FrancophonIA/ELRC3.0 huggingface dataset:
English: If the starting dose is well-tolerated, the dose can be titrated up to a maximum of 1,000-1,200 mg daily (1,000 mg for patients weighing < 75 kg and 1,200 mg for patients weighing ≥ 75 kg).
Danish: Hvis startdosis er veltolereret, kan dosis titreres op til et maksimum på 1.000-1.200 mg dagligt (1.000 mg for patienter, der vejer <75 kg og 1.200 mg for patienter, der vejer ≥75 kg).
English: These should be taken at the same time as Harvoni.
Danish: De bør tages på samme tidspunkt som Harvoni.
English: f. One patient who achieved a viral load < LLOQ at end of treatment had missing baseline NS5A data and was excluded from the analysis.
Danish: f. En patient, der opnåede en viral belastning < LLOQ ved behandlingens afslutning, havde manglende NS5A-data ved baseline, og var ekskluderet fra analysen.
English: Animal studies do not indicate direct harmful effects with respect to reproductive toxicity.
Danish: Dyreforsøg indikerer ingen direkte skadelige virkninger hvad angår reproduktionstoksicitet.
English: Use with potent P-gp inducers
Danish: Brug sammen med potente P-gp-inducere
English: Dose modification of ribavirin in patients taking 1,000-1,200 mg daily If Harvoni is used in combination with ribavirin and a patient has a serious adverse reaction potentially related to ribavirin, the ribavirin dose should be modified or discontinued, if appropriate, until the adverse reaction abates or decreases in severity.
Danish: Dosismodifikation af ribavirin hos patienter, der tager 1.000-1.200 mg dagligt Hvis Harvoni anvendes i kombination med ribavirin og en patient har en alvorlig bivirkning, som muligvis er relateret til ribavirin, skal dosis af ribavirin modificeres eller seponeres, hvis det er hensigtsmæssigt, indtil bivirkningen svinder eller reduceres i sværhedsgrad.
English: Table 5: Activity of ledipasvir and sofosbuvir against chimeric replicons Genotype replicons
Danish: Tabel 5: Aktiviteten af ledipasvir og sofosbuvir mod kimere replikoner Replikonergenotype
English: d. Metavir score = 4 or Ishak score ≥ 5 by liver biopsy, or FibroTest score of > 0.75 and (APRI) of > 2.
Danish: d. Metavir-score = 4 eller Ishak-score ≥5 ved leverbiopsi, eller FibroTest-score på >0,75 og (APRI) på >2.
English: Famotidine dosed 12 hours prior to Harvonid
Danish: Famotidin doseret 12 timer før Harvoni d
English: Tell your doctor or pharmacist if you are taking any of the medicines below:
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du tager nogle af lægemidlerne nedenfor:
English: a. HCV RNA values were determined using the Roche TaqMan Assay; a patient's HCV RNA may vary from visit to visit.
Danish: a. HCV-rna-værdier blev bestemt ved hjælp af Roche TaqMan-analysen, en patients HCV-rna kan variere fra besøg til besøg.
English: Lansoprazole e
Danish: Lansoprazol e
English: Seven patient populations are being evaluated (patients with decompensated cirrhosis [CPT B and C] pre-transplant; post-transplant, no cirrhosis; post-transplant CPT A; post-transplant CPT B; post-transplant CPT C; post-transplant fibrosing cholestatic hepatitis [FCH]).
Danish: Syv patientpopulationer evalueres (patienter med dekompenseret cirrose [CPT B og C] før transplantation, efter transplantation ingen cirrose, efter transplantation CPT A, efter transplantation CPT B, efter transplantation CPT C, efter transplantation fibroserende kolestatisk hepatitis [FCH]).
English: Ledipasvir was not carcinogenic in the 6-month rasH2 transgenic mouse study at exposures up to 26-fold higher than human exposure.
Danish: Ledipasvir var ikke karcinogent i et 6-måneders studie med rasH2 transgene muse ved eksponeringer op til 26 gange den humane eksponering.
English: Further data include a double-blind comparison of the safety of ledipasvir/sofosbuvir (12 weeks) and placebo in 155 cirrhotic patients (see section 5.1).
Danish: Yderligere data omfatter en dobbeltblindet sammenligning af sikkerheden af ledipasvir/sofosbuvir (12 uger) og placebo hos 155 patienter med cirrose (se pkt.
English: Concentrations of ledipasvir, sofosbuvir and simeprevir are increased when simeprevir is co-administered with Harvoni.
Danish: Koncentrationerne af ledipasvir, sofosbuvir og simeprevir er øget, når simeprevir administreres samtidigt med Harvoni.
English: Sofosbuvir and GS-331007 AUC0-24 and Cmax were similar in healthy adult subjects and patients with HCV infection.
Danish: Sofosbuvir og GS-331007 AUC0-24 og Cmax var sammenlignelige hos raske voksnepersoner, samt hos patienter med HCV-infektion.
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: Compounds that are substrates of these enzymes may have decreased plasma concentrations when co-administered with ledipasvir/sofosbuvir.
Danish: Stoffer, der er substrater for disse enzymer, kan have nedsatte plasmakoncentrationer ved samtidig administration af ledipasvir/sofosbuvir.
English: The safety and efficacy of Harvoni in children and adolescents aged less than 18 years have not yet been established.
Danish: Harvonis sikkerhed og virkning hos børn og unge i alderen under 18 år er endnu ikke klarlagt.
English: • digoxin used to treat heart conditions;
Danish: • digoxin, anvendes til at behandle hjertesygdomme
English: The use of Harvoni in children and adolescents has not yet been studied.
Danish: Anvendelsen af Harvoni hos børn og unge er endnu ikke undersøgt.
English: In clinical studies - Genotype 2, 3, 4, 5 and 6
Danish: I kliniske studier - genotype 2, 3, 4, 5 og 6
English: Harvoni + ribavirin for 12 weeks or
Danish: Harvoni + ribavirin i 12 uger eller
English: The European Medicines Agency has deferred the obligation to submit the results of studies with ledipasvir/sofosbuvir in one or more subsets of the paediatric population in the treatment of chronic hepatitis C (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med ledipasvir/sofosbuvir i en eller flere undergrupper af den pædiatriske population ved behandling af kronisk hepatitis C (se pkt.
English: Animal studies do not indicate harmful effects of ledipasvir or sofosbuvir on fertility.
Danish: Dyreforsøg indikerer ingen skadelige virkninger af ledipasvir eller sofosbuvir på fertiliteten.
English: b. The chimeric replicons carrying NS5A genes from genotype 2b, 5a, 6a and 6e were used for testing ledipasvir while the chimeric replicons carrying NS5B genes from genotype 2b, 5a or 6a were used for testing sofosbuvir.
Danish: b. Kimere replikoner, der bærer NS5A-gener fra genotype 2b, 5a, 6a og 6e blev anvendt til at teste ledipasvir,mens de kimere replikoner, der bærer NS5B-gener fra genotype 2b, 5a eller 6a blev anvendt til at teste sofosbuvir.
English: In patients with decompensated cirrhosis, ribavirin should be administered at a starting dose of 600 mg given in a divided daily dose.
Danish: Hos patienter med dekompenseret cirrose bør ribavirin administreres med en startdosis på 600 mg, der gives fordelt på to daglige doser.
English: No dose adjustment of Harvoni is required for patients with mild or moderate renal impairment.
Danish: Ingen dosisjustering af Harvoni er påkrævet for patienter med let eller moderat nedsat nyrefunktion.
English: It is not known whether ledipasvir or sofosbuvir, the two active substances of Harvoni, pass into human breast milk.
Danish: Det er ukendt, om ledipasvir eller sofosbuvir, de to aktive stoffer i Harvoni, udskilles i human mælk.
English: Breast-feeding It is unknown whether ledipasvir or sofosbuvir and its metabolites are excreted in human milk.
Danish: Amning Det er ukendt, om ledipasvir eller sofosbuvir og dets metabolitter udskilles i human mælk.
English: The concomitant use of amiodarone was limited through the clinical development of sofosbuvir plus direct-acting antivirals (DAAs).
Danish: Samtidig anvendelse af amiodaron var begrænset gennem den kliniske udvikling af sofosbuvir plus direkte virkende antivirale midler (DAA, direct-acting antivirals).
English: All patients were treatment-naïve to HCV 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: Not interpretable a. One patient in the LDV/SOF 8-week treatment arm did not have a confirmed genotype 1 subtype.
Danish: Kan ikke fortolkes a. En patient i behandlingsarmen med 8 ugers LDV/SOF havde ikke en bekræftet genotype 1-undertype.
English: The following adverse drug reactions have been identified with Harvoni (Table 4).
Danish: De følgende bivirkninger er identificeret med Harvoni (tabel 4).
English: • If you are sick (vomit) more than 5 hours after taking Harvoni, you do not need to take another tablet until your next scheduled tablet.
Danish: • Hvis du er syg (kaster op) mere end 5 timer efter du har taget Harvoni, skal du ikke tage en anden tablet før din næste skemalagte tablet.
English: a. Six patients (1 in the 12-week, 5 in the 24-week treatment group) with HCV RNA < LLOQ at last measurement prior to transplant, were transplanted prior to SVR12 and were excluded from SVR12 and relapse analyses.
Danish: a. Seks patienter (1 i 12 ugers-behandlingsgruppen, 5 i 24 ugers-behandlingsgruppen) med HCV-rna <LLOQ ved den sidste måling før transplantation, blev transplanteret før SVR12 og blev ekskluderet fra SVR12- og recidivanalyser.
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. Adskildt administration (med 12 timers mellemrum) af atazanavir/ritonavir + emtricitabin/tenofovirdisoproxilfumarat eller darunavir/ritonavir + emtricitabin/tenofovirdisoproxilfumarat og Harvoni gav lignende resultater.
English: ANTICONVULSANTS Carbamazepine Phenobarbital Phenytoin
Danish: ANTIKONVULSIVA Carbamazepin Phenytoin
English: Although adverse events, including serious adverse events, occurred more frequently in this study compared to studies that excluded decompensated patients and/or patients who were post-liver transplantation, the adverse events observed were those expected as clinical sequelae of advanced liver disease and/or transplantation or were consistent with the known safety profile of ribavirin (see section 5.1 for details of this study).
Danish: Selvom bivirkninger, herunder alvorlige bivirkninger, opstod hyppigere i dette studie sammenlignet med studier, der ekskluderede dekompenserede patienter og/eller patienter efter levertransplantation, var de observerede bivirkninger de forventede kliniske følgevirkninger fra fremskreden leversygdom og/eller transplantation eller i overensstemmelse med den kendte sikkerhedsprofil for ribavirin (se pkt.
English: No clinically relevant differences in ledipasvir pharmacokinetics were observed between healthy subjects and patients with severe renal impairment.
Danish: Der blev ikke observeret nogen klinisk relevante forskelle i farmakokinetikken for ledipasvir mellem raske personer og patienter med svært nedsat nyrefunktion.
English: • If you are sick (vomit) less than 5 hours after taking Harvoni, take another tablet.
Danish: • Hvis du er syg (kaster op) mindre end 5 timer efter du har taget Harvoni, skal du tage en anden tablet.
English: • simeprevir (a medicine used to treat hepatitis C infection);
Danish: • simeprevir (medicin, der anvendes til at behandle hepatitis C-infektion);
English: Table 2: Ribavirin dose modification guideline for co-administration with Harvoni Laboratory values
Danish: Tabel 2: Retningslinjer for dosismodifikation af ribavirin ved samtidig administration af Harvoni Laboratorieværdier
English: In patients with ESRD, relative to patients with normal renal function, sofosbuvir AUC0-inf was 28% higher when sofosbuvir was dosed 1 hour before haemodialysis compared with 60% higher when sofosbuvir was dosed 1 hour after haemodialysis.
Danish: Hos patienter med ESRD, i forhold til patienter med normal nyrefunktion, var sofosbuvir AUC0-inf 28 % højere, når sofosbuvir blev doseret 1 time før hæmodialyse, sammenlignet med 60 % højere, når sofosbuvir blev doseret 1 time efter hæmodialyse.
English: Of 169 patients with decompensated cirrhosis (pre- or post-transplant CPT B or C), those patients who achieved SVR12 and had post-treatment week 12 laboratory data available (e.g. excluding patients who died, were transplanted, or had missing data at this time-point) were assessed for changes in their MELD and CPT scores.
Danish: Af de 169 patienter med dekompenseret cirrose (før og efter transplantation CPT B eller C), blev de patienter, der opnåede SVR12, og hvor laboratoriedata ved uge 12 efter behandling var tilgængelige (f.eks. eksklusion af patienter, der døde, blev transplanteret, eller hvor data manglede på dette tidspunkt), vurderet for ændringer i MELD- og CPT-score.
English: The safety and efficacy of sofosbuvir have not been established in patients with severe renal impairment or ESRD.
Danish: Sikkerheden og virkningen af sofosbuvir er ikke klarlagt hos patienter med svært nedsat nyrefunktion eller ESRD.
English: Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare
Danish: (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til
English: Yes d
Danish: Ja d
English: In patients without decompensated cirrhosis requiring the addition of ribavirin to their treatment regimen (see Table 1), the daily dose of ribavirin is weight based (< 75 kg = 1,000 mg and ≥ 75 kg = 1,200 mg) and administered orally in two divided doses with food.
Danish: Hos patienter uden dekompenseret cirrose, hvor det kræves, at ribavirin tilføjes til deres behandlingsregimen (se tabel 1), er den daglige dosis af ribavirin vægtbaseret (<75 kg = 1.000 mg og ≥75 kg = 1.200 mg) og administreres oralt fordelt på 2 doser sammen med mad.
English: Interactions between Harvoni and other medicinal products Table 3 provides a listing of established or potentially clinically significant medicinal product interactions (where 90% confidence interval [CI] of the geometric least-squares mean [GLSM] ratio were within “↔”, extended above “↑”, or extended below “↓” the predetermined equivalence boundaries).
Danish: Lægemiddelinteraktioner mellem Harvoni og andre lægemidler Tabel 3 opstiller en liste over etablerede lægemiddelaktioner og lægemiddelinteraktioner, der kan have klinisk signifikans (hvor 90 % konfidensintervallet [CI] af forholdet af det geometriske mindste kvadraters gennemsnit [GLSM] var inden for ”↔”, strakte sig over ”↑” eller strakte sig under ”↓” de ækvivalensgrænser, der var bestemt på forhånd).
English: When used in combination with ribavirin, refer also to the Summary of Product Characteristics of ribavirin.
Danish: Når det anvendes i kombination med ribavirin, henvises også til produktresuméet for ribavirin.
English: IL28CC genotype FibroTest-Determined Metavir score b
Danish: IL28CC-genotype FibroTest-bestemt Metavir-score b
English: Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis had no clinically relevant effect on the exposure to ledipasvir.
Danish: Populationsfarmakokinetisk analyse hos HCV-inficerede patienter indikerer, at cirrose ikke havde nogen klinisk relevant virkning på eksponeringen for ledipasvir.
English: For genotype 3 infection, ledipasvir/sofosbuvir was given with or without ribavirin, also for 12 weeks (Table 17).
Danish: Ved genotype 3-infektion blev ledipasvir/sofosbuvir givet med eller uden ribavirin, også i 12 uger (tabel 17).
English: 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: 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 AUC0-inf of GS-331007 in patients with ESRD administered with sofosbuvir 1 hour before or 1 hour after haemodialysis was at least 10-fold and 20-fold higher, respectively.
Danish: AUC0-inf for GS-331007 hos patienter med ESRD administreret sammen med sofosbuvir hhv. 1 time før eller 1 time efter hæmodialyse var mindst hhv. 10 gange og 20 gange højere.
English: Genotype Genotype 1a Genotype 1b a. The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
Danish: Genotype Genotype 1a Genotype 1b a. Benævnelsen for recidiv er antallet af patienter med HCV-rna < LLOQ ved deres seneste vurdering under behandling.
English: As liver function may change during treatment with Harvoni, a close monitoring of International Normalised Ratio (INR) values is recommended.
Danish: Patienter i behandling med vitamin K-antagonister Da leverfunktionen kan ændre sig under behandling med Harvoni, anbefales tæt monitorering af INR (international normaliseret ratio).
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 dyreforsøg viser, at ledipasvir og metabolitter fra sofosbuvir udskilles i mælk (se pkt.
English: Patients with genotype 1, 4, 5 or 6 CHC
Danish: Behandling og varighed Patienter med genotype 1-, 4-, 5- eller 6-CHC
English: Table 16: Response rates (SVR12) with ledipasvir/sofosbuvir for 12 weeks in patients with genotype 2, 4, 5 and 6 HCV infection
Danish: Tabel 16: Responsrater (SVR12) med ledipasvir/sofosbuvir i 12 uger hos patienter med genotype 2-, 4-, 5- og 6-HCV-infektion.
English: IL28CC genotype FibroTest-Determined Metavir scoreb
Danish: IL28CC-genotype FibroTest-bestemt Metavir-scoreb
English: Harvoni contains lactose monohydrate.
Danish: Harvoni indeholder lactosemonohydrat.
English: Taking Harvoni with any of these may make Harvoni work less well or make any side effects of the medicines worse.
Danish: Hvis du tager Harvoni med nogle af disse, kan det forårsage, at Harvoni virker mindre godt, eller det kan forværre bivirkningerne ved lægemidlerne.
English: Table 17: Response rates (SVR12) in patients with genotype 3 infection (ELECTRON-2) LDV/SOF+RBV 12 weeks
Danish: Tabel 17: Responsrater (SVR12) hos patienter with genotype 3-infektion (ELECTRON-2) LDV/SOF+RBV 12 uger
English: PHARMACEUTICAL FORM AND CONTENTS 28 film-coated tablets.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 28 filmovertrukne tabletter.
English: Table 14: Response rates in study ION-4
Danish: Tabel 14: Responsrater i studie ION-4
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 5.
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 5.
English: The efficacy of Harvoni (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: Harvonis (ledipasvir [LDV]/sofosbuvir [SOF]) virkning 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: Table 15: Response rates (SVR12) in study SOLAR-1 LDV/SOF+RBV 12 weeks (n = 168)
Danish: Tabel 15: Responsrater (SVR12) i studie SOLAR-1 LDV/SOF+RBV 12 uger (n = 168)a
English: 4 hour haemodialysis removed 18% of administered sofosbuvir dose.
Danish: Efter en enkelt 400 mg dosis af sofosbuvir fjernede en 4-timers hæmodialysesession 18 % af den administrerede sofosbuvir-dosis.
English: For genotype 2, 4, 5 and 6 infection, therapy consisted of ledipasvir/sofosbuvir without ribavirin, given for 12 weeks (Table 16).
Danish: Ved genotype 2-, 4-, 5- og 6-infektion bestod behandlingen af ledipasvir/sofosbuvir uden ribavirin i 12 uger (tabel 16).
English: The pharmacokinetics of ledipasvir, sofosbuvir and GS-331007 in paediatric patients have not been established (see section 4.2).
Danish: Farmakokinetikken af ledipasvir, sofosbuvir og GS-331007 hos pædiatriske patienter er ikke klarlagt (se pkt.
English: The safety assessment of ledipasvir/sofosbuvir is based on pooled data from three Phase 3 clinical studies (ION-3, ION-1 and ION-2) including 215, 539 and 326 patients who received ledipasvir/sofosbuvir for 8, 12 and 24 weeks, respectively; and 216, 328 and 328 patients who received ledipasvir/sofosbuvir + ribavirin combination therapy for 8, 12 and 24 weeks, respectively.
Danish: Sikkerhedsvurderingen af ledipasvir/sofosbuvir er baseret på samlede data fra 3 kliniske fase 3-studier (ION-3, ION-1 og ION-2), der inkluderede 215, 539 og 326 patienter, som fik ledipasvir/sofosbuvir i hhv. 8, 12 og 24 uger, og 216, 328 og 328 patienter, som fik kombinationsbehandling med ledipasvir/sofosbuvir + ribavirin i hhv. 8, 12 og 24 uger.
English: Cirrhosis d
Danish: Cirrose d
English: • rosuvastatin (a medicine used to treat high cholesterol).
Danish: • rosuvastatin (medicin, der anvendes til at behandle forhøjet kolesterol)
English: Harvoni is indicated for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4 and
Danish: Harvoni er indiceret til behandling af kronisk hepatitis C (CHC) hos voksne (se pkt.
English: Relative to patients with normal renal function (eGFR > 80 mL/min/1.73 m2), the sofosbuvir AUC0-inf was 61%, 107% and 171% higher in mild, moderate and severe renal impairment, while the GS-331007 AUC0-inf was 55%, 88% and 451% higher, respectively.
Danish: I forhold til patienter med normal nyrefunktion (eGFR >80 ml/min/1,73 m2) var sofosbuvir AUC0-inf 61 %, 107 % og 171 % højere ved let, moderat og svært nedsat nyrefunktion, mens GS-331007 AUC0-inf var hhv. 55 %, 88 % og 451 % højere.
English: • oxcarbazepine (a medicine used to treat epilepsy and prevent seizures);
Danish: • oxcarbazepin (medicin, der anvendes til at behandle epilepsi og forebygge krampeanfald)
English: Cases of severe bradycardia and heart block have been observed when Harvoni is used with concomitant amiodarone with or without other drugs that lower heart rate.
Danish: Der er iagttaget tilfælde af svær bradykardi og hjerteblok ved anvendelse af Harvoni samtidig med amiodaron med eller uden andre hjertefrekvenssænkende lægemidler.
English: The clinical data to support the use of Harvoni in patients infected with HCV genotype 2 and 6 are limited (see section 5.1).
Danish: De kliniske data, der støtter brug af Harvoni hos patienter inficeret med HCV-genotype 2 og 6, er begrænsede (se pkt.
English: Treatment of patients with prior exposure to HCV direct-acting antivirals 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: Behandling af patienter med tidligere eksponering over for HCV direkte virkende antivirale midler 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: Esomeprazolee
Danish: Esomeprazole