FrancophonIA/ELRC3.0 huggingface dataset:
English: This is due to liver function changes during treatment with Harvoni.
Danish: Dette skyldes, at leverfunktionen kan ændre sig under behandling med 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 virusbelastning < LLOQ ved behandlingens afslutning, havde manglende NS5A-data ved baseline, og var ekskluderet fra analysen.
English: Child-Pugh-Turcotte (CPT) Class B cirrhosis pre-transplant
Danish: Child-Pugh-Turcotte (CPT) klasse B cirrose før transplantation
English: • digoxin used to treat heart conditions;
Danish: • digoxin, anvendes til at behandle hjertesygdomme;
English: HCV replicons with reduced susceptibility to sofosbuvir have been selected in cell culture for multiple genotypes including 1b, 2a, 2b, 3a, 4a, 5a and 6a.
Danish: HCV-replikoner med nedsat følsomhed over for sofosbuvir er blevet udvalgt i cellekultur for flere genotyper, herunder 1b, 2a, 2b, 3a, 4a, 5a og 6a.
English: Dephosphorylation results in the formation of nucleoside metabolite GS-331007 that cannot be efficiently rephosphorylated and lacks anti-HCV activity in vitro.
Danish: Dephosphorylering fører til dannelsen af nukleosidmetabolitten, GS-331007, der ikke kan rephosphoryleres effektivt, og mangler anti-HCV-aktivitet in vitro.
English: No human data on the effect of Harvoni on fertility are available.
Danish: Der foreligger ingen data fra mennesker om Harvonis indvirkning på fertiliteten.
English: Within each group, patients were randomized in a 1:1 ratio to receive ledipasvir/sofosbuvir + ribavirin for 12 or 24 weeks.
Danish: Inden for hver gruppe blev patienter randomiseret i et 1:1 forhold til at få ledipasvir/sofosbuvir + ribavirin i 12 eller 24 uger.
English: There were no effects on survival, physical and behavioural development and reproductive performance in the offspring at maternal exposures similar to the exposure in humans at the recommended clinical dose.
Danish: Der var ingen virkning på overlevelse, fysisk og adfærdsmæssig udvikling samt reproduktion hos afkommet ved maternale eksponeringer, der var sammenlignelige med eksponeringen hos mennesker ved den anbefalede kliniske dosis.
English: Skin and subcutaneous tissue disorders: Common rash
Danish: Hud og subkutane væv: Almindelig
English: Median peak plasma concentration of GS-331007 was observed at 4 hours post-dose.
Danish: Median maksimal plasmakoncentration af GS-331007 blev observeret 4 timer efter dosering.
English: • tipranavir (used to treat HIV infection).
Danish: • tipranavir (medicin, der anvendes til at behandle hiv-infektion).
English: The exposures to GS-331007 and ledipasvir were not altered in the presence of either meal type.
Danish: Eksponeringerne for GS-331007 og ledipasvir var uændret sammen med nogen af disse typer måltider.
English: Sofosbuvir activity (EC50, nM)
Danish: Sofosbuvir-aktivitet (EC50, nM)
English: Do not stop taking Harvoni
Danish: Du må ikke holde op med at tage Harvoni
English: When administered to lactating rats, ledipasvir was detected in plasma of suckling rats likely due to excretion of ledipasvir via milk.
Danish: Ved administration til diegivende rotter blev ledipasvir detekteret i plasmaet hos de diende rotter, hvilket sandsynligvis skyldes udskillelse af ledipasvir i mælken.
English: However, it has not been possible to fully estimate exposure margins achieved for sofosbuvir in the rat relative to the exposure in humans at the recommended clinical dose (see section 5.3).
Danish: Det har imidlertid ikke været muligt helt at estimere eksponeringsmarginer, som blev opnået for sofosbuvir hos rotter i forhold til eksponeringen hos mennesker ved den anbefalede kliniske dosis (se pkt.
English: Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, sunset yellow FCF aluminium lake (E110)
Danish: Polyvinylalkohol, titandioxid, macrogol 3350, talcum, sunset yellow FCF aluminiumpigment (E110)
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: Animal studies do not indicate harmful effects of ledipasvir or sofosbuvir on fertility.
Danish: Dyrestudier indikerer ingen skadelige virkninger af ledipasvir eller sofosbuvir på fertiliteten.
English: ANTIARRHYTHMICS Amiodarone
Danish: ANTIARYTMIKA Amiodaron
English: Harvoni + ribavirinA for 12 weeks or
Danish: Harvoni + ribavirinA i 12 uger eller
English: Orange, diamond-shaped, film-coated tablet of dimensions 19 mm x 10 mm, debossed with “GSI” on one side and “7985” on the other side.
Danish: Orange, diamantformet, filmovertrukken tablet med dimensionerne 19 mm x 10 mm, præget med ”GSI” på den ene side og med ”7985” på den anden side.
English: Patients were on a stable HIV-1 antiretroviral therapy that included emtricitabine/tenofovir disoproxil fumarate, administered with efavirenz, rilpivirine or raltegravir.
Danish: Patienterne var på stabil hiv 1-antiretroviral behandling, der omfattede emtricitabin/tenofovirdisoproxilfumarat, administreret sammen med efavirenz, rilpivirin eller raltegravir.
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: SVR was achieved in all 24 patients (n = 20 with L159F+C316N; n = 1 with L159F; and n = 3 with N142T) who had baseline variants associated with resistance to NS5B nucleoside inhibitors.
Danish: SVR blev opnået hos alle 24 patienter (n = 20 med L159F+C316N, n = 1 med L159F og n = 3 med N142T), som havde varianter ved baseline forbundet med resistens over for NS5B nukleosidhæmmere.
English: a Twelve patients transplanted prior to post-treatment Week 12 with HCV RNA< LLOQ at last measurement prior to transplant were excluded.
Danish: a. Tolv patienter transplanteret inden uge 12 efter behandling med HCV-rna <LLOQ ved den sidste måling før transplantation blev ekskluderet.
English: Ledipasvir AUC is dose proportional over the dose range of 3 to 100 mg. Sofosbuvir and GS-331007 AUCs are near dose proportional over the dose range of 200 mg to 400 mg.
Danish: Ledipasvir AUC er dosisproportional over doseringsintervallet fra 3 mg til 100 mg. Sofosbuvir og GS-331007 AUC'er er næsten dosisproportionale over doseringsintervallet fra 200 mg til 400 mg.
English: The safety assessment of Harvoni was mainly based on pooled Phase 3 clinical studies, without a control, in 1952 patients who received Harvoni for 8, 12 or 24 weeks, including 872 patients who received Harvoni in combination with ribavirin.
Danish: Sikkerhedsvurderingen af Harvoni er hovedsageligt baseret på samlede data fra kliniske fase 3 studier uden kontrolgrupper med 1952 patienter, der fik Harvoni i 8, 12 eller 24 uger (herunder 872 patienter, som fik Harvoni i kombination med ribavirin).
English: Harvoni contains lactose
Danish: Harvoni indeholder lactose
English: Should concomitant use of amiodarone be considered necessary it is recommended that patients are closely monitored when initiating Harvoni.
Danish: Hvis samtidig brug af amiodaron findes nødvendig, anbefales tæt overvågning af patienterne ved initiering af behandlingen med Harvoni.
English: The SVR12 rate was 98% overall (98% [78/80] in treatment-naïve patients and 100% [20/20] in treatment experienced patients).
Danish: SVR12-raten var samlet 98 % (98 % [78/80] hos behandlingsnaive patienter og 100 % [20/20] hos behandlingserfarne patienter).
English: Elderly No dose adjustment is warranted for elderly patients (see section 5.2).
Danish: Ældre Ingen dosisjustering er nødvendig hos ældre patienter (se pkt.
English: Relative to fasting conditions, the administration of a single dose of ledipasvir/sofosbuvir with a moderate fat or high fat meal increased the sofosbuvir AUC0-inf by approximately 2-fold, but did not significantly affect the sofosbuvir Cmax.
Danish: I forhold til fastende tilstande, forhøjede administrationen af en enkelt dosis ledipasvir/sofosbuvir sammen med et måltid med moderat fedtindhold eller med et højt fedtindhold sofosbuvir AUC0-inf ca. 2 gange, men det påvirkede ikke signifikant sofosbuvir Cmax.
English: Ledipasvir was not carcinogenic in the 26-week rasH2 transgenic mouse and the 2-year rat carcinogenicity studies at exposures up to 26-times in mice and 8-times in rats higher than human exposure.
Danish: Ledipasvir var ikke karcinogent i et 26-ugers studie med rasH2 transgene mus, samt et 2-årigt karcinogenicitetsstudie med rotter ved eksponeringer op til 26 gange højere hos mus og 8 gange højere hos rotter end den humane eksponering.
English: Both sofosbuvir and ledipasvir were fully active against substitutions associated with resistance to other classes of direct-acting antivirals with different mechanisms of actions, such as NS5B non-nucleoside inhibitors and NS3 protease inhibitors.
Danish: Både sofosbuvir og ledipasvir var helt aktive mod substitutioner, der var forbundet med resistens over for andre direkte virkende antivirale midler med forskellige virkningsmekanismer, såsom NS5B non-nukleosidhæmmere og NS3 proteasehæmmere.
English: When ledipasvir/sofosbuvir was studied with ribavirin, the most frequent adverse drug reactions to ledipasvir/sofosbuvir + ribavirin combination therapy were consistent with the known safety profile of ribavirin, without increasing the frequency or severity of the expected adverse drug reactions.
Danish: Når ledipasvir/sofosbuvir blev undersøgt med ribavirin, var de hyppigste bivirkninger mod kombinationsbehandling med ledipasvir/sofosbuvir + ribavirin i overensstemmelse med den kendte sikkerhedsprofil for ribavirin, uden at øge hyppigheden eller sværhedsgraden af de forventede bivirkninger.
English: Cirrhosis was defined by biopsy, Fibroscan (> 12.5 kPa) or FibroTest > 0.75 and an AST:platelet ratio index (APRI) of > 2.
Danish: Cirrose blev defineret via biopsi, Fibroscan (>12,5 kPa) eller FibroTest >0,75 og ASAT:trombocyt ratio indeks (APRI) >2.
English: The following adverse drug reactions have been identified with Harvoni (Table 6).
Danish: De følgende bivirkninger er identificeret med Harvoni (tabel 6).
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: Nervous system disorders: Very common headache
Danish: Nervesystemet: Meget almindelig
English: SVR Outcome for patients without SVR On-treatment virologic failure
Danish: SVR Resultat for patienter uden SVR Virologisk svigt under behandling
English: If you are taking an antacid, take it at least 4 hours before or at least 4 hours after Harvoni.
Danish: Hvis du tager et syreneutraliserende middel, skal du tage det mindst 4 timer før eller mindst 4 timer efter Harvoni.
English: Sofosbuvir-derived material was transferred through the placenta in pregnant rats and into the milk of lactating rats.
Danish: Sofosbuvirderiveret materiale blev overført over placenta hos drægtige rotter og ind i mælken hos diegivende rotter.
English: Exposure to GS-331007 in these studies was up to 17 times (mouse) and 9 times (rat) higher than the clinical exposure at 400 mg sofosbuvir.
Danish: Eksponering for GS-331007 i disse studier var op til 17 gange (mus) og 9 gange (rotter) højere end den kliniske eksponering ved 400 mg sofosbuvir.
English: Proton pump inhibitor doses comparable to omeprazole 20 mg can be administered simultaneously with Harvoni.
Danish: Doser af protonpumpehæmmere, der er sammenlignelige med omeprazol 20 mg kan administreres sammen med Harvoni.
English: Demographics and baseline characteristics were balanced across treatment-naïve and treatment-experienced patients.
Danish: Demografi og baseline karakteristika var afbalanceret på tværs behandlingsnaive og behandlingserfarne patienter.
English: • If you notice within 18 hours of the time you usually take Harvoni, you must take the tablet as soon as possible.
Danish: • Hvis du opdager det inden for 18 timer fra det tidspunkt, du normalt tager Harvoni skal du tage tabletten snarest muligt.
English: A conservative 24 weeks of therapy is advised in all treatment-experienced genotype 3 patients and those treatment-naïve genotype 3 patients with cirrhosis (see section 4.2).
Danish: Der rådes til en konservativ 24 ugers behandling hos alle behandlingserfarne genotype 3-patienter samt de behandlingsnaive genotype 3-patienter med cirrose (se pkt.
English: In clinical studies - Adults-Genotype 1
Danish: I kliniske studier - Voksne - genotype 1
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
English: GS-331007 is not a substrate for renal transporters including organic anion transporter (OAT) 1 or OAT3, or OCT2.
Danish: GS-331007 er ikke et substrat for nyretransportere, herunder organisk aniontransporter (OAT) 1 eller OAT3 eller OCT2.
English: HCV replicons with reduced susceptibility to ledipasvir have been selected in cell culture for genotype 1a and 1b.
Danish: HCV-replikoner med nedsat følsomhed over for ledipasvir er blevet udvalgt i cellekultur for genotype 1a og 1b.
English: However, patients should be advised that fatigue was more common in patients treated with ledipasvir/sofosbuvir compared to placebo.
Danish: Patienterne bør imidlertid informeres om, at træthed var mere almindeligt hos patienter i behandling med ledipasvir/sofosbuvir, sammenlignet med placebo.
English: GS-331007 is efficiently removed by haemodialysis with an extraction coefficient of approximately 53%.
Danish: GS-331007 fjernes effektivt ved hæmodialyse, med en ekstraktionskoefficient på ca. 53 %.
English: Table 5 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: Tabel 5 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: Adults-Genotype 2, 3, 4, 5 and 6
Danish: Voksne - genotype 2, 3, 4, 5 og 6
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 endnu en tablet.
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 postliver 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: A Adults: weight based ribavirin (< 75 kg = 1,000 mg and ≥ 75 kg = 1,200 mg), administered orally in two divided doses with food.
Danish: A Voksne: Vægtbaseret ribavirin (< 75 kg = 1.000 mg og ≥ 75 kg = 1.200 mg) administreret oralt fordelt på 2 doser sammen med mad.
English: Medicinal products that increase gastric pH are expected to decrease concentration of ledipasvir.
Danish: Lægemidler, der øger mavens pH-værdi forventes at nedsætte koncentrationen af ledipasvir.
English: In cirrhotic patients relapses occurred with both regimens, and in the absence and presence of baseline NS5A RAVs.
Danish: Hos patienter med cirrose forekom recidiver med begge regimer, og ved fravær og tilstedeværelse af baseline-NS5A-RAVs.
English: Adult and adolescent patients 12 years of age or older with genotype 1, 4, 5 or 6 CHC Patients without cirrhosis
Danish: Voksne og unge patienter 12 år eller ældre med genotype 1-, 4-, 5- eller 6-CHC Patienter uden cirrose
English: In this limited clinical safety data set, the rate of adverse events and deaths was not clearly elevated from what is expected in ESRD patients.
Danish: I dette begrænsede kliniske datasæt var hyppigheden af bivirkninger og dødsfald ikke tydeligt øget i forhold til forventningen for ESRD-patienter.
English: Baseline NS5A RAVs were overrepresented in patients who experienced relapse in the Phase 3 studies (see “Clinical efficacy and safety”).
Danish: NS5A-RAVs ved baseline var overrepræsenteret hos patienter, der oplevede recidiv i fase IIIstudierne (se ”Klinisk virkning og sikkerhed”).
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: 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 voksne personer, samt hos patienter med HCV-infektion.
English: In the pooled analysis of the Phase 3 studies, 16% of patients had baseline NS5A RAVs identified by population or deep sequencing irrespective of subtype.
Danish: I den samlede analyse af fase 3-studier, havde 16 % af patienterne baselineNS5A-RAVs identificeret ved populationssekventering eller dyb sekventering uanset undertype.
English: Changes in MELD and CPT score from baseline to post-treatment Week 12 were analyzed for all patients with decompensated cirrhosis (pre- or post-transplant) who achieved SVR12 and for whom data were available (n = 123) to assess the effect of SVR12 on hepatic function.
Danish: Ændringer i MELD- og CPT-score fra baseline til uge 12 efter behandling blev analyseret for alle patienter med dekompenseret cirrose (før eller efter transplantation), som opnåede SVR12 og for hvem data var tilgængelige (n = 123) til vurdering af virkningen af SVR12 på leverfunktionen.
English: • proton pump inhibitors (such as omeprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole).
Danish: • protonpumpehæmmere (såsom omeprazol, lansoprazol, rabeprazol, pantoprazol og esomeprazol).
English: If you are taking a proton pump inhibitor, take it at the same time as Harvoni.
Danish: Hvis du tager en protonpumpehæmmer, skal du tage den på samme tidspunkt som Harvoni.
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 endnu en tablet før din næste skemalagte tablet.
English: SVR Outcome for patients without SVR On-treatment virologic failure Relapsea Otherb SVR rates for selected subgroups Genotype Genotype 1a Genotype 1b Cirrhosis No
Danish: SVR Resultat for patienter uden SVR Virologisk svigt under behandling Recidiva Andetb SVR-rater for udvalgte undergrupper Genotype Genotype 1a Genotype 1b Cirrose Nej
English: Renal impairment No dose adjustment of Harvoni is required for patients with mild or moderate renal impairment.
Danish: Nedsat nyrefunktion Ingen dosisjustering af Harvoni er påkrævet for patienter med let eller moderat nedsat nyrefunktion.
English: In a rat pre- and postnatal study, at a maternally toxic dose, the developing rat offspring exhibited mean decreased body weight and body weight gain when exposed in utero (via maternal dosing) and during lactation (via maternal milk) at a maternal exposure 4 times the exposure in humans at the recommended clinical dose.
Danish: I et præ- og postnatalt studie med rotter ved en maternal, toksisk dosis, udviste det udviklende rotteafkom en gennemsnitlig, nedsat legemsvægt og legemsvægtøgning under eksponering in utero (via maternal dosering) og under diegivning (via maternal mælk) ved maternale eksponeringer, der var 4 gange større end eksponeringen hos mennesker ved den anbefalede kliniske dosis.
English: HMG-CoA REDUCTASE INHIBITORS Rosuvastating
Danish: HMG-CoA REDUCTASEHÆMMERE Rosuvastating
English: Copovidone
Danish: Copovidon
English: GS-461203 (the active metabolite of sofosbuvir) is neither an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase.
Danish: GS-461203 (den aktive metabolit af sofosbuvir) er hverken en hæmmer af humane dna- og rna-polymeraser, eller en hæmmer af mitokondriel rna-polymerase.
English: • rifapentine (antibiotic used to treat infections, including tuberculosis);
Danish: • rifapentin (antibiotikum, der anvendes til behandling af infektioner, herunder tuberkulose);
English: Reduced susceptibility to ledipasvir was associated with the primary NS5A substitution Y93H in both genotype 1a and 1b.
Danish: Nedsat følsomhed over for ledipasvir var forbundet med den primære NS5Asubstitution Y93H i både genotype 1a og 1b.
English: Potential for other medicinal products to affect Harvoni Ledipasvir and sofosbuvir are substrates of drug transporter P-gp and BCRP while GS-331007 is not.
Danish: Potentialet for andre lægemidlers påvirkning af Harvoni Ledipasvir og sofosbuvir er substrater for lægemiddeltransporterne P-gp og BCRP, hvorimod GS-331007 ikke er det.
English: Other effects that may be seen during treatment with Harvoni
Danish: Andre bivirkninger, der kan ses ved behandling med Harvoni
English: Patients were randomised in a 1:1:1 ratio to one of the three treatment groups and stratified by HCV genotype (1a versus 1b).
Danish: Patienterne blev randomiseret i forholdet 1:1:1 til en af de tre behandlingsgrupper, og stratificeret efter HCV-genotype (1a versus 1b).
English: When Harvoni is used in combination with ribavirin refer also to the Summary of Product Characteristics for ribavirin for patients with creatinine clearance (CrCl) < 50 mL/min (see section 5.2).
Danish: Når Harvoni anvendes i kombination med ribavirin, henvises også til produktresuméet for ribavirin for patienter med kreatininclearance (CrCl) <50 ml/min (se pkt.
English: Each film-coated tablet contains 156.8 mg of lactose (as monohydrate) and 261 micrograms of sunset yellow FCF aluminium lake.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver filmovertrukken tablet indeholder 156,8 mg lactose (som monohydrat) og 261 mikrogram sunset yellow FCF aluminiumpigment.
English: Concerning genotype-specific virological and clinical activity, see section 5.1.
Danish: Angående genotypespecifik virologisk og klinisk aktivitet, se pkt.
English: Reporting of side effects If you get any side effects, talk to your doctor or pharmacist.
Danish: Indberetning af bivirkninger Hvis du oplever bivirkninger, bør du tale med din læge eller apotekspersonalet.
English: This patient was subsequently retreated with ledipasvir/sofosbuvir + ribavirin for 24 weeks and achieved SVR following retreatment.
Danish: Denne patient blev derefter igen behandlet med ledipasvir/sofosbuvir + ribavirin i 24 uger, og opnåede SVR efter genbehandling.