika koji nisu postigli SVR.
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)
Laboratory parameter WHO toxicity range
Laboratorijski parametar
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
(inhibition of CYP3A4 enzymes and P-gp transporter by both erythromycin and simeprevir)
(inhibicija enzima CYP3A4 i P-gp prijenosnika i eritromicinom i simeprevirom)
Seventy-seven percent (200/259) of simeprevir-treated patients had undetectable HCV RNA at week 4; in these patients the SVR12 rate was 87%.
Sedamdeset i sedam posto (200/259) bolesnika liječenih simeprevirom imalo je nedetektabilnu HCV RNK u 4. tjednu; u tih bolesnika stopa SVR12 bila je 87%.
Population pharmacokinetic estimates of exposure of simeprevir were comparable between Caucasian and Black/African American HCV infected patients treated with simeprevir in combination with peginterferon alfa and ribavirin.
Populacijska farmakokinetika procjenjuje izloženost simeprevira što je usporedivo među bolesnicima bijele i crne/afro-američke rase inficiranima HCV-om liječenih simeprevirom u kombinaciji s peginterferonom alfa i ribavirinom.
Simeprevir is highly protein bound, therefore dialysis is unlikely to result in significant removal of
Simeprevir se u visokoj mjeri veže na proteine, stoga nije vjerojatno da će dijaliza dovesti do značajnog uklanjanja simeprevira (vidjeti dio 5.2).
However, reports of hepatic decompensation and hepatic failure during OLYSIO combination therapy have been received in the post marketing setting (see section 4.4).
Međutim, tijekom kombiniranog liječenja lijekom OLYSIO, postmarketinški su zaprimljene prijave hepatičke dekompenzacije i zatajenja jetre (vidjeti dio 4.4).
Mild increases in concentrations of PDE-5 inhibitors may be expected.
Moguća su blaga povišenja koncentracija PDE-5 inhibitora u plazmi.
It is not recommended to co-administer OLYSIO with ritonavir.
Ne preporučuje se istovremeno primjenjivati OLYSIO s ritonavirom.
Table 13: Treatment outcome in HCV genotype 1 infected patients receiving 12 weeks simeprevir + sofosbuvir (studies HPC3017 and HPC3018)
Tablica 13: Ishod liječenja u bolesnika inficiranih HCV genotipom 1 koji su primali 12 tjedana simeprevir + sofosbuvir (ispitivanja HPC3017 i HPC3018)
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)
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)
It is not recommended to co-administer OLYSIO with systemic erythromycin.
Ne preporučuje se istovremeno primjenjivati OLYSIO sa sistemskim eritromicinom.
In the pooled analysis of studies C208 and C216, 69% (58/84) of the simeprevir-treated HCV genotype 1a infected patients with Q80K polymorphism at baseline were eligible for a total treatment duration of 24 weeks; in these patients the SVR12 rate was 78%.
U objedinjenoj analizi ispitivanja C208 i C216, 69% (58/84) bolesnika inficiranih HCV genotipom 1a liječenih simeprevirom s Q80K početnim polimorfizmom bili su pogodni za ukupno trajanje liječenja od 24 tjedna; u tih bolesnika stope SVR12 bile su 78%.
Dosage adjustment or interruption of medicinal products used in combination with OLYSIO for the
Prilagodbe doziranja ili prekid liječenja lijekom OLYSIO
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 u kombinaciji sa sofosbuvirom: ‘Povišen bilirubin u krvi' bio je prijavljen u 1,0% bolesnika koji su liječeni tijekom 12 tjedana u usporedbi s 3,2% u bolesnika koji su liječenji tijekom24 tjedna (svi stupnjevi).
Median simeprevir FC values against genotype 2 and genotype 3 baseline isolates tested were 25 (N = 4) and 1,014 (N = 2), respectively.
Vrijednosti medijana promjene simeprevira protiv početnih izolata genotipa 2 i genotipa 3 bile su 25 puta (N = 4), odnosno 1,014 puta (N = 2).
In study HPC2002, photosensitivity reactions (grouped term) was reported in 7.1% of patients receiving 12 weeks of simeprevir and sofosbuvir without ribavirin versus 5.6% of patients receiving 12 weeks of simeprevir and sofosbuvir with ribavirin.
U ispitivanju HPC2002, reakcije fotoosjetljivosti (grupni izraz) bile su prijavljene u 7,1% bolesnika koji su 12 tjedana primali simeprevir i sofosbuvir bez ribavirina naspram 5,6% bolesnika koji su primali simeprevir i sofosbuvir s ribavirinom 12 tjedana.
In study C206 (ASPIRE), patients who failed prior peg-IFN/RBV therapy received 12, 24 or 48 weeks simeprevir (100 mg or 150 mg once daily) in combination with 48 weeks of peginterferon alfa-2a + ribavirin (see tables 17 and 18).
U ispitivanju C206 (ASPIRE), bolesnici koji su doživjeli neuspjeh prethodne terapije s peg-IFN/RBV primali su 12, 24 ili 48 tjedana simeprevir (100 mg ili 150 mg jedanput dnevno) u kombinaciji s peginterferonom alfa-2a + ribavirinom tijekom 48 tjedana (vidjeti tablice 17 i 18).
Following prior treatment with interferon (pegylated or non-pegylated), with or without ribavirin (see section 5.1).
Nakon prethodnog liječenja s interferonom (pregiliranim ili nepegiliranim), sa ili bez ribavirina (vidjeti dio 5.1) Preporučeno trajanje liječenja pod uvjetom da bolesnik ne dostigne pravilo za prekid liječenja (vidjeti tablicu 3).
Eighty-nine percent (54/61) of the simeprevir-treated treatment-naïve patients and prior relapsers without cirrhosis were eligible for 24 weeks of treatment; in these patients the SVR12 rate was 87%.
Osamdeset i devet posto (54/61) bolesnika bez ciroze liječenih simeprevirom, koji prethodno nisu bili liječeni ili su prethodno doživjeli relaps bilo je pogodno za 24 tjedna liječenja; u tih bolesnika stopa SVR12 bila je 87%.
Includes relapsers, partial and null reponders to prior treatment with interferon (pegylated or non-pegylated), with or without ribavirin, and interferon-intolerant patients.
Uključuje bolesnike s relapsom, djelomičnim odgovorom ili bez odgovora na prethodno liječenje s interferonom (pegiliranim ili nepegiliranim), s ili bez ribavirina, i bolesnici koji ne podnose interferon.
Table 16: Treatment outcome in HCV genotype 4 infected patients receiving 12 weeks simeprevir + sofosbuvir (studies HPC2014 and HPC3021) Treatment outcome
Tablica 16: Ishod liječenja u bolesnika inficiranih HCV genotipom 4 koji su primali 12 tjedana simeprevir + sofosbuvir (ispitivanja HPC2014 i HPC3021)
It is not recommended to co-administer OLYSIO with a ledipasvir-containing medicinal product.
Ne preporučuje se istovremeno primjenjivati OLYSIO s lijekovima koji sadrže ledipasvir.
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% bolesnika nije bilo prethodno liječeno.
Prior null responders N = 40 % (n/N)
Prethodno bez odgovora N = 40 % (n/N)
Sixty-five percent (53/81) of the simeprevir-treated HCV genotype 1a infected patients with Q80K polymorphism had undetectable HCV RNA at week 4; in these patients the SVR12 rate was 79%.
Šezdeset i pet posto (53/81) bolesnika inficiranih HCV genotipom 1a s Q80K polimorfizmom imalo je nedetektabilnu HCV RNA u 4. tjednu; u tih bolesnika stopa SVR12 bila je 79%.
100 mg twice daily simeprevir Cmax 4.70 (3.84-5.76) ↑ simeprevir Cmin 14.35 (10.29-20.01) ↑
simeprevir AUC 7,18 (5,63-9,15)  simeprevir Cmax 4,70 (3,84-5,76)  simeprevir Cmin 14,35 (10,29-20,01) 
Increased plasma concentrations of orally administered calcium channel blockers may be expeced.
Mogu se očekivati povišene koncentracije peroralno primijenjenih blokatora
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 jedanput na 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) 
Prior null responders N = 28 % (n/N)
Prethodno bez odgovora N = 28 % (n/N)
To prior treatment with peginterferon alfa and ribavirin.
Na prethodno liječenje s peginterferonom alfa i ribavirinom.
Rash has been observed with OLYSIO combination treatment (see section 4.8).
Osip je uočen s lijekom OLYSIO u kombiniranom liječenju (vidjeti dio 4.8).
Eighty-nine percent (51/57) of the simeprevir-treated treatment-naïve patients and prior relapsers were eligible for a total treatment duration of 24 weeks; in these patients the SVR12 rate was 94%.
Osamdeset i devet posto (51/57) bolesnika liječenih simeprevirom koji prethodno nisu bili liječeni i bolesnika s prethodnim relapsom bilo je pogodno za liječenje ukupnog trajanja od 24 tjedna; kod tih bolesnika stopa SVR12 bila je 94%.
Table 23 shows the response rates in HCV genotype 4 infected patients.
U tablici 23 prikazane su stope odgovora u bolesnika inficiranih HCV genotipom 4.
OLYSIO is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C) (see sections 4.2, 4.8 and 5.2).
Lijek OLYSIO se ne preporučuje u bolesnika s umjerenim ili teškim oštećenjem jetre (Child-Pugh B ili C) (vidjeti dijelove 4.2, 4.8 i 5.2).
Genotype 4, treatment-naïve or treatment-experienced patients, with compensated cirrhosis or without cirrhosis treatment-naïve patients or prior relapsers: 12 weeks SMV + peg-IFN-alfa + RBV, followed by 12 or 36 weeks peg-IFN-alfa + RBV prior non-responder patients (partial and null responders): 12 weeks SMV + peg-IFN-alfa + RBV, followed by 36 weeks peg-IFN-alfa + RBV
4, HCV/HIV-1 koinficirani bolesnici, s kompenziranom cirozom ili bez ciroze prethodno neliječeni bolesnici ili bolesnici s prethodnim relapsom bez ciroze: 12 tjedana SMV + peg-IFN-alfa + RBV, nakon čega slijedi 12 ili 36 tjedana peg-IFN-alfa + RBV bolesnici koji prethodno nisu odgovorili na liječenje (s djelomičnim odgovorom ili bez odgovora) bez ciroze i svi bolesnici koji prethodno nisu bili liječeni i prethodno liječeni s cirozom: 12 tjedana SMV + peg-IFN-alfa + RBV, nakon čega je slijedilo 36 tjedana peg-IFN-alfa + RBV prethodno neliječeni bolesnici ili bolesnici s prethodnim relapsom: 12 tjedana SMV + peg-IFN-alfa + RBV, nakon čega je slijedilo 12 ili 36 tjedana peg-IFN-alfa + RBV bolesnici koji prethodno nisu odgovorili na liječenje (s djelomičnim odgovorom ili bez odgovora): 12 tjedana SMV + peg-IFN-alfa + RBV, nakon čega je slijedilo 36 tjedana peg-IFN-alfa + RBV
Talk to your doctor if you are breast-feeding before taking OLYSIO.
Ako dojite, obratite se svom liječniku prije uzimanja lijeka OLYSIO.
Table 22: Treatment outcome in HCV genotype 1 infected patients with HIV-1 co-infection
Tablica 22: Ishod liječenja u bolesnika inficiranih HCV genotipom 1 i koinfekcijom HIV-om-1
Prior partial responders N = 10 % (n/N)
Prethodni djelomični odgovor N = 10 % (n/N)
Forty-five percent (13/29) of the simeprevir-treated HCV genotype 1a infected patients with Q80K polymorphism had undetectable HCV RNA at week 4; in these patients the SVR12 rate was 77%.
Četrdeset i pet posto (13/29) bolesnika inficiranih HCV genotipom 1a liječenih simeprevirom s Q80K polimorfizmom imalo je nedetektabilnu HCV RNA u 4. tjednu; u tih bolesnika stopa SVR12 bila je 77%.
(OATP1B1 transporter and/or CYP3A4 enzyme
(inhibicija prijenosnika OATP1B1/3 i/ili enzima CYP3A4)
No dose adjustment is required for either drug when OLYSIO is co-administered with tacrolimus.
Nije potrebna prilagodba doze za bilo koji od lijekova kada se lijek OLYSIO istovremeno primijeni s takrolimusom.
In study HPC3007, 80% (24/30) of the simeprevir-treated HCV genotype 1a infected patients with Q80K polymorphism at baseline were eligible for a total treatment duration of 24 weeks; in these patients the SVR12 rate was 58%.
U ispitivanju HPC3007, 80% (24/30) bolesnika inficiranih HVC genotipom 1a liječenih simeprevirom s početnim Q80K polimorfizmom bilo je pogodno za ukupno trajanje liječenja od 24 tjedna; u tih bolesnika stopa SVR12 bila je 58%.
Simeprevir in combination with peginterferon alfa and ribavirin: During the 12 weeks treatment with simeprevir, rash and pruritus were reported in 21.8% and 21.9% of simeprevir-treated patients, compared to 16.6% and 14.6% in placebo-treated patients, respectively (all grades; pooled phase 3).
Simeprevir u kombinaciji s peginterferonom alfa i ribavirinom: Tijekom 12 tjedana liječenja simeprevirom, osip i pruritus bili su prijavljeni u 21,8% i 21,9% bolesnika liječenih simeprevirom, u usporedbi s 16,6% odnosno 14,6% u bolesnika liječenih placebom (svi stupnjevi; objedinjeno za fazu 3).
Table 22 shows the response rates in HCV genotype 1 infected patients with HIV-1 co-infection.
Tablica 22 pokazuje stope odgovora u bolesnika inficiranih HCV genotipom 1 s koinfekcijom HIV-om-1.
In HCV genotype 1a infected patients with cirrhosis, testing for the presence of the Q80K polymorphism may be considered prior to initiation of therapy with OLYSIO in combination with sofosbuvir (see section 4.4).
U bolesnika s infekcijom HCV genotipom 1a s cirozom može se prije početka liječenja s lijekom OLYSIO u kombinaciji sa sofosbuvirom uzeti u obzir ispitivanje prisutnosti Q80K polimorfizma (vidjeti dio 4.4).
Altered plasma concentrations of simeprevir are expected.
Očekuju se promijenjene koncentracije simeprevira u plazmi.
Refer also to the Summary of Product Characteristics of the medicinal products that are used in
Također pogledajte sažetak opisa svojstava lijeka za lijekove koji se koriste u kombinaciji s lijekom
This effect was observed at higher systemic exposures (11-fold) than those in humans at the
Ovaj učinak bio je uočen pri višim sistemskim izloženostima (11-puta) nego u onih kod ljudi pri preporučenoj dozi od 150 mg jedanput na dan.
As exposure may be increased in HCV infected patients with severe renal impairment, caution is recommended when prescribing simeprevir to these patients (see section 4.2).
Budući da izloženost može biti povećana u bolesnika inficiranih HCV-om s teškim oštećenjem bubrega, preporučuje se oprez kada se simeprevir propisuje tim bolesnicima
OLYSIO is not recommended for patients with moderate or severe hepatic impairment (Child-Pugh B or C) (see sections 4.4 and 5.2).
Lijek OLYSIO se ne preporučuje za bolesnike s umjerenim ili teškim oštećenjem jetre (Child-Pugh B ili C) (vidjeti dijelove 4.4 i 5.2).
When considering OLYSIO combination treatment with peginterferon alfa and ribavirin in HCV genotype 1a patients, testing for NS3 Q80K polymorphism should be performed before starting treatment (see section 4.4).
Kada se razmatra kombinirano liječenje lijekom OLYSIO s peginterferonom alfa i ribavirinom u bolesnika s HCV genotipom 1a, prije početka liječenja treba provesti ispitivanje na NS3 Q80K polimorfizam (vidjeti dio 4.4).
12 or 24 weeks SMV + sofosbuvir, with or without ribavirin patients without cirrhosis: 8 or 12 weeks SMV + sofosbuvir; patients with cirrhosis:
Genotip 4, prethodno neliječeni ili kompenziranom cirozom ili bez bolesnici bez ciroze: 8 ili 12 tjedana SMV + sofosbuvir; bolesnici s cirozom: 12 tjedana SMV + sofosbuvir
Refer to the respective Summary of Product Characteristics of the medicinal products used in combination with simeprevir regarding their use in patients with hepatic impairment.
Pogledajte odgovarajući sažetak opisa svojstava lijeka za lijekove koji se uzimaju u kombinaciji sa simeprevirom vezano uz njihovu primjenu u bolesnika s oštećenjem bubrega.
The median baseline CD4+ cell count in patients on highly active antiretroviral
Medijan početnog broja CD4+ stanica u bolesnika na visoko aktivnom antiretrovirusnom liječenju (HAART-u) bio je 561 x 10
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
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.
Excess exposure to sun and use of tanning devices during treatment with OLYSIO should be avoided.
Tijekom liječenja lijekom OLYSIO mora se izbjegavati prekomjerno izlaganje suncu i korištenje solarija.
Mild increased or decreased plasma
Mogu se javiti blago povišene ili snižene koncentracije sirolimusa u plazmi.
Table 20: Treatment outcome in treatment-experienced 1 HCV genotype 1 infected patients
Tablica 20: Ishod liječenja u bolesnika inficiranih HCV genotipom 1 koji su prethodno bili
HCV geno/subtype and presence of Q80K polymorphism in HCV genotype 1a with Q80K without Q80K Genotype 1b
HCV geno/podtip i prisutnost Q80K polimorfizma u HCV genotipu 1a Genotip 1a s Q80K bez Q80K Genotip 1b p < 0,001.
- digoxin, disopyramide, flecainide, mexiletine, propafenone or quinidine (when taken by mouth)
Naročito recite svom liječniku ili ljekarniku ako uzimate bilo koji od sljedećih lijekova: - digoksin, dizopiramid, flekainid, meksiletin, propafenon ili kinidin (kada se uzimaju kroz usta)
Plasma exposure of simeprevir in HCV infected patients was about 2- to 3-fold higher compared to
Izloženost simepreviru u plazmi HCV-om inficiranih bolesnika bila je oko 2- do 3-puta viša u usporedbi s onom uočenom u zdravih ispitanika.
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%
U ispitivanju HPC3021 (PLUTO), bolesnici su primali simeprevir + sofosbuvir tijekom 12 tjedana (vidjeti tablicu 11). 40 uključenih bolesnika imalo je medijan dobi od 51 godinu (raspon 29 do 69 godina; s 5% iznad 65 godina); 73% bili su muškarci; 18% imalo je BMI ≥ 30 kg/m2; medijan početne razine HCV RNA bio je 6,35 log10 IU/ml; 18% imalo je cirozu; 25% imalo je HCV genotip 4a, i 73% HCV genotip 4d; 85% imalo je ne-CC IL28B alele (CT ili TT); 33% prethodno nisu bili liječeni, i 68% bili su prethodno liječeni.
Each hard capsule contains simeprevir sodium equivalent to 150 mg of simeprevir.
Jedna tvrda kapsula sadrži simeprevirnatrij što odgovara 150 mg simeprevira.
OLYSIO is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C) (see sections 4.2 and 4.4).
Lijek OLYSIO se ne preporučuje u bolesnika s umjerenim ili teškim oštećenjem jetre (Child-Pugh B ili C) (vidjeti dijelove 4.2 i 4.4).
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) ↑
etinilestradiol AUC 1,12 (1,05-1,20) ↔ etinilestradiol Cmax 1,18 (1,09-1,27)  etinilestradiol Cmin 1,00 (0,89-1,13) ↔ noretindron AUC 1,15 (1,08-1,22) ↔ noretindron Cmax 1,06 (0,99-1,14) ↔ noretindron Cmin 1,24 (1,13-1,35) 
In HCV genotype 1a infected patients without cirrhosis, simeprevir efficacy in combination with sofosbuvir at the recommended 12-week treatment duration was not impacted by the presence of the NS3 Q80K polymorphism (see section 5.1).
U bolesnika s infekcijom HCV genotipa 1a bez ciroze na djelotvornost simeprevira u kombinaciji sa sofosbuvirom nije utjecala prisutnost NS3 Q80K polimorfizma kod preporučenog trajanja liječenja od
Pregnancy
ANTITUSICI
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).
Pri razmatranju kombiniranog liječenja lijekom OLYSIO s peginterferonom alfa i ribavirinom u bolesnika s HCV genotipom 1a, prije početka liječenja bolesnika se mora ispitati na prisutnost virusa s polimorfizmom NS3 Q80K (vidjeti dio 4.4).
(OATP1B1/3, BCRP transporter inhibition)
(inhibicija OATP1B1/3, BCRP prijenosnika)