natgillin/translations-raw huggingface dataset:
Efter administration af 14C- entecavir sås ingen oxidative eller acetylerede metabolitter og der sås mindre mængder af fase II metabolitterne, glucuronid - og sulfatkonjugater.
Following administration of 14C-entecavir, no oxidative or acetylated metabolites and minor amounts of the phase II metabolites, glucuronide and sulfate conjugates, were observed.
Entecavir elimineres primært via nyrerne, hvor omkring 75% af dosis ved steady- state kan genfindes som uomdannet lægemiddelmiddel i urinen.
12 Elimination: entecavir is predominantly eliminated by the kidney with urinary recovery of unchanged drug at steady-state of about 75% of the dose.
Nyre- clearance er uafhængig af dosis inden for området 360 - 471 ml/ min, hvilket tyder på, at entecavir gennemgår såvel glomerulær filtration som net tubulær udskillelse.
Renal clearance is independent of dose and ranges between 360-471 ml/ min suggesting that entecavir undergoes both glomerular filtration and net tubular secretion.
Efter maksimalt niveau er nået, falder plasmakoncentrationen af entecavir bi- eksponentielt med en halveringstid på ≈ 128 - 149 timer.
After reaching peak levels, entecavir plasma concentrations decreased in a bi-exponential manner with a terminal elimination half-life of ≈ 128-149 hours.
24 timer.
The observed drug accumulation index is ≈ 2 times with once daily dosing, suggesting an effective accumulation half-life of about 24 hours.
Farmakokinetiske parametre hos patienter med moderat eller svær leverinsufficiens svarede til dem hos patienter med normal leverfunktion.
Hepatic impairment: pharmacokinetic parameters in patients with moderate or severe hepatic impairment were similar to those in patients with normal hepatic function.
Entecavir- clearance falder med faldende creatinin- clearance.
Renal impairment: entecavir clearance decreases with decreasing creatinine clearance.
En 4 timers hæmodialyseperiode fjernede ≈ 13% af dosis, og 0, 3% blev fjernet ved CAPD.
A 4 hour period of haemodialysis removed ≈ 13% of the dose, and 0.3% was removed by CAPD.
Tabellen viser entecavirs farmakokinetik efter enkelt 1 mg dosis (til patienter uden kronisk hepatitis B infektion):
The pharmacokinetics of entecavir following a single 1 mg dose in patients (without chronic hepatitis B infection) are shown in the table below:
Creatinin- clearance ved baseline (ml/ min)
Baseline Creatinine Clearance (ml/ min)
Mild
Mild
Svær Svær
Severe Severe
funktion > 50; ≤ 80 > 80
> 80
30- 50
> 50;
20 - < 30
< 30
behandlet med hæmodialyse
Haemodialysis
behandlet med CAPD
with CAPD
(n = 6) (n = 6) (n = 6) (n = 6) (n = 6)
(n = 6)
(n = 4)
(n = 6)
8, 1 10, 4 10, 5 15, 3 15, 4
(n = 6)
(CV%)
(n = 4)
(30, 7) (37, 2) (22, 7) (33, 8) (56, 4)
Cmax (ng/ ml) (CV%)
(29, 7)
8.1 (30.7)
AUC( 0- T) (ng· t / ml)
AUC(0-T) (ng·h / ml)
27, 9 51, 5 69, 5 145, 7 233, 9
233.9
(25, 6) (22, 8) (22, 7) (31, 5) (28, 4)
(28.4)
Entecavir eksponering hos HBV- inficerede levertransplanterede patienter i behandling med stabil dosis ciclosporin A eller tacrolimus (n = 9) var ≈ 2 gange eksponeringen hos raske frivillige med normal nyrefunktion.
Post-Liver transplant: entecavir exposure in HBV-infected liver transplant recipients on a stable dose of cyclosporine A or tacrolimus (n = 9) was ≈ 2 times the exposure in healthy subjects with normal renal function.
4. 4).
Altered renal function contributed to the increase in entecavir exposure in these patients (see section 4.4).
Efter justering for forskelle i creatinin- clearance og kropsvægt var der ingen forskel i optagelse hos kvindelige og mandlige patienter.
After adjusting for differences in creatinine clearance and body weight there was no difference in exposure between male and female subjects.
Effekt af alder på entecavirs farmakokinetik er vurderet ved at sammenligne ældre patienter i aldersgruppen 65 - 83 år (gennemsnitsalder for kvinder 69 år, for mænd 74 år) med yngre patienter i aldersgruppen 20 - 40 år (gennemsnitsalder for kvinder 29 år, for mænd 25 år).
Elderly: the effect of age on the pharmacokinetics of entecavir was evaluated comparing elderly subjects in the age range 65-83 years (mean age females 69 years, males 74 years) with young subjects in the age range 20-40 years (mean age females 29 years, males 25 years).
Den populations- farmakokinetiske analyse, der dækker patienter i aldersgruppen 16 - 75 år, kunne ikke påvise, at alder i signifikant grad påvirkede entecavirs farmakokinetik.
After adjusting for differences in creatinine clearance and body weight, elderly subjects had a 12.5% higher AUC than young subjects. The population pharmacokinetic analysis covering patients in the age range 16-75 years did not identify age as significantly influencing entecavir pharmacokinetics.
Den populations- farmakokinetiske analyse viste ikke, at race i signifikant grad påvirkede entecavirs farmakokinetik.
Race: the population pharmacokinetic analysis did not identify race as significantly influencing entecavir pharmacokinetics.
I toksikologiske studier med gentagne doser til hunde, sås reversibel perivaskulær inflammation i det centrale nervesystem, hvor 0- effekt dosis svarede til 19 og 10 gange den hos mennesker (ved henholdsvis 0, 5 og 1 mg).
In repeat-dose toxicology studies in dogs, reversible perivascular inflammation was observed in the central nervous system, for which no-effect doses corresponded to exposures 19 and 10 times those in humans (at 0.5 and 1 mg respectively).
Dette fund blev ikke observeret i studier med gentagne doser til andre arter, inklusiv aber, der fik entecavir daglig i 1 år i doser ≥ 100 gange den humane dosis.
This finding was not observed in repeat-dose studies in other species, including monkeys administered entecavir daily for 1 year at exposures ≥ 100 times those in humans.
I reproduktions- toksikologiske studier, hvor dyr fik entecavir i op til 4 uger, sås ingen tegn på nedsat fertilitet hos han - eller hunrotter ved høje doser.
In reproductive toxicology studies in which animals were administered entecavir for up to 4 weeks, no evidence of impaired fertility was seen in male or female rats at high exposures.
Der sås ingen testikelforandringer i et 1- årigt studie med aber.
No testicular changes were evident in a 1-year study in monkeys.
Hos drægtige rotter og kaniner, der fik entecavir, svarede nul- effektniveauer for embryotoksicitet og toksicitet hos moderdyret til doser ≥ 21 gange humandosis.
In pregnant rats and rabbits administered entecavir, no effect levels for embryotoxicity and maternal toxicity corresponded to exposures ≥ 21 times those in humans.
Der er hos rotter observeret toksicitet hos moderdyret, embryo- føtal toksicitet (resorptioner), lavere føtal kropsvægt, hale - og vertebrale deformationer, reduceret ossifikation (vertebra, sternebra og falanger) samt ekstra vertebrae lumbalis og ribben ved store doser.
In rats, maternal toxicity, embryo- foetal toxicity (resorptions), lower foetal body weights, tail and vertebral malformations, reduced ossification (vertebrae, sternebrae, and phalanges), and extra lumbar vertebrae and ribs were observed at high exposures.
Der er hos kaniner observeret embryo- føtal toksicitet (resorptioner), reduceret ossifikation (hyoid) samt øget forekomst af 13. ribben ved store doser.
In rabbits, embryo-foetal toxicity (resorptions), reduced ossification (hyoid), and an increased incidence of 13th rib were observed at high exposures.
I et peri- postnatalt studie med rotter sås ingen bivirkninger hos afkommet.
In a peri-postnatal study in rats, no adverse effects on offspring were observed.
I et separat studie, hvor entecavir blev administreret til gravide, diegivende rotter med 10 mg/ kg, påvistes både føtal optagelse af entecavir og udskillelse af entecavir i mælken.
In a separate study wherein entecavir was administered to pregnant lactating rats at 10 mg/ kg, both foetal exposure to entecavir and secretion of entecavir into milk were demonstrated.
Der sås ingen tegn på genotoksicitet i Ames mikrobielle mutagenicitetsassay, en genmutations- assay med pattedyrsceller og en transformations- assay med embryoceller fra syrisk hamster.
No evidence of genotoxicity was observed in an Ames microbial mutagenicity assay, a mammalian- cell gene mutation assay, and a transformation assay with Syrian hamster embryo cells.
Et mikronukleus- studie og et DNA- reparationsstudie med rotter var ligeledes negative.
A micronucleus study and a DNA repair study in rats were also negative.
I 2- årige carcinogenicitetsstudier med hanmus sås stigninger i forekomst af lungetumorer ved doser ≥ 4 og ≥ 2 gange humandosis ved henholdsvis 0, 5 mg og 1 mg.
Two-year carcinogenicity studies: in male mice, increases in the incidences of lung tumours were observed at exposures ≥ 4 and ≥ 2 times that in humans at 0.5 mg and 1 mg respectively.
Øget forekomst af andre tumorer, inklusiv hjernegliomer hos han - og hunrotter, levercarcinomer hos hanmus, benigne vaskulæretumorer hos hunmus samt leveradenomer og carcinomer hos hunrotter sås udelukkende ved høje livstidsdoser.
Increased incidences of other tumours including brain gliomas in male and female rats, liver carcinomas in male mice, benign vascular tumours in female mice, and liver adenomas and carcinomas in female rats were seen only at high lifetime exposures.
Det er dog ikke muligt at bestemme præcise effektniveauer.
However, the no effect levels could not be precisely established.
Det vides ikke om fundene er prædikative for mennesker.
The predictivity of the findings for humans is not known.
Crospovidon Lactosemonohydrat Magnesiumstearat Cellulose, mikrokrystallinsk Povidon
Crospovidone Lactose monohydrate Magnesium stearate Cellulose, Microcrystalline Povidone
Titandioxid Hypromellose Macrogol 400
Titanium dioxide Hypromellose Macrogol 400 Polysorbate 80 (E433)
15 Polysorbat 80 (E433)
14 6.2 Incompatibilities
30 x 1 filmovertrukne tabletter; 3 blisterkort med 10 x 1 filmovertrukne tabletter, hver i alu/ alu - perforeret enkeltdosisblister eller 90 x 1 filmovertrukne tabletter; 9 blisterkort med 10 x 1 filmovertrukne tabletter, hver i alu/ alu - perforeret enkeltdosisblister.
30 x 1 film-coated tablets; 3 blister cards of 10 x 1 film-coated tablets each in Alu/ Alu perforated unit dose blisters, or 90 x 1 film-coated tablets; 9 blister cards of 10 x 1 film-coated tablets each in Alu/ Alu perforated unit dose blisters.
HDPE- beholder (high- density polyethylene) med børnesikret, polypropylen- lukning der indeholder 30 filmovertrukne tabletter.
High-density polyethylene (HDPE) bottle with child resistant polypropylene closure containing 30 film-coated tablets.
BRISTOL- MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH Storbritannien
BRISTOL-MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom
Beholdere:
Bottle packs:
Hjælpestoffer: hver tablet indeholder 241 mg lactose.
Excipients: each tablet contains 241 mg lactose.
Lyserød, trekantet tablet med “ BMS ” mærket på den ene side og “ 1612 ” på den anden.
Pink and triangular-shaped tablet with “ BMS ” debossed on one side and “ 1612” on the other.
19 Akut hepatitis- exacerbation er ligeledes indberettet hos patienter, som har seponeret hepatitis B - behandling.
18 Acute exacerbation of hepatitis has also been reported in patients who have discontinued hepatitis B therapy.
20 Human immundefekt virus (HIV) / HBV- inficererede patienter som ikke samtidig får antiretroviral behandling:
Human immunodeficiency virus (HIV)/ HBV co-infected patients not receiving concomitant antiretroviral therapy: entecavir has not been evaluated in HIV/ HBV co-infected patients not
Entecavir er ikke blevet evalueret hos HIV/ HBV- inficerede patienter, som ikke samtidig får effektiv HIV- behandling.
19 concurrently receiving effective HIV treatment.
Dette lægemiddel indeholder 241 mg lactose i hver 1 mg daglig dosis.
Lactose: this medicinal product contains 241 mg of lactose in each 1 mg daily dose.
4. 8 Bivirkninger
20 4.8 Undesirable effects
22 Laboratorietest- abnormaliteter:
Laboratory test abnormalities:
Behandling ud over 48 uger: fortsat behandling med entecavir, med en gennemsnitlig varighed på 96 uger, har ikke rejst nye sikkerhedsspørgsmål.
21 Treatment beyond 48 weeks: continued treatment with entecavir for a median duration of 96 weeks did not reveal any new safety signals.
23 skal patienten monitoreres for tegn på toksicitet og gives understøttende standardbehandling efter behov.
If overdose occurs, the patient must be monitored for evidence of toxicity and given standard supportive treatment as necessary.
Tabellen viser resultater efter 48 uger fra randomiserede, dobbeltblinde forsøg, der sammenligner entecavir (ETV) med lamivudin (LVD) hos HBeAg- positive (022) og HBeAg- negative (027) patienter.
23 (LVD) in HBeAg positive (022) and HBeAg negative (027) patients are presented in the table.
25 Lamivudin- refraktion HBeAg- positiv (studie 026)
Lamivudine-refractory HBeAg positive (study 026) ETV 1.0 mg once daily LVD 100 mg once daily n
26 Lamivudin- refraktion:
Lamivudine-refractory:
Entecavir er ikke blevet evalueret hos HIV/ HBV- inficerede patienter, der ikke samtidig fik effektiv HIV- behandling.
25 HIV/ HBV co-infected patients not receiving concomitant HAART: entecavir has not been evaluated in HIV/ HBV co-infected patients not concurrently receiving effective HIV treatment.
27 Opståen af entecavir genotype- resistens til og med år 5 i forsøg med patienter, der ikke tidligere er behandlet med nukleosid
Emerging Genotypic Entecavir Resistance Through Year 5, Nucleoside-Naive Studies a
28 Opståen af entecavir genotype- resistens til og med År 5, lamivudin- refraktoriske forsøg
26 Genotypic Entecavir Resistance Through Year 5, Lamivudine-Refractory Studies
Entecavir elimineres primært via nyrerne, hvor omkring 75% af dosis ved steady- state kan genfindes som uomdannet lægemiddelmiddel i urinen.
27 Elimination: entecavir is predominantly eliminated by the kidney with urinary recovery of unchanged drug at steady-state of about 75% of the dose.
5. 3 Prækliniske sikkerhedsdata
28 5.3 Preclinical safety data
Titandioxid Hypromellose Macrogol 400
Titanium dioxide Hypromellose Macrogol 400 Iron oxide red
6. 2 Uforligeligheder
29 6.2 Incompatibilities
Baraclude 0, 05 mg/ ml oral opløsning
Baraclude 0.05 mg/ ml oral solution
Hver ml oral opløsning indeholder 0, 05 mg entecavir (som monohydrat).
Each ml oral solution contains 0.05 mg entecavir (as monohydrate).
650 mg maltitol, flydende/ ml 2 mg methylhydroxybenzoat/ ml 0, 28 mg propylhydroxybenzoat/ ml
650 mg maltitol liquid/ ml 2 mg methylhydroxybenzoate/ ml 0.28 mg propylhydroxybenzoate/ ml
6. 1.
of excipients, see section 6.1.
Den optimale behandlingsvarighed kendes ikke.
Duration of therapy: the optimal duration of treatment is unknown.
Ved længerevarende behandling igennem mere end 2 år, anbefales
With prolonged treatment for more than 2 years, regular
34 jævnlige revurderinger med henblik på at bekræfte, at den valgte behandling fortsat er relevant for patienten.
32 reassessment is recommended to confirm that continuing the selected therapy remains appropriate for the patient.
Baraclude dosis
Baraclude dosage
én gang dagligt ELLER
0.5 mg once daily 0.25 mg once daily OR
0, 5 mg hver 48. time
0.5 mg every 48 hours
én gang dagligt ELLER
0.15 mg once daily OR
én gang dagligt ELLER
once daily OR
0, 5 mg hver 72. time
0.5 mg every 72 hours
0, 05 mg én gang dagligt
0.05 mg once daily
0, 1 mg én gang dagligt
0.1 mg once daily
Hæmodialyse eller
Haemodialysis or
0, 5 mg hver 5- 7. dag
0.5 mg every 5-7 days
** på hæmodialysedage administreres entecavir efter hæmodialysen.
**on haemodialysis days, administer entecavir after haemodialysis.
Patienter med cirrhose kan have højere
Patients with cirrhosis
35 risiko for hepatisk inkompensation efter hepatitis- exacerbation og bør derfor monitoreres tæt under behandling.
33 may be at a higher risk for hepatic decompensation following hepatitis exacerbation, and therefore should be monitored closely during therapy.
Akut hepatitis- exacerbation er ligeledes indberettet hos patienter, som har seponeret hepatitis B - behandling.
Acute exacerbation of hepatitis has also been reported in patients who have discontinued hepatitis B therapy.
Patienter, der oplever tegn på leverinsufficiens under eller efter behandling, skal - alt efter behov - monitoreres hyppigere.
Patients experiencing signs of hepatic insufficiency during or post-treatment should be monitored more frequently as appropriate.
Mutationer i den HBV- polymerase, der koder for lamivudinresistenssubstitutioner, kan forårsage sekundære substitutioner, inklusive entecavir- associerede resistenssubstitutioner (ETVr).
Resistance and specific precaution for lamivudine-refractory patients: mutations in the HBV polymerase that encode lamivudine-resistance substitutions may lead to the subsequent emergence of secondary substitutions, including those associated with entecavir associated resistance (ETVr).).
Patienter med lamivudin- resistent HBV har højere risiko for efterfølgende at udvikle entecavir- reistens end patienter, der ikke er lamivudin - resistente.
Patients with lamivudine-resistant HBV are at higher risk of developing subsequent entecavir resistance than patients without lamivudine-resistance.
Entecavir er ikke blevet evalueret hos HIV/ HBV- inficerede patienter, som ikke samtidig får effektiv HIV- behandling.
34 Human immunodeficiency virus (HIV)/ HBV co-infected patients not receiving concomitant antiretroviral therapy: entecavir has not been evaluated in HIV/ HBV co-infected patients not concurrently receiving effective HIV treatment.
Patienterne skal informeres om, at det ikke er påvist at behandling med entecavir mindsker risikoen for overførsel af HBV, og at der derfor fortsat skal tages relevante forholdsregler.
General: patients should be advised that therapy with entecavir has not been proven to reduce the risk of transmission of HBV and therefore appropriate precautions should still be taken.
Baraclude oral opløsning indeholder maltitol (13 g maltitol væske per 20 ml dosis).
Baraclude oral solution contains maltitol (13 g maltitol liquid per 20 ml dose).
Baraclude kan have en let afførende virkning.
Baraclude may have a mild laxative effect.
Maltitol indeholder 2, 3 kalorier per gram.
Calorific value 2.3 kcal/ g maltitol.
Baraclude tabletter indeholder ikke maltitol og kan tages af patienter med fruktoseintolerans.
Baraclude tablets do not contain maltitol and can be taken by patients with fructose intolerance.
Parahydroxybenzoater:
Parahydroxybenzoates:
Baraclude oral opløsning indeholder konserveringsmidlerne methylhydroxybenzoat og propylhydroxybenzoat, som kan forårsage allergiske reaktioner (muligvis forsinkede).
Baraclude oral solution contains the preservatives methylhydroxybenzoate and propylhydroxybenzoate, that may cause allergic reactions (possibly delayed).
Baraclude bør ikke anvendes under graviditet, medmindre det er absalut nødvendigt.
Baraclude should not be used during pregnancy unless clearly necessary.
37 Det vides ikke, om entecavir udskilles i modermælk.
It is unknown whether entecavir is excreted in human breast milk.
4. 7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
35 4.7 Effects on ability to drive and use machines
På baggrund af entecavirs farmakodynamiske profil, forventes disse aktiviteter ikke påvirket.
No effect on such activities is expected based on the pharmacodynamic profile of entecavir.
Inden for hverenkelt frekvensgruppe skal bivirkningerne opstilles efter, hvor alvorlige de er.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Behandling ud over 48 uger: fortsat behandling med entecavir, med en gennemsnitlig varighed på 96 uger, har ikke rejst nye sikkerhedsspørgsmål.
Treatment beyond 48 weeks: continued treatment with entecavir for a median duration of 96 weeks did not reveal any new safety signals.
38 Almene lidelser og reaktioner på indgivelsesstedet:
General disorders and administration site conditions:
Laboratorietest- abnormaliteter:
36 Laboratory test abnormalities:
Raske frivillige, som har fået op til 20 mg/ dag i op til 14 dage og enkeltdoser på op til 40 mg, har ikke oplevet uventede bivirkninger.
Healthy subjects who received up to 20 mg/ day for up to 14 days, and single doses up to 40 mg had no unexpected adverse reactions.
Farmakoterapeutisk klassifikation: nukleosid og nukleotidreverstranskriptase- hæmmer ATC- kode:
Pharmacotherapeutic group: nucleoside and nucleotide reverse transcriptase inhibitors ATC code:
Rekombinante, vira- kodende for adefovir- resistente substitutioner ved rtN236T eller rtA181V forblev fuldt følsomme over for entecavir.
Recombinant viruses encoding adefovir-resistant substitutions at either rtN236T or rtA181V remained fully susceptible to entecavir.
Respons hos patienter med en Knodell fibrose- score på 4 (cirrhose) ved baseline var sammenlignelig med den overordnede respons på alle effektmæssige resultatmål (alle patienter havde kompenseret leversygdom).
Responses for patients with baseline Knodell Fibrosis Scores of 4 (cirrhosis) were comparable to overall responses on all efficacy outcome measures (all patients had compensated liver disease).
Høje baseline Knodell nekroinflammatoriske scorer (> 10) var forbundet med større histologisk forbedring hos patienter der ikke tidligere havde været i nukleosidbehandling.
High baseline Knodell necroinflammatory scores (> 10) were associated with greater histological improvement in nucleoside- naive patients.
Såvel baseline ALAT- niveauer ≥ 2 x ULN som baseline HBV DNA ≤ 9, 0 log10 kopier/ ml var forbundet med højere forekomst af virologisk respons (Uge 48 HBV DNA < 400 kopier/ ml) hos HBeAg- positive patienter, der ikke tidligere var blevet behandlet med nukleosid.
Baseline ALT levels ≥ 2 x ULN and baseline HBV DNA ≤ 9.0 log10 copies/ ml were
Uafhængigt af baseline- karakteristika viste de fleste patienter histologisk og virologisk respons på behandling.
38 both associated with higher rates of virologic response (Week 48 HBV DNA < 400 copies/ ml) in nucleoside-naive HBeAg-positive patients.
Tabellen viser resultater efter 48 uger fra randomiserede, dobbeltblinde forsøg, der sammenligner entecavir (ETV) med lamivudin (LVD) hos HBeAg- positive (022) og HBeAg- negative (027) patienter.
Results at 48 weeks of randomised, double blind studies comparing entecavir (ETV) to lamivudine (LVD) in HBeAg positive (022) and HBeAg negative (027) patients are presented in the table.
ETV
ETV
ETV LVD ETV
ETV LVD ETV
LVD 100 mg
LVD 100 mg
0, 5 mg én
0.5 mg
100 mg én
100 mg 0.5 mg
0, 5 mg én én gang daglig
0.5 mg 100 mg 0.5 mg
gang
once daily
gang daglig
once daily once daily
N Histologisk forbedringb Forbedring i Ishak fibrose- score Forværring i Ishak fibrose- score N
n Histological improvementb Ishak fibrosis score improvement Ishak fibrosis score worsening n
314a 62% 35% 10% 355
314a 314a 72%* 62% 39% 35% 8% 10% 354 355
296a 70% * 36% 12% 325
296a 70%* 36% 12% 325
287a 61% 38% 15% 313
287a 61% 38% 15% 313
Fald i viral load (log10 kopier/ ml) c HBV- DNA kan ikke påvises (< 300 kopier/ ml ved PCR) c
Viral load reduction (log10 copies/ ml)c HBV DNA undetectable (< 300 copies/ ml by PCR)c
- 6, 86 * 67% *
-6.86* 67%*
- 5, 39 36%
-5.39 36%
- 5, 04 * 90% *
-5.04* 90%*
- 4, 53 72%
-4.53 72%
I et randomiseret, dobbeltblindt forsøg med HBeAg- positive, lamivudin- refraktoriske patienter (026), hvor 85% af patienterne havde LVDr - mutationer ved baseline, skiftede patienter, der fik lamivudin ved inklusion, til entecavir 1 mg, én gang dagligt, uden udvaskning eller overlap (n = 141) eller patienterne fortsatte med lamivudin 100 mg, én gang daglig (n = 145).
In a randomised, double-blind study in HBeAg positive lamivudine-refractory patients (026), with 85% of patients presenting LVDr mutations at baseline, patients receiving lamivudine at study entry either switched to entecavir 1 mg once daily, with neither a washout nor an overlap period (n = 141), or continued on lamivudine 100 mg once daily (n = 145).
41 Lamivudin- refraktion HBeAg- positiv (studie 026)
Lamivudine-refractory HBeAg positive (study 026) n
ETV 1, 0 mg én gang daglig a
mg once daily 124a
LVD 100
LVD 100 mg once daily 116a
mg én gang daglig
55%* 34%* 11% 141