FrancophonIA/ELRC3.0 huggingface dataset:
English: These HCV protease inhibitors are anticipated to be cross-resistant, and co-administration is not recommended (see also section 4.5).
Danish: Man kan forudse krydsresistens med disse HCV-proteasehæmmere, og samtidig administration kan ikke anbefales (se
English: Table 12: Demographics and baseline characteristics (studies HPC3017 and HPC3018) HPC3017 N = 310
Danish: Tabel 12: Demografiske karakteristika og baseline-karakteristika (studie HPC3017 og
English: 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).
Danish: 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.
English: 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)
Danish: 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
English: In patients aged > 45 years, dyspnoea was reported in 16.4% of simeprevir-treated patients compared to 9.1% in placebo-treated
Danish: 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).
English: 1 12 weeks simeprevir + sofosbuvir N = 286 n (%)
Danish: 12 ugers simeprevir + sofosbuvir N = 286 n (%)
English: 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.
Danish: 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).
English: No dose adjustment is necessary based on gender.
Danish: Dosisjustering på baggrund af patientens køn er ikke nødvendig.
English: 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
Danish: De 40 inkluderede patienter havde en medianalder på 51 år (29 til 69 år, heraf 5% over 65 år); 73% var
English: 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';
Danish: Det gælder især, hvis: - du har hepatitis C, som ikke er ‘genotype 1' eller ‘genotype 4'
English: 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).
Danish: 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.
English: OLYSIO 150 mg hard capsules simeprevir
Danish: OLYSIO 150 mg hårde kapsler simeprevir
English: When used together with other medicines to treat chronic hepatitis C infection, OLYSIO helps to clear HCV from
Danish: Når OLYSIO anvendes sammen med andre lægemidler til behandling af kronisk hepatitis C-infektion, er det med til at fjerne HCV fra kroppen.
English: 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.
Danish: 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.
English: Table 23 shows the response rates in HCV genotype 4 infected patients.
Danish: Tabel 23 viser responsraterne hos HCV-genotype 4-inficerede patienter.
English: 24 weeks simeprevir + sofosbuvir N = 31 n (%)
Danish: 24 ugers simeprevir + sofosbuvir N = 31 n (%)
English: (OATP1B1 transporter and/or CYP3A4 enzyme
Danish: (Hæmning af OATP1B1/3-transportør og/eller CYP3A4)
English: The proportion of simeprevir-treated patients with HCV RNA < 25 IU/ml detectable at week 4 was 18% (47/259); 60% achieved SVR12.
Danish: 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.
English: What OLYSIO looks like and contents of the pack The hard capsules are white, with ‘TMC435 150' printed in black ink.
Danish: De hårde kapsler er hvide med ‘TMC435 150' trykt i sort farve.
English: pruritus*, photosensitivity photosensitivity reaction*
Danish: lysfølsomhedsreaktion*
English: Increased simeprevir concentrations may occur due to mild inhibition of CYP3A4 by amlodipine and moderate inhibition of CYP3A4 by
Danish: Koncentration af simeprevir kan øges på grund af amlodipins svage hæmning af CYP3A4 og diltiazems og verapamils moderate hæmning af
English: The recommended dosage of OLYSIO is one capsule of 150 mg once daily, taken with food.
Danish: Den anbefalede dosis af OLYSIO er én kapsel på 150 mg én gang dagligt.
English: 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.
Danish: 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.
English: It is not recommended to co-administer OLYSIO with cobicistat-containing medicinal products.
Danish: Det anbefales ikke at administrere OLYSIO sammen med cobicistatholdige lægemidler.
English: 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
Danish: 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.
English: Janssen-Cilag GmbH Johnson & Johnson Platz 1 D-41470 Neuss Tel: +49 2137 955-955
Danish: Janssen-Cilag GmbH Johnson & Johnson Platz 1 D-41470 Neuss
English: 24 weeks simeprevir + sofosbuvir
Danish: 24 uger simeprevir + sofosbuvir
English: 8 or 12 weeks SMV + sofosbuvir
Danish: 8 eller 12 ugers SMV + sofosbuvir
English: 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).
Danish: 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.
English: OLYSIO is not recommended for patients with moderate or severe hepatic impairment (Child-Pugh B or C) (see sections 4.4 and 5.2).
Danish: OLYSIO anbefales ikke til patienter med moderat eller svær leverinsufficiens (Child-Pugh B eller C) (se pkt.
English: It is not recommended to co-administer OLYSIO with ritonavir.
Danish: Det anbefales ikke at administrere OLYSIO sammen med ritonavir.
English: 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%.
Danish: 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
English: 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).
Danish: 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).
English: 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).
Danish: 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).
English: 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.
Danish: Simeprevir hæmmer i let grad aktiviteten af CYP1A2 samt den intestinale aktivitet af CYP3A4, men påvirker ikke aktiviteten af CYP3A4 i leveren.
English: 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).
Danish: 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
English: Substitutions only observed in combinations with other emerging substitutions at one or more of the NS3 positions 80,
Danish: Substitutioner, der kun blev observeret i kombinationer med andre opståede substitutioner ved en eller flere af NS3positionerne 80, 122, 155 og/eller 168.
English: (CYP3A4 enzyme induction [etravirine or nevirapine] or inhibition [delavirdine])
Danish: (Induktion af CYP3A4 [etravirin eller nevirapin]
English: No dose adjustment is required for either drug when OLYSIO is co-administered with tacrolimus.
Danish: Dosisjustering ikke nødvendig for nogen af lægemidlerne ved samtidig administration af OLYSIO og tacrolimus.
English: Table 20 shows the response rates in treatment-experienced patients with HCV genotype 1 infection.
Danish: Tabel 20 viser responsraterne hos behandlingserfarne patienter med HCV-genotype 1-infektion.
English: Treatment Outcome simeprevir + peginterferon + ribavirin N = 521 % (n/N)
Danish: Behandlingsresultat simeprevir + peginterferon + ribavirin N = 521 % (n/N)
English: (OATP1B1/3, BCRP transporter inhibition)
Danish: (Hæmning af OATP1B1/3-, BCRP-transportør.)
English: HCV geno/subtype and presence of Q80K polymorphism in HCV genotype 1a p < 0.001 compared to historical control of peginterferon alfa and ribavirin.
Danish: HCV-geno-/undertype og forekomst af Q80K-polymorfisme i HCV-genotype 1a uden Q80K Genotype 1b p < 0,001 sammenlignet med en tidligere kontrol med peginterferon alfa og ribavirin.
English: No dose adjustment of simeprevir is required in elderly patients (see section 4.2).
Danish: Justering af simeprevirdosis er ikke nødvendig hos ældre patienter (se
English: The overall safety profile of simeprevir is based on data from 580 HCV genotype 1 infected patients who received simeprevir in combination with sofosbuvir with or without ribavirin (pooled data from the clinical phase 2 study HPC2002 and the clinical phase 3 studies HPC3017 and HPC3018) and 1,486 HCV genotype 1 infected patients who received simeprevir (or placebo) in combination with peginterferon alfa and ribavirin (pooled data from the clinical phase 2 studies C205 and C206 and the clinical phase 3 studies C208, C216 and HPC3007).
Danish: Simeprevirs overordnede sikkerhedsprofil er baseret på data fra 580 HCV-genotype 1-inficerede patienter, der fik simeprevir i kombination med sofosbuvir med eller uden ribavirin (puljede data fra det kliniske fase 2-studie HPC2002 og de kliniske fase 3-studier HPC3017 og HPC3018) og 1.486 HCV-genotype 1-inficerede patienter, der fik simeprevir (eller placebo) i kombination med peginterferon alfa og ribavirin (puljede data fra de kliniske fase 2-studier C205 og C206 og de kliniske fase 3-studier C208, C216 og HPC3007).
English: Based on the elimination pathway of azithromycin, no drug interactions are expected between azithromycin and simeprevir.
Danish: Baseret på elimineringsvejen for lægemiddelinteraktioner mellem azithromycin
English: The safety profile of simeprevir is comparable in patients with HCV genotype 4 infection and HCV genotype 1 infection, when given either in combination with sofosbuvir or in combination with peginterferon alfa and ribavirin.
Danish: Simeprevirs sikkerhedsprofil er sammenlignelig hos patienter med HCV-genotype 4-infektion og HCV-genotype 1-infektion, når det enten gives i kombination med sofosbuvir eller i kombination med
English: Plasma protein binding is not meaningfully altered in patients with
Danish: Plasmaproteinbindingen gennemgår ingen ændring af betydning hos patienter med nyre- eller leverinsufficiens.
English: Grade 3 rash was reported in one patient (0.3%; 12-week treatment group) which led to treatment discontinuation; none of the patients experienced grade 4 rash.
Danish: Udslæt af grad 3 blev indberettet for en enkelt patient (0,3% i gruppen med 12 ugers behandling), hvilket førte til seponering behandlingen; ingen af patienterne havde udslæt af grad 4; ingen af patienterne havde kløe af grad 3 eller 4; ingen af patienterne seponerede behandlingen på grund af kløe.
English: Check with your doctor
Danish: Se i pkt.
English: Mild increases in simeprevir concentrations may occur due to inhibition of CYP3A4 by amiodarone.
Danish: Der kan opstå mindre stigninger i simeprevirkoncentrationen på grund af amiodarons hæmning af CYP3A4.
English: Female patients of childbearing potential must use an effective form of contraception.
Danish: Kvindelige patienter i den fertile alder skal anvende sikker kontraception under behandlingen.
English: Each hard capsule contains simeprevir sodium equivalent to 150 mg of simeprevir.
Danish: Hver hård kapsel indeholder simeprevirnatrium svarende til 150 mg simeprevir.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: OLYSIO-kapslerne indeholder lactosemonohydrat og bør ikke anvendes til patienter med med arvelig galactoseintolerans, en særlig form af arvelig lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: Table 19 shows the response rates in HCV genotype 1 infected treatment-naïve patients.
Danish: Tabel 19 viser responsraterne for HCV-genotype 1-inficerede behandlingsnaive patienter.
English: Refer to the respective Summary of Product Characteristics of the medicinal products used in combination with OLYSIO regarding their use in patients with renal impairment.
Danish: Der henvises til de respektive produktresumeer for de lægemidler, der anvendes i kombination med OLYSIO, for så vidt angår deres anvendelse til patienter med nyreinsufficiens.
English: It is not recommended to co-administer OLYSIO with a ledipasvir-containing medicinal product.
Danish: Det anbefales ikke at administrere OLYSIO sammen med ledipasvirholdige lægemidler.
English: Gender had no clinically relevant effect on the pharmacokinetics of simeprevir based on a population pharmacokinetic analysis of HCV infected patients treated with simeprevir in combination with peginterferon alfa and ribavirin.
Danish: Køn havde ingen klinisk relevant virkning på simeprevirs farmakokinetik, baseret på en farmakokinetisk populationsanalyse af HCVinficerede patienter, der blev behandlet med simeprevir i kombination med peginterferon alfa og
English: HCV PRODUCTS Antiviral
Danish: HCV-PRÆPARATER
English: - 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
Danish: Din læge vil muligvis skulle tage blodprøver oftere for at kontrollere, hvor godt dit blod kan størkne - carbamazepin, oxcarbazepin, phenobarbital eller phenytoin til forebyggelse af krampeanfald - astemizol eller terfenadin til behandling af allergier - itraconazol, fluconazol, ketoconazol, posaconazol eller voriconazol (når det tages gennem munden eller gives som en injektion) til behandling af svampeinfektioner - rifabutin, rifampicin eller rifapentin til behandling af infektioner som tuberkulose - amlodipin, bepridil, diltiazem, felodipin, nicardipin, nifedipin, nisoldipin eller verapamil (når det tages gennem munden) til sænkning af blodtrykket - dexamethason (når det gives som en injektion eller tages gennem munden) til behandling af astma eller inflammation og autoimmune sygdomme - cisaprid til behandling af problemer med maven - Marietidsel (naturlægemiddel) til behandling af problemer med leveren - Perikon (Hypericum perforatum, naturlægemiddel) til behandling af angst eller depression - ledipasvir til behandling af hepatitis C-infektion - cobicistat til at øge virkningen af nogle lægemidler, der bruges til behandling af HIV
English: Plasma exposure of simeprevir in HCV infected patients was about 2- to 3-fold higher compared to
Danish: Plasmaeksponeringen af simeprevir hos HCV-inficerede patienter var cirka 2-3 gange højere end den, der er observeret hos raske personer.
English: OLYSIO is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients (see sections 4.2, 4.4 and 5.1).
Danish: OLYSIO er i kombination med andre lægemidler indiceret til behandling af kronisk hepatitis C (CHC) hos voksne patienter (se pkt.
English: Simeprevir is metabolised in the liver.
Danish: Simeprevir metaboliseres i leveren.
English: If you take more OLYSIO than you should If you take more OLYSIO than you should, talk to your doctor or pharmacist immediately.
Danish: Hvis du har taget for meget OLYSIO Fortæl det straks til din læge eller apotekspersonalet, hvis du har taget mere OLYSIO, end du skulle.
English: Human experience of overdose with simeprevir is limited.
Danish: Der er kun begrænset erfaring med overdosering af simeprevir hos mennesker.
English: 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%.
Danish: I studie HPC3007 var 80% (24/30) af de simeprevir-behandlede HCV-genotype 1a-inficerede patienter med Q80K-polymorfisme ved baseline egnede til en samlet behandlingsvarighed på 24 uger; SVR12-raten var 58% for disse patienter.
English: Includes relapsers, partial and null reponders to prior treatment with interferon (pegylated or non-pegylated), with or without ribavirin, and interferon-intolerant patients.
Danish: Inkluderer patienter med recidiv og patienter med delvist eller nul respons inden behandling med interferon (pegyleret eller ikke-pegyleret) med eller uden ribavirin samt interferon-intolerante patienter.
English: 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.
Danish: I studie HPC2002 blev der indberettet forhøjet bilirubin for 0% af de patienter, som fik 12 ugers behandling med simeprevir og sofosbuvir uden ribavirin, vs. 9,3% af de patienter, der fik 12 ugers behandling med simeprevir og sofosbuvir med ribavirin.
English: HCV geno/subtype and presence of Q80K polymorphism in HCV genotype 1a with Q80K without Q80K Genotype 1b
Danish: TT HCV-geno-/undertype og forekomst af Q80K-polymorfisme i HCV-genotype 1a Genotype-1a med Q80K uden Q80K Genotype-1b
English: Supernumerary ribs and delayed ossification were reported in mice at 4-fold higher exposures than those observed in humans at the recommended dose of 150 mg once daily.
Danish: Der blev rapporteret for mange ribben og forsinket ossifikation hos mus ved eksponeringer, der var 4 gange højere end den observede humane eksponering ved den anbefalede
English: 12 weeks OLYSIO + sofosbuvir
Danish: 12 ugers OLYSIO + sofosbuvir
English: Read the package leaflets for the other medicines used for treating your hepatitis C infection for side
Danish: Læs indlægssedlerne til de andre lægemidler, som du tager til behandling af din hepatitis C-infektion, med information om de bivirkninger, der er indberettet for disse lægemidler.
English: Table 18: Studies conducted with simeprevir + peginterferon alfa + ribavirin: demographics
Danish: Tabel 18: Studier udført med simeprevir + peginterferon alfa + ribavirin: Demografiske karakteristika og baselinekarakteristika
English: 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
Danish: Hos HCV-genotype 1a-inficerede patienter med cirrose kan test for forekomst af NS3 Q80Kpolymorfisme overvejes inden initiering af behandling med OLYSIO i kombination med sofosbuvir