FrancophonIA/ELRC3.0 huggingface dataset:
English: Multiple-dose administration of elbasvir or grazoprevir is unlikely to induce the metabolism of medicinal products metabolised by CYP isoforms based on in vitro data.
Danish: Baseret på in vitro-data er det ikke sandsynligt, at administration af gentagne doser af elbasvir eller grazoprevir vil inducere metaboliseringen af lægemidler, der metaboliseres via CYP-isoformer.
English: Schering-Plough Labo N.V. Industriepark 30 - Zone A 2220 Heist-op-den-Berg BELGIUM
Danish: Industriepark 30 - Zone A 2220 Heist-op-den-Berg Belgien
English: Co-administration of ZEPATIER and OATP1B inhibitors is contraindicated because it may significantly increase grazoprevir plasma concentrations.
Danish: Samtidig administration af ZEPATIER og OATP1B-hæmmere er kontraindiceret, da det kan øge plasmakoncentrationen af grazoprevir betydeligt.
English: In general, in HCV genotype 1a, 1b or 4replicons, combinations of grazoprevir resistance-associated substitutions further reduced grazoprevir antiviral activity.
Danish: I HCV-genotype 1a-, 1b- eller 4-replikoner reducerede kombinationer af grazoprevir-resistens-associerede substitutioner generelt grazoprevirs antivirale aktivitet yderligere.
English: ZEPATIER contains lactose monohydrate.
Danish: ZEPATIER indeholder lactosemonohydrat.
English: As liver function may change during treatment with ZEPATIER, a close monitoring of International
Danish: Da leverfunktionen kan ændre sig under behandling med ZEPATIER, anbefales tæt monitorering af INR (international normaliseret ratio).
English: GT 1, 4, 6 TN with or without cirrhosis
Danish: GT 1, 4, 6 TN med eller uden cirrose
English: Adverse reactions Metabolism and nutrition disorders: Common decreased appetite
Danish: Metabolisme og ernæring: Almindelig
English: Driving and using machines Do not drive or operate machines if you feel tired after taking your medicine.
Danish: Trafik- og arbejdssikkerhed Hvis du føler dig træt efter, at du har taget din medicin, må du ikke køre bil eller betjene maskiner.
English: What ZEPATIER looks like and contents of the pack The film-coated tablets are beige, oval, debossed with “770” on one side and plain on the other.
Danish: De filmovertrukne tabletter er ovale beige tabletter med “770” præget på den ene side og uden prægning på den anden side.
English: Grazoprevir was excreted into the milk of lactating rats with concentrations < 1-fold of the maternal plasma concentrations.
Danish: Grazoprevir blev udskilt i mælken hos diegivende rotter i koncentrationer, der var lavere end de maternelle plasmakoncentrationer.
English: TN subjects with GT 3 infection without cirrhosis were randomised to EBR + GZR with RBV for 12 or 18 weeks.
Danish: TN forsøgspersoner med GT 3-infektion uden cirrose blev randomiseret til EBR + GZR med RBV i 12 eller 18 uger.
English: NS3 Any of the following NS3 substitutions: V36L/M, Y56F/H, V107I, R155I/K, A156G/M/T/V, V158A, D168A/C/E/G/N/V/Y, V170I
Danish: NS3 Enhver af følgende NS3substitutioner: V36L/M, Y56F/H, V107I, R155I/K, A156G/M/T/V, V158A, D168A/C/E/G/N/V/Y, V170I
English: A should be considered in patients with baseline HCV RNA level >800,000 IU/ml to minimise the risk of treatment failure (see section 5.1).
Danish: HCV-RNA > 800.000 IE/ml ved baseline for at minimere risikoen for behandlingssvigt (se pkt.
English: • EBR* + GZR* for 8, 12, or 18 weeks (N=31, 136, and 63, respectively)
Danish: • EBR* + GZR* i 8, 12 eller 18 uger (N= hhv. 31, 136 og 63)
English: ZEPATIER is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) (see sections 4.3 and 5.2).
Danish: ZEPATIER er kontraindiceret hos patienter med moderat eller svært nedsat leverfunktion (Child-Pugh B eller C) (se pkt.
English: Dabigatran etexilate
Danish: Dabigatranetexilat
English: For patients receiving 16 weeks of therapy, additional hepatic laboratory testing should be performed at treatment week 12.
Danish: Yderligere laboratorieanalyser for leverfunktionen skal udføres i behandlingsuge 12 hos patienter, som får 16 ugers behandling.
English: How ZEPATIER works
Danish: Hvad ZEPATIER er
English: Subjects with GT 1b infection without cirrhosis were randomised in a 1:1 ratio to EBR + GZR with or without RBV for 8 weeks.
Danish: Forsøgspersoner med GT 1binfektion uden cirrose blev randomiseret i forholdet 1:1 til EBR + GZR med eller uden RBV i 8 uger.
English: Each film-coated tablet contains 87.02 mg of lactose (as monohydrate) and 3.04 mmol (or 69.85 mg) of sodium.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver filmovertrukken tablet indeholder 87,02 mg lactose (som monohydrat) og 3,04 mmol (sv.t.
English: In population pharmacokinetic analyses, elbasvir and grazoprevir AUCs are estimated to be 16 % and 45 % higher, respectively, in subjects ≥ 65 years of age compared to subjects less than 65 years of age.
Danish: I farmakokinetiske populationsanalyser estimeres AUC for elbasvir og grazoprevir at være hhv. 16% og 45% højere hos forsøgspersoner ≥65 år sammenlignet med forsøgspersoner under 65 år.
English: The dose of fluvastatin, lovastatin, or simvastatin should not exceed a daily dose of 20 mg when co-administered with ZEPATIER.
Danish: Fluvastatin-, lovastatin- eller simvastatin-dosis må ikke overstige 20 mg dagligt ved administration sammen med ZEPATIER.
English: ZEPATIER is indicated for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4 and 5.1).
Danish: ZEPATIER er indiceret til behandling af kronisk hepatitis C (CHC) hos voksne (se pkt.
English: SVR EBR with GZR for 12 weeks (N = 312)
Danish: SVR EBR med GZR i 12 uger (N = 312)
English: Elderly No dose adjustment of ZEPATIER is required for elderly patients (see sections 4.4 and 5.2).
Danish: Ældre Dosisjustering af ZEPATIER er ikke nødvendig hos ældre patienter (se pkt.
English: C-WORTHY (open-label)
Danish: C-WORTHY (ikke-blindet)
English: Overall SVR Outcome for subjects without SVR On-treatment virologic failure Relapse Other SVR by cirrhosis status Non-cirrhotic Cirrhotic SVR by presence of baseline NS5A resistance-associated polymorphisms Absent Present SVR by baseline HCV RNA <=800,000 IU/mL >800,000 IU/mL
Danish: Samlet SVR Resultat for forsøgspersoner, der ikke opnåede SVR Virologisk svigt under behandling Recidiv Andet SVR ud fra cirrosestatus Uden cirrose Med cirrose SVR ud fra forekomst af NS5A-resistens-associerede polymorfismer ved baseline Ikke til stede Til stede SVR ud fra HCV-RNA ved baseline ≤800.000 IE/ml >800.000 IE/ml
English: Less than 1% of subjects treated with ZEPATIER with or without ribavirin experienced ALT elevations >2.5 - 5 times the ULN during treatment; there were no treatment discontinuations due to these ALT elevations.
Danish: Mindre end 1% af forsøgspersonerne, som blev behandlet med ZEPATIER med eller uden ribavirin, oplevede ALAT-forhøjelser >2,5-5 gange ULN i løbet af behandlingen.
English: • have any other medical conditions.
Danish: • lider af andre sygdomme.
English: HIV ANTIVIRAL AGENTS: PROTEASE INHIBITORS
Danish: HIV-ANTIVIRALE MIDLER: PROTEASEHÆMMERE
English: Treatment outcomes in genotype 1b-infected subjects treated with elbasvir/grazoprevir for 12 weeks are presented in Table 9.
Danish: Behandlingsresultater for genotype 1b-inficerede forsøgspersoner, som blev behandlet med elbasvir/grazoprevir i 12 uger, er vist i tabel 9.
English: The concomitant use of ZEPATIER and strong CYP3A inhibitors increases elbasvir and grazoprevir concentrations, and co-administration is not recommended (see section 4.5).
Danish: Samtidig brug af ZEPATIER og potente CYP3A-hæmmere øger koncentrationen af elbasvir og grazoprevir, og samtidig administration anbefales ikke (se pkt.
English: Expected: ↔ Elbasvir ↔ Grazoprevir
Danish: Forventet: ↔ Elbasvir ↔ Grazoprevir
English: Expected: ↓ Elbasvir ↓ Grazoprevir
Danish: Forventet: ↓ Elbasvir ↓ Grazoprevir
English: Elbasvir is active in vitro against genotype 1a NS5A substitutions, M28V and Q30L, genotype 1b substitutions, L28M/V, R30Q, L31V, Y93C, and genotype 4 substitution, M31V, which confer resistance to other NS5A inhibitors.
Danish: Elbasvir er aktivt in vitro mod genotype 1a NS5A-substitutionerne M28V og Q30L, genotype 1bsubstitutionerne L28M/V, R30Q, L31V og Y93C og genotype 4-substitutionen M31V, der giver resistens over for andre NS5A-hæmmere.
English: During clinical studies with ZEPATIER with or without ribavirin, regardless of treatment duration, < 1 % (13/1,690) of subjects experienced elevations of ALT from normal levels to greater than 5 times the ULN, generally at or after treatment week 8 (mean onset time 10 weeks, range 6-12 weeks).
Danish: Uanset behandlingsvarighed oplevede <1% (13/1.690) af forsøgspersonerne forhøjet ALAT fra et normalt niveau til et niveau på mere end 5 gange ULN, som regel i eller efter behandlingsuge 8 (gennemsnitlig tid til indtræden 10 uger, interval 6-12 uger) i kliniske studier med ZEPATIER med eller uden ribavirin.
English: GT1a NS5A polymorphisms: M28T/A, Q30E/H/R/G/K/D, L31M/V/F, H58D, and Y93C/H/N.
Danish: GT1a-NS5A-polymorfismer: M28T/A, Q30E/H/R/G/K/D, L31M/V/F, H58D og Y93C/H/N.
English: Tell your doctor or pharmacist if you notice any of the following side effects.
Danish: Fortæl det til lægen eller apotekspersonalet, hvis du får en eller flere af følgende bivirkninger:
English: If you are taking ZEPATIER with ribavirin, make sure that you also read the Pregnancy and Breast-feeding sections of the package leaflet for this other medicine.
Danish: Hvis du tager ZEPATIER sammen med ribavirin, skal du sørge for at læse punkterne ”Graviditet” og ”Amning” i indlægssedlen for lægemidlet med ribavirin.
English: In non-HCV-infected subjects with moderate hepatic impairment (Child-Pugh B [CP-B], score of 7-9), and severe hepatic impairment (Child-Pugh C [CP-C], score of 10-15) elbasvir AUC decreased by 28 % and 12%, respectively, while the grazoprevir steady-state AUC0-24 was increased 5-fold and 12-fold respectively, compared to matched healthy subjects (see sections 4.2 and 4.3).
Danish: Hos forsøgspersoner uden HCV-infektion med moderat nedsat leverfunktion (Child-Pugh B [CP-B], score på 7-9) og svært nedsat leverfunktion (Child-Pugh C [CP-C], score på 10-15) var AUC for elbasvir hhv. 28% og 12% lavere, hvorimod steady state AUC0-24 for grazoprevir var hhv. 5 gange og 12 gange højere sammenlignet med tilsvarende raske forsøgspersoner (se pkt.
English: ASTHMA AGENTS
Danish: ASTMAMIDLER
English: In pooled analyses of subjects who achieved SVR12 or met criteria for virologic failure, the prevalence and impact of NS5A polymorphisms (including M28T/A, Q30E/H/R/G/K/D, L31M/V/F, H58D, and Y93C/H/N) and NS3 polymorphisms (substitutions at positions 36, 54, 55, 56, 80, 107, 122, 132, 155, 156, 158, 168, 170, and 175) that confer greater than 5-fold reduction of elbasvir and grazoprevir antiviral activity respectively in vitro were evaluated.
Danish: I puljede analyser af forsøgspersoner, som opnåede SVR12 (vedvarende virologisk respons (sustained virologic response, SVR) 12 uger efter behandlingsophør) eller opfyldte kriterierne for virologisk svigt, blev prævalensen og indvirkningen af NS5A-polymorfismer (inklusive M28T/A, Q30E/H/R/G/K/D, L31M/V/F, H58D og Y93C/H/N) og NS3-polymorfismer (substitutioner i position 36, 54, 55, 56, 80, 107, 122, 132, 155, 156, 158, 168, 170 og 175), der giver mere en 5 gange reduktion i hhv. elbasvirs og grazoprevirs antivirale aktivitet in vitro, evalueret.
English: In general, in HCV genotype 1a, 1b or 4 combinations of elbasvir resistance-associated substitutions further reduced elbasvir antiviral activity.
Danish: I HCV-genotype 1a-, 1b- og 4-replikoner reducerede kombinationer af elbasvir-resistens-associerede substitutioner generelt elbasvirs antivirale aktivitet yderligere.
English: (possibly due to intestinal BCRP inhibition)
Danish: (muligvis på grund af intestinal BCRPhæmning)
English: HIV ANTIVIRAL AGENTS: NON-NUCLEOSIDE HIV REVERSE TRANSCRIPTASE INHIBITORS
Danish: HIV-ANTIVIRALE MIDLER: NON-NUKLEOSID REVERS TRANSKRIPTASE-HÆMMERE
English: For specific dosage instructions for ribavirin, including dose modification, refer to the ribavirin Summary of Product Characteristics.
Danish: Se produktresuméet for ribavirin for specifikke instruktioner vedrørende dosering af ribavirin, inklusive dosisjustering.
English: NS5A Any of the following NS5A substitutions: M/L28A/G/T/S* Q30H/K/R/Y, L/M31F/M/I/V, H/P58D, Y93H/N/S
Danish: NS5A Enhver af følgende NS5Asubstitutioner: M/L28A/G/T/S* Q30H/K/R/Y, L/M31F/M/I/V, H/P58D, Y93H/N/S
English: Treatment outcomes in genotype 4-infected subjects treated with elbasvir/grazoprevir for 12 weeks or elbasvir/grazoprevir with ribavirin for 16 weeks are presented in Table 11.
Danish: Behandlingsresultater for genotype 4-inficerede forsøgspersoner, som blev behandlet med elbasvir/grazoprevir i 12 uger eller elbasvir/grazoprevir med ribavirin i 16 uger, er vist i tabel 11.
English: Clinical study in subjects with advanced chronic kidney disease with genotype 1 CHC infection In the C-SURFER study, overall SVR was achieved in 94 % (115/122) of subjects receiving EBR + GZR for 12 weeks.
Danish: I C-SURFER-studiet blev samlet SVR opnået hos 94% (115/122) af forsøgspersonerne, som fik EBR + GZR i 12 uger.
English: Buprenorphine/naloxone (8 mg/2 mg single dose)/ elbasvir (50 mg single dose)
Danish: Buprenorphin/naloxon (8 mg/2 mg enkeltdosis)/elbasvir (50 mg enkeltdosis)
English: In non-HCV-infected subjects with mild hepatic impairment (Child-Pugh A [CP-A], score of 5-6), elbasvir AUC0-inf was decreased by 40% and grazoprevir steady-state AUC0-24 was increased 70 % compared to matched healthy subjects.
Danish: Hos forsøgspersoner uden HCV-infektion med let nedsat leverfunktion (Child-Pugh A [CP-A], score på 5-6) var AUC0-inf for elbasvir 40% lavere og steady state AUC0-24 for grazoprevir 70% højere sammenlignet med tilsvarende raske forsøgspersoner.
English: GT 1 TN or TE with or without cirrhosis Chronic Kidney Disease
Danish: GT 1 TN eller TE med eller uden cirrose Kronisk nyresygdom
English: *Reference sequences for NS5A at amino acid 28 are M (genotype 1a) and L (genotype 1b and genotype 4a and 4d).
Danish: *Referencesekvenser for NS5A ved aminosyreposition 28 er: M (genotype 1a) og L (genotype 1b og genotype 4a og 4d).
English: The dose of rosuvastatin should not exceed a daily dose of 10 mg when co-administered with ZEPATIER.
Danish: Rosuvastatin-dosis må ikke overstige 10 mg dagligt ved administration sammen med ZEPATIER.
English: Placebo-controlled study in which subjects were randomised in a 3:1 ratio to: EBR/GZR for 12 weeks (immediate treatment group [ITG]) or placebo for 12 weeks followed by open-label treatment with EBR/GZR for 12 weeks (deferred treatment group (DTG)).
Danish: Placebokontrolleret studie, hvor forsøgspersonerne blev randomiseret i forholdet 3:1 til EBR/GZR i 12 uger (øjeblikkelig behandlingsgruppe [ITG]) eller placebo i 12 uger efterfulgt af ikke-blindet behandling med EBR/GZR i 12 uger (udskudt behandlingsgruppe (DTG)).
English: (primarily due to intestinal BCRP inhibition)
Danish: (primært på grund af intestinal BCRPhæmning)
English: Treatment outcomes in genotype 1a-infected subjects treated with elbasvir/grazoprevir for 12 weeks or elbasvir/grazoprevir with ribavirin for 16 weeks are presented in Table 10.
Danish: Behandlingsresultater for genotype 1a-inficerede forsøgspersoner, som blev behandlet med elbasvir/grazoprevir i 12 uger eller elbasvir/grazoprevir med ribavirin i 16 uger, er vist i tabel 10.
English: The frequency of late ALT elevations was higher in subjects with higher grazoprevir plasma concentration (see sections 4.4, 4.5 and 5.2).
Danish: Hyppigheden af sene ALAT-forhøjelser var større hos forsøgspersoner med en højere plasmakoncentration af grazoprevir (se pkt.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Danish: ZEPATIER indeholder lactosemonohydrat og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for arvelig lactasemangel (Lapp lactase deficiency) eller glucose/galactosemalabsorption.
English: Table 9: SVR in genotype 1b †-infected subjects Baseline Characteristics
Danish: Tabel 9: SVR hos genotype 1b †-inficerede forsøgspersoner Baseline-karakteristika
English: SVR by cirrhosis status Non-cirrhotic
Danish: SVR ud fra cirrosestatus
English: Gastrointestinal disorders: Common nausea, diarrhoea, constipation, upper abdominal pain, abdominal pain, dry mouth, vomiting Skin and subcutaneous tissue disorders: Common pruritus, alopecia
Danish: Kvalme, diarré, obstipation, øvre adominalsmerter, abdominalsmerter, mundtørhed, opkastning
English: Among genotype 1b/1 other-infected subjects, the median age was 55 years (range: 22 to 82); 61% were male; 60 % were White; 20% were Black or African American; 6% were Hispanic or Latino; 82% were treatment-naïve subjects; 18% were treatment-experienced subjects; mean body mass index was 26 kg/m2; 64 % had baseline HCV RNA levels greater than 800,000 IU/mL; 22 % had cirrhosis; 71% had non-C/C IL28B alleles (CT or TT); 18 % had HCV/HIV-1 co-infection.
Danish: Blandt genotype 1b/1 andet-inficerede forsøgspersoner var medianalderen 55 år (22 til 82); 61% var mænd; 60% var kaukasere; 20% var negroide eller afroamerikanere; 6% var latinamerikanere; 82% var behandlingsnaive; 18% var behandlingserfarne; gennemsnitligt BMI (body mass index) var 26 kg/m2; 64% havde HCV-RNA over 800.000 IE/ml ved baseline; 22% havde cirrose; 71% havde ikke-C/C IL28B-alleler (CT- eller TT-genotyper); 18% havde HCV/hiv 1-co-infektion.
English: • Placebo for 12 weeks (N=113)
Danish: • Placebo i 12 uger (N=113)
English: C-SCAPE (open-label)
Danish: C-SCAPE (ikke-blindet)
English: GT 1, 4, 6 TE with or without cirrhosis, and with or without HCV/HIV-1 co-infection
Danish: GT 1, 4, 6 TE med eller uden cirrose og med eller uden HCV/hiv 1-co-infektion
English: In population pharmacokinetic analyses, elbasvir and grazoprevir AUCs are estimated to be 50 % and 30 % higher, respectively, in females compared to males.
Danish: I farmakokinetiske populationsanalyser estimeres AUC for elbasvir og grazoprevir at være hhv. 50% og 30% højere hos kvinder sammenlignet med mænd.
English: Methadone (20-120 mg once daily)/ elbasvir (50 mg once daily)
Danish: Methadon (20-120 mg en gang dagligt)/elbasvir (50 mg en gang dagligt)
English: (0.03 mg EE/ 0.15 mg LNG single-dose)/ grazoprevir (200 mg once daily)
Danish: (0,03 mg EE/0,15 mg LNG som enkeltdosis)/grazoprevir (200 mg en gang dagligt)
English: • Placebo for 12 weeks (N=105)
Danish: • Placebo i 12 uger (N=105)
English: GT 1, 3 TN with or without cirrhosis TE Null Responder with or without cirrhosis TN HCV/HIV1 co-infection without cirrhosis
Danish: GT 1, 3 TN med eller uden cirrose TE med nul respons med eller uden cirrose TN HCV/hiv 1-coinfektion uden cirrose
English: Lactose monohydrate Croscarmellose sodium Sodium chloride
Danish: Lactosemonohydrat Croscarmellosenatrium Natriumchlorid
English: How to take ZEPATIER
Danish: Sådan skal du tage ZEPATIER
English: ↔ Prednisolone AUC 1.08 (1.01, 1.16) Cmax 1.04 (0.99, 1.09)
Danish: ↔ Prednisolon AUC 1,08 (1,01; 1,16) Cmax 1,04 (0,99; 1,09)
English: Among genotype 1a-infected subjects, NS5A resistance-associated substitutions persisted at detectable levels at follow-up week 12 in 95% (35/37) of subjects and in 100% (9/9) of subjects with follow-up week 24 data.
Danish: Blandt genotype 1a-inficerede forsøgspersoner var NS5A-resistens-associerede substitutioner persistente med detekterbare niveauer ved opfølgningsuge 12 hos 95% (35/37) af forsøgspersonerne og hos 100% (9/9) af forsøgspersonerne med data fra opfølgningsuge 24.
English: In genotype 1b replicons, single NS3 substitutions F43S, A156S/T/V, and D168A/G/V reduced grazoprevir antiviral activity by 3- to 375-fold.
Danish: I genotype 1b-replikoner reducerede enkeltsubstitutionerne F43S, A156S/T/V og D168A/G/V i NS3 grazoprevirs antivirale aktivitet 3 til 375 gange.
English: The tablets are packaged into a carton containing two cardboard cards, each cardboard card containing two 7-count aluminium blisters.
Danish: Tabletterne er pakket i en æske, der indeholder to blisteromslag af karton.
English: Table 10: SVR in genotype 1a-infected subjects Baseline Characteristics
Danish: Tabel 10: SVR hos genotype 1a-inficerede forsøgspersoner Baseline-karakteristika
English: ‡Reference sequences for NS5A at amino acid 58 are H (genotype 1a) and P (genotype 1b and genotype 4a and 4d).
Danish: Referencesekvenser for NS5A ved aminosyreposition 58 er: H (genotype 1a) og P (genotype 1b og genotype 4a og 4d).
English: • Placebo for 12 weeks (N=100)
Danish: • Placebo i 12 uger (N=100)
English: C-SALVAGE (open-label)
Danish: C-SALVAGE (ikke-blindet)
English: Table 11: SVR in genotype 4-infected subjects Baseline Characteristics
Danish: Tabel 11: SVR hos genotype 4-inficerede forsøgspersoner Baseline-karakteristika
English: Co-administration of ZEPATIER with strong CYP3A inhibitors increases elbasvir and grazoprevir plasma concentrations, and co-administration is not recommended (see Table 2 and section 4.4).
Danish: Samtidig administration af ZEPATIER og potente CYP3A-hæmmere øger plasmakoncentrationen af elbasvir og grazoprevir, og samtidig administration anbefales ikke (se tabel 2 og pkt.
English: Placebo-controlled study in which subjects were randomised in a 2:1 ratio to EBR/GZR for 12 weeks (ITG) or placebo for 12 weeks followed by open-label treatment with EBR/GZR for 12 weeks (DTG).
Danish: Placebokontrolleret studie, hvor forsøgspersonerne blev randomiseret i forholdet 2:1 til EBR/GZR i 12 uger (ITG) eller placebo i 12 uger efterfulgt af ikke-blindet behandling med EBR/GZR i 12 uger (DTG).
English: For elbasvir, in HCV genotype 1a replicons, single NS5A substitutions Q30D/E/H/R, L31M/V and Y93C/H/N reduced elbasvir antiviral activity by 6- to 2,000-fold.
Danish: Elbasvir: I HCV-genotype 1a-replikoner reducerede enkeltsubstitutionerne Q30D/E/H/R, L31M/V og Y93C/H/N i NS5A elbasvirs antivirale aktivitet 6 til 2.000 gange.
English: Co-administration of inducers of CYP3A or P-gp with ZEPATIER is contraindicated because it may decrease elbasvir and grazoprevir plasma concentrations, which may lead to reduced therapeutic effect of ZEPATIER (see sections 4.3 and 4.4).
Danish: Samtidig administration af CYP3A- eller Pgp-induktorer og ZEPATIER er kontraindiceret, da det kan nedsætte plasmakoncentrationen af elbasvir og grazoprevir, hvilket kan medføre reduceret terapeutisk virkning af ZEPATIER (se pkt.
English: (OATP1B inhibition)
Danish: (OATP1B-hæmning)
English: †Reference sequences for NS5A at amino acid 31 are L (genotype 1a and genotype 1b) and M (genotype 4a and 4d).
Danish: Referencesekvenser for NS5A ved aminosyreposition 31 er: L (genotype 1a og genotype 1b) og M (genotype 4a og 4d).
English: In population pharmacokinetic analyses, elbasvir and grazoprevir AUCs are estimated to be 15 % and 50 % higher, respectively, for Asians compared to Whites.
Danish: I farmakokinetiske populationsanalyser estimeres AUC for elbasvir og grazoprevir at være hhv. 15% og 50% højere for asiater sammenlignet med kaukasere.
English: ↔ S-Methadone AUC 1.23 (1.12, 1.35) Cmax 1.15 (1.07, 1.25)
Danish: ↔ S-methadon AUC 1,23 (1,12; 1,35) Cmax 1,15 (1,07; 1,25)
English: Overall SVR Outcome for subjects without SVR On-treatment virologic failure Relapse Other SVR by cirrhosis status Non-cirrhotic Cirrhotic SVR by baseline HCV RNA <=800,000 IU/mL >800,000 IU/mL
Danish: Samlet SVR Resultat for forsøgspersoner, der ikke opnåede SVR Virologisk svigt under behandling Recidiv Andet SVR ud fra cirrosestatus Uden cirrose Med cirrose SVR ud fra HCV-RNA ved baseline ≤800.000 IE/ml >800.000 IE/ml
English: Among genotype 1b-infected subjects, NS3 resistance-associated substitutions persisted at detectable levels at follow-up week 24 in 50% (1/2) of subjects.
Danish: Blandt genotype 1b-inficerede forsøgspersoner var NS3-resistens-associerede substitutioner persistente med detekterbare niveauer ved opfølgningsuge 24 hos 50% (1/2) af forsøgspersonerne.