natgillin/translations-raw huggingface dataset:
Sikkerhedsprofilen for simeprevir i kombination med peginterferon alfa og ribavirin er sammenlignelig mellem patienter med HCV-genotype 1-infektion med og uden samtidig HIV-1infektion. 
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.
Tabel 1: Anbefalet varighed af kombinationsbehandling med OLYSIO og sofosbuvir med eller uden ribavirin til patienter med HCV-genotype 1 eller 4 
Table 1: Recommended treatment duration for OLYSIO combination therapy with sofosbuvir with or without ribavirin in patients with HCV genotype 1 or 4 Patient population
Seponér OLYSIO, peginterferon alfa og ribavirin 
Discontinue OLYSIO, peginterferon alfa and ribavirin
Det er ikke nødvendigt at justere dosis af OLYSIO hos ældre patienter (se pkt. 
No dose adjustment of OLYSIO is required in elderly patients (see section 5.2).
Data fra et fase 2-studie med 11 HCV-inficerede levertransplanterede 
Data from a phase 2 study in 11 HCV infected post-liver transplant patients.
Let stigning i koncentrationen af amiodaron kan forventes, når amiodaron indgives oralt. 
Mild increases in concentrations of amiodarone may be expected when amiodarone
Den samlede SVR12-rate for patienter uden cirrose, der fik 8 ugers behandling med simeprevir + sofosbuvir, var 75% (15/20); alle patienter, der ikke opnåede SVR12, havde virusrecidiv (25%; 5/20). 
The overall SVR12 rate for patients without cirrhosis receiving 8 weeks of simeprevir + sofosbuvir was 75% (15/20); all patients not achieving SVR12 had viral relapse (25%; 5/20).
Seponering af simeprevir på grund af udslæt eller kløe forekom hos henholdsvis 0,8% og 0,1% i simeprevir-armen sammenlignet med henholdsvis 0,3% og 0% i placebo-armen. 
Discontinuation of simeprevir due to rash or pruritus occurred in 0.8% and 0.1% of simeprevir-treated patients, compared to 0.3% and 0% of placebo-treated patients, respectively.
To patienter havde manglende HIV-virologisk effekt, hvilket defineres som bekræftet HIV-1 RNA ≥ 200 kopier/ml efter tidligere < 50 kopier/ml. 
Two patients had HIV virologic failure defined as confirmed HIV-1 RNA ≥ 200 copies/ml after previous < 50 copies/ml; these failures occurred 36 and 48 weeks after end of simeprevir treatment.
Læs produktresumeet for de samtidigt ordinerede lægemidler, inden behandlingen med OLYSIO iværksættes. 
Consult the Summary of Product Characteristics of the co-prescribed medicinal products before starting therapy with OLYSIO.
Interaktionen mellem simeprevir og lægemidlet blev undersøgt i et farmakokinetisk delstudie i et fase 2-studie med 22 HCV-inficerede patienter. 
The interaction between simeprevir and the medicinal product was evaluated in a pharmacokinetic substudy within a phase 2 study in 22 HCV infected patients.
OLYSIO må ikke indgives som monoterapi, men skal ordineres i kombination med andre lægemidler 
OLYSIO must not be administered as monotherapy and must be prescribed in combination with other medicinal products for the treatment of CHC.
I tilfælde af alvorligt udslæt skal OLYSIO og anden samtidig medicin til behandling af CHC seponeres, og patienten skal monitoreres, 
In case of severe rash, OLYSIO and other co-administered medicinal products for the treatment of CHC should be discontinued and the patients should be monitored until the symptoms have resolved.
12, 24 eller 48 ugers SMV i kombination med 48 ugers peg-IFN-alfa + RBV; kontrolgruppe: 48 ugers placebo + peg-IFN-alfa + RBV Behandlingsnaive patienter eller patienter med tidligere recidiv uden cirrose: 12 ugers SMV + peg-IFN-alfa + RBV efterfulgt af 12 eller 36 ugers peg-IFN-alfa + RBV patienter med tidligere manglende respons (delvist eller nul respons) uden cirrose og alle behandlingsnaive og behandlingserfarne patienter med cirrose: 12 ugers SMV + peg-IFN-alfa + RBV efterfulgt af 36 ugers peg-IFN-alfa + RBV Behandlingsnaive patienter eller patienter med tidligere recidiv: 
12, 24 or 48 weeks SMV in combination with 48 weeks peg-IFN-alfa + RBV; control group: 48 weeks placebo + peg-IFN-alfa + RBV treatment-naïve patients or prior relapsers without cirrhosis: 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) without cirrhosis and all treatment-naïve and treatment-experienced patients with cirrhosis: 12 weeks SMV + peg-IFN-alfa + RBV, followed by 36 weeks peg-IFN-alfa + RBV
I en samlet analyse af patienter, der blev behandlet med 150 mg simeprevir i kombination med peginterferon alfa og ribavirin, og som ikke opnåede SVR i de kontrollerede, kliniske fase 2- og fase 3-studier (studierne C205, C206, C208, C216, HPC3007), blev der observeret opståede aminosyresubstitutioner ved NS3-positionerne 80, 122, 155 og/eller 168 hos 180 ud af 197 patienter (91%). 
In a pooled analysis of patients treated with 150 mg simeprevir in combination with peginterferon alfa and ribavirin who did not achieve SVR in the controlled phase 2 and phase 3 clinical studies (studies C205, C206, C208, C216, HPC3007), emerging amino acid substitutions at NS3 positions 80, 122, 155 and/or 168 were observed in 180 out of 197 (91%) patients.
OLYSIO skal altid bruges sammen med andre lægemidler til behandling af kronisk hepatitis C-infektion. 
OLYSIO must always be used as part of a course of treatment with other medicines for treating chronic hepatitis C infection.
Behandlingsrelaterede laboratorieanomalier, der blev observeret med en højere incidens hos de simeprevir-behandlede patienter end hos de patienter, som fik placebo, peginterferon alfa og ribavirin, 
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
Varighed af resistensrelaterede substitutioner Varigheden af simeprevir-resistente NS3-aminosyresubstitutioner blev undersøgt efter manglende 
The persistence of simeprevir-resistant NS3 amino acid substitutions was assessed following treatment failure.
I studie HPC2002 (COSMOS) fik patienter med tidligere nul respons og METAVIR-fibrose-score F0-F2 og behandlingsnaive patienter og patienter med tidligere nul respons med METAVIRfibrosescore F3-F4 og kompenseret leversygdom simeprevir + sofosbuvir med eller uden ribavirin i 12 eller 24 uger (se tabel 11). 
In study HPC2002 (COSMOS), prior null responders with METAVIR fibrosis score F0-F2, or treatment-naïve and prior null responder patients with METAVIR fibrosis score F3-F4 and compensated liver disease received simeprevir + sofosbuvir, with or without ribavirin, for 12 or 24 weeks (see table 11).
Samtidig infektion med HCV/humant immundefektvirus type 1 (HIV-1) Dosisjustering af OLYSIO er ikke nødvendig til patienter med samtidig HCV- og HIV-1-infektion (se 
HCV/Human immunodeficiency virus type 1 (HIV-1) co-infection No dose adjustment of OLYSIO is required in HCV/HIV-1 co-infected patients (see sections 4.8, 5.1
Dosis af ribavirin baseret på legemsvægt og fordelt på to daglige doser i henhold til produktresumeet for ribavirin. 
Body-weight based twice daily ribavirin dosing, according to the Summary of Product Characteristics of ribavirin.
> 1,5 til ≤ 2,5 x ULN 
≥ 1.1 to ≤ 1.5 x ULN 34 (11.9%)
Tabel 14: Behandlingsresultat hos HCV-genotype 1-inficerede patienter uden cirrose, der fik 12 ugers behandling med simeprevir + sofosbuvir med eller uden ribavirin simeprevir + sofosbuvir + ribavirin N = 43 % (n/N) 
Table 14: Treatment outcome in HCV genotype 1 infected patients without cirrhosis receiving 12 weeks simeprevir + sofosbuvir, with or without ribavirin simeprevir + sofosbuvir + ribavirin N = 43 % (n/N)
Størstedelen af de HCV-genotype 1-inficerede patienter, der blev behandlet med simeprevir i kombination med sofosbuvir (med eller uden ribavirin) i 12 eller 24 uger, som ikke opnåede SVR af virologiske årsager, og for hvem der var sekventeringsdata til rådighed, havde opståede NS3aminosyresubstitutioner ved position 168 og/eller opstået R155K: 5 ud af 6 patienter i studie HPC2002, 1 ud af 3 patienter i studie HPC3017 og 11 ud af 13 patienter i studie HPC3018. 
The majority of HCV genotype 1 infected patients treated with simeprevir in combination with sofosbuvir (with or without ribavirin) for 12 or 24 weeks who did not achieve SVR due to virologic reasons and with sequencing data available had emerging NS3 amino acid substitutions at position 168 and/or emerging R155K: 5 out of 6 patients in study HPC2002, 1 out of 3 patients in study HPC3017 and 11 out of 13 patients in study HPC3018.
Optagelse af simeprevir i leveren formidles af OATP1B1/3. 
Hepatic uptake of simeprevir is mediated by OATP1B1/3.
Efter administration til diegivende rotter blev simeprevir påvist i plasma hos diende rotter, hvilket sandsynligvis skyldes udskillelse af simeprevir i mælken (se pkt. 
When administered to lactating rats, simeprevir was detected in plasma of suckling rats likely due to excretion of simeprevir via milk (see section 5.3).
De mediane FC-værdier for simeprevir i forhold til de undersøgte genotype 2 og genotype 3-isolater ved baseline var henholdsvis 25 (N = 4) og 1.014 (N = 2). 
Median simeprevir FC values against genotype 2 and genotype 3 baseline isolates tested were 25 (N = 4) and 1,014 (N = 2), respectively.
Simeprevir in vitro inducerede en fototoksisk respons på BALB/c 3T3-fibroblaster efter UVA-eksponering ved både mangel på og forekomst af proteiner Simeprevir forårsagede ikke hudirritation hos kaniner og vil sandsynligvis ikke forårsage hudsensibilisering. 
In vitro, simeprevir induced a phototoxic response on BALB/c 3T3 fibroblasts after UVA exposure, in the absence and presence of protein supplements.
Det anbefales ikke at administrere OLYSIO sammen med ciclosporin 
It is not recommended to co-administer OLYSIO with ciclosporin.
Simeprevir i kombination med sofosbuvir: Puljede studier HPC2002, HPC3017 og HPC3018 (12 uger) og studie HPC2002 (24 uger); simeprevir i kombination med peginterferon alfa og ribavirin: Puljede fase 3-studier C208, C216 og HPC3007 (første 12 behandlingsuger). 
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).
Simeprevir hæmmer OATP1B1/3, P-gp- og BCRP-transportører. 
Simeprevir inhibits OATP1B1/3, P-gp and BCRP transporters.
Justering af simeprevirdosis er ikke nødvendig til patienter med let leverinsufficiens. 
No dose adjustment of simeprevir is necessary in patients with mild hepatic impairment.
Der bør udvises forsigtighed ved oral administration af dette lægemiddel med et smalt terapeutisk indeks sammen med OLYSIO. 
Caution is warranted when this medicinal product with narrow therapeutic index is co-administered with OLYSIO via the oral route.
Data fra et fase 2-studie med 9 HCV-inficerede levertransplanterede 
Data from a phase 2 study in 9 HCV infected post-liver transplant patients.
Det anbefales ikke at administrere OLYSIO sammen med cisaprid. 
It is not recommended to co-administer OLYSIO with cisapride.
Følgende bivirkninger kan opstå, når du tager OLYSIO sammen med peginterferon alfa og 
The following side effects may happen with OLYSIO when used in combination with peginterferon
OLYSIO i kombination med peginterferon alfa og ribavirin Simeprevirs effekt i kombination med peginterferon alfa og ribavirin er betydeligt nedsat hos patienter, der er inficerede med hepatitis C genotype 1a med NS3 Q80K-polymorfisme ved baseline, sammenlignet med patienter med hepatitis C genotype 1a uden Q80K-polymorfisme (se pkt. 
OLYSIO in combination with peginterferon alfa and ribavirin Simeprevir efficacy in combination with peginterferon alfa and ribavirin is substantially reduced in patients infected with hepatitis C genotype 1a with the NS3 Q80K polymorphism at baseline compared to patients with hepatitis C genotype 1a without the Q80K polymorphism (see section 5.1).
Det anbefales på det kraftigste at teste for forekomst af Q80K-polymorfisme hos patienter med HCVgenotype 1a, hvis behandling med OLYSIO i kombination med peginterferon alfa og ribavirin overvejes. 
Testing for the presence of the Q80K polymorphism in patients with HCV genotype 1a is strongly recommended when considering therapy with OLYSIO in combination with peginterferon alfa and ribavirin.
Man kan forudse krydsresistens med disse HCV-proteasehæmmere, og samtidig administration kan ikke anbefales (se 
These HCV protease inhibitors are anticipated to be cross-resistant, and co-administration is not recommended (see also section 4.5).
Tabel 12: Demografiske karakteristika og baseline-karakteristika (studie HPC3017 og 
Table 12: Demographics and baseline characteristics (studies HPC3017 and HPC3018) HPC3017 N = 310
Da eksponeringen for lægemidlet kan være øget hos HCV-inficerede patienter med svær nyreinsufficens, anbefales det at udvise forsigtighed ved behandling af disse patienter (se pkt. 
As exposure may be increased in HCV infected patients with severe renal impairment, caution is recommended when prescribing OLYSIO to these patients (see section 5.2).
Tabel 6: Behandlingsrelaterede laboratorieanomalier i amylase og lipase hos patienter, der fik 12 eller 24 ugers behandling med simeprevir i kombination med sofosbuvir (12 uger: de puljede studier HPC2002, HPC3017 og HPC3018; 24 uger: studie 
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)
Hos patienter > 45 år blev der indberettet dyspnø hos 16,4% af de simeprevir-behandlede patienter sammenlignet med hos 9,1% i placebo-gruppen (alle grader; puljede fase 3-studier). 
In patients aged > 45 years, dyspnoea was reported in 16.4% of simeprevir-treated patients compared to 9.1% in placebo-treated
12 ugers simeprevir + sofosbuvir N = 286 n (%) 
1 12 weeks simeprevir + sofosbuvir N = 286 n (%)
Median FC for simeprevir i forhold til genotype 4a-, genotype 4d- og genotype 4-andet-isolater ved baseline var henholdsvis 0,5 (N = 38), 0,4 (N = 24) og 0,8 (N = 29). 
Median simeprevir FC values against baseline isolates of genotype 4a, genotype 4d and genotype 4other were 0.5 (N = 38), 0.4 (N = 24), and 0.8 (N = 29), respectively.
Dosisjustering på baggrund af patientens køn er ikke nødvendig. 
No dose adjustment is necessary based on gender.
De 40 inkluderede patienter havde en medianalder på 51 år (29 til 69 år, heraf 5% over 65 år); 73% var 
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
Det gælder især, hvis: - du har hepatitis C, som ikke er ‘genotype 1' eller ‘genotype 4' 
Talk to your doctor or pharmacist about all your medical conditions before taking OLYSIO in particular if: - you have hepatitis C that is not ‘genotype 1' or ‘genotype 4';
Der findes ingen kliniske data vedrørende anvendelse af OLYSIO til genbehandling af patienter, som ikke har reageret på HCV-behandling, baseret på en NS3-4A-proteasehæmmer (se pkt. 
There are no clinical data on the use of OLYSIO in re-treating patients who have failed an HCV NS3-4A protease inhibitor-based therapy (see sections 5.1 and 5.3).
OLYSIO 150 mg hårde kapsler simeprevir 
OLYSIO 150 mg hard capsules simeprevir
Når OLYSIO anvendes sammen med andre lægemidler til behandling af kronisk hepatitis C-infektion, er det med til at fjerne HCV fra kroppen. 
When used together with other medicines to treat chronic hepatitis C infection, OLYSIO helps to clear HCV from
6,7 log10 IE/ml; 75% havde ingen cirrose (METAVIR-fibrose-score F0-3), og 25% havde cirrose (METAVIR-fibrosescore F4); 78% havde HCV-genotype 1a, hvoraf 45% havde Q80K ved baseline, og 22% havde HCV-genotype 1b; 86% havde non-CC IL28B-alleler (CT eller TT); 76% var patienter med tidligere nul respons på peginterferon alfa og ribavirin, og 24% var behandlingsnaive. 
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.
Tabel 23 viser responsraterne hos HCV-genotype 4-inficerede patienter. 
Table 23 shows the response rates in HCV genotype 4 infected patients.
24 ugers simeprevir + sofosbuvir N = 31 n (%) 
24 weeks simeprevir + sofosbuvir N = 31 n (%)
(Hæmning af OATP1B1/3-transportør og/eller CYP3A4) 
(OATP1B1 transporter and/or CYP3A4 enzyme
Andelen af simeprevir-behandlede patienter med HCVRNA < 25 IE/ml detekterbart ved uge 4 var 18% (47/259); SVR12-raten var 60% hos disse patienter. 
The proportion of simeprevir-treated patients with HCV RNA < 25 IU/ml detectable at week 4 was 18% (47/259); 60% achieved SVR12.
De hårde kapsler er hvide med ‘TMC435 150' trykt i sort farve. 
What OLYSIO looks like and contents of the pack The hard capsules are white, with ‘TMC435 150' printed in black ink.
lysfølsomhedsreaktion* 
pruritus*, photosensitivity photosensitivity reaction*
Koncentration af simeprevir kan øges på grund af amlodipins svage hæmning af CYP3A4 og diltiazems og verapamils moderate hæmning af 
Increased simeprevir concentrations may occur due to mild inhibition of CYP3A4 by amlodipine and moderate inhibition of CYP3A4 by
Den anbefalede dosis af OLYSIO er én kapsel på 150 mg én gang dagligt. 
The recommended dosage of OLYSIO is one capsule of 150 mg once daily, taken with food.
Baseline-polymorfisme ved NS3-positionerne 43, 80, 122, 155, 156 og/eller 168, forbundet med nedsat aktivitet af simeprevir in vitro, var generelt ikke almindelige (1,3%) hos patienter med HCVgenotype 1-infektion (n = 2.007; puljede fase 2- og fase 3-studier med simeprevir i kombination med peginterferon alfa og ribavirin), bortset fra substitutionen Q80K hos patienter med HCV-genotype 1a, som blev observeret hos 30% af patienterne med HCV-genotype 1a og hos 0,5% af patienterne med HCV-genotype 1b. I Europa var prævalensen lavere; 19% (73/377) hos patienter med HCVgenotype 1a og 0,3% (3/877) hos patienter med HCV-genotype 1b. 
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 in 30% of patients with HCV genotype 1a and in 0.5% of patients with HCV genotype 1b.
Det anbefales ikke at administrere OLYSIO sammen med cobicistatholdige lægemidler. 
It is not recommended to co-administer OLYSIO with cobicistat-containing medicinal products.
Simeprevir i kombination med peginterferon alfa og ribavirin Sikkerhedsprofilen for simeprevir i kombination med peginterferon alfa og ribavirin hos patienter med HCV-genotype 1-infektion er baseret på de puljede data fra fase 2-studierne og fase 3-studierne C205, C206, C208, C216 og HPC3007 med 924 patienter, der fik simeprevir 150 mg én gang dagligt i 12 uger, og 540 patienter, der fik placebo sammen med peginterferon alfa og ribavirin. 
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
Janssen-Cilag GmbH Johnson & Johnson Platz 1 D-41470 Neuss 
Janssen-Cilag GmbH Johnson & Johnson Platz 1 D-41470 Neuss Tel: +49 2137 955-955
24 uger simeprevir + sofosbuvir 
24 weeks simeprevir + sofosbuvir
8 eller 12 ugers SMV + sofosbuvir 
8 or 12 weeks SMV + sofosbuvir
I kliniske studier fik patienter, randomiseret til simeprevir i kombination med peginterferon alfa-2b og ribavirin, numerisk lavere SVR12-rater og havde også hyppigere viralt gennembrud og recidiv end de patienter, der fik simeprevir i kombination med peginterferon alfa-2a og ribavirin (se pkt. 
OLYSIO in combination with peginterferon alfa-2b In the clinical studies, patients randomised to simeprevir in combination with peginterferon alfa-2b and ribavirin obtained numerically lower SVR12 rates and also experienced viral breakthrough and viral relapse more frequently than those treated with simeprevir in combination with peginterferon alfa-2a and ribavirin (see section 5.1).
OLYSIO anbefales ikke til patienter med moderat eller svær leverinsufficiens (Child-Pugh B eller C) (se pkt. 
OLYSIO is not recommended for patients with moderate or severe hepatic impairment (Child-Pugh B or C) (see sections 4.4 and 5.2).
Det anbefales ikke at administrere OLYSIO sammen med ritonavir. 
It is not recommended to co-administer OLYSIO with ritonavir.
89% (51/57) af de simeprevir-behandlede behandlingsnaive patienter og patienter med tidligere recidiv var egnede til en samlet behandlingsvarighed på 24 uger; hos disse patienter var SVR12-raten 
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%.
Simeprevir i kombination med sofosbuvir: Der blev indberettet lysfølsomhedsreaktioner hos 3,1% af de simeprevir-behandlede patienter, som fik 12 ugers behandling, sammenlignet med 6,5% af de patienter, der fik 24 ugers behandling (alle grader). 
Simeprevir in combination with sofosbuvir: Photosensitivity reactions were reported in 3.1% of simeprevir-treated patients receiving 12 weeks of treatment compared to 6.5% in patients receiving 24 weeks of treatment (all grades).
Simeprevir i kombination med sofosbuvir: Der blev indberettet udslæt og kløe hos henholdsvis 8,0% og 8,4% af de patienter, der fik 12 ugers behandling, sammenlignet med henholdsvis 12,9% og 3,2% af de patienter, som fik 24 ugers behandling (alle grader). 
Simeprevir in combination with sofosbuvir: Rash and pruritus were reported in 8.0% and 8.4%, respectively, of patients receiving 12 weeks of treatment compared to 12.9% and 3.2%, respectively, of patients receiving 24 weeks of treatment (all grades).
Simeprevir hæmmer i let grad aktiviteten af CYP1A2 samt den intestinale aktivitet af CYP3A4, men påvirker ikke aktiviteten af CYP3A4 i leveren. 
Medicinal products that are affected by the use of simeprevir Simeprevir mildly inhibits the CYP1A2 activity and intestinal CYP3A4 activity, while it does not affect hepatic CYP3A4 activity.
Sikkerhedsprofilen af simeprevir i kombination med sofosbuvir hos patienter med HCV-genotype 1infektion med eller uden cirrose er baseret på puljede data fra fase 2-studiet HPC2002 og fase 3studierne HPC3017 og HPC3018 med 472 patienter inkluderet, der fik simeprevir sammen med sofosbuvir uden ribavirin (155, 286 og 31 patienter fik henholdsvis 8, 12 eller 24 ugers behandling), og 108 patienter, der fik simeprevir sammen med sofosbuvir og ribavirin (54 patienter fik 12 og 54 fik 
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).
Substitutioner, der kun blev observeret i kombinationer med andre opståede substitutioner ved en eller flere af NS3positionerne 80, 122, 155 og/eller 168. 
Substitutions only observed in combinations with other emerging substitutions at one or more of the NS3 positions 80,
(Induktion af CYP3A4 [etravirin eller nevirapin] 
(CYP3A4 enzyme induction [etravirine or nevirapine] or inhibition [delavirdine])