FrancophonIA/ELRC3.0 huggingface dataset:
English: The potential risks and benefits associated with co-administration of Harvoni with the fixed-dose combination tablet containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or tenofovir disoproxil fumarate given in conjunction with a boosted HIV protease inhibitor (e.g. atazanavir or darunavir) should be considered, particularly in patients at increased risk of renal dysfunction.
Danish: De mulige risici og fordele forbundet med administration af Harvoni med fastdosis kombinationstabletter, der indeholder elvitegravir/cobicistat/emtricitabin/tenofovirdisoproxilfumarat eller tenofovirdisoproxilfumarat brugt sammen med en boostet hiv proteasehæmmer (f.eks. atazanavir eller darunavir) bør overvejes, især hos patienter med øget risiko for nyredysfunktion.
English: For the combination of tenofovir/emtricitabine + darunavir/ritonavir, please see below.
Danish: For kombinationen tenofovir/emtricitabin + darunavir/ritonavir, se nedenfor.
English: HCV/HIV co-infected adults - ION-4
Danish: Voksne med samtidig HCV/hiv-infektion - ION-4
English: Baseline HCV RNAa HCV RNA < 6 million IU/mL HCV RNA ≥ 6 million IU/mL
Danish: Køn Mand Kvinde IL28 genotype CC Non-CC Baseline HCV-rnaa HCV-rna <6 millioner IE/ml HCV-rna ≥6 millioner IE/ml
English: FibroTest-Determined Metavir scoreb F0-F1
Danish: IL28CC-genotype FibroTest-bestemt Metavir-scoreb F0-F1
English: Based on the population pharmacokinetic analysis in HCV-infected patients, geometric mean steady-state AUC0-24 for ledipasvir (n = 2,113), sofosbuvir (n = 1,542), and GS-331007 (n = 2,113) were 7,290, 1,320 and 12,000 ng•h/mL, respectively.
Danish: Baseret på den populationsfarmakokinetiske analyse hos HCV-inficerede patienter, var den geometriske gennemsnitlige steady-state AUC0-24 for ledipasvir (n = 2.113), sofosbuvir (n = 1.542) og GS-331007 (n = 2.113) hhv. 7.290, 1.320 og 12.000 ng•t/ml.
English: Table 16: Response rates in study ION-4
Danish: Tabel 16: Responsrater i studie ION-4
English: Safety and efficacy of ledipasvir/sofosbuvir have been established in patients with decompensated cirrhosis (see section 5.1).
Danish: Ledipasvir/sofosbuvirs sikkerhed og virkning er klarlagt hos patienter med dekompenseret cirrose (se pkt.
English: Among patients with a baseline HCV RNA < 6 million IU/mL, the SVR was 97% (119/123) with 8-week treatment of ledipasvir/sofosbuvir and 96% (126/131) with 12-week treatment of ledipasvir/sofosbuvir.
Danish: Blandt patienterne med baseline HCV-rna <6 millioner IE/ml var SVR 97 % (119/123) med 8-ugers behandling af ledipasvir/sofosbuvir, og 96 % (126/131) med 12-ugers behandling af ledipasvir/sofosbuvir.
English: Cases of severe bradycardia and heart block have been observed when Harvoni is used with amiodarone with or without other drugs that lower heart rate.
Danish: Der er iagttaget tilfælde af svær bradykardi og hjerteblok ved anvendelse af Harvoni med amiodaron med eller uden andre hjertefrekvenssænkende lægemidler.
English: Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis (including decompensated cirrhosis) had no clinically relevant effect on the exposure to ledipasvir.
Danish: Populationsfarmakokinetisk analyse hos HCV-inficerede patienter indikerer, at cirrose (inklusive dekompenseret cirrose) ikke havde nogen klinisk relevant virkning på eksponeringen for ledipasvir.
English: Table 2: Guidance for ribavirin dosing when administered with Harvoni to patients with decompensated cirrhosis
Danish: Tabel 2: Vejledning vedrørende dosering af ribavirin ved administration sammen med Harvoni til patienter med dekompenseret cirrose
English: LDV/SOF 12 weeks
Danish: LDV/SOF 12 uger
English: No new adverse drug reactions were detected among patients with decompensated cirrhosis and/or who were post-liver transplant and who received ledipasvir/sofosbuvir with ribavirin.
Danish: Der blev ikke detekteret nogen nye bivirkninger blandt patienter med dekompenseret cirrose og/eller patienter efter levertransplantation, som fik ledipasvir/sofosbuvir sammen med ribavirin.
English: Available pharmacokinetic data in animals has shown excretion of ledipasvir and metabolites of sofosbuvir in milk (see section 5.3).
Danish: De tilgængelige farmakokinetiske data fra dyrestudier viser, at ledipasvir og metabolitter fra sofosbuvir udskilles i mælk (se pkt.
English: No liver or heart findings were observed in chronic toxicity studies at exposures 5 times (rat) and 16 times (dog) higher than the clinical exposure.
Danish: Der blev ikke observeret nogen fund i lever og hjerte i kroniske toksicitetsstudier ved eksponeringer, der var 5 gange (rotter) og 16 gange (hunde) højere end den kliniske eksponering.
English: Of the 7 patients who failed to achieve SVR12, 3 relapsed, all had decompensated cirrhosis and were treated with ledipasvir/sofosbuvir + ribavirin for 12 weeks.
Danish: Af de 7 patienter, som ikke opnåede SVR12, recidiverede 3, som alle havde dekompenseret cirrose og blev behandlet med ledipasvir/sofosbuvir + ribavirin i 12 uger.
English: In non-cirrhotic patients relapses only occurred in the presence of baseline NS5A RAVs, and during therapy with ledipasvir/sofosbuvir without ribavirin.
Danish: Hos patienter uden cirrose forekom recidiv kun ved tilstedeværelse af baseline-NS5A-RAVs, og i løbet af behandling med ledipasvir/sofosbuvir uden ribavirin.
English: Adults with decompensated cirrhosis and/or who are awaiting liver transplant or post-liver transplant
Danish: Voksne med dekompenseret cirrose og/eller som venter på levertransplantation eller efter levertransplantation
English: At baseline, two patients had cirrhosis and the mean eGFR was 24.9 mL/min (range: 9.0-39.6).
Danish: Ved baseline havde to patienter cirrose, og den gennemsnitlige eGFR var 24,9 ml/min.
English: The 8-week treatment of ledipasvir/sofosbuvir without ribavirin was non-inferior to the 8-week treatment of ledipasvir/sofosbuvir with ribavirin (treatment difference 0.9%; 95% confidence interval: -3.9% to 5.7%) and the 12-week treatment of ledipasvir/sofosbuvir (treatment difference -2.3%; 97.5% confidence interval: -7.2% to 3.6%).
Danish: Den 8 ugers behandling af ledipasvir/sofosbuvir uden ribavirin var non-inferiør til den 8-ugers behandling af ledipasvir/sofosbuvir med ribavirin (behandlingsforskel 0,9 %, 95 % konfidensinterval: -3,9 % til 5,7 %) og den 12-ugers behandling med ledipasvir/sofosbuvir (behandlingsforskel -2,3 %, 97,5 % konfidensinterval: -7,2 % til 3,6 %).
English: Of the remaining 154 patients, a total of 149 achieved SVR12 across both treatment groups; 96% (74/77) of patients in the ledipasvir/sofosbuvir with ribavirin 12-week group and 97% (75/77) of patients in the ledipasvir/sofosbuvir 24-week group.
Danish: Af de resterende 154 patienter opnåede i alt 149 i de 2 behandlingsgrupper SVR12; 96 % (74/77) af patienterne i 12-ugers gruppen med ledipasvir/sofosbuvir sammen med ribavirin og 97 % (75/77) af patienterne i 24-ugers gruppen med ledipasvir/sofosbuvir.
English: A NS5B substitution E237G was detected in 3 patients (1 genotype 1b and 2 genotype 1a) in the Phase 3 studies (ION-3, ION-1 and ION-2) and 3 patients with genotype 1a infection in the SOLAR-1 and SOLAR-2 studies at the time of relapse.
Danish: En NS5B-substitution E237G blev detekteret hos 3 patienter (1 genotype 1b og 2 genotype 1a) i fase 3-studier (ION-3, ION-1 og ION-2), og hos 3 patienter med genotype 1a-infektion i studierne SOLAR-1 og SOLAR-2 på tidspunktet for recidiv.
English: No liver or heart findings were observed in the 2-year carcinogenicity studies at exposures 17 times (mouse) and 9 times (rat) higher than the clinical exposure.
Danish: Der blev ikke observeret nogen fund i lever og hjerte i de 2-års karcinogenicitetsstudier ved eksponeringer, der var 17 gange (mus) og 9 gange (rotter) højere end den kliniske eksponering.
English: This is so that:
Danish: Dette gøres så:
English: The pharmacokinetics of sofosbuvir were studied following 7-day dosing of 400 mg sofosbuvir in HCV-infected patients with moderate and severe hepatic impairment (CPT class B and C).
Danish: Sofosbuvirs farmakokinetik blev undersøgt efter 7 dages dosering med 400 mg sofosbuvir hos HCV-inficerede patienter med moderat og svært nedsat leverfunktion (CPT klasse B og C).
English: • amiodarone used to treat irregular heartbeats;
Danish: • amiodaron mod uregelmæssig hjerterytme;
English: Your doctor may give you a different medicine or adjust the dose of the medicine you are taking.
Danish: Din læge kan give dig et andet lægemiddel eller justere dosis af det lægemiddel, du tager.
English: The pharmacokinetics of sofosbuvir were studied in HCV negative patients with mild (eGFR ≥ 50 and < 80 mL/min/1.73 m2), moderate (eGFR ≥ 30 and < 50 mL/min/1.73 m2), severe renal impairment (eGFR < 30 mL/min/1.73 m2) and patients with ESRD requiring haemodialysis following a single 400 mg dose of sofosbuvir,relative to patients with normal renal function (eGFR > 80 mL/min/1.73 m2).
Danish: Sofosbuvirs farmakokinetik blev undersøgt hos HCV-negative patienter med let (eGFR ≥50 og <80 ml/min/1,73m2), moderat (eGFR ≥30 og <50 ml/min/1,73m2), svært nedsat nyrefunktion (eGFR <30 ml/min/1,73 m2) og patienter med ESRD, der krævede hæmodialyse efter en enkelt 400 mg dosis sofosbuvir i forhold til patienter med normal nyrefunktion (eGFR >80 ml/min/1,73 m2).
English: NS5A resistance-associated variants (RAVs) were observed in post-baseline isolates from 29/37 patients (22/29 genotype 1a and 7/8 genotype 1b) not achieving sustained virologic response (SVR).
Danish: NS5A-varianter, der forårsager resistens (resistance-associated variants, RAVs) blev observeret i isolater efter baseline fra 29/37 patienter (22/29 genotype 1a og 7/8 genotype 1b), der ikke opnåede vedvarende virologisk respons (sustained virologic response, SVR).
English: TOTAL (n = 647)
Danish: I ALT (n = 647)
English: TOTAL (n = 865)
Danish: I ALT (n = 865)
English: NS5A RAVs were seen at relapse in 5/5 patients (for genotype 1a: Q30R/H + L31M/V [n = 1] and Q30R [n = 1]; for genotype 1b: Y93H [n = 3]).
Danish: NS5A-RAVs blev set ved recidiv hos 5/5 patienter (for genotype 1a: Q30R/H + L31M/V [n = 1] og Q30R [n = 1]; for genotype 1b: Y93H [n = 3]).
English: For the combination of tenofovir/emtricitabine + atazanavir/ritonavir, please see below.
Danish: For kombinationen tenofovir/emtricitabin + atazanavir/ritonavir, se nedenfor.
English: Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analogue triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator.
Danish: Sofosbuvir er et nukleotid prodrug, der gennemgår intracellulær metabolisme og danner farmakologisk aktivt uridin-analog triphosphat (GS-461203), som kan indbygges i HCV-rna af NS5B-polymerasen og virke som en kædeterminator.
English: Co-administration with rosuvastatin (see section 4.5).
Danish: Samtidig administration med rosuvastatin (se pkt.
English: Do not take proton pump inhibitors before Harvoni.
Danish: Tag ikke protonpumpehæmmere før Harvoni.
English: The clinical data to support the use of Harvoni in adults infected with HCV genotype 2 and 6 are limited (see section 5.1).
Danish: De kliniske data, der støtter brug af Harvoni hos voksne inficeret med HCV-genotype 2 og 6, er begrænsede (se pkt.
English: In female rats, the mean number of corpora lutea and implantation sites were slightly reduced at maternal exposures 6-fold the exposure in humans at the recommended clinical dose.
Danish: Hos hunrotter var de gennemsnitlige antal corpora lutea og implantationssteder let reduceret ved maternal eksponering, der var 6 gange større end eksponeringen hos mennesker ved den anbefalede kliniske dosis.
English: Such co-administration is not recommended (see section 4.4).
Danish: En sådan samtidig administration bør ikke anvendes (se pkt.
English: Population pharmacokinetic analysis in HCV-infected patients showed that within the age range (18 to 80 years) analysed, age did not have a clinically relevant effect on the exposure to ledipasvir, sofosbuvir or GS-331007.
Danish: Populationsfarmakokinetisk analyse hos HCV-inficerede patienter viste, at inden for det analyserede aldersinterval (18 til 80 år), havde alder ingen klinisk relevant virkning på eksponeringen for ledipasvir, sofosbuvir eller GS-331007.
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Danish: Lactosemonohydrat Mikrokrystallinsk cellulose Croscarmellosenatrium Kolloid vandfri silica Magnesiumstearat
English: The pharmacokinetics of ledipasvir were studied with a single dose of 90 mg ledipasvir in HCV negative patients with severe hepatic impairment (CPT class C).
Danish: Ledipasvirs farmakokinetik blev undersøgt efter en enkelt dosis af 90 mg ledipasvir hos HCV-negative patienter med svært nedsat leverfunktion (CPT klasse C).
English: SIRIUS included patients with compensated cirrhosis who first failed therapy with pegylated interferon (PEG-IFN) + ribavirin, and then failed a regimen consisting of a pegylated interferon + ribavirin + an NS3/4A protease inhibitor.
Danish: SIRIUS inkluderede patienter med kompenseret cirrose, hvor behandling med pegyleret interferon (PEG-IFN) + ribavirin først svigtede, og hvor et regime bestående af et pegyleret interferon + ribavirin + en NS3/4A proteasehæmmer dernæst svigtede.
English: Ledipasvir was fully active against the sofosbuvir resistance-associated substitution S282T in NS5B while all ledipasvir resistance-associated substitutions in NS5A were fully susceptible to sofosbuvir.
Danish: Ledipasvir var fuldt aktiv over for substitutionen S282T i NS5B, som er forbundet med resistens over for sofosbuvir, mens alle substitutioner forbundet med resistens over for ledipasvir i NS5A var helt følsomme over for sofosbuvir.
English: All 5 patients who did not achieve SVR12 relapsed after having end-of-treatment response (see section “Resistance” - “In clinical studies” above).
Danish: Alle 5 patienter, der ikke opnåede SVR12, recidiverede, efter de havde et respons efter afslutning af behandlingen (se pkt.
English: The safety of tenofovir disoproxil fumarate in the setting of Harvoni and a pharmacokinetic enhancer has not been established.
Danish: Tenofovirdisoproxilfumarats sikkerhed ved anvendelse af Harvoni og en farmakokinetisk forstærker er ikke klarlagt.
English: Your doctor may need to give you a different medicine or adjust the dose of medicine you are taking.
Danish: Det kan være nødvendigt, at din læge giver dig et andet lægemiddel, eller justerer dosis af det lægemiddel, du tager.
English: Patients who are post-liver transplant without cirrhosis or with compensated cirrhosis
Danish: Patienter efter levertransplantation uden cirrose eller med kompenseret cirrose
English: The efficacy of ledipasvir/sofosbuvir in genotype 5 and genotype 6 HCV-infected patients with decompensated cirrhosis and/or who are awaiting liver transplant or post-liver transplant has not been investigated.
Danish: Ledipasvir/sofosbuvirs virkning er ikke blevet undersøgt hos HCV-genotype 5- og 6-inficerede patienter med dekompenseret cirrose, og/eller som venter på levertransplantation eller har gennemgået en levertransplantation.
English: Ledipasvir (90 mg once daily)
Danish: Ledipasvir (90 mg én gang dagligt)
English: • outer cartons containing 1 bottle of 28 film-coated tablets
Danish: • ydre kartoner indeholdende 1 tabletbeholder med 28 filmovertrukne tabletter
English: The efficacy of ledipasvir [LDV]/sofosbuvir [SOF] was evaluated in three open-label Phase 3 studies with data available for a total of 1,950 patients with genotype 1 CHC.
Danish: Virkningen af ledipasvir [LDV]/sofosbuvir [SOF] blev evalueret i tre åbne fase 3-studier med data tilgængelige hos i alt 1.950 patienter med CHC forårsaget af infektion med HCV af genotype 1.
English: d Lack of pharmacokinetics interaction bounds 70-143%.
Danish: d. Interval på 70-143 %, hvor der ikke opstår farmakokinetisk interaktion.
English: The pharmacokinetics of ledipasvir, sofosbuvir, and GS-331007 have not been established in paediatric patients aged < 12 years (see section 4.2).
Danish: Farmakokinetikken af ledipasvir, sofosbuvir og GS-331007 hos pædiatriske patienter i alderen < 12 år er ikke klarlagt (se pkt.
English: Antacids e.g. Aluminium or magnesium hydroxide; calcium carbonate
Danish: Antacida f.eks. Aluminium- eller magnesiumhydroxid, calciumcarbonat
English: Cardiac arrhythmias
Danish: Hjertearytmier
English: White
Danish: Hvid
English: What you need to know before you take Harvoni Do not take Harvoni
Danish: Det skal du vide, før du begynder at tage Harvoni Tag ikke Harvoni
English: Of the 8 genotype 1b patients who qualified for resistance testing, 7/8 (88%) harboured one or more NS5A RAVs at positions L31 and Y93 at failure, while 1/8 patients had no NS5A RAVs at failure.
Danish: Ud af de 8 genotype 1b-patienter, som kvalificerede for resistenstestning havde 7/8 (88 %) en eller flere NS5A-RAVs ved positionerne L31 og Y93 ved tidspunktet for svigt, mens 1/8 patienter ikke havde NS5A-RAVs, ved tidspunktet for svigt.
English: EC50 (K24G/N/R, M28A/G/T, Q30E/G/H/L/K/R/T, L31I/F/M/V, P32L, S38F, H58D, A92K/T, and Y93C/F/H/N/S for genotype 1a and L31I/F/M/V, P32L, P58D, A92K, and Y93C/H/N/S for genotype 1b HCV infection).
Danish: EC50 (K24G/N/R, M28A/G/T, Q30E/G/H/L/K/R/T, L31I/F/M/V, P32L, S38F, H58D, A92K/T og Y93C/F/H/N/S for genotype 1a HCV-infektion og L31I/F/M/V, P32L, P58D, A92K og Y93C/H/N/S for genotype 1b HCV-infektion).
English: therapy without cirrhosis, 26% (13/50) of patients were HIV antiretroviral naïve and 74% (37/50) of patients were receiving concomitant HIV antiretroviral therapy.
Danish: Alle patienter var behandlingsnaive med hensyn til HCV-behandling uden cirrose, 26 % (13/50) af patienterne var naive med hensyn til hiv-antiretrovirale midler, og 74 % (37/50) af patienterne fik samtidig antiretroviral behandling mod hiv.
English: Among the 8 patients who had no NS5A RAVs at failure, 7 patients received 8 weeks of treatment (n = 3 with ledipasvir/sofosbuvir; n = 4 with ledipasvir/sofosbuvir + ribavirin) and 1 patient received ledipasvir/sofosbuvir for 12 weeks.
Danish: Blandt de 8 patienter, som ikke havde NS5A-RAVs ved tidspunktet for svigt, fik 7 patienter 8 ugers behandling (n = 3 med ledipasvir/sofosbuvir, n = 4 med ledipasvir/sofosbuvir + ribavirin) og 1 patient fik ledipasvir/sofosbuvir i 12 uger.
English: Women of childbearing potential / contraception in males and females When Harvoni is used in combination with ribavirin, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients.
Danish: Når Harvoni anvendes i kombination med ribavirin, skal der udvises ekstrem forsigtighed, så graviditet undgås hos kvindelige patienter og hos mandlige patienters kvindelige partnere.
English: Table 3: Guidance for ribavirin dosing when administered with Harvoni to adolescents aged 12 to < 18 years.
Danish: Vejledning vedrørende dosering af ribavirin ved administration sammen med Harvoni til unge i alderen 12 til < 18 år.
English: The proportion of patients who permanently discontinued treatment due to adverse events was 0%, < 1% and 1% for patients receiving ledipasvir/sofosbuvir for 8, 12 and 24 weeks, respectively; and < 1%, 0%, and 2% for patients receiving ledipasvir/sofosbuvir + ribavirin combination therapy for 8, 12 and 24 weeks, respectively.
Danish: Andelen af patienter, som seponerede behandlingen permanent på grund af bivirkninger, var 0 %, <1 % og 1 % for patienter, som fik ledipasvir/sofosbuvir i hhv. 8, 12 og 24 uger, og <1 %, 0 % og 2 % for patienter, som fik kombinationsbehandling med ledipasvir/sofosbuvir + ribavirin i hhv. 8, 12 og 24 uger.
English: SEDATIVES/HYPNOTICS Midazolam (2.5 mg single dose)/ ledipasvir (90 mg single dose)
Danish: SEDATIVER/HYPNOTIKA Midazolam (2,5 mg enkeltdosis)/ ledipasvir (90 mg enkeltdosis)
English: b Non-missing FibroTest results are mapped to Metavir scores according to: 0-0.31 = F0-F1; 0.32-0.58 = F2; 0.59-1.00 = F3-F4.
Danish: b. Ikke manglende FibroTest-resultater blev kortlagt til Metavir-scores i henhold til: 0-0,31 = F0-F1, 0,32-0,58 = F2, 0,59-1,00 = F3-F4.
English: No dose adjustment of Harvoni or ciclosporin is required at initiation of co-administration.
Danish: Ingen dosisjustering af Harvoni eller ciclosporin er nødvendig ved påbegyndelse af samtidig administration.
English: Copovidone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate
Danish: Copovidon, lactosemonohydrat, mikrokrystallinsk cellulose, croscarmellosenatrium, kolloid vandfri silica, magnesiumstearat
English: ANTICONVULSANTS Phenobarbital Phenytoin
Danish: ANTIKONVULSIVA Phenytoin
English: When co-administered with Harvoni, a reduced dose of statins should be considered and careful monitoring for statin adverse reactions should be undertaken (see section 4.4).
Danish: Ved administration sammen med Harvoni skal en reduceret dosis af statiner overvejes, og der skal udføres en nøje overvågning for statinbivirkninger (se pkt.
English: Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV direct-acting antiviral treatment.
Danish: Patienter med diabetes kan opleve forbedret blodsukkerkontrol efter påbegyndelse af HCV-behandling med direkte virkende antivirale lægemidler, hvilket potentielt kan resultere i symptomatisk hypoglykæmi.
English: In this setting, exposure of sofosbuvir metabolite GS331007 is 20-fold increased, exceeding levels where adverse reactions have been observed in preclinical trials.
Danish: Eksponeringen for sofosbuvirs metabolit GS-331007 var i dette studie 20 gange højere, hvilket oversteg de niveauer, hvor der blev set bivirkninger i prækliniske forsøg.
English: In a pooled analysis of patients who received ledipasvir/sofosbuvir in Phase 3 studies (ION-3, ION-1 and ION-2), 37 patients (29 with genotype 1a and 8 with genotype 1b) qualified for resistance analysis due to virologic failure or early study drug discontinuation and having HCV RNA > 1,000 IU/mL.
Danish: I en samlet analyse af patienter, som fik ledipasvir/sofosbuvir i fase 3-studier (ION-3, ION-1 og ION-2), kvalificerede 37 patienter (29 med genotype 1a og 8 med genotype 1b) sig til resistensanalyse på grund af virologisk svigt eller tidlig seponering af studielægemidlet, samt at de havde HCV-rna >1.000 IE/ml.
English: The pharmacokinetics of ledipasvir, sofosbuvir, and GS-331007 were studied in HCV-infected patients with ESRD requiring dialysis treated with ledipasvir/sofosbuvir (n=94) for 8, 12, or 24 weeks, and compared to patients without renal impairment in the ledipasvir/sofosbuvir Phase 2/3 trials.
Danish: Farmakokinetikken af ledipasvir, sofosbuvir og GS-331007 blev undersøgt hos HCV-inficerede patienter med ESRD, der krævede dialyse, og som blev behandlet med ledipasvir/sofosbuvir (n=94) i 8, 12 eller 24 uger, og sammenlignet med patienter uden nedsat nyrefunktion i fase II-/III-studierne med ledipasvir/sofosbuvir.
English: In vitro resistance selection and cross-resistance studies indicate ledipasvir targets NS5A as its mode of action.
Danish: In vitro resistensudvælgelse og krydsresistensstudier indikerer, at ledipasvirs virkningsmåde er målrettet mod ledipasvir.
English: In HCV-infected patients with severe renal impairment treated with ledipasvir/sofosbuvir for 12 weeks (n = 18), the pharmacokinetics of ledipasvir, sofosbuvir, and GS-331007 were consistent with that observed in HCV negative patients with severe renal impairment.
Danish: Hos HCV-inficerede patienter med svært nedsat nyrefunktion, behandlet med ledipasvir/sofosbuvir i 12 uger (n=18), var farmakokinetiken for ledipasvir, sofosbuvir og GS-331007 i overensstemmelse med, hvad der blev observeret hos HCV-negative patienter med svært nedsat nyrefunktion.
English: For genotype 2, 4, 5 and 6 infection, therapy consisted of ledipasvir/sofosbuvir without ribavirin, given for 12 weeks (Table 18).
Danish: Ved genotype 2-, 4-, 5- og 6-infektion bestod behandlingen af ledipasvir/sofosbuvir uden ribavirin i 12 uger (tabel 18).