FrancophonIA/ELRC3.0 huggingface dataset:
English: Harvoni tablets are supplied in high density polyethylene (HDPE) bottles with a polypropylene child-resistant closure containing 28 film-coated tablets with a silica gel desiccant and polyester coil.
Danish: Harvoni tabletter leveres i tabletbeholdere af højdensitets polyethylen (HDPE) med et børnesikret lukke af polypropylen, som indeholder 28 filmovertrukne tabletter med et tørremiddel af silicagel og en vatspiral af polyester.
English: When ribavirin is added to Harvoni, refer also to the Summary of Product Characteristics of ribavirin.
Danish: Når ribavirin føjes til Harvoni, henvises også til produktresuméet for ribavirin.
English: The safety and efficacy of Harvoni in paediatric patients aged < 12 years have not been established.
Danish: Havonis sikkerhed og virkning hos pædiatriske patienter i alderen < 12 år er ikke klarlagt.
English: Ledipasvir solubility decreases as pH increases.
Danish: Opløseligheden af ledipasvir nedsættes, når pH øges.
English: The E237G substitution showed a 1.3-fold reduction in susceptibility to sofosbuvir in the genotype 1a replicon assay.
Danish: E237G-substitutionen viste en 1,3 gange nedsat følsomhed over for sofosbuvir i genotype 1a-replikonanalysen.
English: The following pack sizes are available: outer cartons containing 1 bottle of 28 film-coated tablets and outer cartons containing 84 (3 bottles of 28) film-coated tablets.
Danish: De følgende pakningsstørrelser er tilgængelige: ydre kartoner indeholdende 1 tabletbeholder med 28 filmovertrukne tabletter, og ydre kartoner indeholdende 84 (3 tabletbeholdere med 28) filmovertrukne tabletter.
English: Decreases in haemoglobin to < 10 g/dL and < 8.5 g/dL during treatment were experienced by 39% and 13% of patients treated with ledipasvir/sofosbuvir with ribavirin, respectively.
Danish: Reduktion i hæmoglobin til <10 g/dl og <8,5 g/dl i løbet af behandlingen blev oplevet hos hhv. 39 % og 13 % af patienterne i behandling med ledipasvir/sofosbuvir sammen med ribavirin.
English: Starting dose of 600 mg, which can be titrated up to a maximum of 1,000/1,200 mg (1,000 mg for patients weighing < 75 kg and 1,200 mg for patients weighing ≥ 75 kg) if well tolerated.
Danish: Startdosis på 600 mg, som kan optitreres til maksimum 1.000/1.200 mg (1.000 mg til patienter, som vejer < 75 kg, og 1.200 mg til patienter, som vejer ≥ 75 kg), hvis den er veltolereret.
English: Sofosbuvir is extensively metabolised in the liver to form the pharmacologically active nucleoside analogue triphosphate GS-461203.
Danish: Sofosbuvir metaboliseres i udbredt grad i leveren, så der dannes den farmakologisk aktive nukleosidanalog triphosphat GS-461203.
English: • antacids (such as aluminium/magnesium hydroxide or calcium carbonate).
Danish: • syreneutraliserende midler (såsom aluminium/magnesiumhydroxid eller calciumcarbonat).
English: Table 20: Effect of Varying Degrees of Renal Impairment on Exposures (AUC) of Sofosbuvir, GS-331007, and Ledipasvir Compared to Subjects with Normal Renal Function
Danish: Tabel 20: Virkningen af forskellige grader af nedsat nyrefunktion (RI) på eksponeringer (AUC) for sofosbuvir, GS-331007 og ledipasvir sammenlignet med forsøgspersoner med normal nyrefunktion
English: Among the patients who had decompensated cirrhosis (pre- or post-transplant), 64% and 36% were CPT class B and C at screening, respectively, 24% had a baseline Model for End Stage Liver Disease (MELD) score greater than 15.
Danish: Blandt patienterne, som havde dekompenseret cirrose (før eller efter transplantation), var hhv. 64 % og 36 % CPT klasse B og C ved screening, 24 % havde en baseline MELD-score (model for end stage liver disease) på over 15.
English: Relative to patients with normal hepatic function, the sofosbuvir AUC0-24 was 126% and 143% higher in moderate and severe hepatic impairment, while the GS-331007 AUC0-24 was 18% and 9% higher, respectively.
Danish: I forhold til patienter med normal leverfunktion var sofosbuvir AUC0-24 126 % og 143 % højere ved moderat og svært nedsat leverfunktion, mens GS-331007 AUC0-24 var hhv. 18 % og 9 % højere.
English: Harvoni has been shown to increase tenofovir exposure, especially when used together with an HIV regimen containing tenofovir disoproxil fumarate and a pharmacokinetic enhancer (ritonavir or cobicistat).
Danish: Harvoni har vist sig at øge tenofovireksponeringen, især når det bruges sammen med et hiv-regimen, der indeholder tenofovirdisoproxilfumarat og en farmakokinetisk forstærker (ritonavir eller cobicistat).
English: The median terminal half-lives of sofosbuvir and GS-331007 following administration of ledipasvir/sofosbuvir were 0.5 and 27 hours, respectively.
Danish: Den mediane terminale halveringstider for sofosbuvir og GS-331007 efter administration af ledipasvir/sofosbuvir var hhv. 0,5 og 27 timer.
English: The NS5A substitution Y93C emerged in the HCV of 1 patient (genotype 4), while NS5A RAVs present at baseline were observed at the time of failure in all patients.
Danish: NS5A-substitutionen Y93C opstod i HCV hos 1 patient (genotype 4), mens NS5A-RAVs, som var til stede ved baseline, blev observeret på tidspunktet for svigt hos samtlige patienter.
English: Patients should be instructed that if vomiting occurs within 5 hours of dosing an additional tablet should be taken.
Danish: Patienterne skal instrueres i at tage en ekstra tablet, hvis de kaster op inden for 5 timer efter dosering.
English: Impact of DAA therapy on drugs metabolized by the liver
Danish: DAA-behandlings indvirkning på lægemidler, der metaboliseres i leveren
English: 84 (3 bottles of 28) film-coated tablets.
Danish: 84 (3 tabletbeholdere med 28) filmovertrukne tabletter.
English: a Mean ratio (90% CI) of co-administered drug pharmacokinetics of study medicinal products alone or in combination.
Danish: Det gennemsnitlige forhold (90 % KI) af farmakokinetiske parametre for lægemidler, der administreres sammen med én type forsøgsmedicin alene eller i kombination med begge typer forsøgsmedicin.
English: If you forget to take Harvoni
Danish: Hvis du har glemt at tage Harvoni
English: Potential for Harvoni to affect other medicinal products Ledipasvir is an in vitro inhibitor of drug transporter P-gp and breast cancer resistance protein (BCRP) and may increase intestinal absorption of co-administered substrates for these transporters.
Danish: Harvonis potentiale for at påvirke andre lægemidler Ledipasvir er en in vitro-hæmmer af lægemiddeltransporteren P-gp og brystcancer-resistent protein (BCRP), og kan øge tarmabsorptionen af samtidigt administrerede substrater for disse transportere.
English: In clinical studies - Adults-Genotype 2, 3, 4, 5 and 6
Danish: I kliniske studier - Voksne - genotype 2, 3, 4, 5 og 6
English: Contents of the pack and other information What Harvoni contains
Danish: Pakningsstørrelser og yderligere oplysninger Harvoni indeholder:
English: Ledipasvir, sofosbuvir, and GS-331007 exposures in adolescents aged 12 to < 18 years were similar to those in adults from Phase 2/3 studies, following administration of ledipasvir/sofosbuvir (90 mg/400 mg).
Danish: Ledipasvir, sofosbuvir og GS-331007 eksponering hos unge i alderen 12 til < 18 år var lig med den hos voksne fra fase 2/3 studierne efter administrering af ledipasvir/sofosbuvir (90 mg/400 mg).
English: Refer to the Summary of Product Characteristics for ribavirin for additional information.
Danish: Se produktresuméet for ribavirin for yderligere information.
English: f Staggered administration (12 hours apart) of atazanavir/ritonavir + emtricitabine/tenofovir disoproxil fumarate or darunavir/ritonavir + emtricitabine/tenofovir disoproxil fumarate and Harvoni provided similar results.
Danish: f. Adskilt administration (med 12 timers mellemrum) af atazanavir/ritonavir + emtricitabin/tenofovirdisoproxilfumarat eller darunavir/ritonavir + emtricitabin/tenofovirdisoproxilfumarat og Harvoni gav lignende resultater.
English: Patients in the latter treatment arm received placebo (for ledipasvir/sofosbuvir and ribavirin) during the first 12 weeks, followed by active blinded therapy during the subsequent 12 weeks.
Danish: Patienter i den sidstnævnte behandlingsarm fik placebo (for ledipasvir/sofosbuvir og ribavirin) i de første 12 uger, efterfulgt af aktiv blindet behandling i de efterfølgende 12 uger.
English: HCV/HBV (hepatitis B virus) co-infection
Danish: Samtidig infektion med HCV/HBV (hepatitis B-virus)
English: You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Harvoni.
Danish: Det kan være, at dit blodsukker skal overvåges tættere, og/eller at din diabetesmedicin skal justeres efter påbegyndelse af behandling med Harvoni.
English: Similarly, there are presently no data to support the effectiveness of NS3/4A protease inhibitors in patients who previously failed prior therapy that included an NS3/4A protease inhibitor.
Danish: På samme måde er der aktuelt ingen data, der støtter virkningen af NS3/4A-proteasehæmmere hos patienter, hvor tidligere behandling, der omfattede en NS3/4A-proteasehæmmer, svigtede.
English: Following a single dose of 90 mg [14C]-ledipasvir, systemic exposure was almost exclusively due to the parent drug (> 98%).
Danish: Efter en enkelt dosis på 90 mg [14C]-ledipasvir, skyldtes den systemiske eksponering næsten udelukkende udgangsstoffet (>98 %).
English: Site-directed mutagenesis of the Y93H substitution in both genotype 1a and 1b as well as the Q30R and L31M substitution in genotype 1a conferred high levels of reduced susceptibility to ledipasvir (fold-change in EC50 ranging from 544-fold to 1,677-fold).
Danish: Site-directed mutagenese af Y93H-substitutionen i både genotype 1a og 1b samt Q30R- og L31M-substitutionen i genotype 1a tildelte høje niveauer af nedsat følsomhed over for ledipasvir (interval på 544 til 1.677 gange større ændring i EC50).
English: Following a single 400 mg oral dose of [14C]-sofosbuvir, mean total recovery of the dose was greater than 92%, consisting of approximately 80%, 14%, and 2.5% recovered in urine, faeces, and expired air, respectively.
Danish: Efter en enkelt 400 mg oral dosis af [14C]-sofosbuvir, var den gennemsnitlige totale genfinding af dosis over 92 %, og bestod af ca. 80 %, 14 % og 2,5 %, som blev genfundet i hhv. urin, fæces og udåndingsluft.
English: - Harvoni for 8 weeks may be considered in previously untreated genotype 1-infected patients (see section 5.1, ION-3 study).
Danish: - Harvoni i 8 uger kan overvejes hos tidligere ubehandlede genotype 1-inficerede patienter (se pkt.
English: • oxcarbazepine (a medicine used to treat epilepsy and prevent seizures);
Danish: • oxcarbazepin (medicin, der anvendes til at behandle epilepsi og forebygge krampeanfald);
English: B For ribavirin dosing recommendations in patients with decompensated cirrhosis, see table 2 below.
Danish: B For anbefalinger vedrørende dosering af ribavirin til patienter med dekompenseret cirrose, se tabel 2 herunder.
English: HCV-Infected Subjects
Danish: HCV-inficerede forsøgspersoner
English: In repeat dose toxicology studies in rat and dog, high doses of the 1:1 diastereomeric mixture caused adverse liver (dog) and heart (rat) effects and gastrointestinal reactions (dog).
Danish: I toksikologiske studier med gentagne doser hos rotter og hunde, forårsagede høje doser af den 1:1 diastereomere blanding bivirkninger i leveren (hunde) og hjertet (rotter) samt i mave-tarm-kanalen (hunde).
English: In clinical studies, fatigue and headache were more common in patients treated with ledipasvir/sofosbuvir compared to placebo.
Danish: I kliniske studier var træthed og hovedpine mere almindelige hos patienter i behandling med ledipasvir/sofosbuvir, sammenlignet med placebo.
English: Neither ledipasvir nor sofosbuvir are substrates for hepatic uptake transporters, organic cation transporter (OCT) 1, organic anion-transporting polypeptide (OATP) 1B1 or OATP1B3.
Danish: Hverken ledipasvir eller sofosbuvir er substrater for leveroptagelsestransporterne, organisk kationtransporter (OCT) 1, organisk aniontransporterende polypeptid (OATP) 1B1 eller OATP1B3.
English: Adults-Genotype 1
Danish: Voksne - genotype 1
English: For genotype 3 infection, ledipasvir/sofosbuvir was given with or without ribavirin, also for 12 weeks (Table 19).
Danish: Ved genotype 3-infektion blev ledipasvir/sofosbuvir givet med eller uden ribavirin, også i 12 uger (tabel 19).
English: Ribavirin Dose* 15 mg/kg/day 600 mg/day 800 mg/day 1000 mg/day
Danish: 15 mg/kg/dag 600 mg/dag 800 mg/dag 1000 mg/dag
English: In genotype 3 infected patients experiencing virologic failure, development of NS5A RAVs (including enrichment of RAVs present at baseline) was typically not detected at the time of failure (n = 17).
Danish: Hos genotype 3-inficerede patienter, der oplevede virologisk svigt, blev udvikling af NS5A-RAVs (herunder forøgelse af RAVs, som var til stede ved baseline) typisk ikke detekteret på tidspunktet for svigt (n = 17).
English: Sofosbuvir had no effects on embryo-foetal viability or on fertility in rat and was not teratogenic in rat and rabbit development studies.
Danish: Sofosbuvir havde ingen virkning på embryo-føtal levedygtighed eller på fertilitet hos rotter, og det var ikke teratogent i udviklingsstudier med rotter og kaniner.
English: - Harvoni (without ribavirin) for 12 weeks may be considered for patients deemed at low risk for clinical disease progression and who have subsequent retreatment options (see section 4.4).
Danish: - Harvoni (uden ribavirin) i 12 uger kan overvejes for patienter, der bedømmes til at have en lav risiko for klinisk sygdomsprogression, og som har efterfølgende muligheder for genbehandling (se pkt.
English: Clinical monitoring, looking for signs of bleeding and anaemia, is recommended when dabigatran etexilate is co-administered with Harvoni.
Danish: Klinisk overvågning, med overvågning af tegn på blødning og anæmi anbefales, når dabigatranetexilat administreres sammen med Harvoni.
English: Sofosbuvir and GS-331007 are not inhibitors or inducers of CYP or uridine diphosphate glucuronosyltransferase (UGT) 1A1 enzymes.
Danish: Sofosbuvir og GS-331007 er ikke hæmmere eller inducere af CYP eller uridindiphosphatglucuronosyltransferase (UGT) 1A1-enzymer.
English: Table 17: Combined response rates (SVR12) in studies SOLAR-1 and SOLAR-2 LDV/SOF+RBV 12 weeks (n = 307)a,b
Danish: Tabel 17: Kombinerede responsrater (SVR12) i studierne SOLAR-1 og SOLAR-2 LDV/SOF+RBV 12 uger (n = 307)a,b
English: Reduced susceptibility to sofosbuvir was associated with the primary NS5B substitution S282T in all replicon genotypes examined.
Danish: Nedsat følsomhed over for sofosbuvir var forbundet med den primære NS5B-substitution S282T i alle de undersøgte replikon-genotyper.
English: Ledipasvir/sofosbuvir was administered for 12 weeks to 18 patients with genotype 1 CHC and severe renal impairment in an open-label study (Study 0154).
Danish: Ledipasvir/sofosbuvir blev administreret i 12 uger hos 18 patienter med genotype 1 CHC og svært nedsat nyrefunktion i et åbent studie (Studie 0154).
English: The SVR rates for the 8, 12, and 24 week ledipasvir/sofosbuvir treatment groups were 93% (42/45), 100% (31/31), and 79% (15/19), respectively.
Danish: SVR-raterne for grupperne, som fik 8, 12 og 24 ugers behandling med ledipasvir/sofosbuvir, var henholdsvis 93 % (42/45), 100 % (31/31) og 79 % (15/19).
English: No adverse effects on behaviour, reproduction or development of offspring in rat were reported.
Danish: Ingen afvigende virkning blev rapporteret på adfærd, reproduktion eller afkommets udvikling hos rotter.
English: Ledipasvir had no adverse effects on mating and fertility.
Danish: Ledipasvir havde ingen bivirkninger på parring og fertilitet.
English: Use with moderate P-gp inducers
Danish: Samtidig brug med moderate P-gp-inducere
English: Proton pump inhibitors should not be taken before Harvoni.
Danish: Protonpumpehæmmere må ikke tages før Harvoni.
English: Steady-state Cmax for ledipasvir, sofosbuvir and GS-331007 were 323, 618 and 707 ng/mL, respectively.
Danish: Steady-state Cmax for ledipasvir, sofosbuvir og GS-331007 var hhv. 323, 618 og 707 ng/ml.
English: Harvoni 90 mg/400 mg film-coated tablets
Danish: Harvoni 90 mg/400 mg filmovertrukne tabletter
English: ↔ GS-331007 (Induction of P-gp)
Danish: ↔ GS-331007 (Induktion af P-gp)
English: HCV-Negative Subjects
Danish: HCV-negative forsøgspersoner
English: The pharmacokinetics of drugs that are metabolized by the liver (e.g. immunosuppressive agents such as calcineurin inhibitors) may be impacted by changes in liver function during DAA therapy, related to clearance of HCV virus.
Danish: Farmakokinetikken hos lægemidler, der metaboliseres i leveren (f.eks. immunsuppressive stoffer såsom calcineurinhæmmere), kan påvirkes af ændringer i leverfunktionen under DAA-behandling, relateret til clearance af HCV-virus.
English: Presence of baseline NS5A resistance-associated substitutionsc No
Danish: Tilstedeværelse af NS5A-substitution ved baseline forbundet med resistensc Nej
English: Ledipasvir is a HCV inhibitor targeting the HCV NS5A protein, which is essential for both RNA replication and the assembly of HCV virions.
Danish: Ledipasvir er en HCV-hæmmer, der er målrettet mod HCV NS5A-protein, som er essentiel for både rna-replikation og samlingen af HCV-virioner.
English: Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication.
Danish: Sofosbuvir er en pan-genotypisk hæmmer af HCV NS5B rna-afhængig rna-polymerase, som er essentiel for viral replikation.
English: - Harvoni (without ribavirin) for 12 weeks (in patients without cirrhosis) or 24 weeks (in patients with cirrhosis) may be considered for patients who are ineligible for or intolerant to ribavirin.
Danish: - Harvoni (uden ribavirin) i 12 uger (hos patienter uden cirrose) eller i 24 uger (hos patienter med cirrose) kan overvejes for patienter, der ikke er egnede til eller er intolerante over for ribavirin.
English: Table 19: Response rates (SVR12) in patients with genotype 3 infection (ELECTRON-2) LDV/SOF+RBV 12 weeks
Danish: Tabel 19: Responsrater (SVR12) hos patienter with genotype 3-infektion (ELECTRON-2) LDV/SOF+RBV 12 uger
English: In the SIRIUS study (see “Clinical efficacy and safety”, below) 5 patients with genotype 1 infection relapsed after treatment with ledipasvir/sofosbuvir with or without ribavirin.
Danish: I SIRIUS-studiet (se ”Klinisk virkning og sikkerhed” nedenfor) recidiverede 5 patienter med genotype 1-infektion efter behandling med ledipasvir/sofosbuvir sammen med eller uden ribavirin.
English: The EC50 values of ledipasvir and sofosbuvir against full-length or chimeric replicons encoding NS5A and NS5B sequences from clinical isolates are detailed in Table 7.
Danish: EC50-værdier af ledipasvir og sofosbuvir mod fuld længde eller kimære replikoner, der koder NS5A- og NS5B-sekvenser fra kliniske isolater er beskrevet i tabel 7.
English: Demographics and baseline characteristics were balanced across the two treatment groups.
Danish: Demografi og baselinekarakteristika var afbalanceret i de to behandlingsgrupper.
English: Patients were stratified by HCV genotype (1a versus 1b) and prior treatment response (whether HCV RNA < LLOQ had been achieved).
Danish: Patienterne blev stratificeret pr. HCV-genotype (1a versus 1b) og tidligere behandlingsrespons (om HCV-rna <LLOQ var nået).
English: If ribavirin is co-administered with Harvoni, the contraindications regarding use of ribavirin during pregnancy and breast-feeding apply (see also the Summary of Product Characteristics for ribavirin).
Danish: Hvis ribavirin administreres samtidig med Harvoni, træder kontraindikationerne vedrørende anvendelse af ribavirin under graviditeten og amningen i kraft (se også produktresuméet for ribavirin).
English: Harvoni 90 mg/400 mg film-coated tablets ledipasvir/sofosbuvir
Danish: Harvoni 90 mg/400 mg filmovertrukne tabletter ledipasvir/sofosbuvir
English: The pharmacokinetics of ledipasvir were studied with a single dose of 90 mg ledipasvir in HCV negative patients with severe renal impairment (eGFR < 30 mL/min by Cockcroft-Gault, median [range] CrCl 22 [17-29] mL/min).
Danish: Ledipasvirs farmakokinetik blev undersøgt med en enkelt dosis af 90 mg ledipasvir hos HCV-negative patienter med svært nedsat nyrefunktion (eGFR <30 ml/min ved Cockcroft-Gault, median [interval] CrCl 22 [17-29] ml/min).
English: Lopinavir boosted with ritonavir + emtricitabine/ tenofovir disoproxil fumarate
Danish: Lopinavir boostet med ritonavir + emtricitabin/ tenofovirdisoproxilfumarat
English: In phenotypic analyses, post-baseline isolates from patients who harboured NS5A RAVs at failure showed 20- to at least a 243-fold (the highest dose tested) reduced susceptibility to ledipasvir.
Danish: I fænotype-analyser viste isolater efter baseline fra patienter, som havde NS5A-RAVs ved tidspunktet for svigt, 20- til mindst 243 gange (den højest testede dosis) nedsat følsomhed over for ledipasvir.
English: No target organs of toxicity were identified in rat and dog studies with ledipasvir at AUC exposures approximately 7 times the human exposure at the recommended clinical dose.
Danish: Der blev ikke identificeret nogen målorganer af toksicitet i studier med ledipasvir hos rotter og hunde ved AUC-eksponeringer, der var ca. 7 gange den humane eksponering ved den anbefalede kliniske dosis.
English: The study (double-blind and placebo-controlled) evaluated 24 weeks of treatment ledipasvir/sofosbuvir (with ribavirin placebo) versus 12 weeks of treatment with ledipasvir/sofosbuvir with ribavirin.
Danish: Studiet (dobbeltblindet og placebokontrolleret) evaluerede 24 ugers behandling med ledipasvir/sofosbuvir (sammen med ribavirin - placebo) versus 12 ugers behandling med ledipasvir/sofosbuvir sammen med ribavirin.
English: Outcome for patients without SVR On-treatment virologic failure Relapseb Otherc SVR rates for selected subgroups Patients with cirrhosis Previously treated patients with cirrhosis a 8 patients with genotype 4 HCV infection were enrolled in the study with 8/8 achieving SVR12.
Danish: Resultat for patienter uden SVR Virologisk svigt under behandling Recidivb Andetc SVR-rater for udvalgte undergrupper Patienter med cirrose Tidligere behandlede patienter med cirrose a. 8 patienter med genotype 4 HCV-infektion indgik i studiet, og 8/8 opnåede SVR12.
English: The safety profile of ledipasvir/sofosbuvir with ribavirin for 12 or 24 weeks in adults with decompensated liver disease and/or those post-liver transplant was assessed in two open-label studies (SOLAR-1 and SOLAR-2).
Danish: Sikkerhedsprofilen for ledipasvir/sofosbuvir sammen med ribavirin i 12 eller 24 uger hos voksne med dekompenseret leversygdom og/eller patienter efter levertransplantation blev vurderet i to åbne studier (SOLAR-1 og SOLAR-2).
English: Haemodialysis can efficiently remove the predominant circulating metabolite of sofosbuvir, GS-331007, with an extraction ratio of 53%.
Danish: Hæmodialyse er effektivt til at fjerne den dominerende cirkulerende metabolit fra sofosbuvir, GS-331007, med et ekstraktionsforhold på 53 %.
English: In this limited clinical safety data set, the rate of adverse events was not clearly elevated from what is expected in patients with severe renal impairment.
Danish: I dette begrænsede kliniske datasæt var hyppigheden af bivirkninger ikke tydeligt øget i forhold til forventningen for patienter med svært nedsat nyrefunktion.
English: Table 18: Response rates (SVR12) with ledipasvir/sofosbuvir for 12 weeks in patients with genotype 2, 4, 5 and 6 HCV infection
Danish: Tabel 18: Responsrater (SVR12) med ledipasvir/sofosbuvir i 12 uger hos patienter med genotype 2-, 4-, 5og 6-HCV-infektion.
English: However, the NS5B S282T substitution in combination with NS5A substitutions L31M, Y93H and Q30L were detected in one patient at failure following 8 weeks of treatment with ledipasvir/sofosbuvir from a Phase 2 study (LONESTAR).
Danish: NS5B S282T-substitutionen i kombination med NS5A-substitutionerne L31M, Y93H og Q30L blev imidlertid detekteret hos en patient ved tidspunktet for svigt efter 8 ugers behandling med ledipasvir/sofosbuvir fra et fase 2-studie (LONESTAR).