FrancophonIA/ELRC3.0 huggingface dataset:
English: Sovaldi has been studied in combination with ribavirin, with or without peginterferon alfa.
Danish: Sovaldi er blevet undersøgt i kombination med ribavirin, sammen med eller uden peginterferon alfa.
English: The exposure to GS-331007 was not altered in the presence of a high-fat meal.
Danish: Eksponeringen for GS-331007 var uændret sammen med et måltid med højt fedtindhold.
English: ANTICOAGULANTS Vitamin K antagonists
Danish: ANTIKOAGULANTIA Vitamin K-antagonister
English: Exposure to GS-331007 in these studies was up to 30 times (mouse) and 15 times (rat) higher than the clinical exposure at 400 mg sofosbuvir.
Danish: Eksponering for GS-331007 i disse studier var op til 30 gange (mus) og 15 gange (rotter) højere end den kliniske eksponering ved 400 mg sofosbuvir.
English: General disorders and administration site conditions: Very common fatigue, irritability chills, fatigue, influenza-like illness, irritability, pain, pyrexia
Danish: Almene symptomer og reaktioner på administrationsstedet: Meget almindelig træthed, irritabilitet kulderystelser, træthed, influenzalignende sygdom, irritabilitet, smerter, pyreksi
English: Eleven HCV genotype 3 patients had already completed treatment with sofosbuvir and ribavirin for 12 weeks at the time of the amendment.
Danish: Elleve HCV-genotype 3-patienter havde allerede gennemført behandlingen med sofosbuvir og ribavirin i 12 uger på ændringstidspunktet.
English: Renal impairment No dose adjustment of Sovaldi is required for patients with mild or moderate renal impairment.
Danish: Nedsat nyrefunktion Ingen dosisjustering af Sovaldi er påkrævet for patienter med let eller moderat nedsat nyrefunktion.
English: In clinical pharmacology studies, both sofosbuvir and GS-331007 were monitored for purposes of pharmacokinetic analyses.
Danish: I kliniske farmakologistudier blev både sofosbuvir og GS-331007 overvåget med henblik på farmakokinetiske analyser.
English: However, if ribavirin is co-administered with sofosbuvir, the contraindications regarding use of ribavirin during pregnancy apply (see also the Summary of Product Characteristics for ribavirin).
Danish: Hvis ribavirin administreres samtidig med sofosbuvir, træder kontraindikationerne vedrørende anvendelse af ribavirin under graviditeten i kraft (se også produktresuméet for ribavirin).
English: Peak plasma concentration of GS-331007 was observed between 2 to 4 hours post-dose.
Danish: Den maksimale plasmakoncentration af GS-331007 blev observeret 2 til 4 timer efter dosering.
English: Sovaldi is not recommended for administration as monotherapy and should be prescribed in combination with other medicinal products for the treatment of hepatitis C infection.
Danish: Sovaldi bør ikke anvendes til administration som monoterapi, og bør ordineres i kombination med andre lægemidler til behandling af hepatitis C-infektion.
English: Sovaldi is always taken with other medicines to treat hepatitis C. It will not work on its own.
Danish: Sovaldi tages altid sammen med andre lægemidler til behandling af hepatitis C. Det vil ikke virke alene.
English: In a pooled analysis of 991 patients who received sofosbuvir in Phase 3 studies, 226 patients 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 med 991 patienter, som fik sofosbuvir i fase III-studier, kvalificerede 226 patienter sig til resistensanalyse på grund af virologisk svigt eller tidlig seponering af studielægemidlet, samt at de havde HCV-rna > 1.000 IE/ml.
English: You should not breast-feed during treatment with Sovaldi.
Danish: Du må ikke amme under behandlingen med Sovaldi.
English: After oral administration of Sovaldi, sofosbuvir is rapidly absorbed and subject to extensive first-pass hepatic and intestinal metabolism.
Danish: Efter oral administration af Sovaldi absorberes sofosbuvir hurtigt og gennemgår en omfattende first-pass lever- og tarmmetabolisme.
English: Elderly No dose adjustment is warranted for elderly patients (see section 5.2).
Danish: Ældre personer Ingen dosisjustering er nødvendig hos ældre patienter (se pkt.
English: The metabolic activation pathway involves sequential hydrolysis of the carboxyl ester moiety catalysed by human cathepsin A (CatA) or carboxylesterase 1 (CES1) and phosphoramidate cleavage by histidine triad nucleotide-binding protein 1 (HINT1) followed by phosphorylation by the pyrimidine nucleotide biosynthesis pathway.
Danish: Den metaboliske aktiveringsvej omfatter sekventiel hydrolyse af carboxylesterdelen, hvilket katalyseres af humant cathepsin A (CatA) eller carboxylesterase 1 (CES1) og phosphoramidat-kløvning af histidin-triad nukleotid-bindende protein 1 (HINT1), efterfulgt af phosphorylering af pyrimidin-nukleotid-biosyntesevejen.
English: Patients with genotype 2 or 3 HCV were enrolled in an approximately 1:3 ratio.
Danish: Patienter med HCV af genotype 2 eller 3 blev inkluderet i et forhold på ca. 1:3.
English: Sofosbuvir was fully active against substitutions associated with resistance to other direct-acting antivirals with different mechanisms of actions, such as NS5B non-nucleoside inhibitors, NS3 protease inhibitors and NS5A inhibitors.
Danish: Sofosbuvir var helt aktiv mod substitutioner, der var forbundet med resistens over for andre direkte virkende antivirale midler med forskelle virkningsmekanismer, såsom NS5B non-nukleosidhæmmere, NS3-proteasehæmmere og NS5A-hæmmere.
English: Overallc Genotype 1ac Genotype 1bc No cirrhosisc Cirrhosisc n = number of patients with SVR12 response; N = total number of patients per group.
Danish: Genotype 1ac Genotype 1bc Uden cirrosec Cirrosec n = antal patienter med SVR12-respons; N = totalt antal patienter pr. gruppe.
English: The sofosbuvir-associated resistance substitution S282T was not detected in any of these patients by deep sequencing or population sequencing.
Danish: Substitutionen S282T, som er forbundet med resistens over for sofosbuvir, blev ikke detekteret hos nogen af disse patienter ved dyb sekventering eller populationssekventering.
English: • Rifapentine (a medicine used to treat infections, including tuberculosis);
Danish: • Rifapentin (medicin, der anvendes til behandling af infektioner, herunder tuberkulose).
English: Patients with CHC awaiting liver transplantation
Danish: Patienter med CHC, der venter på levertransplantation
English: You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Sovaldi.
Danish: Det kan være, at dit blodsukker skal overvåges tættere, og/eller at din diabetesmedicin skal justeres efter påbegyndelse af behandling med Sovaldi.
English: Contents of the pack and other information What Sovaldi contains
Danish: Pakningsstørrelser og yderligere oplysninger Sovaldi indeholder:
English: HCV ANITIVIRAL AGENTS: HCV PROTEASE INHIBITORS Boceprevir (BOC)
Danish: HCV-ANTIVIRALE STOFFER: HCV-PROTEASEHÆMMERE Boceprevir (BOC)
English: Sovaldi has not been studied in a Phase 3 study in treatment-experienced patients with genotype 1, 4, 5 and 6 HCV infection.
Danish: Sovaldi er ikke blevet undersøgt i et fase III-studie hos behandlingserfarne patienter med HCV-genotype 1, 4, 5 og 6-infektion.
English: 28 out of 40 (70%) patients achieved SVR12: 22/33 (73%) with HCV genotype 1 infection, 6/6 (100%) with HCV genotype 3 infection, and 0/1 (0%) with HCV genotype 4 infection.
Danish: 28 ud af 40 (70 %) patienter opnåede SVR12: 22/33 (73 %) med HCV-genotype 1-infektion, 6/6 (100 %) med HCV-genotype 3-infektion og 0/1 (0 %) med HCV-genotype 4-infektion.
English: Rilpivirinef (25 mg once daily)
Danish: Rilpivirinf (25 mg én gang dagligt)
English: 12 weeksa,b
Danish: 12 ugera, b
English: In the ELECTRON study (N = 11), the duration of peginterferon alfa ranged from 4-12 weeks in combination with sofosbuvir + ribavirin.
Danish: I ELECTRON-studiet (N = 11) var varigheden af peginterferon alfa i intervallet fra 4-12 uger i kombination med sofosbuvir+ribavirin.
English: The median ribavirin dose was 600 mg-800 mg daily at weeks 4-24.
Danish: Den gennemsnitlige ribavirindosis var 600-800 mg dagligt ved uge 4-24.
English: Baseline NS5B sequences were obtained for 1,292 patients from Phase 3 studies by population sequencing and the S282T substitution was not detected in any subject with available baseline sequence.
Danish: Der blev indhentet baseline NS5B-sekvenser for 1.292 patienter fra fase III-studier ved populationssekventering, og S282T-substitutionen blev ikke detekteret hos nogen personer med en tilgængelig baselinesekvens.
English: Sovaldi + ribavirin Only for use in patients ineligible or intolerant to peginterferon alfa (see section 4.4)
Danish: Sovaldi + ribavirin Bør kun anvendes til patienter, der er uegnede eller intolerante over for peginterferon alfa (se pkt.
English: Available pharmacokinetic data in animals have shown excretion of metabolites in milk (for details see section 5.3).
Danish: De tilgængelige farmakokinetiske data fra dyrestudier viser, at metabolitter udskilles i mælk (se pkt.
English: Table 19: Virologic response post-transplant in patients with HCV RNA <LLOQ at the time of liver transplantation
Danish: Tabel 19: Virologisk respons efter transplantation hos patienter med HCV-rna < LLOQ på tidspunktet for levertransplantationen
English: Patients awaiting liver transplantation
Danish: Patienter, der venter på levertransplantation
English: Relative to fasting conditions, the administration of a single dose of sofosbuvir with a standardised high fat meal slowed the rate of absorption of sofosbuvir.
Danish: I forhold til fastende tilstande, sænkede administrationen af en enkelt dosis sofosbuvir sammen med et standardiseret måltid med højt fedtindhold absorptionshastigheden af sofosbuvir.
English: Co-administration of Sovaldi with medicinal products that inhibit P-gp and/or BCRP may increase sofosbuvir plasma concentration without increasing GS-331007 plasma concentration, thus Sovaldi may be co-administered with P-gp and/or BCRP inhibitors.
Danish: Samtidig administration af Sovaldi og lægemidler, der hæmmer P-gp og/eller BCRP kan øge plasmakoncentrationen af sofosbuvir uden at øge plasmakoncentrationen af GS-331007, og derved kan Sovaldi administreres samtidigt med P-gp- og/eller BCRP-hæmmere.
English: Forty patients (33 with HCV genotype 1 infection, 6 with HCV genotype 3 infection, and 1 with HCV genotype 4 infection) were enrolled, 35 of whom had previously failed interferon-based treatment, and 16 of whom had cirrhosis.
Danish: 40 patienter (33 med HCV-genotype 1-infektion, 6 med HCV-genotype 3-infektion og 1 med HCVgenotype 4-infektion) indgik, hvoraf 35 havde tidligere svigt af interferonbaseret behandling, og 16 havde cirrose.
English: When Sovaldi is used in combination with ribavirin or peginterferon alfa/ribavirin, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients.
Danish: Når Sovaldi anvendes i kombination med ribavirin eller peginterferon alfa/ribavirin, skal der udvises ekstrem forsigtighed, så graviditet undgås hos kvindelige patienter og hos mandlige patienters kvindelige partnere.
English: Sofosbuvir is extensively metabolised in the liver to form the pharmacologically active nucleoside analog triphosphate GS-461203.
Danish: Sofosbuvir metaboliseres i udbredt grad i leveren, så der dannes den farmakologisk aktive nukleosidanalog triphosphat GS-461203.
English: The intracellular metabolic activation pathway of sofosbuvir is mediated by generally low affinity and high capacity hydrolase and nucleotide phosphorylation pathways that are unlikely to be affected by concomitant medicinal products (see section 5.2).
Danish: Den intracellulære metaboliske aktiveringsvej for sofosbuvir er medieret af en hydrolase med generelt lav affinitet og høj kapacitet, og nukleotid fosforyleringsveje, der sandsynligvis ikke påvirkes af samtidige lægemidler (se pkt.
English: The most common adverse drug reactions occurring in patients receiving sofosbuvir and ribavirin or sofosbuvir, ribavirin and peginterferon alfa were fatigue, headache, nausea and insomnia.
Danish: De mest almindelige bivirkninger, der forekom hos patienter, som fik sofosbuvir og ribavirin eller sofosbuvir, ribavirin og peginterferon alfa var træthed, hovedpine, kvalme og søvnløshed.
English: Sofosbuvir is not a substrate for hepatic uptake transporters, organic anion-transporting polypeptide (OATP) 1B1 or 1B3, and organic cation transporter (OCT) 1.
Danish: Sofosbuvir er ikke et substrat for hepatiske optagelsestransportere, organisk aniontransporterende polypeptid (OATP) 1B1 eller 1B3, eller organisk kation-transporter (OCT) 1.
English: No shift in the phenotypic susceptibility to sofosbuvir or ribavirin of subject isolates with these substitutions was detected.
Danish: Der blev ikke detekteret skift i fænotype-følsomhed for sofosbuvir eller ribavirin i isolater fra patienter med disse substitutioner.
English: Interferon-free regimens for patients with genotype 1, 4, 5 and 6 HCV infection with Sovaldi have not been investigated in Phase 3 studies (see section 5.1).
Danish: Interferonfrie behandlingsprogrammer for patienter med HCV-genotype 1, 4, 5 og 6-infektion med Sovaldi er ikke blevet undersøgt i fase III-studier (se pkt.
English: If 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: Hvis 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: Hepatobiliary disorders: Very common blood bilirubin increased blood bilirubin increased
Danish: Lever og galdeveje: Meget almindelig forhøjet bilirubin i blodet forhøjet bilirubin i blodet
English: 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 sofosbuvir (400 mg).
Danish: Eksponeringer for sofosbuvir og GS-331007 hos unge i alderen 12 til <18 år var lig med eksponeringer hos voksne fra fase II/III-studier efter administration af sofosbuvir (400 mg).
English: Refer to the peginterferon alfa Summary of Product Characteristics for additional information about how to reduce and/or discontinue the peginterferon alfa dose.
Danish: Se produktresuméet for peginterferon alfa for yderligere information om, hvordan dosis af peginterferon alfa reduceres og/eller seponeres.
English: Two NS5B substitutions, L159F and V321A, were detected in post-treatment relapse samples from multiple genotype 3 HCV infected patients in the Phase 3 clinical studies.
Danish: To NS5B-substitutioner, L159F og V321A, blev detekteret i recidivprøver efter behandlingen fra flere patienter med HCV-genotype 3-infektion i de kliniske fase III-studier.
English: The ribavirin dose was weight-based at 1,000-1,200 mg daily administered in two divided doses, and the peginterferon alfa 2a dose, where applicable, was 180 μg per week.
Danish: Ribavirindosis var vægtbaseret med 1.000-1.200 mg dagligt, administreret fordelt på to doser, og peginterferon alfa 2a-dosis, hvor det var relevant, var 180 μg ugentligt.
English: Sofosbuvir retained activity against the NS5B substitutions L159F and L320F associated with resistance to other nucleoside inhibitors.
Danish: Sofosbuvir bibeholdt aktivitet mod NS5B-substitutionerne L159F og L320F forbundet med resistens over for andre nuklosidhæmmere.
English: • low blood platelet count
Danish: • lavt antal blodplader
English: Table 24: Effect of varying degrees of renal impairment on exposures (AUC) of sofosbuvir and GS-331007 compared to subjects with normal renal function
Danish: Tabel 24: Virkningen af forskellige grader af nedsat nyrefunktion (RI) på eksponeringer (AUC) for sofosbuvir og GS-331007 sammenlignet med forsøgspersoner med normal nyrefunktion
English: Treatment-naïve (FISSION)
Danish: Behandlingsnaive (FISSION)
English: HIV ANTIVIRAL AGENTS: HIV PROTEASE INHIBITORS Darunavir boosted with ritonavirf (800/100 mg once daily)
Danish: HIV-ANTIVIRALE STOFFER: HIV-PROTEASEHÆMMERE Darunavir boostet med ritonavirf (800/100 mg én gang dagligt)
English: The pharmacokinetic properties of sofosbuvir and the predominant circulating metabolite GS-331007 have been evaluated in healthy adult subjects and in patients with chronic hepatitis C. Following oral administration, sofosbuvir was absorbed quickly and the peak plasma concentration was observed ~0.5-2 hour post-dose, regardless of dose level.
Danish: De farmakokinetiske egenskaber for sofosbuvir og den primære cirkulerende metabolit, GS-331007, er blevet evalueret hos raske voksne personer, og hos patienter med kronisk hepatitis C. Efter oral administration blev sofosbuvir absorberet hurtigt, og den maksimale plasmakoncentration blev observeret ~0,5-2 timer efter dosering, uanset dosisniveau.
English: HCV replicons expressing the sofosbuvir-associated resistance substitution S282T were fully susceptible to other classes of anti-HCV agents.
Danish: HCV-replikoner, der udtrykker substitutionen S282T, som er forbundet med resistens over for sofosbuvir, var helt følsomme over for andre klasser af anti-HCV-stoffer.
English: No clinically relevant pharmacokinetic differences due to gender or race have been identified for sofosbuvir and GS-331007.
Danish: Der blev ikke identificeret nogen klinisk relevante farmakokinetiske forskelle, der skyldes køn eller race, for sofosbuvir og GS-331007.
English: Sovaldi 400 mg film-coated tablets sofosbuvir
Danish: Sovaldi 400 mg filmovertrukne tabletter sofosbuvir
English: Treatment-naïve (QUANTUMb and 11-1-0258b) SOF+RBV 24 weeks
Danish: Behandlingsnaive (QUANTUMb og 11-1-0258b) SOF+RBV 24 uger
English: Baseline NS5B sequences were obtained for 47 patients in the Phase 2 study.
Danish: NS5B-sekvenser ved baseline blev opnået hos 47 patienter i fase II-studiet.
English: After a single 400 mg dose of [14C]-sofosbuvir in healthy subjects, the blood to plasma ratio of 14C-radioactivity was approximately 0.7.
Danish: Efter en enkelt 400 mg dosis af [14C]-sofosbuvir hos raske personer, var forholdet af 14C-radioaktivitet mellem blod og plasma ca. 0,7.
English: The safety and efficacy of 12 weeks of treatment with ledipasvir/sofosbuvir in 18 genotype 1 HCV-infected patients with severe renal impairment not requiring dialysis was also studied in Study 0154.
Danish: Sikkerheden og effekten af 12 ugers behandling med ledipasvir/sofosbuvir hos 18 genotype 1 HCV-inficerede patienter med svært nedsat nyrefunktion, som ikke krævede dialyse, blev også undersøgt i Studie 0154.
English: Relative to healthy subjects (n = 284), the sofosbuvir and GS-331007 AUC0-24 was 57% higher and 39% lower, respectively in HCV infected patients.
Danish: I forhold til raske personer (n = 284) var sofosbuvir og GS-331007 AUC0-24 hhv. 57 % højere og 39 % lavere hos HCV-inficerede patienter.
English: Cases of severe bradycardia and heart block have been observed when sofosbuvir-containing regimens are used in combination with amiodarone with or without other medicinal products that lower heart rate.
Danish: Der er iagttaget tilfælde af svær bradykardi og hjerteblok ved anvendelse af regimer, der indeholder sofosbuvir, i kombination med amiodaron med eller uden andre hjertefrekvenssænkende lægemidler.
English: No patient experienced on-treatment virologic failure or relapse.
Danish: Ingen patienter havde virologisk svigt eller recidiverede under behandling.
English: Patients with HCV genotype 2 or 3 infection in the trial were treated with sofosbuvir with ribavirin for 12 or 24 weeks, respectively.
Danish: Patienter i studiet med HCV-genotype 2- eller 3-infektion blev behandlet med sofosbuvir med ribavirin i henholdsvis 12 eller 24 uger.
English: Patients were randomised in a 1:1 ratio and stratified by cirrhosis (presence versus absence), HCV genotype (2 versus 3) and baseline HCV RNA level (<6 log10 IU/mL versus ≥6 log10 IU/mL).
Danish: Patienterne blev randomiseret i forholdet 1:1 og stratificeret efter cirrose (til stede versus ikke til stede), HCV-genotype (2 versus 3) og baseline HCV-rna-niveau (< 6 log10 IE/ml versus ≥ 6 log10 IE/ml).
English: The dose of ribavirin, when used in combination with Sovaldi is weight-based (<75 kg = 1,000 mg and ≥75 kg = 1,200 mg) and administered orally in two divided doses with food.
Danish: Dosis af ribavirin, når det anvendes i kombination med Sovaldi, er vægtbaseret (< 75 kg = 1.000 mg og ≥ 75 kg = 1.200 mg) og administreres oralt fordelt på 2 doser sammen med mad.
English: In biochemical assays, recombinant NS5B polymerase from genotypes 1b, 2a, 3a and 4a expressing the S282T substitution showed reduced susceptibility to GS-461203 compared to respective wild-types.
Danish: I biokemiske analyser viste rekombinant NS5Bpolymerase fra genotype 1b, 2a, 3a og 4a, der udtrykte S282T-substitutionen, reduceret følsomhed over for GS-461203, sammenlignet med de tilhørende vildtyper.
English: The dose linearity of sofosbuvir and its primary metabolite, GS-331007, was evaluated in fasted healthy subjects.
Danish: Dosislinearitet for sofosbuvir og den primære metabolit, GS-331007, blev evalueret hos fastende, raske personer.
English: Psychiatric disorders: Very common insomnia insomnia
Danish: Psykiske forstyrrelser: Meget almindelig søvnløshed
English: What you need to know before you take Sovaldi Do not take Sovaldi
Danish: Det skal du vide, før du begynder at tage Sovaldi Tag ikke Sovaldi
English: It is not known whether sofosbuvir, the active substance of Sovaldi, passes into human breast milk.
Danish: Det er ukendt, om sofosbuvir, det aktive stof i Sovaldi, udskilles i modermælken.
English: GS-331007 is not an inhibitor of OAT1, OCT2, and MATE1.
Danish: GS-331007 er ikke hæmmer af OAT1, OCT2 eller MATE1.
English: • Oxcarbazepine (a medicine used to treat epilepsy and prevent seizures);
Danish: • Oxcarbazepin (medicin, der anvendes til at behandle epilepsi og forebygge krampeanfald)
English: Following a single 400 mg dose of sofosbuvir, a 4 hour haemodialysis removed 18% of administered sofosbuvir dose.
Danish: Efter en enkelt dosis på 400 mg sofosbuvir, fjernede en 4-timers hæmodialysesession ca. 18 % af den administrerede dosis.
English: Cirrhosis n = number of patients with SVR12 response; N = total number of patients per group.
Danish: Samlet Uden cirrose Cirrose n = antal patienter med SVR12-respons; N = totalt antal patienter pr. gruppe.
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: Based on population pharmacokinetic analysis in patients with genotypes 1 to 6 HCV infection (n = 986), steady-state AUC0-24 for sofosbuvir and GS-331007 was 1,010 ng•h/mL and 7,200 ng•h/mL, respectively.
Danish: Baseret på populationsfarmakokinetisk analyse hos patienter med HCV-infektion af genotype 1 til 6 (n = 986) var steady-state AUC0-24 for sofosbuvir og GS-331007 hhv. 1.010 ng•t/ml og 7.200 ng•t/ml.
English: Patients were randomised in 3:1 ratio and stratified by cirrhosis (presence versus absence).
Danish: Patienterne blev randomiseret i forholdet 3:1, og stratificeret efter cirrose (til stede versus ikke til stede).
English: Sovaldi + ribavirin a for 24 weeks
Danish: Sovaldi + ribavirin a i 24 uger