FrancophonIA/ELRC3.0 huggingface dataset:
English: NS5B RAVs: The NS5B substitution S282T emerged in the HCV of 1/17 genotype 3-failures, and in the HCV of 1/3, 1/1 and 1/1 of genotype 4-, 5- and 6-failures, respectively.
Danish: NS5B RAVs: NS5B-substitutionen S282T opstod i HCV hos 1/17 genotype 3-svigt, og i HCV hos henh.
English: Close monitoring is recommended if this medicinal product is administered with Harvoni (see sections 4.4 and 4.8).
Danish: Tæt overvågning anbefales, hvis dette lægemiddel administreres med Harvoni (se pkt.
English: Change in CPT score and class: Among those who achieved SVR12 with 12 weeks treatment with ledipasvir/sofosbuvir with ribavirin, 60% (74/123) and 34% (42/123) had an improvement or no change of CPT scores from baseline to post-treatment week 12, respectively; of the 32 patients who had CPT C cirrhosis at baseline, 53% (17/32) had CPT B cirrhosis at post-treatment Week 12; of the 88 patients who had CPT B cirrhosis at baseline, 25% (22/88) had CPT A cirrhosis at post-treatment Week 12.
Danish: Ændring i CPT-score og klasse: Blandt patienter, som opnåede SVR12 med 12 ugers behandling med ledipasvir/sofosbuvir med ribavirin, havde hhv. 60 % (74/123) og 34 % (42/123) en forbedring eller ingen ændring af CPT-scorer fra baseline til uge 12 efter behandlingen; af de 32 patienter, som havde CPT C cirrose ved baseline, havde 53 % (17/32) CPT B cirrose ved uge 12 efter behandlingen; af de 88 patienter, som havde CPT B cirrose ved baseline, havde 25 % (22/88) CPT A cirrose ved uge 12 efter behandlingen.
English: The sofosbuvir resistance-associated substitution S282T in NS5B was not detected in any virologic failure isolate from the Phase 3 studies.
Danish: Substitutionen S282T i NS5B, som er forbundet med resistens over for sofosbuvir, blev ikke detekteret i noget isolat fra virologisk svigt fra fase 3-studier.
English: Following 12 weeks of treatment with ledipasvir/sofosbuvir with ribavirin in treatment-experienced patients with compensated cirrhosis (SIRIUS, n = 77), 8/8 patients with baseline NS5A RAVs conferring > 100-fold reduced susceptibility to ledipasvir achieved SVR12.
Danish: Efter 12 ugers behandling med ledipasvir/sofosbuvir sammen med ribavirin hos behandlingserfarne patienter med kompenseret cirrose (SIRIUS, n = 77) opnåede 8/8 patienter med NS5A-RAVs ved baseline, der gav >100 gange nedsat følsomhed for ledipasvir, SVR12.
English: c CPT = Child-Pugh-Turcotte, FCH = Fibrosing cholestatic hepatitis.
Danish: FCH = fibroserende kolestatisk hepatitis.
English: Harvoni contains sunset yellow FCF aluminium lake (E110) which can cause allergic reactions
Danish: Harvoni indeholder sunset yellow FCF aluminiumpigment (E110), som kan forårsage allergiske reaktioner
English: At the no observed effect level, AUC exposure to ledipasvir was approximately 7- and 3-fold, in males and females, respectively, the human exposure at the recommended clinical dose.
Danish: Ved niveauet for ingen observeret virkning, var AUC-eksponeringen over for ledipasvir hhv. ca. 7 og 3 gange større, hos hanog hunrotter, end den humane eksponering ved den anbefalede kliniske dosis.
English: For hepatitis C virus (HCV) genotype-specific activity see sections 4.4 and 5.1.
Danish: For genotypespecifik aktivitet af hepatitis C-virus (HCV), se pkt.
English: Co-administration with medicinal products that inhibit P-gp and/or BCRP may increase ledipasvir and sofosbuvir plasma concentrations without increasing GS-331007 plasma concentration; Harvoni may be co-administered with P-gp and/or BCRP inhibitors.
Danish: Samtidig administration af lægemidler, der hæmmer P-gp og/eller BCRP, kan øge plasmakoncentrationerne af ledipasvir og sofosbuvir uden at øge plasmakoncentrationen af GS-331007.
English: Table 11: Demographics and baseline characteristics in study ION-1 Patient disposition
Danish: Tabel 11: Demografi og baselinekarakteristika i studie ION-1 Patientdisposition
English: Table 8: Demographics and baseline characteristics in study ION-3 Patient disposition
Danish: Tabel 8: Demografi og baselinekarakteristika i studie ION-3 Patientdisposition
English: Methadone (Methadone maintenance therapy [30 to 130 mg/daily])/ sofosbuvir (400 mg once daily)d
Danish: Methadon (Methadon vedligeholdelsesbehandling [30 til 130 mg/dagligt])/ sofosbuvir (400 mg én gang dagligt)d
English: No dose adjustment of Harvoni or abacavir/ lamivudine is required.
Danish: Ingen dosisjustering af Harvoni eller abacavir/ lamivudin er nødvendig.
English: Severe RI (eGFR <30 mL/min/1.73 m2)
Danish: Svært RI (eGFR <30 ml/ min/ 1,73 m2)
English: No teratogenic effects were observed in rat and rabbit developmental toxicity studies with ledipasvir.
Danish: Der blev ikke observeret nogen teratogen virkning i udviklings-toksicitetsstudier med ledipasvir hos rotter og kaniner.
English: Study 4063 was an open-label three-arm clinical study that evaluated 8, 12, and 24 weeks of treatment with ledipasvir/sofosbuvir in a total of 95 patients with genotype 1 (72%), 2 (22%), 4 (2%), 5 (1%), or 6 (2%) CHC and ESRD requiring dialysis: 45 treatment-naïve genotype 1 HCV-infected patients without cirrhosis received ledipasvir/sofosbuvir for 8 weeks; 31 treatment-experienced genotype 1
Danish: Studie 4063 var et åbent klinisk studie med tre grupper, som evaluerede 8, 12 og 24 ugers behandling med ledipasvir/sofosbuvir hos i alt 95 patienter med genotype 1 (72 %), 2 (22 %), 4 (2 %), 5 (1 %) eller 6 (2 %) CHC og ESRD, der krævede dialyse: 45 behandlingsnaive genotype 1 HCV-inficerede patienter uden cirrose fik ledipasvir/sofosbuvir i 8 uger; 31 behandlingserfarne genotype 1 HCVinficerede patienter, og behandlingsnaive eller behandlingserfarne patienter med genotype 2, 5 og 6 infektion uden cirrose fik ledipasvir/sofosbuvir i 12 uger; og 19 genotype 1, 2 og 4 HCV-inficerede patienter med kompenseret cirrose fik ledipasvir/sofosbuvir i 24 uger.
English: Safety data are limited in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) and end stage renal disease (ESRD) requiring dialysis.
Danish: Der foreligger begrænsede sikkerhedsdata hos patienter med svært nedsat nyrefunktion (estimeret glomulær filtrationshastighed [eGFR] <30 ml/min/1,73 m2) og nyresygdom i slutstadiet (ESRD, end stage renal disease), der kræver dialyse.
English: Medicinal products that are moderate P-gp inducers in the intestine (e.g. oxcarbazepine) may decrease ledipasvir and sofosbuvir plasma concentrations leading to reduced therapeutic effect of Harvoni.
Danish: Lægemidler, der er moderate P-gp-inducere i tarmen (f.eks. oxcarbazepin), kan nedsætte plasmakoncentrationerne af ledipasvir og sofosbuvir og medføre reduceret terapeutisk virkning af Harvoni.
English: Dosed 1 hr After Dialysis
Danish: Doseret 1 time efter dialyse
English: No dose adjustment of Harvoni or midazolam is required.
Danish: Ingen dosisjustering af Harvoni eller midazolam er påkrævet.
English: Omeprazole dosed simultaneously with Harvoni
Danish: Omeprazol doseret sammen med Harvoni
English: LDV/SOF+RBV 24 weeks (n = 307)a,b
Danish: LDV/SOF+RBV 24 uger (n = 307)a,b
English: As a precautionary measure, it is preferable to avoid the use of Harvoni during pregnancy.
Danish: For en sikkerheds skyld bør Harvoni undgås under graviditeten.
English: No dose adjustment of Harvoni or darunavir (ritonavir boosted) is required.
Danish: Ingen dosisjustering af Harvoni eller darunavir (ritonavir-boostet) er nødvendig.
English: Following 12 weeks of treatment with ledipasvir/sofosbuvir (without ribavirin) in treatmentexperienced patients (arm 1 of ION-2 study) 4/4 patients with baseline NS5A RAVs conferring a ledipasvir fold-change of ≤ 100 achieved SVR.
Danish: Efter 12 ugers behandling med ledipasvir/sofosbuvir (uden ribavirin) hos behandlingserfarne patienter (arm 1 af ION-2-studiet) opnåede 4/4 patienter SVR med baseline-NS5A-RAVs, der gav ≤100 gange mindre ændring af ledipasvir.
English: Use with HMG-CoA reductase inhibitors
Danish: Samtidig brug med HMG-CoA reductasehæmmere
English: The median age was 56 years (range: 23 to 77); 74% of patients were male; 97% were white; 63% had genotype 1a HCV infection; 94% had non-CC IL28B alleles (CT or TT).
Danish: Medianalderen var 56 år (interval 23 til 77), 74 % af patienterne var mænd, 97 % var hvide, 63 % havde genotype 1a HCV-infektion, 94 % havde non-CC IL28B-alleller (CT eller TT).
English: Harvoni contains the azo colouring agent sunset yellow FCF aluminium lake (E110), which may cause allergic reactions.
Danish: Harvoni indeholder azo-farvestoffet sunset yellow FCF aluminiumpigment (E110), som kan forårsage allergiske reaktioner.
English: Of the 95 total patients, at baseline, 20% of patients had cirrhosis, 22% were treatment experienced, 21% had received a kidney transplant, 92% were on hemodialysis, and 8% were on peritoneal dialysis;
Danish: Ud af de i alt 95 patienter havde ved baseline 20 % af patienterne cirrose, 22 % var behandlingserfarne, 21 % havde fået foretaget en nyretransplantation, 92 % var i hæmodialyse, og 8 % var i peritoneal dialyse; den gennemsnitlige varighed i dialyse var 11,5 år (interval: 0,2 til 43,0 år).
English: Previously treated adults with or without cirrhosis - ION-2 (study 0109) - Genotype 1 ION-2 was a randomised, open-label study that evaluated 12 and 24 weeks of treatment with ledipasvir/sofosbuvir with or without ribavirin (randomised 1:1:1:1) in genotype 1 HCV-infected patients with or without cirrhosis who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor.
Danish: Tidligere behandlede voksne med eller uden cirrose - ION-2 (studie 0109) - genotype 1 ION-2 var et randomiseret, åbent studie, der evaluerede 12 og 24 ugers behandling med ledipasvir/sofosbuvir med eller uden ribavirin (randomiseret 1:1:1:1) hos genotype 1 HCV-inficerede patienter med eller uden cirrose, hvor tidligere behandling med et interferon-baseret regime svigtede, herunder regimer, hvor der indgik en HCV-proteasehæmmer.
English: Of the 100 treated patients, the median age was 15 years (range: 12 to 17); 63% of the patients were female; 90% were White, 7% were Black, and 2% were Asian; 13% were Hispanic/Latino; mean weight was 61.3 kg (range: 33.0 to 126.0 kg); 55% had baseline HCV RNA levels greater than or equal to 800,000 IU/mL; 81% had genotype 1a HCV infection; 76% had non-CC IL28B alleles (CT or TT) and 1% had known cirrhosis.
Danish: Blandt de 100 behandlede patienter var medianalderen 15 år (interval: 12 til 17); 63 % af patienterne var kvinder; 90 % var hvide, 7 % var sorte og 2 % var asiatere; 13 % var latinamerikanere; den gennemsnitlige kropsvægt var 61,3 kg (interval: 33,0 til 126,0 kg; 55 % havde baseline HCV RNA-niveauer større end eller lig med 800.000 IU/ml; 81 % havde genotype 1a HCV-infektion; 76 % havde non-CC IL28B-alleller (CT eller TT) og 1 % havde kendt cirrose.
English: Previously treated adults who have failed on sofosbuvir + ribavirin ± PEG-IFN The efficacy of ledipasvir/sofosbuvir in patients who had previously failed treatment with sofosbuvir + ribavirin ± PEG-IFN is supported by two clinical studies.
Danish: Virkningen af ledipasvir/sofosbuvir hos patienter, hvor behandling med sofosbuvir + ribavirin ± PEG-IFN svigtede, understøttes af to kliniske studier.
English: ION-4 was an open-label clinical study that evaluated the safety and efficacy of 12 weeks of treatment with ledipasvir/sofosbuvir without ribavirin in HCV treatment-naïve and treatment-experienced patients with genotype 1 or 4 CHC who were co-infected with HIV-1.
Danish: ION-4 var et åbent klinisk studie, der evaluerede sikkerhed og virkning af 12 ugers behandling med ledipasvir/sofosbuvir uden ribavirin hos HCV-behandlingsnaive og -behandlingserfarne patienter med genotype 1- eller 4-CHC med samtidig hiv 1-infektion.
English: ORAL CONTRACEPTIVES Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ ledipasvir (90 mg once daily)d
Danish: ORALE ANTIKONTRACEPTIVA Norgestimat/ ethinylestradiol (norgestimat 0,180 mg/ 0,215 mg/ 0,25 mg/ ethinylestradiol 0,025 mg)/ ledipasvir (90 mg én gang dagligt)d
English: Other medicines and Harvoni
Danish: Brug af anden medicin sammen med Harvoni
English: Of the 670 treated patients, the median age was 59 years (range: 21 to 81 years); 77% of the patients were male; 91% were White; mean body mass index was 28 kg/m2 (range: 18 to 49 kg/m2); 94% and 6% had genotype 1 and 4 HCV infection, respectively; 78% of the patients failed a prior HCV therapy.
Danish: Blandt de 670 behandlede patienter var medianalderen 59 år (interval 21 til 81 år); 77 % af patienterne var mænd; 91 % var hvide; det gennemsnitlige kropsmasseindeks var 28 kg/m2 (interval 18 til 49 kg/m2); 94 % og 6 % havde hhv. genotype 1 og 4 HCV-infektion; tidligere HCV-behandling svigtede hos 78 % af patienterne.
English: Treatment-naïve adults with or without cirrhosis - ION-1 (study 0102) - Genotype 1 ION-1 was a randomised, open-label study that evaluated 12 and 24 weeks of treatment with ledipasvir/sofosbuvir with or without ribavirin in 865 treatment-naïve patients with genotype 1 CHC including those with cirrhosis (randomised 1:1:1:1).
Danish: Behandlingsnaive voksne med eller uden cirrose - ION-1 (studie 0102) - genotype 1 ION-1 var et randomiseret, åbent studie der undersøgte 12 og 24 ugers behandling med ledipasvir/sofosbuvir med eller uden ribavirin hos 865 behandlingsnaive patienter med CHC forårsaget af infektion med HCV af genotype 1, herunder patienter med cirrose (randomiseret 1:1:1:1).
English: Cases of severe bradycardia and heart block have been observed when Harvoni is used with amiodarone and/or other drugs that lower heart rate (see sections 4.4 and 4.5).
Danish: Der er iagttaget tilfælde af svær bradykardi og hjerteblok ved anvendelse af Harvoni med amiodaron og/eller andre hjertefrekvenssænkende lægemidler (se pkt.
English: No dose adjustment of Harvoni or methadone is required.
Danish: Ingen dosisjustering af Harvoni eller methadon er nødvendig.
English: Exposure to sofosbuvir in rodent studies could not be detected likely due to high esterase activity; however, exposure to the major metabolite GS-331007 at doses which cause adverse effects was 16 times (rat) and 71 times (dog) higher than the clinical exposure at 400 mg sofosbuvir.
Danish: Eksponeringen for den primære metabolit, GS-331007, ved doser, der forårsager bivirkninger, var imidlertid 16 gange (rotter) og 71 gange (hunde) højere end den kliniske eksponering med 400 mg sofosbuvir.
English: ANTIMYCOBACTERIALS Rifampicin (600 mg once daily)/ ledipasvir (90 mg single dose)d
Danish: ANTIMYKOBAKTERIELLE MIDLER Rifampicin (600 mg én gang dagligt)/ ledipasvir (90 mg enkeltdosis)d
English: 24% (4/17)e a These 4 non-cirrhotic relapsers all had baseline NS5A resistance-associated polymorphisms.
Danish: a. Disse 4 patienter uden cirrose med recidiv havde alle NS5A-polymorfisme forbundet med resistens ved baseline.
English: Co-administration of Harvoni with tipranavir (ritonavir boosted) is expected to decrease the concentration of ledipasvir, leading to reduced therapeutic effect of Harvoni.
Danish: Administration af Harvoni sammen med tipranavir (ritonavir-boostet) forventes at nedsætte koncentrationen af ledipasvir og føre til en nedsat terapeutisk virkning af Harvoni.
English: Ribavirin dose*
Danish: Ribavirin-dosis*
English: 24 weeks (n = 111)
Danish: 24 uger (n = 111)
English: AUC, Cmax, Cmina, b
Danish: Gennemsnitligt forhold (90 % konfidensinterval) for AUC, Cmax, Cmina,b
English: Darunavir boosted with ritonavir (800 mg/ 100 mg once daily)/ sofosbuvir (400 mg once daily)
Danish: Darunavir boostet med ritonavir (800 mg/ 100 mg én gang dagligt)/ sofosbuvir (400 mg én gang dagligt)
English: When given with elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate, Harvoni is expected to increase the concentration of tenofovir.
Danish: Når det gives med elvitegravir/ cobicistat/ emtricitabin/ tenofovirdisoproxilfumarat, forventes Harvoni at øge koncentrationen af tenofovir.
English: Co-administration of such medicinal products is not recommended with Harvoni (see section 4.5).
Danish: Samtidig administration af sådanne lægemidler og Harvoni anbefales ikke (se pkt.
English: d Patients with missing cirrhosis status were excluded from this subgroup analysis.
Danish: d. Patienter med manglende cirrose-status blev ekskluderet fra denne undergruppeanalyse.
English: Refer to tenofovir disoproxil fumarate, emtricitabine/tenofovir disoproxil fumarate, or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate Summary of Product Characteristics for recommendations on renal monitoring.
Danish: Se produktresuméerne for tenofovirdisoproxilfumarat, emtricitabin/tenofovirdisoproxilfumarat eller elvitegravir/cobicistat/emtricitabin/tenofovirdisoproxilfumarat for anbefalinger om nyreovervågning.
English: At concentrations achieved in the clinic, ledipasvir is not an inhibitor of hepatic transporters including the OATP 1B1 or 1B3, BSEP, OCT1, OCT2, OAT1, OAT3, multidrug and toxic compound extrusion (MATE) 1 transporter, multidrug resistance protein (MRP) 2 or MRP4.
Danish: Ved koncentrationer, der blev opnået i klinikken, er ledipasvir ikke en hæmmer af levertransportere, herunder OATP 1B1 eller 1B3, BSEP, OCT1, OCT2, OAT1, OAT3, multidrug- og toksisk stofekstrusion (MATE) 1-transporter, multidrug resistance protein (MRP) 2 eller MRP4.Sofosbuvir og GS-331007 er ikke hæmmere af lægemiddeltransporterne P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3, OCT1 og GS-331007 er ikke en hæmmer af OAT1, OCT2 og MATE1.
English: No dose adjustment of Harvoni or atazanavir (ritonavir boosted) is required.
Danish: Ingen dosisjustering af Harvoni eller atazanavir (ritonavir-boostet) er nødvendig.
English: No dose adjustment of Harvoni or efavirenz/ emtricitabine/ tenofovir disoproxil fumarate is required.
Danish: Ingen dosisjustering af Harvoni eller efavirenz/ emtricitabin/ tenofovirdisoproxilfumarat er nødvendig.
English: Raltegravir (400 mg twice daily)/ sofosbuvir (400 mg once daily)d
Danish: Raltegravir (400 mg to gange dagligt)/ sofosbuvir (400 mg én gang dagligt)d
English: Medicinal products that are strong P-gp inducers (carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. John's wort) may significantly decrease ledipasvir and sofosbuvir plasma concentrations leading to reduced therapeutic effect of ledipasvir/sofosbuvir and thus are contraindicated with Harvoni (see section 4.3).
Danish: Lægemidler, der er stærke P-gp-inducere (carbamazepin, phenobarbital, phenytoin, rifampicin, rifabutin og perikon), kan nedsætte plasmakoncentrationerne af ledipasvir og sofosbuvir signifikant og føre til en reduceret terapeutisk virkning af ledipasvir/sofosbuvir.
English: b Patients with missing cirrhosis status were excluded from this subgroup analysis.
Danish: b. Patienter med manglende cirrose-status blev ekskluderet fra denne undergruppeanalyse.
English: Rifapentine
Danish: Rifapentin
English: Famotidine dosed simultaneously with Harvonid
Danish: Famotidin doseret sammen med Harvonid
English: No patient experienced virologic failure (see section 4.2 for information on paediatric use).
Danish: Ingen patient oplevede virologisk svigt (se pkt.
English: HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS Raltegravir (400 mg twice daily)/ ledipasvir (90 mg once daily)d
Danish: HIV ANTIVIRALE STOFFER: INTEGRASEHÆMMERE Raltegravir (400 mg to gange dagligt)/ ledipasvir (90 mg én gang dagligt)d
English: • If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: • Kontakt lægen, før du tager dette lægemiddel, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: How to take Harvoni
Danish: Sådan skal du tage Harvoni
English: c Patients with missing cirrhosis status were excluded from this subgroup analysis.
Danish: c. Patienter med manglende cirrose-status blev ekskluderet fra denne undergruppeanalyse.
English: Breast-feeding Do not breast-feed during treatment with Harvoni.
Danish: Amning Du må ikke amme under behandlingen med Harvoni.
English: Table 15: Relapse rates for selected subgroups in study ION-2 LDV/SOF
Danish: Tabel 15: Recidivrater for udvalgte undergrupper i studie ION-2 LDV/SOF
English: Tacrolimus (5 mg single dose)/ sofosbuvir (400 mg single dose)h
Danish: Tacrolimus (5 mg enkeltdosis)/ sofosbuvir (400 mg enkeltdosis)h
English: Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ sofosbuvir (400 mg once daily)d
Danish: Norgestimat/ ethinylestradiol (norgestimat 0,180 mg/ 0,215 mg/ 0,25 mg/ ethinylestradiol 0,025 mg)/ sofosbuvir (400 mg én gang dagligt)d
English: ↑ Statins
Danish: ↑ Statiner
English: ↑ Cmin 1.48 (1.34, 1.63) Emtricitabine ↔ Cmax 1.02 (0.96, 1.08)
Danish: ↑ Cmin 1,48 (1,34; 1,63) Emtricitabin ↔ Cmax 1,02 (0,96; 1,08)
English: Harvoni + ribavirinA for 12 weeks (see section 5.1).
Danish: Harvoni + ribavirinA i 12 uger (se pkt.
English: 8 weeks (n = 215)
Danish: 8 uger (n = 215)
English: No dose adjustment of Harvoni or emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate is required.
Danish: Ingen dosisjustering af Harvoni eller emtricitabin/ rilpivirin/ tenofovirdisoproxilfumarat er nødvendig.
English: ↑ Cmin 1.45 (1.27, 1.64) Emtricitabine ↔ Cmax 0.98 (0.94, 1.02)
Danish: ↑ Cmin 1,45 (1,27; 1,64) Emtricitabin ↔ Cmax 0,98 (0,94; 1,02)
English: H2-receptor antagonists Famotidine (40 mg single dose)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)c, d
Danish: H2-receptorantagonister Famotidin (40 mg enkeltdosis)/ ledipasvir (90 mg enkeltdosis)c/ sofosbuvir (400 mg enkeltdosis)c,d
English: Abacavir/ lamivudine (600 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Danish: Abacavir/ lamivudin (600 mg/ 300 mg én gang dagligt)/ ledipasvir (90 mg én gang dagligt)c/ sofosbuvir (400 mg én gang dagligt)c,d
English: The median age was 52 years (range: 26 to 72); 82% of the patients were male; 61% were white; 34% were black; 75% had genotype 1a HCV infection; 2% had genotype 4 infection; 76% had non-CC IL28B alleles (CT or TT); and 20% had compensated cirrhosis.
Danish: Medianalderen var 52 år (interval 26 til 72), 82 % af patienterne var mænd, 61 % var hvide, 34 % var sorte, 75 % havde genotype 1a HCV-infektion, 2 % havde genotype 4-infektion, 76 % havde non-CC IL28B-alleller (CT eller TT), og 20 % havde kompenseret cirrose.
English: 12 weeks (n = 111)
Danish: 12 uger (n = 111)
English: Co-administration of Harvoni with oxcarbazepine is expected to decrease the concentration of ledipasvir and sofosbuvir leading to reduced therapeutic effect of Harvoni.
Danish: Administration af Harvoni sammen med oxcarbazepin forventes at nedsætte koncentrationen af ledipasvir og sofosbuvir og føre til en nedsat terapeutisk virkning af Harvoni.
English: General disorders: Very common fatigue
Danish: Almene symptomer: Meget almindelig
English: 8 weeks (n = 213)
Danish: 8 uger (n = 213)
English: c Other includes patients who did not achieve SVR and did not meet virologic failure criteria (e.g. lost to follow-up).
Danish: c. Andet omfatter patienter, der ikke opnåede SVR og ikke opfyldte kriterierne for virologisk svigt (f.eks. lost to follow-up).
English: Co-administration of Harvoni with rifapentine is expected to decrease the concentration of ledipasvir and sofosbuvir, leading to reduced therapeutic effect of Harvoni.
Danish: Administration af Harvoni sammen med rifapentin forventes at nedsætte koncentrationen af ledipasvir og sofosbuvir og føre til en nedsat terapeutisk virkning af Harvoni.
English: b Other includes patients who did not achieve SVR and did not meet virologic failure criteria (e.g. lost to follow-up).
Danish: b. Andet omfatter patienter, der ikke opnåede SVR og ikke opfyldte kriterierne for virologisk svigt (f.eks. lost to follow-up).
English: Rifampicin (600 mg once daily)/ sofosbuvir (400 mg single dose)d
Danish: Rifampicin (600 mg én gang dagligt)/ sofosbuvir (400 mg enkeltdosis)d
English: 12 weeks (n = 214)
Danish: 12 uger (n = 214)