FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety of tenofovir disoproxil fumarate in the setting of Harvoni and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Danish: Tenofovirdisoproxilfumarats sikkerhed ved anvendelse af Harvoni og en farmakokinetisk forstærker (f.eks. ritonavir eller cobicistat) er ikke klarlagt.
English: The clinical data to support the use of Harvoni in adults infected with HCV genotype 3 are limited (see section 5.1).
Danish: De kliniske data, der støtter brug af Harvoni hos voksne inficeret med HCV-genotype 3 er begrænsede (se pkt.
English: In patients who fail treatment with ledipasvir/sofosbuvir, selection of NS5A resistance mutations that substantially reduce the susceptibility to ledipasvir is seen in the majority of cases (see section 5.1).
Danish: Hos patienter, hvor behandlingen med ledipasvir/sofosbuvir svigter, ses der i de fleste tilfælde en udvælgelse af NS5A-resistensmutationer, der reducerer følsomheden over for ledipasvir betragteligt (se pkt.
English: TOTAL (n = 440)
Danish: I ALT (n = 440)
English: No dose adjustment of Harvoni or tacrolimus is required at initiation of co-administration.
Danish: Ingen dosisjustering af Harvoni eller tacrolimus er nødvendig ved påbegyndelse af samtidig administration.
English: If you are not sure about taking any other medicines, talk to your doctor or pharmacist.
Danish: Hvis du er i tvivl med hensyn til at tage andre lægemidler, skal du kontakte lægen eller apotekspersonalet.
English: Haemoglobin in patients with history of stable cardiac disease
Danish: Hæmoglobin hos patienter med tidligere stabil hjertesygdom
English: Harvoni is contraindicated with phenobarbital and phenytoin (see section 4.3).
Danish: Harvoni er kontraindiceret sammen med phenobarbital og phenytoin (se pkt.
English: Among post-transplant patients with compensated liver disease or patients with decompensated liver disease either pre- or post-transplant (SOLAR-1 and SOLAR-2 studies), relapse was associated with the detection of one or more of the following NS5A RAVs: K24R, M28T, Q30R/H/K, L31V, H58D and Y93H/C in 12/14 genotype 1a patients, and L31M, Y93H/N in 6/6 genotype 1b patients.
Danish: Blandt levertransplanterede patienter med kompenseret leversygdom eller patienter med dekompenseret leversygdom enten før eller efter transplantation (studierne SOLAR-1 og SOLAR-2) var recidiv forbundet med detektion af en eller flere af følgende NS5A RAV'er: K24R, M28T, Q30R/H/K, L31V, H58D og Y93H/C hos 12/14 genotype 1a-patienter, og L31M, Y93H/N hos 6/6 genotype 1b-patienter.
English: Patients with compensated cirrhosis
Danish: Patienter med kompenseret cirrose
English: Sunset yellow FCF aluminium lake (E110)
Danish: Sunset yellow FCF aluminiumpigment (E110)
English: Caution is warranted and therapeutic concentration monitoring of digoxin is recommended when co-administered with Harvoni.
Danish: Der rådes til forsigtighed, samt overvågning af terapeutiske koncentrationer af digoxin ved administration sammen med Harvoni.
English: HCV protease inhibitor + PEG-IFN+RBV
Danish: HCV-proteasehæmmer + PEG-IFN+RBV
English: Patients receiving Harvoni concomitantly with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or with tenofovir disoproxil fumarate and a boosted HIV protease inhibitor should be monitored for tenofovirassociated adverse reactions.
Danish: Patienter, der får Harvoni administreret sammen med elvitegravir/cobicistat/emtricitabin/tenofovirdisoproxilfumarat eller med tenofovirdisoproxilfumarat og en boostet hiv proteasehæmmer, bør overvåges for tenofovirassocierede bivirkninger.
English: After a single 90 mg dose of [14C]-ledipasvir in healthy subjects, the blood to plasma ratio of [14C]-radioactivity ranged between 0.51 and 0.66.
Danish: Efter en enkelt 90 mg dosis af [14C]-ledipasvir hos raske personer, var forholdet af [14C]-radioaktivitet mellem blod og plasma fra 0,51 til 0,66.
English: Following a single 90 mg oral dose of [14C]-ledipasvir, mean total recovery of the [14C]-radioactivity in faeces and urine was 87%, with most of the radioactive dose recovered from faeces (86%).
Danish: Efter en enkelt 90 mg oral dosis af [14C]-ledipasvir, var den gennemsnitlige totale genfinding af [14C]-radioaktivitet i fæces og urin 87 %, hvoraf størstedelen af den radioaktive dosis blev genfundet i fæces (86 %).
English: b Non-missing FibroTest results are mapped to Metavir scores according to: 0-0.31 = F0-F1; 0.32-0.58 = F2;
Danish: b. Ikke manglende FibroTest-resultater blev kortlagt til Metavir-scores i henhold til: 0-0,31 = F0-F1, 0,32-0,58 = F2,
English: AUC and Cmax of ledipasvir were 77% and 58% higher, respectively, in females than males; however, the relationship between gender and ledipasvir exposures was not considered clinically relevant.
Danish: AUC og Cmax for ledipasvir var hhv. 77 % og 58 % højere hos kvinder end hos mænd.
English: Oxcarbazepine
Danish: Oxcarbazepin
English: Age (years): median (range) Male gender Race: Black/ African American White Genotype 1aa IL28CC genotype FibroTest-Determined Metavir scoreb F0-F1 F2 F3-F4 Not interpretable a Two patients in the LDV/SOF 12-week treatment arm, one patient in the LDV/SOF+RBV 12-week treatment arm, two patients in the LDV/SOF 24-week treatment arm, and two patients in the LDV/SOF+RBV 24-week treatment arm did not have a confirmed genotype 1 subtype.
Danish: Alder (år): median (interval) 52 (18-75) Køn: Mand Race: Sort/amerikaner med afrikansk herkomst Hvid Genotype 1aa IL28CC-genotype FibroTest-bestemt Metavir-scoreb F0-F1 F2 F3-F4 Kan ikke fortolkes a. To patienter i behandlingsarmen med 12-ugers LDV/SOF, en patient i behandlingsarmen med 12-ugers LDV/SOV + RBV, to patienter i behandlingsarmen med 24-ugers LDV/SOF og to patienter i behandlingsarmen med 24-ugers LDV/SOF+RBV havde ikke en bekræftet genotype 1-undertype.
English: Haemoglobin in patients with no cardiac disease
Danish: Hæmoglobin hos patienter uden hjertesygdom
English: Harvoni is indicated for the treatment of chronic hepatitis C (CHC) in adults and in adolescents aged 12 to < 18 years (see sections 4.2, 4.4 and 5.1).
Danish: Harvoni er indiceret til behandling af kronisk hepatitis C (CHC) hos voksne og unge i alderen 12 til < 18 år (se pkt.
English: Co-administration of Harvoni and HMG-CoA reductase inhibitors (statins) can significantly increase the concentration of the statin, which increases the risk of myopathy and rhabdomyolysis (see section 4.5).
Danish: Administration af Harvoni sammen med HMG-CoA reductasehæmmere (statiner) kan forhøje koncentrationen af statin signifikant, hvilket øger risikoen for myopati og rhabdomyolyse (se pkt.
English: The sofosbuvir resistance-associated substitution S282T was not detected in the baseline NS5B sequence of any patient in Phase 3 studies by population or deep sequencing.
Danish: Substitutionen S282T, som er forbundet med resistens over for sofosbuvir, blev ikke detekteret i baseline-NS5B-sekvensen hos nogen af patienterne i fase 3-studier ved populationssekventering eller dyb sekventering.
English: Of the 29 genotype 1a patients who qualified for resistance testing, 22/29 (76%) patients harboured one or more NS5A RAVs at positions K24, M28, Q30, L31, S38 and Y93 at failure, while the remaining 7/29 patients had no NS5A RAVs detected at failure.
Danish: Ud af de 29 genotype 1apatienter, som kvalificerede for resistenstestning havde 22/29 (76 %) patienter en eller flere NS5A-RAVs ved positionerne K24, M28, Q30, L31, S38 og Y93 ved tidspunktet for svigt, mens de resterende 7/29 patienter ikke havde NS5A-RAVs, der kunne detekteres ved tidspunktet for svigt.
English: The safety and efficacy of Harvoni in adolescents aged 12 to < 18 years is based on data from a Phase 2, open-label clinical study (Study 1116) that enrolled 100 patients with genotype 1 HCV infection who were treated with ledipasvir/sofosbuvir for 12 weeks.
Danish: Harvonis sikkerhed og virkning hos unge i alderen 12 til <18 år er baseret på data fra et fase 2, ikkeblindet klinisk studie (Studie 1116), der inkluderede 100 patienter med genotype 1 HCV-infektion, som blev behandlet med ledipasvir/sofosbuvir i 12 uger.
English: Co-administration of Harvoni with rosuvastatin may significantly increase the concentration of rosuvastatin (several fold-increase in AUC) which is associated with increased risk of myopathy, including rhabdomyolysis.
Danish: Administration af Harvoni sammen med rosuvastatin kan forhøje koncentrationen af rosuvastatin signifikant (AUC mange gange større), hvilket er forbundet med en øget risiko for myopati, herunder rhabdomyolyse.
English: Forty patients with genotype 4 CHC were enrolled in SOLAR-1 and SOLAR-2 studies, SVR12 were 92% (11/12) and 100% (10/10) in post-transplant patients without decompensated cirrhosis and 60% (6/10) and 75% (6/8) in patients with decompensated cirrhosis (pre- and post-liver transplantation) treated for 12 or 24 weeks, respectively.
Danish: 40 patienter med genotype 4 CHC indgik i studierne SOLAR-1 og SOLAR-2, SVR 12 var 92 % (11/12) og 100 % (10/10) hos levertransplanterede patienter uden dekompenseret cirrose og 60 % (6/10) og 75 % (6/8) hos patienter med dekompenseret cirrose (før og efter levertransplantation) behandlet i hhv. 12 eller 24 uger.
English: Among post-transplant patients with compensated liver disease (SOLAR-1 and SOLAR-2 studies), no relapse occurred in patients with baseline NS5A RAVs (n = 23) following 12 weeks of treatment with ledipasvir/sofosbuvir + ribavirin.
Danish: Blandt levertransplanterede patienter med kompenseret leversygdom (studierne SOLAR-1 og SOLAR-2) forekom der ikke recidiv hos patienter med baseline-NS5A RAV'er (n = 23) efter 12 ugers behandling med ledipasvir/sofosbuvir + ribavirin.
English: Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis (including decompensated cirrhosis) had no clinically relevant effect on the exposure to sofosbuvir and GS-331007.
Danish: Populationsfarmakokinetisk analyse hos HCV-inficerede patienter indikerer, at cirrose (inklusive dekompenseret cirrose) ikke havde nogen klinisk relevant virkning på eksponeringen for sofosbuvir og GS-331007.
English: No significant effects on foetal development have been observed with ledipasvir or sofosbuvir in rats and rabbits.
Danish: Der er ikke blevet observeret nogen signifikante virkninger med ledipasvir eller sofosbuvir på fosterudviklingen hos rotter og kaniner.
English: Patients with cirrhosis
Danish: Patienter med cirrose
English: No dose adjustment required.
Danish: Ingen dosisjustering er nødvendig.
English: The efficacy of ledipasvir/sofosbuvir in HCV infected adolescents aged 12 to < 18 years was evaluated in a Phase 2, open label clinical study that enrolled 100 patients with genotype 1 CHC (Study 1116).
Danish: Virkningen af ledipasvir/sofosbuvir hos HCV-inficerede unge i alderen 12 til < 18 år blev vurderet i et fase 2, ikke-blindet klinisk studie, der inkluderede 100 patienter med genotype 1 CHC (Studie 1116).
English: ↔ Emtricitabine ↑ Tenofovir
Danish: ↔ Emtricitabin ↑ Tenofovir
English: ↑ Ledipasvir ↔ Ciclosporin
Danish: ↔ Ciclosporin
English: Ledipasvir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo rat micronucleus assays.
Danish: Ledipasvir var ikke genotoksisk i et arsenal af in vitro- eller in vivo-analyser, herunder bakteriel mutagenicitet, kromosomafvigelse med lymfocytter fra humant perifert blod og in vivo mikronukleusanalyser hos rotter.
English: Demographics and baseline characteristics were balanced across the treatment groups.
Danish: Demografi og baselinekarakteristika var afbalanceret på tværs af behandlingsgrupperne.
English: Therefore, Harvoni should not be used during breast-feeding.
Danish: Derfor må Harvoni ikke anvendes under amning.
English: • outer cartons containing 3 bottles of 28 (84) film-coated tablets.
Danish: • ydre kartoner indeholdende 3 tabletbeholdere med 28 (84) filmovertrukne tabletter.
English: Sofosbuvir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo mouse micronucleus assays.
Danish: Sofosbuvir var ikke genotoksisk i et arsenal af in vitro- eller in vivo-analyser, herunder bakteriel mutagenicitet, kromosomafvigelse med lymfocytter fra humant perifert blod og in vivo mikronukleusanalyser hos mus.
English: No clinically relevant pharmacokinetic differences due to race have been identified for ledipasvir, sofosbuvir or GS-331007.
Danish: Der blev ikke identificeret nogen klinisk relevante farmakokinetiske forskelle, der skyldes race, for ledipasvir, sofosbuvir eller GS-331007.
English: (Increase in gastric pH)
Danish: (Øget pH-værdi i maven)
English: Prior HCV therapy PEG-IFN+RBV HCV protease inhibitor + PEG-IFN+RBV
Danish: Tidligere HCV-behandling PEG-IFN+RBV HCV-proteasehæmmer + PEG-IFN+RBV
English: Harvoni can be used in these patients with no dose adjustment when no other relevant treatment options are available (see sections 4.8, 5.1 and 5.2).
Danish: Harvoni kan anvendes hos disse patienter uden dosisjustering, når ingen andre relevante behandlingsmuligheder er tilgængelige (se pkt.
English: Co-administration of Harvoni with rosuvastatin is contraindicated (see section 4.3).
Danish: Administration af Harvoni sammen med rosuvastatin er kontraindiceret (se pkt.
English: Patients awaiting liver transplantation and post-liver transplant - SOLAR-1 and SOLAR-2 SOLAR-1 and SOLAR-2 were two open-label clinical studies that evaluated 12 and 24 weeks of treatment with ledipasvir/sofosbuvir in combination with ribavirin in genotype 1 and 4 HCV-infected patients who have undergone liver transplantation and/or who have decompensated liver disease.
Danish: Patienter, der venter på levertransplantation og efter levertransplantation - SOLAR-1 og SOLAR-2 SOLAR-1 og SOLAR-2 var to åbne kliniske studier, der evaluerede 12 og 24 ugers behandling med ledipasvir/sofosbuvir i kombination med ribavirin hos patienter med genotype 1 og 4 HCV-infektion, der har gennemgået en levertransplantation, og/eller som har dekompenseret leversygdom.
English: After a single 400 mg dose of [14C]-sofosbuvir in healthy subjects, the blood to plasma ratio of [14C]-radioactivity was approximately 0.7.
Danish: Efter en enkelt 400 mg dosis af [14C]-sofosbuvir hos raske personer, var forholdet af [14C]-radioaktivitet mellem blod og plasma ca. 0,7.
English: No clinically relevant pharmacokinetic differences due to gender have been identified for sofosbuvir or GS-331007.
Danish: Der blev ikke identificeret nogen klinisk relevante farmakokinetiske forskelle, der skyldes køn, for sofosbuvir eller GS-331007.
English: The three Phase 3 studies included one study conducted in non-cirrhotic treatment-naïve patients (ION-3); one study in cirrhotic and non-cirrhotic treatment-naïve patients (ION-1); and one study in cirrhotic and non-cirrhotic patients who failed prior therapy with an interferon-based regimen, including regimens containing an
Danish: De tre fase 3-studier omfattede et studie udført hos behandlingsnaive patienter uden cirrose (ION-3), et studie med behandlingsnaive patienter med og uden cirrose (ION-1) og et studie med patienter med og uden cirrose, hvor tidligere behandling med et interferon-baseret regime har svigtet, herunder regimer, der indeholder en HCV-proteasehæmmer (ION-2).
English: In study 1118, 44 patients with genotype 1 infection, including 12 cirrhotic patients, who had previously failed treatment with sofosbuvir + ribavirin + PEG-IFN or with sofosbuvir + ribavirin were treated with ledipasvir/sofosbuvir + ribavirin for 12 weeks; the SVR was 100% (44/44).
Danish: I studie 1118 blev 44 patienter med genotype 1-infektion, herunder 12 patienter med cirrose, hvor behandling med sofosbuvir + ribavirin + PEG-IFN eller med sofosbuvir + ribavirin tidligere havde svigtet, behandlet med ledipasvir/sofosbuvir + ribavirin i 12 uger.
English: CPT Class C cirrhosis pre-transplant CPT Class B or C cirrhosis posttransplant
Danish: CPT klasse B eller C cirrose efter transplantation
English: Table 10: Relapse rates by baseline characteristics in the ION-3 study, virological failure population* LDV/SOF
Danish: Tabel 10: Recidivrater pr. baselinekarakteristika i ION-3-studiet, population med virologisk svigt* LDV/SOF
English: Treatment-experienced patients had failed prior treatment with PEG-IFN + ribavirin ± an HCV protease inhibitor or sofosbuvir + ribavirin ± PEG-IFN.
Danish: Hos behandlingserfarne patienter havde tidligere behandling med PEG-IFN + ribavirin ± en HCV-proteasehæmmer eller sofosbuvir + ribavirin ± PEG-IFN svigtet.
English: Table 15 presents relapse rates with the 12-week regimens (with or without ribavirin) for selected subgroups (see also previous section “Effect of baseline HCV resistance-associated variants on treatment outcome”).
Danish: Tabel 15 viser recidivrater med det 12-ugers regime (med eller uden ribavirin) for udvalgte undergrupper (se også tidligere pkt.
English: a One patient in the LDV/SOF 24-week treatment arms and one patient in the LDV/SOF+RBV 24-week treatment arm were prior treatment failures of a non-pegylated interferon-based regimen.
Danish: Kan ikke fortolkes a. En patient i behandlingsarmen med 24 ugers LDV/SOF og en patient i behandlingsarmen med 24 ugers LDV/SOV+RBV havde oplevet svigt af en tidligere behandling med et non-pegyleret interferonbaseret regimen.
English: • tenofovir disoproxil fumarate or any medicine containing tenofovir disoproxil fumarate,
Danish: • tenofovirdisoproxilfumarat eller andre lægemidler, der indeholder tenofovirdisoproxilfumarat, anvendes til at behandle hiv-infektion;
English: The clinical studies enrolled patients with or without cirrhosis, who were treatment-naïve or with prior treatment failure after therapy with PEG-IFN + ribavirin +/- an HCV protease inhibitor.
Danish: De kliniske studier inkluderede patienter med eller uden cirrose, som var behandlingsnaive, eller som tidligere havde oplevet behandlingssvigt efter behandling med PEG-IFN + ribavirin +/- en HCVproteasehæmmer.
English: No major differences in outcomes were observed by the presence or absence of baseline NS5A RAVs.
Danish: Der blev ikke observeret udtalte forskelle mellem resultaterne afhængigt af, om baselineNS5A-RAVs var til stede eller ikke til stede.
English: Co-administration of Harvoni with pravastatin may significantly increase the concentration of pravastatin which is associated with increased risk of myopathy.
Danish: Administration af Harvoni sammen med pravastatin kan forhøje koncentrationen af pravastatin signifikant, hvilket er forbundet med en øget risiko for myopati.
English: ION-3 evaluated 8 weeks of treatment with ledipasvir/sofosbuvir with or without ribavirin and 12 weeks of treatment with ledipasvir/sofosbuvir in treatment-naïve non-cirrhotic patients with genotype 1 CHC.
Danish: ION-3 evaluerede 8 ugers behandling med ledipasvir/sofosbuvir med eller uden ribavirin, og 12 ugers behandling med ledipasvir/sofosbuvir hos behandlingsnaive patienter uden cirrose med CHC forårsaget af infektion med HCV af genotype 1 CHC.
English: Contains lactose and sunset yellow FCF aluminium lake (E110).
Danish: Indeholder lactose og sunset yellow FCF aluminiumpigment (E110).
English: The group of NS5A RAVs that conferred > 100-fold shift and was observed in patients were the following substitutions in genotype 1a (M28A, Q30H/R/E, L31M/V/I, H58D, Y93H/N/C) or in genotype 1b (Y93H).
Danish: Gruppen af NS5A-RAVs, der gav >100 gange skift og som blev observeret hos patienterne, omfattede de følgende substitutioner i genotype 1a (M28A, Q30H/R/E, L31M/V/I, H58D, Y93H/N/C) eller i genotype 1b (Y93H).
English: Randomisation was stratified by the presence or absence of cirrhosis, HCV genotype (1a versus 1b) and response to prior HCV therapy (relapse/breakthrough versus non-response).
Danish: Randomisering blev stratificeret efter cirrose (til stede eller ikke til stede), HCV-genotype (1a versus 1b) og respons på tidligere HCV-behandling (recidiv/gennembrud versus non-respons).
English: Among patients with decompensated liver disease (pre- and posttransplant), 4/16 (25%) patients with NS5A RAVs conferring > 100-fold resistance relapsed after 12 weeks treatment with ledipasvir/sofosbuvir + ribavirin compared to 7/120 (6%) in those without any baseline NS5A RAVs or RAVs conferring a fold-change of ≤ 100.
Danish: Blandt patienter med dekompenseret leversygdom (før og efter transplantation) recidiverede 4/16 (25 %) patienter med NS5A RAV'er, der gav en > 100 gange større resistens efter 12 ugers behandling med ledipasvir/sofosbuvir + ribavirin sammenlignet med 7/120 (6 %) patienter uden baseline-NS5A RAV'er eller RAV'er, der gav en ≤ 100 gange større ændring.
English: ↑ Rosuvastatin (Inhibition of drug transporters OATP and BCRP)
Danish: (Hæmning af lægemiddeltransporterne OATP og BCRP)
English: Dosed 1 hr Before Dialysis
Danish: Doseret 1 time før dialyse
English: ↔ GS-331007 (Increase in gastric pH)
Danish: ↔ GS-331007 (Øget pH-værdi i maven)
English: Safety data are limited in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) and ESRD requiring haemodialysis.
Danish: Der foreligger begrænsede sikkerhedsdata hos patienter med svært nedsat nyrefunktion (estimeret glomerulær filtrationshastighed [eGFR] <30 ml/min/1,73 m2) og ESRD, der kræver hæmodialyse.
English: Study 0154 was an open-label clinical study that evaluated the safety and efficacy of 12 weeks of treatment with ledipasvir/sofosbuvir in 18 genotype 1 HCV-infected patients with severe renal impairment not requiring dialysis.
Danish: Studie 0154 var et ikke-blindet studie, der evaluerede sikkerheden og virkningen af 12 ugers behandling med ledipasvir/sofosbuvir hos 18 genotype 1 HCV-inficerede patienter med svært nedsat nyrefunktion, der ikke krævede dialyse.
English: Table 4: Ribavirin dose modification guideline for co-administration with Harvoni in adults Laboratory values
Danish: Tabel 4: Retningslinjer for dosismodifikation af ribavirin ved samtidig administration af Harvoni hos voksne
English: Change in MELD score: Among those who achieved SVR12 with 12 weeks treatment with ledipasvir/sofosbuvir + ribavirin, 57% (70/123) and 19% (23/123) had an improvement or no change in MELD score from baseline to post-treatment week 12, respectively; of the 32 patients whose MELD score was ≥ 15 at baseline, 59% (19/32) had a MELD score < 15 at post-treatment Week 12.
Danish: Ændring i MELD-score (model for end stage liver disease): Blandt dem, som opnåede SVR12 med 12 ugers behandling med ledipasvir/sofosbuvir + ribavirin, havde hhv. 57 % (70/123) og 19 % (23/123) en forbedring eller ingen ændring i MELD-score fra baseline til 12 uger efter behandling; af de 32 patienter, hvis MELD-score var ≥ 15 ved baseline, havde 59 % (19/32) en MELD-score < 15 ved uge 12 efter behandlingen.
English: Randomisation was stratified by the presence or absence of cirrhosis and HCV genotype (1a versus 1b).
Danish: Randomisering blev stratificeret efter cirrose (til stede eller ikke til stede) og HCV-genotype (1a versus 1b).
English: No dose adjustment of Harvoni or raltegravir is required.
Danish: Ingen dosisjustering af Harvoni eller raltegravir er nødvendig.
English: • carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures); • rosuvastatin (a medicine used to treat high cholesterol).
Danish: • carbamazepin, phenobarbital og phenytoin (medicin, der anvendes til at behandle epilepsi og forebygge krampeanfald)
English: There are presently no data to support the effectiveness of retreatment of patients who have failed ledipasvir/sofosbuvir with a subsequent regimen that contains an NS5A inhibitor.
Danish: Der er aktuelt ingen data, der støtter virkningen af genbehandling med et efterfølgende regime, som indholder en NS5A-hæmmer hos patienter, hvor ledipasvir/sofosbuvir har svigtet.
English: Missed dose
Danish: Manglende dosis
English: 12 weeks (n = 109)
Danish: 12 uger (n = 109)