natgillin/translations-raw huggingface dataset:
Interaktion kun undersøgt med velpatasvir Forventet:
Interaction only studied with velpatasvir Expected:
Studie 4062 var et åbent klinisk forsøg, som evaluerede 12 ugers behandling med Epclusa hos 59 HCV-inficerede patienter med ESRD, der krævede dialyse.
Study 4062 was an open-label clinical trial that evaluated 12 weeks of treatment with Epclusa in 59 HCV-infected patients with ESRD requiring dialysis.
De tilgængelige farmakokinetiske data fra dyrestudier viser, at velpatasvir og sofosbuvirs metabolitter udskilles i mælk.
Available pharmacokinetic data in animals have shown excretion of velpatasvir and metabolites of sofosbuvir in milk.
Ved baseline havde 29 % af patienterne cirrose, 22 % var behandlingserfarne, 32 % havde fået foretaget en nyretransplantation, 92 % var i hæmodialyse og 8 % var i peritoneal dialyse; den gennemsnitlige varighed i dialyse var 7,3 år (interval: 0 til 40 år).
At baseline, 29% of patients had cirrhosis, 22% were treatment experienced, 32% had received a kidney transplant, 92% were on haemodialysis, and 8% were on peritoneal dialysis; mean duration on dialysis was 7.3 years (range: 0 to 40 years).
Sofosbuvir og GS-331007 er hverken substrater for eller hæmmere af UGT1A1 eller enzymerne CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 og CYP2D6.
Sofosbuvir and GS-331007 are not substrates or inhibitors of UGT1A1 or CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6 enzymes.
92,9 % til 98,0 % 82,8 % til 96,4 % 92,8 % til 98,6 %
92.9% to 98.0% 82.8% to 96.4% 92.8% to 98.6%
Patienter, hvor tidligere behandling med et NS5A-indeholdende regime er mislykket Der er ingen kliniske data, der understøtter virkningen af sofosbuvir/velpatasvir hos patienter, hvor behandling med et regime indeholdende en anden NS5A-hæmmer er mislykket.
Patients who have previously failed therapy with an NS5A-containing regimen There are no clinical data to support the efficacy of sofosbuvir/velpatasvir for the treatment of patients who have failed treatment with a regimen containing another NS5A inhibitor.
Følgende pakningsstørrelse er tilgængelige: • kartonæske indeholdende 1 tabletbeholder med 28 filmovertrukne tabletter
The following pack sizes are available: • outer cartons containing 1 bottle of 28 film-coated tablets
Norelgestromin ↔ ↔ ↔ Dosisjustering af orale kontraceptiva er ikke nødvendig.
↔ ↔ ↔ No dose adjustment of oral contraceptives is required.
• rifampicin og rifabutin (antibiotika, der anvendes til behandling af infektioner, herunder tuberkulose)
• rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis);
b. n = 4 for genotype 2 og n = 2 for genotype 4
b n = 4 for genotype 2 and n = 2 for genotype 4.
Det er vist, at Epclusa øger tenofovireksponering (P-gp-hæmning).
Epclusa has been shown to increase tenofovir exposure (P-gp-inhibition).
Baseret på NS5Aresistensforbundne varianter (RAV'er), der typisk ses hos patienter, hvor behandling med andre regimer indeholdende NS5A-hæmmere er mislykket, på farmakologien af velpatasvir in vitro og på resultaterne af sofosbuvir/velpatasvir-behandling hos NS5A-naive patienter med NS5A-RAV'er ved baseline i ASTRAL-studierne, kan behandling med Epclusa + RBV i 24 uger imidlertid overvejes hos patienter, hvor behandling med et NS5A-indeholdende regime er mislykket, og som skønnes at have en høj risiko for sygdomsprogression, og hvor der ikke er alternative behandlingsmuligheder.
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.
Sofosbuvir er en pan-genotypisk hæmmer af HCV-NS5B-RNA-afhængig RNA-polymerase, som er essentiel for viral replikation.
Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication.
Omeprazol doseret 4 timer efter Epclusad
Omeprazole dosed 4 hours after Epclusad
Følgende pakningsstørrelse er tilgængelig: kartonæske indeholdende 1 beholder med 28 filmovertrukne tabletter.
The following pack sizes are available: outer cartons containing 1 bottle of 28 film-coated tablets.
Tabletkerne: Copovidon, mikrokrystallinsk cellulose, croscarmellosenatrium, magnesiumstearat
Tablet core: Copovidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearate
Epclusa + ribavirin i 12 uger a. Inklusive patienter med samtidig infektion med humant immundefektvirus (hiv) og patienter med recidiverende HCV efter levertransplantation (se pkt.
Epclusa + ribavirin for 12 weeks a Includes patients co-infected with human immunodeficiency virus (HIV) and patients with recurrent HCV post-liver transplant (see section 4.4.
0,2 % af patienterne seponerede behandlingen permanent pga. bivirkninger, og 3,2 % af de patienter, der fik Epclusa i 12 uger, oplevede alvorlige bivirkninger.
The proportion of patients who permanently discontinued treatment due to adverse events was 0.2% and the proportion of patients who experienced any severe adverse events was 3.2% for patients receiving Epclusa for 12 weeks.
ANTIVIRALE MIDLER MOD HIV: INTEGRASEHÆMMERE
HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS
Patienterne var i stabil hiv 1-antiretroviral behandling, der omfattede emtricitabin/tenofovirdisoproxilfumarat eller abacavir/lamivudin administreret sammen med en hiv-proteasehæmmer boostet med ritonavir (atazanavir, darunavir eller lopinavir), rilpivirin, raltegravir eller emtricitabin/tenofovirdisoproxilfumarat/elvitegravir/cobicistat.
Patients were on a stable HIV-1 antiretroviral therapy that included emtricitabine/tenofovir disoproxil fumarate or abacavir/lamivudine administered with a ritonavir boosted protease inhibitor (atazanavir, darunavir, or lopinavir), rilpivirine, raltegravir or emtricitabine/tenofovir disoproxil fumarate /elvitegravir/cobicistat.
Lægemidler, der hæmmer OATP, CYP2B6, CYP2C8 eller CYP3A4, kan øge plasmakoncentrationen af velpatasvir.
Medicinal products that inhibit OATP, CYP2B6, CYP2C8, or CYP3A4 may increase plasma concentration of velpatasvir.
Filmovertræk: Polyvinylalkohol, titandioxid, polyethylenglycol, talcum, rød jernoxid.
Film-coating: Polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide red
• oxcarbazepin (anvendes til at behandle epilepsi og forebygge krampeanfald)
• oxcarbazepine (medicine used to treat epilepsy and prevent seizures);
EC50-værdierne for sofosbuvir og velpatasvir i forhold til kliniske isolater er vist i tabel 5.
The EC50 values of sofosbuvir and velpatasvir against clinical isolates are presented in Table 5.
Replikoner, der indeholder NS5A fra kliniske isolater
Replicons containing NS5A from clinical isolates
Den anden patient med virologisk svigt havde virus med Y93H ved baseline og udviklede også lave niveauer (< 5 %) af NS5B-NI-RAV'er N142T og E237G på tidspunktet for svigt.
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.
50 % effektive koncentrationsværdier (EC50) for sofosbuvir og velpatasvir mod replikoner af fuld længde eller kimære replikoner, der koder for NS5B- og NS5A-sekvenser, fra laboratoriestammer er vist i tabel 4.
The 50% effective concentration (EC50) values of sofosbuvir and velpatasvir against full-length or chimeric replicons encoding NS5B and NS5A sequences from the laboratory strains are presented in Table 4.
Velpatasvir er en HCV-hæmmer, der er målrettet mod HCV-NS5A-protein, som er essentielt for både RNA-replikation og samlingen af HCV-virioner.
Velpatasvir is a HCV inhibitor targeting the HCV NS5A protein, which is essential for both RNA replication and the assembly of HCV virions.
Behandling med Epclusa i 12 uger viste statistisk superioritet (p = 0,018) i forhold til behandling med SOF+RBV i 12 uger (behandlingsdifferens +5,2 %; 95 % konfidensinterval: +0,2 % til +10,3 %).
Treatment with Epclusa for 12 weeks demonstrated the statistical superiority (p = 0.018) over treatment with SOF+RBV for 12 weeks (treatment difference +5.2%; 95% confidence interval: +0.2% to +10.3%).
Patienter uden cirrose og patienter med kompenseret cirrose.
Patients without cirrhosis and patients with compensated cirrhosis
Det skal du vide, før du begynder at tage Epclusa Tag ikke Epclusa
What you need to know before you take Epclusa Do not take Epclusa
Uden cirrose (n = 197)
Non-Cirrhotic (n = 197)
Farmakokinetikken af sofosbuvir, GS-331007 og velpatasvir hos pædiatriske patienter er ikke klarlagt (se pkt.
The pharmacokinetics of sofosbuvir, GS-331007 and velpatasvir in paediatric patients have not been established (see section 4.2).
De demografiske karakteristika og baseline-karakteristika var afbalanceret mellem behandlingsgrupperne.
Demographics and baseline characteristics were balanced across the treatment groups.
Sikkerhedsvurderingen af Epclusa blev baseret på de samlede data fra kliniske fase III-studier hos patienter med genotype 1-, 2-, 3-, 4-, 5- eller 6-HCV-infektion (med eller uden kompenseret cirrose), herunder 1.035 patienter, der fik Epclusa i 12 uger.
The safety assessment of Epclusa was based on pooled Phase 3 clinical study data from patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection (with or without compensated cirrhosis) including 1,035 patients who received Epclusa for 12 weeks.
Populationsfarmakokinetisk analyse hos HCV-inficerede patienter viste, at inden for det analyserede aldersinterval (18 til 82 år) havde alder ingen klinisk relevant indvirkning på eksponeringen for sofosbuvir, GS-331007 eller velpatasvir.
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.
TN og TE uden cirrose eller med kompenseret cirrose
TN and TE, without cirrhosis or with compensated cirrhosis
Baseret på den populationsfarmakokinetiske analyse hos HCV-inficerede patienter var middelAUC0-24 for sofosbuvir (n = 982), GS-331007 (n = 1.428) og velpatasvir (n = 1,425) hhv. 1.260, 13.970 og 2.970 ng•t/ml ved steady state.
Based on the population pharmacokinetic analysis in HCV-infected patients, mean steady-state AUC0-24 for sofosbuvir (n = 982), GS-331007 (n = 1,428) and velpatasvir (n = 1,425) were 1,260, 13,970 and 2,970 ng•h/mL, respectively.
Hos HCV-inficerede patienter med svært nedsat nyrefunktion, som blev behandlet med sofosbuvir 200 mg med ribavirin (n=10) eller sofosbuvir 400 mg med ribavirin (n=10) i 24 uger eller ledipasvir/sofosbuvir 90/400 mg (n=18) i 12 uger, var farmakokinetikken af sofosbuvir og GS-331007 overensstemmende med farmakokinetikken, som blev set hos HCV-negative patienter med svært nedsat nyrefunktion.
In HCV-infected patients with severe renal impairment treated with sofosbuvir 200 mg with ribavirin (n=10) or sofosbuvir 400 mg with ribavirin (n=10) for 24 weeks or ledipasvir/sofosbuvir 90/400 mg (n=18) for 12 weeks, the pharmacokinetics of sofosbuvir and GS-331007 were consistent with that observed in HCV negative patients with severe renal impairment.
De mulige risici og fordele forbundet med administration af Epclusa sammen med fastdosis-kombinationstabletter, der indeholder elvitegravir/cobicistat/emtricitabin/tenofovirdisoproxilfumarat eller tenofovirdisoproxilfumarat, givet sammen med en boostet hiv-proteasehæmmer (f.eks. atazanavir eller darunavir) bør overvejes, især hos patienter med øget risiko for renal dysfunktion.
The potential risks and benefits associated with co-administration of Epclusa with the fixed-dose combination tablet containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or tenofovir disoproxil fumarate given in conjunction with a boosted HIV protease inhibitor (e.g. atazanavir or darunavir) should be considered, particularly in patients at increased risk of renal dysfunction.
Hvis de kaster op senere end 3 timer efter dosering af Epclusa, er en yderligere dosis ikke nødvendig (se pkt.
If vomiting occurs more than 3 hours after dosing, no further dose of Epclusa is needed (see section 5.1).
Derfor bør Epclusa ikke anvendes under amning.
Therefore, Epclusa should not be used during breast-feeding.
Tabel 7: SVR12 hos patienter med og uden Y93H ved baseline, 1 % cut-off (resistensanalysepopulationsgruppe) ASTRAL 3
Table 7: SVR12 in patients with and without baseline Y93H, 1% Cut-off (Resistance Analysis Population Set) ASTRAL 3
c. En patient havde virologisk svigt under behandlingen.
c One patient had on-treatment virologic failure.
Sofosbuvir og GS-331007 hæmmer ikke lægemiddeltransportørerne P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 og OCT1.
Sofosbuvir and GS-331007 are not inhibitors of drug transporters P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 and OCT1.
Henholdsvis 23 % og 7 % af de 87 patienter, der blev behandlet med Epclusa + RBV i 12 uger, oplevede fald i hæmoglobin til under 10 g/dl og 8,5 g/dl under behandlingen.
Among the 87 patients who were treated with Epclusa + RBV for 12 weeks, decreases in haemoglobin to less than 10 g/dL and 8.5 g/dL during treatment were experienced by 23% and 7% patients, respectively.
Behandlingsnaive (n = 206)
Treatment-naïve (n = 206)
Der blev ikke observeret nogen teratogene virkninger i studier af udviklingstoksicitet hos mus og rotter med velpatasvir ved AUCeksponeringer ca. hhv. 31 og 6 gange højere end den humane eksponering ved den anbefalede kliniske dosis.
No teratogenic effects were observed in the mouse and rat developmental toxicity studies with velpatasvir at AUC exposures approximately 31- and 6-fold higher, respectively, than the human exposure at the recommended clinical dose.
Andelene af patienter med genotype 1-, 2-, 3-, 4-, 6- eller ubestemt HCV-infektion var henholdsvis 42 %, 12 %, 27 %, 7 % , 3 % og 9 %.
The proportions of patients with genotype 1, 2, 3, 4, 6 or indeterminate HCV infection were 42%, 12%, 27%, 7% , 3%, and 9%, respectively.
Blandt de patienter, der fik behandling med Epclusa + RBV i 12 uger, havde 29 % (25/85) af patienterne virus med NS5A-RAV'er ved baseline: 29 % (19/66), 75 % (3/4), 15 % (2/13) og 50 % (1/2) for patienter med henholdsvis genotype 1-, 2-, 3- og 4-HCV.
Among the patients who received treatment with Epclusa + RBV for 12 weeks, 29% (25/85) of patients had baseline virus with NS5A RAVs: 29% (19/66), 75% (3/4), 15% (2/13), and 50% (1/2) for patients with genotype 1, 2, 3 and 4 HCV, respectively.
Tre patienter i gruppen, der fik Epclusa + RBV i 12 uger, havde NS5B-NI-RAV'er ved baseline (N142T og L159F), og alle tre patienter opnåede SVR12.
Three patients in the Epclusa + RBV 12 week group had baseline NS5B NI RAVs (N142T and L159F) and all three patients achieved SVR12.
Efter en enkelt dosis på 100 mg [14C]-velpatasvir var størstedelen (> 98 %) af radioaktiviteten i plasma moderstof.
Following a single dose of 100 mg [14C]-velpatasvir, the majority (> 98%) of radioactivity in plasma was parent drug.
Virkning på rifampicineksponering ikke undersøgt.
Effect on rifampicin exposure not studied.
Interaktioner mellem Epclusa og andre lægemidler Tabel 3 viser en liste over påviste eller potentielt klinisk signifikante lægemiddelinteraktioner (hvor 90 % konfidensintervallet [KI] for middelratio beregnet ved mindste kvadraters metode var inden for
Interactions between Epclusa and other medicinal products Table 3 provides a listing of established or potentially clinically significant medicinal product interactions (where 90% confidence interval [CI] of the geometric least-squares mean [GLSM] ratio were within “↔”, extended above “↑”, or extended below “↓” the predetermined interaction boundaries).
Behandling med Epclusa i 12 uger viste statistisk superioritet (p < 0,001) i forhold til behandling med SOF+RBV i 24 uger (behandlingsdifferens +14,8 %, 95 % konfidensinterval: +9,6 % til +20,0 %).
Treatment with Epclusa for 12 weeks demonstrated the statistical superiority (p < 0.001) compared to treatment with SOF+RBV for 24 weeks (treatment difference +14.8%; 95% confidence interval: +9.6% to +20.0%).
F.eks. aluminium- eller magnesiumhydroxid, calciumcarbonat
Antacids e.g. Aluminium or magnesium hydroxide; calcium carbonate
Ribavirin blev seponeret hos 15 % af patienterne, der blev behandlet med Epclusa + RBV i 12 uger, pga. bivirkninger.
Ribavirin was discontinued in 15% of patients treated with Epclusa + RBV for 12 weeks due to adverse events.
Med cirrose (n = 80)
Cirrhotic (n = 80)
Epclusa anvendes i kombination med ribavirin til patienter med kreatininclearance < 50 ml/min (se pkt.
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).
Alle forsøgspersoner (n = 274)
All Subjects (n = 274)
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.
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.
Mikrokrystallinsk cellulose Croscarmellosenatrium Magnesiumstearat
Microcrystalline cellulose Croscarmellose sodium Magnesium stearate
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.
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)
Se produktresuméet for det tenofovirdisoproxilfumaratholdige præparat for anbefalinger vedrørende monitorering af nyrefunktion (se pkt.
Refer to the tenofovir disoproxil fumarate-containing product's Summary of Product Characteristics for recommendations on renal monitoring (see section 4.4).
Epclusa + RBV 12 uger
Epclusa + RBV 12 weeks
HCV-replikoner med nedsat følsomhed for sofosbuvir er blevet udvalgt i cellekultur for flere genotyper, herunder 1b, 2a, 2b, 3a, 4a, 5a og 6a.
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.
Epclusa skal tages sammen med mad, 4 timer før du får en protonpumpehæmmer.
Epclusa should be taken with food 4 hours before using a proton pump inhibitor.
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.
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.
• digoxin (anvendes til at behandle hjertesygdomme)
• digoxin used to treat heart conditions;
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.
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.
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).
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).
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
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).
Hvis du oplever bivirkninger, skal du tale med lægen.
 If you get any side effects tell your doctor.
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.
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.
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.
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.
Tabel 4: Aktivitet af sofosbuvir og velpatasvir mod laboratoriereplikoner af fuld længde eller kimære laboratoriereplikoner
Table 4: Activity of sofosbuvir and velpatasvir against full-length or chimeric laboratory replicons
Epclusa er kontraindiceret sammen med phenobarbital og phenytoin (se pkt.
Epclusa is contraindicated with phenobarbital and phenytoin (see section 4.3).
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).
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).
AUC0-24 og Cmax for sofosbuvir og GS-331007 var sammenlignelige hos raske voksne personer og hos patienter med HCV-infektion.
Sofosbuvir and GS-331007 AUC0-24 and Cmax were similar in healthy adult subjects and patients with HCV infection.
Epclusa + RBV i 12 uger (87) Epclusa i 24 uger (90)
Epclusa + RBV 12 weeks (87) Epclusa 24 weeks (90)
Det gives til behandling af voksne i alderen 18 år og derover med en kronisk (langvarig) virusinfektion i leveren, der kaldes hepatitis C.
It is given to treat a chronic (long-term) viral infection of the liver called hepatitis C in adults of 18 years and older.
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.
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.
Tabel 15: Virologisk resultat for patienter med genotype 1- og 3-HCV-infektion i studie ASTRAL-4
Table 15: Virologic outcome for patients with genotype 1 and 3 HCV infection in study ASTRAL-4
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.
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.