natgillin/translations-raw huggingface dataset:
Tabel 8: SVR12 hos patienter med eller uden NS5A-RAV'er ved baseline efter HVC-genotype (ASTRAL-4-studiet).
Table 8: SVR12 in patients with or without baseline NS5A RAVs by HCV genotype (study ASTRAL-4)
Lægemidler, der er stærke induktorer af P-gp og/eller CYP2B6, CYP2C8 eller CYP3A4 (f.eks. carbamazepin, phenobarbital og phenytoin, rifampicin, rifabutin og perikon) kan nedsætte plasmakoncentrationen af sofosbuvir og velpatasvir, hvilket fører til en nedsat terapeutisk virkning af sofosbuvir/velpatasvir.
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.
Det frarådes at administrere Epclusa samtidig med efavirenz-holdige regimer (se pkt.
Co-administration of Epclusa with efavirenz-containing regimens is not recommended (see section 4.4).
Epclusas sikkerhed og virkning er blevet vurderet hos patienter med CPT-klasse B-cirrose, men ikke hos patienter med CPT-klasse C-cirrose (se pkt.
Safety and efficacy of Epclusa have been assessed in patients with CPT Class B cirrhosis, but not in patients with CPT Class C cirrhosis (see sections 4.4, 4.8 and 5.1).
I alt (alle GT'er) (n = 624)
Total (all GTs) (n = 624)
Epclusa er indiceret til behandling af kronisk hepatitis C-virus- (HCV-) infektion hos voksne (se pkt.
Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1).
Genotype 1, 2, 4, 5 og 6
Genotype 1, 2, 4, 5 and 6
Dosisjustering af Epclusa eller atorvastatin er ikke nødvendig.
No dose adjustment of Epclusa or atorvastatin is required.
Efter en enkelt 400 mg-dosis af [14C]-sofosbuvir hos raske personer var forholdet af [14C]-radioaktivitet mellem blod og plasma ca. 0,7.
After a single 400 mg dose of [14C]-sofosbuvir in healthy subjects, the blood to plasma ratio of [14C]-radioactivity was approximately 0.7.
Velpatasvirs farmakokinetik efter en enkelt dosis på 100 mg velpatasvir blev undersøgt hos HCV-negative patienter med moderat og svært nedsat leverfunktion (CPT-klasse B og C).
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).
1b, 2a, 3a og 4a, der udtrykker S282T-substitutionen, reduceret, sammenlignet med dets evne til at hæmme rekombinant NS5B-polymerase fra vildtypen, som angivet af en 8,5 til 24 gange øgning i 50 % hæmningskoncentrationen (IC50).
In biochemical assays, the ability of the active triphosphate of sofosbuvir (GS-461203) to inhibit recombinant NS5B polymerase from genotypes 1b, 2a, 3a and 4a expressing the S282T substitution was reduced compared to its ability to inhibit wild-type recombinant NS5B polymerase, as indicated by a 8.5- to 24-fold increase in the 50% inhibitory concentration (IC50).
↔ ↔ ↔ Dosisjustering af Epclusa eller dolutegravir er ikke nødvendig.
Dolutegravir ↔ ↔ ↔ No dose adjustment of Epclusa or dolutegravir is required.
Epclusa i 12 uger (106)
Epclusa 12 weeks (106)
Se produktresuméerne for tenofovirdisoproxilfumarat, emtricitabin/tenofovirdisoproxilfumarat eller elvitegravir/cobicistat/emtricitabin/tenofovirdisoproxilfumarat for anbefalinger vedrørende monitorering af nyrefunktionen.
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.
Ingen patienter med genotype 2-, 4- eller 6-HVC-infektion oplevede virologisk svigt.
No patients with genotype 2, 4 or 6 HCV infection experienced virologic failure.
Brug sammen med stærke P-gp-induktorer og stærke CYP-induktorer Lægemidler, der er stærke induktorer af P-glykoprotein (P-gp) og/eller af CYP (carbamazepin, phenobarbital, phenytoin, rifampicin, rifabutin og perikon).
Medicinal products that are strong P-glycoprotein (P-gp) and/or strong cytochrome P450 (CYP) inducers (carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. John's wort).
Lægemidler, der er moderate P-gpinduktorer og/eller moderate CYP-induktorer (f.eks. efavirenz, modafinil, oxcarbazepin eller rifapentin), kan nedsætte plasmakoncentrationen af sofosbuvir og velpatasvir og medføre reduceret terapeutisk virkning af Epclusa.
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.
SOF+RBV 24 ugera
SOF+RBV 24 weeksa
Famotidin doseret samtidig med Epclusad
Famotidine dosed simultaneously with Epclusad
influenzalignende symptomer, blærer i munden, øjnene og/eller på kønsorganerne
• a wide spread severe rash with peeling skin which may be accompanied by fever, flu like symptoms, blisters in the mouth, eyes, and/or genitals (Stevens Johnson syndrome).
Tabel 11 viser SVR12 for ASTRAL-2-studiet.
Table 11 presents the SVR12 for the ASTRAL-2 study.
Tabel 12 viser SVR12 for ASTRAL-3-studiet.
Table 12 presents the SVR12 for the ASTRAL-3 study.
Tacrolimus (5 mg enkeltdosis)f/ sofosbuvir (400 mg enkeltdosis)d
Tacrolimus (5 mg single dose)f/ sofosbuvir (400 mg single dose)d
Uden cirrose Med cirrose a. Fem patienter med manglende cirrosestatus i gruppen, der fik SOF+RBV i 24 uger, blev ekskluderet fra denne undergruppeanalyse.
Without cirrhosis 98% (160/163) With cirrhosis a Five patients with missing cirrhosis status in the SOF+RBV 24 week group were excluded from this subgroup analysis.
Svært RI (eGFR < 30 ml/min/ 1,73m2)
Severe RI (eGFR <30 mL/min/1.7 3m2)
g. Interval på 50-200 %, hvor der ikke er farmakokinetisk interaktion.
g Lack of pharmacokinetics interaction bounds 50-200%.
Omeprazol doseret samtidig med Epclusad
Omeprazole dosed simultaneously with Epclusad
Voksne med genotype 3-HCV-infektion - ASTRAL-3 (studie 1140) ASTRAL-3 var et randomiseret åbent studie, der evaluerede 12 ugers behandling med Epclusa versus 24 ugers behandling med SOF+RBV hos patienter med genotype 3-HCV-infektion.
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.
Brug sammen med moderate P-gp-induktorer og/eller moderate CYP-induktorer Lægemidler, der er moderate P-gp- og/eller moderate CYP-induktorer (f.eks. efavirenz, modafinil, oxcarbazepin eller rifapentin), kan nedsætte plasmakoncentrationen af sofosbuvir og velpatasvir og medføre reduceret terapeutisk virkning af Epclusa.
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.
Hvis samtidig administration anses for nødvendig, skal Epclusa administreres sammen med mad og tages 4 timer før protonpumpehæmmeren.
If it is considered necessary to co-administer, then Epclusa should be administered with food and taken 4 hours before proton pump inhibitor at max doses comparable to omeprazole 20 mg.
Dolutegravir (50 mg én gang dagligt)/sofosbuvir/ velpatasvir (400/100 mg én gang dagligt)
Dolutegravir (50 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)
Digoxin (0,25 mg enkeltdosis)f/velpatasvir (100 mg enkeltdosis)
Digoxin (0.25 mg single dose)f/ velpatasvir (100 mg single dose)
IMMUNOSUPPRESSIVA Ciclosporin (600 mg enkeltdosis)/ sofosbuvir (400 mg enkeltdosis)f
IMMUNOSUPPRESSANTS Ciclosporin (600 mg single dose)/ sofosbuvir (400 mg single dose)f
Epclusa i 12 uger (90)
Epclusa 12 weeks (90)
Med enhver NS5A-RAV'er ved baseline
With any baseline NS5A RAVs Without baseline NS5A RAVs
Voksne med genotype 2-HCV-infektion - ASTRAL-2 (studie 1139) ASTRAL-2 var et randomiseret åbent studie, der evaluerede 12 ugers behandling med Epclusa versus 12 ugers behandling med SOF+RBV hos patienter med genotype 2-HCV-infektion.
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.
Observeret: Velpatasvir
Observed: Velpatasvir
Andetd a. Der var ingen patienter med genotype 1-HCV, der havde virologisk svigt under behandlingen.
Otherd a No patients with genotype 1 HCV had on-treatment virologic failure.
Epclusa 24 uger (n = 90)
Epclusa 24 weeks (n = 90)
R-methadon ↔ ↔ ↔ Dosisjustering af Epclusa eller methadon er ikke nødvendig.
↔ ↔ ↔ No dose adjustment of Epclusa or methadone is required.
• åndenød
• shortness of breath;
(Hæmning af P-gp og CYP'er)
(Inhibition of P-gp and CYPs)
598 celler/μl (183-1.513 celler/μl).
The overall mean CD4+ count was 598 cells/µL (range: 183−1513 cells/µL).
Epclusa er kontraindiceret sammen med rifabutin (se pkt.
Epclusa is contraindicated with rifabutin (see section 4.3).
Samtidig administration af sådanne lægemidler og Epclusa frarådes (se pkt.
Co-administration of such medicinal products with Epclusa is not recommended (see section 4.5).
Rifampicin (600 mg én gang dagligt)/velpatasvir (100 mg enkeltdosis)
Rifampicin (600 mg once daily)/ velpatasvir (100 mg single dose)
Observeret: Sofosbuvir
Observed: Sofosbuvir
H2-receptorantagonister Famotidin (40 mg enkeltdosis)/ sofosbuvir/velpatasvir (400/100 mg enkeltdosis)c
H2-receptor antagonists Famotidine (40 mg single dose)/ sofosbuvir/ velpatasvir (400/ 100 mg single dose)c
Patienterne blev randomiseret i et 1:1-forhold til behandling med Epclusa i 12 uger eller SOF+RBV i 24 uger.
Patients were randomised in a 1:1 ratio to treatment with Epclusa for 12 weeks or SOF+RBV for 24 weeks.
Tabel 13: SVR12 i udvalgte undergrupper i studie ASTRAL-3 (HCV-genotype 3)
Table 13: SVR12 for selected subgroups in study ASTRAL-3 (HCV genotype 3)
Ciclosporin (600 mg enkeltdosis)f/ velpatasvir (100 mg enkeltdosis)d
Ciclosporin (600 mg single dose)f/ velpatasvir (100 mg single dose)d
Ketoconazol (200 mg to gange dagligt)/velpatasvir (100 mg enkeltdosis)d
Ketoconazole (200 mg twice daily)/ velpatasvir (100 mg single dose)d
Resultat for patienter, der ikke opnåede SVR12 Virologisk svigt under behandling
Outcome for patients without SVR12 Ontreatment virologic failure
Pravastatin (40 mg enkeltdosis)/velpatasvir (100 mg én gang dagligt)d
Pravastatin (40 mg single dose)/ velpatasvir (100 mg once daily)d
Af de 1.035 patienter, der blev behandlet med sofosbuvir/velpatasvir i de tre kliniske fase III-studier, blev 1.023 patienter inkluderet i analysen af NS5A-RAV'er.
Of the 1,035 patients treated with sofosbuvir/velpatasvir in the three Phase 3 clinical studies, 1,023 patients were included in the analysis of NS5A RAVs; 7 patients were excluded as they neither achieved sustained virologic response (SVR12) nor had virologic failure and 5 additional patients were excluded as NS5A gene sequencing failed.
Patienterne blev randomiseret i et 1:1-forhold til behandling med Epclusa i 12 uger eller SOF+RBV i 12 uger.
Patients were randomised in a 1:1 ratio to treatment with Epclusa for 12 weeks or SOF+RBV for 12 weeks.
Epclusa er kontraindiceret sammen med rifampicin (se pkt.
Epclusa is contraindicated with rifampicin (see section 4.3).
Dosisjustering af Epclusa eller pravastatin er ikke nødvendig.
No dose adjustment of Epclusa or pravastatin is required.
Sådan skal du tage Epclusa
How to take Epclusa
Genotype 2 eller 4 I alt
Genotypes 2 or 4
Epclusa i 12 uger (n = 277)
Epclusa 12 weeks (n = 277)
Epclusa er kontraindiceret sammen med carbamazepin (se pkt.
Epclusa is contraindicated with carbamazepine (see section 4.3).
• Få rådgivning fra en læge eller apotekspersonalet, hvis du tager lægemidler, der anvendes til at behandle mavesår, halsbrand eller sure opstød, da disse kan nedsætte mængden af velpatasvir i blodet.
• Get advice from a doctor or pharmacist if you take medicines used to treat stomach ulcers,
Genotype 2, 4, 5 eller 6 I alt
Genotypes 2, 4, 5 or 6 Total
(40 mg enkeltdosis)/
(400/ 100 mg single dose fed)c
• svimmelhed
• fainting.
Den ene genotype 3-patient, der havde NS5A-RAV'er ved baseline og ikke opnåede SVR12, havde NS5A-substitution Y93H ved baseline.
The single genotype 3 patient who had baseline NS5A RAVs and failed to achieve SVR12 had NS5A substitution Y93H at baseline; pharmacokinetic data from this patient was consistent with non-adherence to treatment.
Epclusa i 12 uger (n = 106)
Epclusa 12 weeks (n = 106)
HMG-CoA-REDUKTASEHÆMMERE Atorvastatin (40 mg enkelt dosis) + sofosbuvir/velpatasvir (400/100 mg én gang dagligt)d
HMG-CoA REDUCTASE INHIBITORS Atorvastatin (40 mg single dose) + sofosbuvir / velpatasvir (400/ 100 mg once daily)d
Epclusa i 12 uger (n = 624)
Epclusa 12 weeks (n = 624)
Epclusa i 12 uger (n = 134)
Epclusa 12 weeks (n = 134)
Epclusa 12 uger
Epclusa 12 weeks
Epclusa 12 uger (n = 90)
Epclusa 12 weeks (n = 90)
Patienterne blev randomiseret i et 1:1:1-forhold til behandling med Epclusa i 12 uger, Epclusa + RBV i 12 uger eller Epclusa i 24 uger.
Patients were randomised in a 1:1:1 ratio to treatment with Epclusa for 12 weeks, Epclusa + RBV for 12 weeks or Epclusa for 24 weeks.
Epclusa i 12 uger
Epclusa for 12 weeks
de to aktive stoffer i Epclusa, udskilles i mælken hos mennesker.
It is not known whether sofosbuvir or velpatasvir, the two active substances of Epclusa, pass into human breast milk.
De højeste dokumenterede doser af sofosbuvir og velpatasvir var henholdsvis en enkeltdosis på 1.200 mg og en enkeltdosis på 500 mg. I disse studier med raske frivillige blev der ikke set nogen uønskede virkninger ved disse dosisniveauer, og bivirkningerne var sammenlignelige i hyppighed og sværhedsgrad med dem, der blev rapporteret i placebogrupperne.
In these healthy volunteer studies, there were no untoward effects observed at these dose levels, and adverse events were similar in frequency and severity to those reported in the placebo groups.
Tabel 11: SVR12 i studie ASTRAL-2 (HCV-genotype 2)
Table 11: SVR12 in study ASTRAL-2 (HCV genotype 2)
ANTIVIRALE MIDLER MOD HIV: PROTEASEHÆMMERE Atazanavir boostet med ritonavir (300/100 mg én gang dagligt) + emtricitabin/ tenofovirdisoproxilfumarat (200/300 mg én gang dagligt)/sofosbuvir/ velpatasvir (400/100 mg én gang dagligt)c, d
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
ANTIMYKOBAKTERIELLE MIDLER Rifampicin (600 mg én gang dagligt)/sofosbuvir (400 mg enkeltdosis)d (Induktion af P-gp og CYP'er)
ANTIMYCOBACTERIALS Rifampicin (600 mg once daily)/ sofosbuvir (400 mg single dose)d
Dosisjustering af Epclusa, raltegravir eller emtricitabin/ tenofovirdisoproxilfumarat er ikke nødvendig.
No dose adjustment of Epclusa, raltegravir or emtricitabine/ tenofovir disoproxil fumarate is required.
Henholdsvis 90 % og 95 % af patienterne havde CPTklasse B-cirrose og MELD (Model for End Stage Liver Disease)-score ≤ 15 ved baseline.
cirrhosis and Model for End Stage Liver Disease (MELD) score ≤ 15 at baseline, respectively.
70 % af patienterne var mænd, 90 % var hvide, 6 % var sorte, 42 % havde baseline-BMI ≥ 30 kg/m2.
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.
Se produktresuméet for ribavirin for yderligere anbefalinger om graviditet, kontraception og amning, hvis ribavirin administreres sammen med Epclusa.
If ribavirin is co-administered with Epclusa, refer to the Summary of Product Characterisitics for ribavirin for detailed recommendations regarding pregnancy, contraception, and breast-feeding.
0,215 mg/0,25 mg/ ethinylestradiol 0,025 mg)/velpatasvir (100 mg én gang dagligt)d
Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ velpatasvir (100 mg once daily)d
Se produktresuméet for det lægemiddel, der indeholder ribavirin, vedrørende dosisjustering af ribavirin.
For ribavirin dose modifications, refer to the Summary of Product Characteristics of the medicinal product containing ribavirin.
Det skal du vide, før du begynder at tage Epclusa Sådan skal du tage Epclusa Bivirkninger
What Epclusa is and what it is used for What you need to know before you take Epclusa How to take Epclusa
For en sikkerheds skyld frarådes Epclusa under graviditet.
As a precautionary measure, Epclusa use is not recommended during pregnancy.
Tabel 12: SVR12 i studie ASTRAL-3 (HCV-genotype 3)
Table 12: SVR12 in study ASTRAL-3 (HCV genotype 3)
Protonpumpehæmmere Omeprazol (20 mg én gang dagligt)/ sofosbuvir/velpatasvir (400/100 mg enkeltdosis fastende)c
Proton pump inhibitors Omeprazole (20 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg single dose fasted)c
Tæt overvågning anbefales, hvis amiodaron administreres med Epclusa (se pkt.
Close monitoring is recommended if this medicinal product is administered with Epclusa (see sections 4.4 and 4.8).
Darunavir boostet med ritonavir (800 mg/100 mg én gang dagligt) + emtricitabin/ tenofovirdisoproxilfumarat (200/300 mg én gang dagligt)/sofosbuvir/ velpatasvir (400/100 mg én gang dagligt)c, d
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
↔ ↔ ↔ Dosisjustering af Epclusa, darunavir (ritonavir-boostet) eller emtricitabin/ tenofovirdisoproxilfumarat er ikke nødvendig.
↔ ↔ ↔ No dose adjustment of Epclusa, darunavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required.
Tabel 10: SVR12 i studiet ASTRAL-1 efter HCV-genotype
Table 10: SVR12 in study ASTRAL-1 by HCV genotype
Dosisjustering af Epclusa, atazanavir (ritonavir-boostet) eller emtricitabin/ tenofovirdisoproxilfumarat er ikke nødvendig.
No dose adjustment of Epclusa, atazanavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required.
Se også produktresuméet for det lægemiddel, der indeholder ribavirin, når der anvendes kombinationsbehandling med ribavirin (RBV).
When used in combination with ribavirin, refer also to the Summary of Product Characteristics of the medicinal product containing ribavirin.
Doseret 1 time efter dialyse
hr After Dialysis
Tabel 14: SVR12 i studiet ASTRAL-4 efter HCV-genotype
Table 14: SVR12 in study ASTRAL-4 by HCV genotype
56 % havde HCV-RNA-niveau ved baseline på mindst 800.000 IE/ml.
76% of the patients had non-CC IL28B alleles (CT or TT); 56% had baseline HCV RNA levels of at least 800,000 IU/mL, 55% were treatment-experienced; 90% and 95% of patients had CPT Class B
Tabel 10 viser SVR12 i ASTRAL-1-studiet efter HCV-genotyper.
Table 10 presents the SVR12 for the ASTRAL-1 study by HCV genotypes.
Efavirenz/emtricitabin/ tenofovirdisoproxilfumarat (600/200/300 mg én gang dagligt)/sofosbuvir/velpatasvir (400/100 mg én gang dagligt)c, d
Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate (600/ 200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Tabel 17: SVR12 i studiet ASTRAL-5 efter HCV-genotype
Table 17: SVR12 in study ASTRAL-5 by HCV genotype
↔ ↔ ↔ Dosisjustering af Epclusa eller elvitegravir/cobicistat/ emtricitabin/ tenofoviralafenamidfumarat er ikke nødvendig.
Elvitegravir ↔ ↔ ↔ No dose adjustment of Epclusa or elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate is required.
1,6 gange↑ 2,1 gange↑ 2,7 gange↑
1.4-fold↑
↔ ↔ ↔ Dosisjustering af Epclusa eller elvitegravir/cobicistat/ emtricitabin/ tenofovirdisoproxilfumarat er ikke nødvendig.
Elvitegravir ↔ ↔ ↔ No dose adjustment of Epclusa or elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide fumarate is required.
Lopinavir boostet med ritonavir (4 x 200 mg/50 mg én gang dagligt) + emtricitabin/ tenofovirdisoproxilfumarat (200/300 mg én gang dagligt)/sofosbuvir/ velpatasvir(400/100 mg én gang dagligt)c, d
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
Tabel 14 viser SVR12 i ASTRAL-4-studiet efter HCV-genotype.
Table 14 presents the SVR12 for the ASTRAL-4 study by HCV genotype.
• Perikon (et naturlægemiddel, der anvendes mod depression)
• St. John's wort (herbal medicine used to treat depression);
Emtricitabin/rilpivirin/ tenofovirdisoproxilfumarat (200/25/300 mg én gang dagligt)/sofosbuvir/velpatasvir (400/100 mg én gang dagligt)c, d
Emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate (200/ 25/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Elvitegravir/cobicistat/ emtricitabin/ tenofoviralafenamidfumarat (150/150/200/10 mg én gang dagligt)/sofosbuvir/ velpatasvir (400/100 mg én gang dagligt)c, d
Elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide fumarate (150/ 150/ 200/ 10 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Tabel 17 viser SVR12 i ASTRAL-5-studiet efter HCV-genotyper.
Table 17 presents the SVR12 for the ASTRAL-5 study by HCV genotype.
Elvitegravir/cobicistat/ emtricitabin/ tenofovirdisoproxilfumarat (150/150/200/300 mg én gang dagligt)/sofosbuvir/ velpatasvir (400/100 mg én gang dagligt)c, d
Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate (150/ 150/ 200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Resultat for patienter, der ikke opnåede SVR12 Virologisk svigt under behandling 0/134 Recidiva
Outcome for patients without SVR12 On-treatment virologic failure Relapsea
↔ ↔ ↔ Dosisjustering af Epclusa, lopinavir (ritonavir-boostet) eller emtricitabin/ tenofovirdisoproxilfumarat er ikke nødvendig.
↔ ↔ ↔ No dose adjustment of Epclusa, lopinavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required.
↔ ↔ ↔ Dosisjustering af Epclusa eller emtricitabin/rilpivirin/ tenofovirdisoproxilfumarat er ikke nødvendig.
Rilpivirine ↔ ↔ ↔ No dose adjustment of Epclusa or emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate is required.
Svært RI (eGFR < 30 ml/min/ 1,73 m2)
and <50 mL/min/1.73 m2)
Omeprazol (20 mg en gang dagligt)/ sofosbuvir/velpatasvir (400/100 mg enkeltdosis efter mad)c
Famotidine (40 mg single dose)/ sofosbuvir/ velpatasvir (400/ 100 mg single dose)c
Genotype 2, 4 og 6 100 % (8/8)a
100% (8/8)a
Tenofoviralafe namid
Tenofovir alafenamide Sofosbuvir
Rosuvastatin (10 mg enkeltdosis)/velpatasvir (100 mg én gang dagligt)d
Rosuvastatin (10 mg single dose)/ velpatasvir (100 mg once daily)d (Inhibition of OATP1B and BCRP)
Spørg lægen eller apotekspersonalet, hvis du har spørgsmål om dine lægemidler.
If you have any questions about your medicines, please ask your doctor or pharmacist.
Mildt RI (eGFR ≥ 50 og < 80 ml/min/ 1,73m2)
and <80 mL/min/1.7 3m2)
DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første tilladelse: 16. juli 2008
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 July 2008
• De får en anden slags medicin (se Anvendelse af andre lægemidler)
• if you are taking another type of medicine (see ‘Taking other medicines').
• Hvis De lider af alvorlig leversygdom
• If you suffer from severe liver disease.