FrancophonIA/ELRC3.0 huggingface dataset:
English: Velpatasvir is a substrate of CYP2B6, CYP2C8, and CYP3A4 with slow turnover.
Swedish: Velpatasvir är ett substrat för CYP2B6, CYP2C8 och CYP3A4 med låg omsättning.
English: Potential for other medicinal products to affect Epclusa Sofosbuvir and velpatasvir are substrates of drug transporters P-gp and BCRP.
Swedish: Sofosbuvir och velpatasvir är substrat för läkemedelstransportörerna P-gp och BCRP.
English: Co-administration of Epclusa with rifapentine is expected to decrease the concentration of sofosbuvir and velpatasvir, leading to reduced therapeutic effect of
Swedish: Samtidig administrering av Epclusa med rifapentin förväntas sänka koncentrationen av sofosbuvir och velpatasvir och leda till minskad terapeutisk effekt av Epclusa.
English: Co-administration of Epclusa with efavirenz-containing regimens is not recommended (see section 4.4).
Swedish: Samtidig administrering av Epclusa med efavirenzinnehållande regimer rekommenderas inte (se avsnitt 4.4).
English: Rosuvastatin, at a dose that does not exceed 10 mg, may be administered with Epclusa.
Swedish: Rosuvastatin kan administreras med Epclusa vid en dos som inte överstiger 10 mg.
English: Another patient had virus with Y93H at baseline and virologic failure and also developed low levels (< 5%) of NS5B NI RAVs N142T and E237G at failure.
Swedish: I det andra fallet detekterades Y93H vid både baseline och vid virologisk svikt, och N142T och E237G (NS5B) tillkom i låga nivåer (< 5 %) vid svikt.
English: Of the 267 treated patients, the median age was 59 years (range: 40 to 73); 70% of the patients were male; 90% were White, 6% were Black; 42% had a baseline body mass index of at least 30 kg/m2.
Swedish: Av de 267 behandlade patienterna var medianåldern 59 år (intervall: 40 till 73); 70 % av patienterna var män; 90 % var vita, 6 % var svarta och 42 % hade ett kroppsmasseindex vid baseline på minst 30 kg/m2.
English: In the pooled analysis of the Phase 3 studies, 380/1,023 (37%) patients' virus had baseline NS5A RAVs.
Swedish: NS5A-RAV sågs vid baseline hos 380/1 023 (37 %) av patienternas virus.
English: Otherd a No patients with genotype 1 HCV had on-treatment virologic failure.
Swedish: Övrigtd a. Inga patienter med HCV-infektion av genotyp 1 fick virologisk svikt under behandling.
English: Note: Baseline frequency of ascites was: 20% none, 77% mild/moderate, 3% severe Baseline frequency of encephalopathy was: 38% none, 62% grade 1-2.
Swedish: Frekvens vid baseline för ascites: 20 % ingen, 77 % lindrig/måttlig, 3 % svår.
English: In vitro, slow metabolic turnover of velpatasvir by CYP2B6, CYP2C8 and CYP3A4 was observed.
Swedish: In vitro, har en långsam metabolisk omsättning av velpatasvir observerats med CYP2B6, CYP2C8 och CYP3A4.
English: Population pharmacokinetic analysis in HCV-infected patients showed that within the age range (18 to 82 years) analysed, age did not have a clinically relevant effect on the exposure to sofosbuvir, GS-331007, or velpatasvir.
Swedish: Populationsfarmakokinetisk analys av HCV-infekterade patienter visade att ålder inte hade någon kliniskt relevant effekt på exponeringen för sofosbuvir, GS-331007 eller velpatasvir inom det analyserade åldersintervallet (18 till 82 år).
English: 1.6-fold↑ 2.1-fold↑ 2.7-fold↑ 1.3-fold↑ 1.6-fold↑ ~2-fold↑ 1.8-fold↑ GS-331007 1.6-fold↑ 1.9-fold↑ 5.5-fold↑ ≥10-fold↑ ≥20-fold↑ ~7-fold↑ 18-fold↑ Velpatasvir
Swedish: 5,5 x ↑ ≥ 10 x ↑ ≥ 20 x ↑ ~ 7 x ↑ 18 x ↑
English: Epclusa 12 weeks (106)
Swedish: Epclusa 12 veckor (106)
English: With any baseline NS5A RAVs Without baseline NS5A RAVs
Swedish: Utan NS5A RAV vid baseline
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.
Swedish: Efter en peroral engångsdos på 100 mg av [14C]-velpatasvir var den genomsnittliga totala återvinningen av [14C]-radioaktivitet 95 %, varav cirka 94 % återfanns i feces och 0,4 % i urin.
English: Famotidine dosed simultaneously with Epclusad
Swedish: Famotidin doserat samtidigt med Epclusad
English: The pharmacokinetics of velpatasvir was studied with a single dose of 100 mg velpatasvir in HCV negative patients with moderate and severe hepatic impairment (CPT Class B and C).
Swedish: Farmakokinetiken för velpatasvir studerades med en engångsdos på 100 mg velpatasvir hos HCV-negativa patienter med måttlig eller gravt nedsatt leverfunktion (CPT klass B och C).
English: How to store Epclusa
Swedish: Hur Epclusa ska förvaras
English: Patients were randomised in a 1:1 ratio to treatment with Epclusa for 12 weeks or SOF+RBV for 24 weeks.
Swedish: Patienter randomiserades i förhållandet 1:1 för behandling med Epclusa i 12 veckor eller SOF + RBV i 24 veckor.
English: Digoxin (0.25 mg single dose)f/ velpatasvir (100 mg single dose)
Swedish: Digoxin (0,25 mg engångsdos)f/velpatasvir (100 mg engångsdos)
English: Cmax
Swedish: AKTIV Cmax
English: Safety data are limited in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2) and ESRD requiring haemodialysis.
Swedish: Det finns begränsat med säkerhetsdata om patienter med gravt nedsatt njurfunktion (uppskattad glomerulär filtrationshastighet [eGFR] < 30 ml/min/1,73 m2) och hemodialyskrävande ESRD.
English: Omeprazole dosed simultaneously with Epclusad
Swedish: Omeprazol doserat samtidigt med Epclusad
English: Table 11 presents the SVR12 for the ASTRAL-2 study.
Swedish: Tabell 11 visar SVR12 för ASTRAL-2-studien.
English: Effect on velpatasvir exposure not studied.
Swedish: Effekten på velpatasvirexponering har inte studerats.
English: Refer to tenofovir disoproxil fumarate, emtricitabine/tenofovir disoproxil fumarate, or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate Summary of Product Characteristics for recommendations on renal monitoring.
Swedish: Se produktresumén för tenofovirdisoproxilfumarat, emtricitabin/tenofovirdisoproxilfumarat eller elvitegravir/kobicistat/emtricitabin/tenofovirdisoproxilfumarat för rekommendationer om kontroll av njurfunktionen.
English: Patients were randomised in a 1:1 ratio to treatment with Epclusa for 12 weeks or SOF+RBV for 12 weeks.
Swedish: Patienter randomiserades i förhållandet 1:1 för behandling med Epclusa i 12 veckor eller SOF + RBV i 12 veckor.
English: Epclusa is contraindicated with phenobarbital and phenytoin (see section 4.3).
Swedish: Epclusa är kontraindicerat med fenobarbital och fenytoin (se avsnitt 4.3).
English: Median velpatasvir EC50, nM (range)
Swedish: Median-EC50 för velpatasvir, nM (intervall)
English: No NS5B nucleoside inhibitor (NI) RAVs were observed at failure in the 2 patients.
Swedish: Inga NS5B RAVs observerades vid svikt hos de 2 patienterna.
English: In clinical studies, headache, fatigue and nausea were the most common (incidence ≥ 10%) treatment emergent adverse events reported in patients treated with 12 weeks of Epclusa.
Swedish: I kliniska studier var huvudvärk, trötthet och illamående de vanligaste (förekomst ≥ 10 %)
English: Epclusa 12 weeks (90)
Swedish: Epclusa 12 veckor (90)
English: Epclusa for 12 weeks
Swedish: Epclusa i 12 veckor
English: Table 13: SVR12 for selected subgroups in study ASTRAL-3 (HCV genotype 3)
Swedish: Tabell 13: SVR12 för utvalda subgrupper i ASTRAL-3-studien (HCV-genotyp 3)
English: ANTIMYCOBACTERIALS Rifampicin (600 mg once daily)/ sofosbuvir (400 mg single dose)d
Swedish: ANTIMYKOBAKTERIELLA MEDEL Rifampicin (600 mg en gång dagligen)/sofosbuvir (400 mg engångsdos)d
English: Genotype 3 HCV-infected adults - ASTRAL-3 (study 1140) ASTRAL-3 was a randomised, open-label study that evaluated 12 weeks of treatment with Epclusa compared with 24 weeks of treatment with SOF+RBV in patients with genotype 3 HCV infection.
Swedish: Vuxna infekterade med HCV-genotyp 3 (ASTRAL-3, studie 1140) ASTRAL-3 var en randomiserad, öppen studie som utvärderade 12 veckors behandling med Epclusa jämfört med 24 veckors behandling med SOF + RBV hos patienter med HCV-infektion av genotyp 3.
English: Table 12 presents the SVR12 for the ASTRAL-3 study.
Swedish: Tabell 12 visar SVR12 för ASTRAL-3-studien.
English: Median sofosbuvir EC50, nM (range)
Swedish: Median-EC50 för sofosbuvir, nM (intervall)
English: Dolutegravir (50 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)
Swedish: Dolutegravir (50 mg en gång dagligen)/sofosbuvir/ velpatasvir (400/100 mg en gång dagligen)
English: Genotype 2 HCV-infected adults - ASTRAL-2 (study 1139) ASTRAL-2 was a randomised, open-label study that evaluated 12 weeks of treatment with Epclusa compared with 12 weeks of treatment with SOF+RBV in patients with genotype 2 HCV infection.
Swedish: Vuxna infekterade med HCV-genotyp 2 (ASTRAL-2,studie 1139) ASTRAL-2 var en randomiserad, öppen studie som utvärderade 12 veckors behandling med Epclusa jämfört med 12 veckors behandling med SOF + RBV hos patienter med HCV-infektion av genotyp 2.
English: Medicinal products that are strong inducers of P-gp and/or strong inducers of CYP2B6, CYP2C8, or CYP3A4 (e.g. carbamazepine, phenobarbital and phenytoin, rifampicin, rifabutin and St. John's wort) may decrease plasma concentrations of sofosbuvir or velpatasvir leading to reduced therapeutic effect of sofosbuvir/velpatasvir.
Swedish: Läkemedel som är starka P-gpinducerare och/eller starka CYP2B6-, CYP2C8- eller CYP3A4-inducerare (t.ex. karbamazepin, fenobarbital och fenytoin, rifampicin, rifabutin och johannesört,) kan sänka plasmakoncentrationerna av sofosbuvir eller velpatasvir och medföra minskad terapeutisk effekt av sofosbuvir/velpatasvir.
English: Phenobarbital (Induction of P-gp and CYPs)
Swedish: Rifapentin (Induktion av P-gp och CYP)
English: Medicinal products that are moderate P-gp inducers and/or moderate CYP inducers (e.g. efavirenz, modafinil, oxcarbazepine or rifapentine) may decrease sofosbuvir or velpatasvir plasma concentration leading to reduced therapeutic effect of Epclusa.
Swedish: Läkemedel som är måttliga P-gp-inducerare och/eller måttliga CYP-inducerare (t.ex. efavirenz, modafinil, oxkarbazepin eller rifapentin) kan sänka plasmakoncentrationerna av sofosbuvir eller velpatasvir och leda till minskad terapeutisk effekt av Epclusa.
English: No patients with genotype 2, 4 or 6 HCV infection experienced virologic failure.
Swedish: Inga patienter med HCV-infektion av genotyp 2, 4 eller 6 fick virologisk svikt.
English: No dose adjustment of Epclusa or pravastatin is required.
Swedish: Ingen dosjustering av Epclusa eller pravastatin krävs.
English: Rifampicin (600 mg once daily)/ velpatasvir (100 mg single dose)
Swedish: Rifampicin (600 mg en gång dagligen)/velpatasvir (100 mg engångsdos)
English: Epclusa 24 weeks (n = 90)
Swedish: Epclusa 24 veckor (n = 90)
English: Pravastatin (40 mg single dose)/ velpatasvir (100 mg once daily)d
Swedish: Pravastatin (40 mg engångsdos)/velpatasvir (100 mg en gång dagligen)d
English: Tacrolimus (5 mg single dose)f/ sofosbuvir (400 mg single dose)d
Swedish: Takrolimus (5 mg engångsdos)f/ sofosbuvir (400 mg engångsdos)d
English: Of the 740 treated patients, the median age was 56 years (range: 18 to 82); 60% of the patients were male; 79% were White, 9% were Black; 21% had a baseline body mass index of at least 30 kg/m2; the proportions of patients with genotype 1, 2, 4, 5, or 6 HCV infection were 53%, 17%, 19%, 5% and 7%, respectively; 69% had non-CC IL28B alleles (CT or TT); 74% had baseline HCV RNA levels of at least 800,000 IU/mL; 19% had compensated cirrhosis; and 32% were treatment-experienced.
Swedish: Av de 740 behandlade patienterna var medianåldern 56 år (intervall: 18 till 82); 60 % av patienterna var män; 79 % var vita, 9 % var svarta; 21 % hade ett kroppsmasseindex vid baseline på minst 30 kg/m2; andelen patienter med HCV-infektion av genotyp 1, 2, 4, 5, eller 6 var 53 %, 17 %, 19 %, 5 % respektive 7 %; 69 % hade icke-CC IL28B-alleler (CT eller TT); 74 % hade HCV-RNA-nivåer vid baseline på minst 800 000 IU/ml; 19 % hade kompenserad cirros och 32 % var behandlingserfarna.
English: (Induction of P-gp and CYPs)
Swedish: (induktion av P-gp och CYP)
English: Co-administration with such medicinal products is not recommended with Epclusa (see section 4.4).
Swedish: Samtidig administrering med sådana läkemedel rekommenderas inte med Epclusa (se avsnitt 4.4).
English: Epclusa is contraindicated with rifabutin (see section 4.3).
Swedish: Epclusa är kontraindicerat med rifabutin (se avsnitt 4.3).
English: ORAL CONTRACEPTIVES Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ sofosbuvir (400 mg once daily)d
Swedish: Norgestimat/etinylöstradiol (norgestimat 0,180 mg/ 0,215 mg/0,25 mg/ etinylöstradiol 0,025 mg)/ sofosbuvir (400 mg en gång dagligen)d
English: No patients with genotype 2, 4, 5, or 6 HCV infection experienced virologic failure.
Swedish: Inga patienter med HCV-infektion av genotyp 2, 4, 5 eller 6 fick virologisk svikt.
English: IMMUNOSUPPRESSANTS Ciclosporin (600 mg single dose)/ sofosbuvir (400 mg single dose)f
Swedish: IMMUNSUPPRESSIVA Ciklosporin (600 mg engångsdos)/ sofosbuvir (400 mg engångsdos)f
English: (Inhibition of P-gp)
Swedish: (hämning av P-gp)
English: Epclusa is contraindicated with rifampicin (see section 4.3).
Swedish: Epclusa är kontraindicerat med rifampicin (se avsnitt 4.3).
English: Interaction only studied with sofosbuvir Expected:
Swedish: Interaktionen har endast studerats med sofosbuvir.
English: Tenofovir alafenamide Sofosbuvir
Swedish: Tenofovirala fenamid Sofosbuvir
English: HMG-CoA REDUCTASE INHIBITORS Atorvastatin (40 mg single dose) + sofosbuvir / velpatasvir (400/ 100 mg once daily)d
Swedish: HMG-CoA-REDUKTASHÄMMARE Atorvastatin (40 mg engångsdos) + sofosbuvir / velpatasvir (400/100 mg en gång dagligen)d
English: Co-administration of such medicinal products with Epclusa is not recommended (see section 4.5).
Swedish: Samtidig administrering av sådana läkemedel med Epclusa rekommenderas inte (se avsnitt 4.5).
English: Tablet core
Swedish: Tablettkärna Kopovidon
English: Ketoconazole (200 mg twice daily)/ velpatasvir (100 mg single dose)d
Swedish: Ketokonazol (200 mg två gånger dagligen)/velpatasvir (100 mg engångsdos)d
English: • St. John's wort (herbal medicine used to treat depression);
Swedish: • Johannesört (växtbaserat läkemedel som används för att behandla lätt nedstämdhet)
English: Use with moderate P-gp inducers and/or moderate CYP inducers Medicinal products that are moderate P-gp and/or moderate CYP inducers (e.g. efavirenz, modafinil, oxcarbazepine or rifapentine) may decrease sofosbuvir or velpatasvir plasma concentrations leading to reduced therapeutic effect of Epclusa.
Swedish: Användning med måttliga P-gp-inducerare och/eller måttliga CYP-inducerare Läkemedel som är måttliga P-gp- och/eller måttliga CYP-inducerare (t.ex. efavirenz, modafinil, oxkarbazepin eller rifapentin) kan sänka plasmakoncentrationen av sofosbuvir eller velpatasvir och leda till minskad terapeutisk effekt av Epclusa.
English: ↔ ↔ ↔ No dose adjustment of Epclusa or methadone is required.
Swedish: R-metadon ↔ ↔ ↔ Ingen dosjustering av Epclusa eller metadon krävs.
English: Observed: Sofosbuvir
Swedish: Observerat: Sofosbuvir
English: Otherb
Swedish: Övrigtb
English: Of the 106 treated patients, the median age was 57 years (range: 25 to 72); 86% of the patients were male; 51% were white; 45% were black; 22% had a baseline body mass index ≥ 30 kg/m2; 19 patients (18%) had compensated cirrhosis; and 29% were treatment experienced.
Swedish: Bland de 106 behandlade patienterna låg medianåldern på 57 år (intervall: 25 till 72), 86 % av patienterna var män, 51 % var vita, 45 % var svarta, 22 % hade ett kroppsmasseindex (BMI) vid baseline på ≥ 30 kg/m2, 19 patienter (18 %) hade kompenserad cirros och 29 % var behandlingserfarna.
English: Use with certain HIV antiretroviral regimens
Swedish: som används för att behandla hiv-infektion
English: If you get any side effects, talk to your doctor or pharmacist.
Swedish: Rapportering av biverkningar Om du får biverkningar, tala med läkare eller apotekspersonal.
English: Epclusa 12 Weeks
Swedish: Epclusa 12 veckor
English: Epclusa is contraindicated with carbamazepine (see section 4.3).
Swedish: Epclusa är kontraindicerat med karbamazepin (se avsnitt 4.3).
English: Outcome for patients without SVR12 On-treatment virologic failure Relapsea
Swedish: Resultat för patienter utan SVR12 Virologisk svikt under behandling 0/134 Recidiva
English: Ciclosporin (600 mg single dose)f/ velpatasvir (100 mg single dose)d
Swedish: Ciklosporin (600 mg engångsdos)f/ velpatasvir (100 mg engångsdos)d
English: Of the 552 treated patients, the median age was 52 years (range: 19 to 76); 62% of the patients were male; 89% were White, 9% were Asian; 1% were Black; 20% had a baseline body mass index of at least 30 kg/m2; 61% had non-CC IL28B alleles (CT or TT); 70% had baseline HCV RNA levels of at least 800,000 IU/mL, 30% had compensated cirrhosis and 26% were treatment-experienced.
Swedish: Av de 552 behandlade patienterna var medianåldern 52 år (intervall: 19 till 76); 62 % av patienterna var män; 89 % var vita, 9 % var asiatiska, 1 % var svarta; 20 % hade ett kroppsmasseindex vid baseline på minst 30 kg/m2; 61 % hade icke-CC IL28B-alleler (CT eller TT); 70 % hade HCV-RNA-nivåer vid baseline på minst 800 000 IU/ml; 30 % hade kompenserad cirros och 26 % var behandlingserfarna.
English: Epclusa 12 weeks (n = 277)
Swedish: Epclusa 12 veckor (n = 277)
English: No dose adjustment of Epclusa, raltegravir or emtricitabine/ tenofovir disoproxil fumarate is required.
Swedish: Ingen dosjustering av Epclusa, raltegravir eller emtricitabin/ tenofovirdisoproxilfumarat krävs.
English: Epclusa 12 weeks (n = 106)
Swedish: Epclusa 12 veckor (n = 106)
English: H2-receptor antagonists Famotidine (40 mg single dose)/ sofosbuvir/ velpatasvir (400/ 100 mg single dose)c
Swedish: H2-receptorantagonister Famotidin (40 mg engångsdos)/ sofosbuvir/velpatasvir (400/100 mg engångsdos)c
English: Epclusa 12 weeks (n = 134)
Swedish: Epclusa 12 veckor (n = 134)
English: Famotidine (40 mg single dose)/ sofosbuvir/ velpatasvir (400/ 100 mg single dose)c
Swedish: Famotidin (40 mg engångsdos)/sofosbuvir/ velpatasvir (400/100 mg engångsdos)c
English: Epclusa 12 weeks (n = 624)
Swedish: Epclusa 12 veckor (n = 624)
English: Proton pump inhibitors Omeprazole (20 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg single dose fasted)c
Swedish: Protonpumpshämmare Omeprazol (20 mg en gång dagligen)/ sofosbuvir/velpatasvir (400/100 mg engångsdos på fastande mage)c
English: hr After Dialysis
Swedish: Dosering 1 tim efter dialys
English: ANTICONVULSANTS Phenytoin
Swedish: ANTIKOAGULANTIA Dabigatranetexilat
English: No dose adjustment of Epclusa, atazanavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required.
Swedish: Ingen dosjustering av Epclusa, atazanavir (ritonavirboostrat) eller emtricitabin/ tenofovirdisoproxilfumarat krävs.
English: Epclusa 12 weeks (n = 90)
Swedish: Epclusa 12 veckor (n = 90)
English: Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ velpatasvir (100 mg once daily)d
Swedish: 0,180 mg/0,215 mg/0,25 mg /etinylöstradiol 0,025 mg)/velpatasvir (100 mg en gång dagligen)d
English: and <50 mL/min/1.73 m2)
Swedish: (eGFR < 30 ml/min/ 1,73 m2)
English: ↔ ↔ ↔ No dose adjustment of oral contraceptives is required.
Swedish: ↔ ↔ ↔ Ingen dosjustering av p-piller krävs.
English: Table 12: SVR12 in study ASTRAL-3 (HCV genotype 3)
Swedish: Tabell 12: SVR12 i ASTRAL-3-studien (HCV-genotyp 3)
English: Table 11: SVR12 in study ASTRAL-2 (HCV genotype 2)
Swedish: Tabell 11: SVR12 i ASTRAL-2-studien (HCV-genotyp 2)
English: HIV ANTIVIRAL AGENTS: HIV PROTEASE INHIBITORS Atazanavir boosted with ritonavir (300/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Swedish: ANTIVIRALA HIV-LÄKEMEDEL: HIV-PROTEASHÄMMARE Atazanavir boostrat med ritonavir (300/100 mg en gång dagligen) + emtricitabin/ tenofovirdisoproxilfumarat (200/300 mg en gång dagligen)/sofosbuvir/ velpatasvir (400/100 mg en gång dagligen)c, d
English: Breast-feeding Do not breast-feed during treatment with Epclusa.
Swedish: Amma inte under behandling med Epclusa.
English: Lopinavir boosted with ritonavir (4x200 mg/ 50 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Swedish: Lopinavir boostrat med ritonavir (4x200 mg/50 mg en gång dagligen) + emtricitabin/ tenofovirdisoproxilfumarat (200/300 mg en gång dagligen)/sofosbuvir/ velpatasvir (400/100 mg en gång dagligen)c, d
English: In this study, 2 patients treated with Epclusa for 12 or 24 weeks without ribavirin had emergent NS5B S282T at low levels (< 5%) along with L159F.
Swedish: I denna studie tillkom S282T tillsammans med L159F (NS5B) i låga nivåer (< 5 %) i virusisolat (vid svikt jämfört med baseline) från 2 patienter som behandlades med Epclusa i 12 eller 24 veckor utan ribavirin
English: Rilpivirine ↔ ↔ ↔ No dose adjustment of Epclusa or emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate is required.
Swedish: Rilpivirin ↔ ↔ ↔ Ingen dosjustering av Epclusa eller emtricitabin/rilpivirin/ tenofovirdisoproxilfumarat krävs.
English: However, on the basis of NS5A resistance associated variants (RAVs) typically seen in patients who have failed therapy with other NS5A inhibitor containing regimens, the in vitro pharmacology of velpatasvir, and the outcomes of sofosbuvir/velpatasvir treatment in NS5A-naïve patients with baseline NS5A RAVs enrolled into the ASTRAL-studies, treatment with Epclusa + RBV for 24 weeks can be considered for patients who have failed therapy on an NS5A-containing regimen and who are deemed at high risk for clinical disease progression and who do not have alternative treatment options.
Swedish: Bakgrunden som stödjer sådan re-behandling är jämförelsen av velpatasvirs in vitro-farmakologi och det mönster av NS5A-resistensassocierade varianter (RAV) som ofta ses hos patienter som har haft behandlingsvikt med andra NS5A-hämmarinnehållande regimer, liksom resultaten vid behandling med sofosbuvir/velpatasvir av NS5A-naiva patienter med baseline NS5A-RAV rekryterade till ASTRAL-studierna.
English: and <80 mL/min/1.7 3m2)
Swedish: (eGFR < 3 0 ml/min/ 1,73 m2)
English: Norelgestromin Norgestrel
Swedish: Norelgestro min
English: Outcome for patients without SVR12 Ontreatment virologic failure
Swedish: Resultat för patienter utan SVR12
English: Darunavir boosted with ritonavir (800/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Swedish: Darunavir boostrat med ritonavir (800/100 mg en gång dagligen) + emtricitabin/ tenofovirdisoproxilfumarat (200/300 mg en gång dagligen)/sofosbuvir/ velpatasvir (400/100 mg en gång dagligen)c, d
English: Table 10 presents the SVR12 for the ASTRAL-1 study by HCV genotypes.
Swedish: Tabell 10 visar SVR12 för ASTRAL-1-studien efter HCV-genotyp.
English: Table 10: SVR12 in study ASTRAL-1 by HCV genotype
Swedish: Tabell 10: SVR12 i ASTRAL-1-studien efter HCV-genotyp
English: (Inhibition of P-gp and CYPs)
Swedish: (hämning av P-gp och CYP)
English: ↔ ↔ ↔ No dose adjustment of Epclusa, darunavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required.
Swedish: ↔ ↔ ↔ Ingen dosjustering av Epclusa, darunavir (ritonavirboostrat) eller emtricitabin/ tenofovirdisoproxilfumarat krävs.
English: Table 14 presents the SVR12 for the ASTRAL-4 study by HCV genotype.
Swedish: Tabell 14 visar SVR12 för ASTRAL-4-studien efter HCV-genotyp.
English: Epclusa is contraindicated with St. John's wort (see section 4.3).
Swedish: Epclusa är kontraindicerat med johannesört (se avsnitt 4.3).
English: Table 17 presents the SVR12 for the ASTRAL-5 study by HCV genotype.
Swedish: Tabell 17 visar SVR12 för ASTRAL-5-studien efter HCV-genotyp.
English: Table 17: SVR12 in study ASTRAL-5 by HCV genotype
Swedish: Tabell 17: SVR12 i ASTRAL-5-studien efter HCV-genotyp
English: Table 14: SVR12 in study ASTRAL-4 by HCV genotype
Swedish: Tabell 14: SVR12 i ASTRAL-4-studien efter HCV-genotyp
English: Omeprazole
Swedish: BRUKSANVISNING