FrancophonIA/ELRC3.0 huggingface dataset:
English: Cirrhotic (n = 80)
Danish: Med cirrose (n = 80)
English: When Epclusa is used in combination with ribavirin refer also to the Summary of Product Characteristics for ribavirin for patients with creatinine clearance < 50 mL/min (see section 5.2).
Danish: Epclusa anvendes i kombination med ribavirin til patienter med kreatininclearance < 50 ml/min (se pkt.
English: All Subjects (n = 274)
Danish: Alle forsøgspersoner (n = 274)
English: Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analogue triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator.
Danish: Sofosbuvir er et nukleotid-prodrug, der undergår intracellulær metabolisme og danner den farmakologisk aktive uridin-analog triphosphat (GS-461203), som kan inkorporeres i HCV-RNA via NS5B-polymerase og virke som en kædeterminator.
English: Microcrystalline cellulose Croscarmellose sodium Magnesium stearate
Danish: Mikrokrystallinsk cellulose Croscarmellosenatrium Magnesiumstearat
English: TN = treatment-naïve patients; TE = treatment-experienced patients (including those who have failed a peginterferon alfa + ribavirin based regimen with or without an HCV protease inhibitor)
Danish: TE = Behandlingserfarne patienter (herunder patienter, der havde oplevet behandlingssvigt med et regime baseret på peginterferon alfa + ribavirin med eller uden en HCV-proteasehæmmer) SOF: sofosbuvir.
English: Refer to the tenofovir disoproxil fumarate-containing product's Summary of Product Characteristics for recommendations on renal monitoring (see section 4.4).
Danish: Se produktresuméet for det tenofovirdisoproxilfumaratholdige præparat for anbefalinger vedrørende monitorering af nyrefunktion (se pkt.
English: Epclusa + RBV 12 weeks
Danish: Epclusa + RBV 12 uger
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 for sofosbuvir er blevet udvalgt i cellekultur for flere genotyper, herunder 1b, 2a, 2b, 3a, 4a, 5a og 6a.
English: Epclusa should be taken with food 4 hours before using a proton pump inhibitor.
Danish: Epclusa skal tages sammen med mad, 4 timer før du får en protonpumpehæmmer.
English: Potential for Epclusa to affect other medicinal products Velpatasvir is an inhibitor of drug transporter P-gp, breast cancer resistance protein (BCRP), organic anion-transporting polypeptide (OATP) 1B1 and OATP1B3.
Danish: Epclusas potentiale til at påvirke andre lægemidler Velpatasvir hæmmer lægemiddeltransportørerne P-gp, brystcancer-resistent protein (BCRP) samt organisk anion-transporterende polypeptid (OATP) 1B1 og OATP1B3.
English: • digoxin used to treat heart conditions;
Danish: • digoxin (anvendes til at behandle hjertesygdomme)
English: In vitro selection of HCV replicons with reduced susceptibility to velpatasvir was performed in cell culture for multiple genotypes including 1a, 1b, 2a, 3a, 4a, 5a and 6a.
Danish: In vitro selektion af HCV-replikoner med nedsat følsomhed for velpatasvir blev udført i cellekultur for flere genotyper, herunder 1a, 1b, 2a, 3a, 4a, 5a og 6a.
English: The pharmacokinetics of sofosbuvir was 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 efter en enkelt dosis på 400 mg blev undersøgt hos HCV-negative patienter med let (eGFR ≥ 50 og < 80 ml/min/1,73 m2), moderat (eGFR ≥ 30 og < 50 ml/min/1,73 m2) eller svært nedsat nyrefunktion (eGFR < 30 ml/min/1,73 m2) og hos patienter med ESRD, der krævede hæmodialyse i forhold til patienter med normal nyrefunktion (eGFR > 80 ml/min/1,73 m2).
English: If ribavirin is used in genotype 3 infected patients with compensated cirrhosis (pre- or post-transplant) the recommended dose of ribavirin is 1,000/1,200 mg (1,000 mg for patients weighing < 75 kg and 1,200 mg for patients weighing ≥ 75 kg).
Danish: Hvis ribavirin anvendes hos genotype 3-inficerede patienter med kompenseret cirrose (før eller efter transplantation), er den anbefalede ribavirindosis 1.000/1.200 mg (1.000 mg til patienter, der vejer
English:  If you get any side effects tell your doctor.
Danish: Hvis du oplever bivirkninger, skal du tale med lægen.
English: In one Phase 3 study in patients with decompensated cirrhosis who received Epclusa + RBV for 12 weeks, 3 patients (1 with genotype 1 and 2 with genotype 3) qualified for resistance analysis due to virologic failure.
Danish: I et fase III-studie med patienter med dekompenseret cirrose, der fik Epclusa + RBV i 12 uger, kvalificerede 3 patienter (1 med genotype 1 og 2 med genotype 3) sig til resistensanalyse pga. virologisk svigt.
English: Of the 2 genotype 1 virologic failure patients, one patient had virus with emergent NS5A RAV Y93N and the other patient had virus with emergent NS5A RAVs L31I/V and Y93H at virologic failure.
Danish: Af de 2 genotype 1-patienter med virologisk svigt havde den ene patient virus med begyndende NS5A-RAV Y93N, og den anden patient havde virus med begyndende NS5A-RAV'er L31l/V og Y93H ved virologisk svigt.
English: Table 4: Activity of sofosbuvir and velpatasvir against full-length or chimeric laboratory replicons
Danish: Tabel 4: Aktivitet af sofosbuvir og velpatasvir mod laboratoriereplikoner af fuld længde eller kimære laboratoriereplikoner
English: Epclusa is contraindicated with phenobarbital and phenytoin (see section 4.3).
Danish: Epclusa er kontraindiceret sammen med phenobarbital og phenytoin (se pkt.
English: Studies in patients with decompensated cirrhosis (CPT Class B) Analyses were conducted to explore the association between pre-existing baseline NS5A RAVs and treatment outcome for patients with decompensated cirrhosis in one Phase 3 study (ASTRAL-4).
Danish: Studier med patienter med dekompenseret cirrose (CPT-klasse B) Der blev udført analyser for at undersøge forbindelsen mellem præeksisterende NS5A-RAV'er ved baseline og behandlingsresultatet for patienter med dekompenseret cirrose i et klinisk fase III-studie (ASTRAL-4).
English: Sofosbuvir and GS-331007 AUC0-24 and Cmax were similar in healthy adult subjects and patients with HCV infection.
Danish: AUC0-24 og Cmax for sofosbuvir og GS-331007 var sammenlignelige hos raske voksne personer og hos patienter med HCV-infektion.
English: Epclusa + RBV 12 weeks (87) Epclusa 24 weeks (90)
Danish: Epclusa + RBV i 12 uger (87) Epclusa i 24 uger (90)
English: It is given to treat a chronic (long-term) viral infection of the liver called hepatitis C in adults of 18 years and older.
Danish: Det gives til behandling af voksne i alderen 18 år og derover med en kronisk (langvarig) virusinfektion i leveren, der kaldes hepatitis C.
English: Following a single 400 mg oral dose of [14C]-sofosbuvir, mean total recovery of the [14C]-radioactivity was greater than 92%, consisting of approximately 80%, 14%, and 2.5% recovered in urine, faeces, and expired air, respectively.
Danish: Efter en enkelt oral 400 mg-dosis af [14C]-sofosbuvir var den gennemsnitlige totale genfinding af [14C]-radioaktivitet over 92 %, og henholdsvis ca. 80 %, 14 % og 2,5 % blev genfundet i urin, fæces og udåndingsluft.
English: Table 15: Virologic outcome for patients with genotype 1 and 3 HCV infection in study ASTRAL-4
Danish: Tabel 15: Virologisk resultat for patienter med genotype 1- og 3-HCV-infektion i studie ASTRAL-4
English: Patients with genotype 1, 2, 4 or 6 HCV infection were randomised in a 5:1 ratio to treatment with Epclusa for 12 weeks or placebo for 12 weeks.
Danish: Patienter med genotype 1,- 2-, 4- eller 6-HCV-infektion blev randomiseret i et 5:1-forhold til behandling med Epclusa i 12 uger eller placebo i 12 uger.
English: Treatmentexperienced (n = 71)
Danish: Behandlingserfarne (n = 71)
English: Patients should be instructed that if vomiting occurs within 3 hours of dosing an additional tablet of Epclusa should be taken.
Danish: Patienterne skal informeres om at tage en ekstra tablet Epclusa, hvis de kaster op inden for 3 timer efter doseringen.
English: Epclusa 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: Anvendelse sammen med visse hiv-antiretrovirale regimer Det er vist, at Epclusa øger tenofovir-eksponeringen, særligt når det anvendes sammen med et hivregime, der indeholder tenofovirdisoproxilfumarat og en farmakokinetisk forstærker (ritonavir eller cobicistat).
English: Treatmentexperienced (n = 69)
Danish: Behandlingserfarne (n = 69)
English: The use of such medicinal products with Epclusa is contraindicated (see section 4.3).
Danish: Anvendelse af sådanne lægemidler sammen med Epclusa er kontraindiceret (se pkt.
English: The efficacy of Epclusa was evaluated in three Phase 3 studies in patients with genotype 1 to 6 HCV infection with or without compensated cirrhosis, one Phase 3 study in patients with genotype 1 to 6 HCV infection with decompensated cirrhosis, one Phase 3 study in HCV/HIV-1 co-infected patients with genotype 1 to 6 HCV infection and one Phase 2 trial in patients with HCV infection and ESRD requiring dialysis, as summarised in Table 9.
Danish: Virkningen af Epclusa blev evalueret i tre fase III-studier hos patienter med genotype 1- til 6-HCVinfektion med eller uden kompenseret cirrose, et fase III-studie hos patienter med genotype 1- til 6-HCV-infektion med dekompenseret cirrose, et fase III-studie hos patienter med samtidig infektion med HCV/hiv 1 og med genotype 1- til 6-HCV-infektion og et fase II-studie hos patienter med HCVinfektion og ESRD, som krævede dialyse, som opsummeret i tabel 9.
English: BOTTLE AND CARTON LABELLING
Danish: ETIKETTERING PÅ BEHOLDER OG KARTON
English: Table 15 presents the virologic outcome for patients with genotype 1 or 3 HCV infection in the ASTRAL-4 study.
Danish: Tabel 15 viser det virologiske resultat for patienter med genotype 1- eller 3-HCV-infektion i ASTRAL-4-studiet.
English: d Lack of pharmacokinetics interaction bounds 70-143%.
Danish: d. Interval på 70-143 %, hvor der ikke er farmakokinetisk interaktion.
English: The pharmacokinetics of sofosbuvir, GS-331007, and velpatasvir were studied in HCV-infected patients with ESRD requiring dialysis treated with Epclusa (n=59) for 12 weeks, and compared to patients without renal impairment in the sofosbuvir/velpatasvir Phase 2/3 trials.
Danish: Farmakokinetikken af sofosbuvir, GS-331007 og velpatasvir blev undersøgt hos HCV-inficerede patienter med ESRD, der krævede dialyse, og som blev behandlet med Epclusa (n=59) i 12 uger, og sammenlignet med patienter uden nedsat nyrefunktion i fase II-/III-studierne med sofosbuvir/velpatasvir.
English: Velpatasvir solubility decreases as pH increases.
Danish: Opløseligheden af velpatasvir nedsættes, når pH øges.
English: Sofosbuvir EC50, nMa Velpatasvir EC50, nMa
Danish: Replikongenotype Sofosbuvir EC50, nMa Velpatasvir EC50, nMa 1a
English: No patients with genotype 5 HCV infection were enrolled.
Danish: Der var ingen patienter med genotype 5-HCV-infektion.
English: The proportions of patients with genotype 1, 2, 3, 4 or 6 HCV were 78%, 4%, 15%, 3%, and < 1% (1 patient), respectively.
Danish: Andelene af patienter med genotype 1-, 2-, 3-, 4- eller 6-HCV var henholdsvis 78 %, 4 %, 15 %, 3 % og < 1 % (1 patient).
English: Treatment-naïve (n = 201)
Danish: Behandlingsnaive (n = 201)
English: Studies in patients with decompensated cirrhosis
Danish: Studier med patienter med dekompenseret cirrose
English: • if you have had a liver transplant • have kidney problems or if you are on kidney dialysis, since Epclusa has not been fully tested in patients with some severe kidney problems;
Danish: • hvis du har gennemgået en levertransplantation • har nyreproblemer eller hvis du er i nyredialyse, da Epclusa ikke er fuldstændigt undersøgt hos patienter med svære nyreproblemer; • er i behandling for hiv-infektion, da din læge kan ønske at overvåge dig nøjere.
English: Co-administration of Epclusa with oxcarbazepine is expected to decrease the concentration of sofosbuvir and velpatasvir, leading to reduced therapeutic effect of Epclusa.
Danish: Administration af Epclusa sammen med oxcarbazepin forventes at nedsætte koncentrationen af sofosbuvir og velpatasvir, hvilket medfører nedsat terapeutisk virkning af Epclusa.
English: Treatment with Epclusa in accordance with the recommended posology (see section 4.2) should be guided by an assessment of the potential benefits and risks for the individual patient.
Danish: 4.2) skal ledsages af en vurdering af de mulige fordele og risici for den enkelte patient.
English: ANTIFUNGALS Ketoconazole
Danish: ANTIMYKOTIKA Ketoconazol
English: If you are taking a proton pump inhibitor, take Epclusa with food 4 hours before using a proton pump inhibitor.
Danish: Hvis du tager en protonpumpehæmmer, skal Epclusa tages sammen med mad, 4 timer før du tager en protonpumpehæmmer.
English: The pharmacokinetics of velpatasvir was studied with a single dose of 100 mg velpatasvir in HCV negative patients with severe renal impairment (eGFR < 30 mL/min by Cockcroft-Gault).
Danish: Velpatasvirs farmakokinetik efter en enkelt dosis på 100 mg velpatasvir blev undersøgt hos HCV-negative patienter med svært nedsat nyrefunktion (eGFR <30 ml/min ved Cockcroft-Gault).
English: No dose adjustment of Epclusa or ciclosporin is required at initiation of co-administration.
Danish: Dosisjustering af Epclusa eller ciclosporin er ikke nødvendig ved initiering af samtidig administration.
English: Effect of baseline HCV resistance-associated variants on treatment outcome Studies in patients without cirrhosis and patients with compensated cirrhosis Analyses were conducted to explore the association between pre-existing baseline NS5A RAVs and treatment outcome for patients without cirrhosis or with compensated cirrhosis in three Phase 3 clinical studies (ASTRAL-1, ASTRAL-2 and ASTRAL-3).
Danish: Virkning af HCV-resistensassocierede varianter ved baseline på behandlingsresultatet Studier med patienter uden cirrose og patienter med kompenseret cirrose Der blev udført analyser for at undersøge forbindelsen mellem præeksisterende NS5A-RAV'er ved baseline og behandlingsresultatet for patienter uden cirrose eller med kompenseret cirrose i tre kliniske fase III-studier (ASTRAL-1, ASTRAL-2 og ASTRAL-3).
English: Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis (including decompensated cirrhosis) had no clinically relevant effect on the exposure to sofosbuvir and GS-331007.
Danish: Populationsfarmakokinetisk analyse hos HCV-inficerede patienter indikerer, at cirrose (herunder dekompenseret cirrose) ikke havde nogen klinisk relevant indvirkning på eksponeringen for sofosbuvir og GS-331007.
English: Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis (including decompensated cirrhosis) had no clinically relevant effect on the exposure to velpatasvir (see section 4.2).
Danish: Populationsfarmakokinetisk analyse hos HCV-inficerede patienter indikerer, at cirrose (herunder dekompenseret cirrose) ikke havde nogen klinisk relevant indvirkning på eksponeringen for velpatasvir (se pkt.
English: No patients with genotype 2 or 4 HCV infection in the Epclusa + RBV 12 weeks group experienced virologic failure.
Danish: Ingen patienter med genotype 2- eller 4-HCV-infektion i gruppen, der fik Epclusa + RBV i 12 uger, oplevede virologisk svigt.
English: Itraconazolee Voriconazolee Posaconazolee Isavuconazolee
Danish: Itraconazole Voriconazole Posaconazole Isavuconazole
English: Genotype 2, 4, and 6 HCV-infected patients had a higher prevalence of NS5A RAVs (70%, 63% and 52%, respectively) compared to genotype 1 (23%), genotype 3 (16%), and genotype 5 (18%) HCV-infected patients.
Danish: Patienter inficeret med HCV-genotype 2, 4 eller 6 havde en højere prævalens af NS5A-RAV'er (henholdsvis 70 %, 63 % og 52 %) sammenlignet med patienter inficeret med HCV-genotype 1 (23 %), genotype 3 (16 %) og genotype 5 (18 %).
English: • amiodarone used to treat irregular heartbeats;
Danish: • amiodaron mod uregelmæssig hjerterytme
English: In vitro potential for sofosbuvir/velpatasvir drug-drug interactions Sofosbuvir and velpatasvir are substrates of drug transporters P-gp and BCRP while GS-331007 is not.
Danish: In vitro risikoen for lægemiddelinteraktioner mellem sofosbuvir/velpatasvir Sofosbuvir og velpatasvir er substrater for lægemiddeltransportørerne P-gp og BCRP, hvorimod GS-331007 ikke er det. Velpatasvir er også substrat for OATP1B.
English: Epclusa 12 weeks (134) SOF+RBV 12 weeks (132)
Danish: Epclusa i 12 uger (134) SOF+RBV i 12 uger (132)
English: • If you are sick (vomit) less than 3 hours after taking Epclusa, take another tablet.
Danish: • Hvis du kaster op mindre end 3 timer efter, du har taget Epclusa, skal du tage en ny tablet.
English: The safety and efficacy of Epclusa in the treatment of HCV infection in patients who are post-liver transplant have not been assessed.
Danish: Patienter, der har gennemgået en levertransplantation Epclusas sikkerhed og virkning til behandling af HCV-infektion hos patienter, der har gennemgået en levertransplantation, er ikke blevet vurderet.
English: The pharmacokinetics of sofosbuvir was studied following 7-day dosing of 400 mg sofosbuvir in HCV-infected patients with moderate and severe hepatic impairment (CPT Class B and C).
Danish: Sofosbuvirs farmakokinetik blev undersøgt efter 7 dages dosering med 400 mg sofosbuvir hos HCV-inficerede patienter med moderat og svært nedsat leverfunktion (CPT-klasse B og C).
English: Patients receiving Epclusa concomitantly with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or with tenofovir disoproxil fumarate and a boosted HIV protease inhibitor should be monitored for tenofovir-associated adverse reactions.
Danish: Patienter, der får Epclusa sammen med elvitegravir/cobicistat/emtricitabin/tenofovirdisoproxilfumarat eller med tenofovirdisoproxilfumarat plus en boostet hiv-proteasehæmmer, bør overvåges for tenofovirassocierede bivirkninger.
English: Co-administration will significantly decrease sofosbuvir or velpatasvir plasma concentrations and could result in loss of efficacy of Epclusa (see section 4.5).
Danish: Samtidig administration nedsætter plasmakoncentrationen af sofosbuvir og velpatasvir signifikant og kan resultere i manglende virkning af Epclusa (se pkt.
English: No dose adjustment of Epclusa or tacrolimus is required at initiation of co-administration.
Danish: Dosisjustering af Epclusa eller tacrolimus er ikke nødvendig ved initiering af samtidig administration.
English: Clinical studies in patients with decompensated cirrhosis - ASTRAL-4 (study 1137) ASTRAL-4 was a randomised, open-label study in patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection and CPT Class B cirrhosis.
Danish: Kliniske studier med patienter med dekompenseret cirrose - ASTRAL-4 (studie1137) ASTRAL-4 var et randomiseret åbent studie med patienter med genotype 1-, 2-, 3-, 4-, 5- eller 6HCV-infektion og CPT-klasse B-cirrose.
English: If it is after 18 hours then patients should be instructed to wait and take the next dose of Epclusa at the usual time.
Danish: Hvis der er gået mere end 18 timer, skal de vente og tage den næste dosis Epclusa til sædvanlig tid.
English: Co-administration with medicinal products that inhibit P-gp or BCRP may increase sofosbuvir or velpatasvir plasma concentrations.
Danish: Samtidig administration af lægemidler, der hæmmer P-gp eller BCRP, kan øge plasmakoncentrationen af sofosbuvir og velpatasvir.
English: The 1 virologic failure patient with genotype 1 HCV had no NS5A or NS5B RAVs at failure.
Danish: Patienten med genotype 1-HCV og virologisk svigt havde ingen NS5A- eller NS5B-RAV'er på tidspunktet for svigt.
English: (Induction of P-gp and CYPs)
Danish: (Induktion af P-gp og CYP'er)
English: d Other includes patients who did not achieve SVR12 and did not meet virologic failure criteria.
Danish: d. Andet omfatter patienter, der ikke opnåede SVR12 og ikke opfyldte kriterierne for virologisk svigt.
English: Otherb a The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
Danish: Andetb a. Nævneren for recidiv er antallet af patienter med HCV-RNA < LLOQ ved deres seneste vurdering under behandling.
English: Velpatasvir had no adverse effects on behaviour, reproduction, or development of the offspring in the rat pre- and post-natal development study at AUC exposures approximately 5-fold higher than the human exposure at the recommended clinical dose.
Danish: udviklingsstudiet hos rotter før og efter fødslen havde velpatasvir ingen negative virkninger på adfærd, reproduktion eller udvikling hos afkommet ved AUC-eksponeringer ca. 5 gange højere end den humane eksponering ved den anbefalede kliniske dosis.
English: Caution is warranted and therapeutic concentration monitoring of digoxin is recommended when co-administered with Epclusa.
Danish: Der skal udvises forsigtighed, og det tilrådes at monitorere digoxinkoncentrationen ved administration sammen med Epclusa.
English: Effect on ketoconazole exposure not studied.
Danish: Virkning på ketoconazoleksponering ikke undersøgt.
English: Replicons containing NS5B from clinical isolates
Danish: Replikongenotype Replikoner, der indeholder NS5B fra kliniske isolater
English: Studies in patients without cirrhosis and patients with compensated cirrhosis In a pooled analysis of patients without cirrhosis or with compensated cirrhosis who received Epclusa for 12 weeks in three Phase 3 studies, 12 patients (2 with genotype 1 and 10 with genotype 3) qualified for resistance analysis due to virologic failure.
Danish: Studier med patienter uden cirrose og patienter med kompenseret cirrose I en samlet analyse med patienter uden cirrose eller med kompenseret cirrose, der fik Epclusa i 12 uger i tre fase III-studier, kvalificerede 12 patienter (2 med genotype 1 og 10 med genotype 3) sig til resistensanalyse pga. virologisk svigt.
English: Epclusa 12 weeks (277) SOF+RBV 24 weeks (275)
Danish: Epclusa i 12 uger (277) SOF+RBV i 24 uger (275)
English: b Other includes patients who did not achieve SVR12 and did not meet virologic failure criteria.
Danish: b. Andet omfatter patienter, der ikke opnåede SVR12 og ikke opfyldte kriterierne for virologisk svigt.
English: No dose adjustment of Epclusa or ketoconazole is required.
Danish: Dosisjustering af Epclusa eller ketoconazol er ikke nødvendig.
English: Sofosbuvir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo mouse micronucleus assays.
Danish: Sofosbuvir var ikke genotoksisk i et arsenal af in vitro- eller in vivo-analyser, herunder bakteriel mutagenicitet, kromosomafvigelse ved brug af humane lymfocytter fra perifert blod og in vivomikronukleus-analyser hos mus.
English: Velpatasvir is a substrate of CYP2B6, CYP2C8, and CYP3A4 with slow turnover.
Danish: Velpatasvir er substrat for CYP2B6, CYP2C8 og CYP3A4 med langsom omsætning.
English: Table 6: SVR12 in patients with or without baseline NS5A RAVs by HCV genotype (studies ASTRAL-1, ASTRAL-2 and ASTRAL-3)
Danish: Tabel 6: SVR12 hos patienter med eller uden NS5A-RAV'er ved baseline efter HVC-genotype (studierne ASTRAL-1, ASTRAL-2 og ASTRAL-3).
English: No NS5B NI RAVs were observed at failure in the 10 patients.
Danish: Der blev ikke set nogen NS5B-NI-RAV'er på tidspunktet for svigt hos de 10 patienter.
English: Following a single 100 mg oral dose of [14C]-velpatasvir, mean total recovery of the [14C]-radioactivity was 95%, consisting of approximately 94% and 0.4% recovered from the faeces and urine, respectively.
Danish: Efter en enkelt oral 100 mg-dosis af [14C]-velpatasvir var den gennemsnitlige totale genfinding af [14C]-radioaktivitet 95 %, og henholdsvis ca. 94 % og 0,4 % blev genfundet i fæces og urin.