natgillin/translations-raw huggingface dataset:
Studies NV-02B-007 (GLOBE) and CLDT600A2303 - cumulative genotypic resistance rates The original analysis for cumulative genotypic resistance at week 104 and 208 was based on the ITT population and included all patients who continued treatment until 4 years, regardless of HBV DNA levels.
Ispitivanja NV-02B-007 (GLOBE) i CLDT600A2303 - kumulativne stope genotipske rezistencije Izvorna analiza kumulativne stope genotipske rezistencije u 104. i 208. tjednu temelji se na ITT populaciji i uključuje sve bolesnike u kojih je provedeno liječenje u trajanju od 4 godine, neovisno o razini HBV DNK.
Knodell necroinflammatory score ≤ 3 (no or minimal necroinflammation) was observed in 98.2% (56/57) of patients.
(bez ili s minimalnom nekroinflamacijom) uočen je u 98,2% (56/57) bolesnika.
In HBeAg-negative patients with HBV DNA < 300 copies/ml at week 24, resistance was 0% (0/177) at 48 weeks and 5% (9/177) at week 104, whilst in patients with HBV DNA ≥ 300 copies/ml resistance was 11% (5/44) at 48 weeks and 34% (15/44) at week 104.
U HBeAg-negativnih bolesnika s HBV DNK <300 kopija/ml u 24. tjednu, rezistencija je bila 0% (0/177) u 48. tjednu i 5% (9/177) u 104. tjednu, dok je u bolesnika s HBV DNK ≥300 kopija/ml rezistencija u 48. tjednu bila 11% (5/44), a u 104. tjednu 34% (15/44).
Table 7 Key efficacy endpoints at week 104 by serum HBV DNA levels at week 24, telbivudine-treated patients in NV-02B-007 (GLOBE) study
Tablica 7 Ključni pokazatelji djelotvornosti u 104. tjednu prema razinama HBV DNK u serumu u 24. tjednu, bolesnici liječeni telbivudinom u ispitivanju NV-02B-007 (GLOBE)
300 copies/ml to < 3 log10 copies/ml
300 kopija/ml do <3 log10 kopija/ml
Discard the solution left in the cup into the sink.
Otopinu koja je preostala u čaši odbacite u sudoper.
Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Liječnik će Vas redovito kontrolirati kako bi provjerio djeluje li Sebivo.
Push the plunger carefully and slowly to remove the air until a droplet of solution appears.
Pažljivo i polagano pritišćite klip dok se ne pojavi kapljica otopine kako biste uklonili zrak.
HBeAg-positive n = 443 and 444, HBeAg-negative n = 219 and 219, for both telbivudine and lamivudine groups, respectively.
HBeAg-pozitivni n = 443 za telbivudin i 444 za lamivudin, HBeAg-negativni n = 219 za telbivudin i 219 za lamivudin.
CLDT600A2303 - Off-treatment durability of HBeAg responses Study CLDT600A2303 included HBeAg-positive patients from studies NV-02B-007 (GLOBE) or NV-02B-015 for off-treatment follow up.
CLDT600A2303 - Trajanje odgovora na HBeAg u periodu bez liječenja Ispitivanje CLDT600A2303 uključivalo je praćenje HBeAg-pozitivnih bolesnika iz ispitivanja NV02B-007 (GLOBE) ili NV-02B-015 u periodu bez liječenja.
There were no significant changes in telbivudine pharmacokinetics in hepatically impaired subjects compared to unimpaired subjects.
U ispitanika s oštećenjem jetre nije bilo značajnih promjena u farmakokinetici telbivudina u odnosu na ispitanike bez oštećenja.
ALT normalisation n/N (%)
ALT normalizacija n/N (%)
HBeAg seroconversion n/N (%)
HBeAg serokonverzija n/N (%)
In cell-based assays, lamivudine-resistant HBV strains containing either the rtM204I mutation or the rtL180M/rtM204V double mutation had ≥ 1,000-fold reduced susceptibility to telbivudine.
U analizi s pomoću staničnih kultura, HBV sojevi rezistentni na lamivudin koji sadrže ili samo mutaciju rtM204I ili dvostruku mutaciju rtL180M/rtM204V pokazali su ≥1000 puta manju osjetljivost na telbivudin.
HBeAg-positive < 300 copies/ml
HBeAg-pozitivni <300 kopija/ml
Table 5 Virological, biochemical and serological endpoints at week 52 in NV-02B-007 (GLOBE) study
Tablica 5 Virološke, biokemijske i serološke mjere ishoda u 52. tjednu ispitivanja NV-02B-007 (GLOBE)
Moreover, in the subgroup of patients with baseline ALT levels ≥ 2x ULN (320), a significantly higher proportion of telbivudine patients than lamivudine patients achieved HBeAg seroconversions at week 104 (36% vs 28%, respectively).
Osim toga, u podskupini bolesnika s početnim razinama ALT-a ≥2x GGN (320), značajno veći udio bolesnika liječenih telbivudinom je postiglo HBeAg serokonverziju u 104. tjednu (36%) u odnosu na bolesnike liječene lamivudinom (28%).
Excipient with known effect: A 600 mg dose (30 ml) of oral solution contains approximately 47 mg sodium.
Pomoćna tvar s poznatim učinkom: doza od 600 mg (30 ml) oralne otopine sadrži otprilike 47 mg natrija.
HBeAg-negative < 300 copies/ml
HBeAg-negativni <300 kopija/ml
Allow the syringe to air-dry and store with the bottle.
Pustite da se štrcaljka prirodno osuši i spremite je s bocom.
Close the bottle by screwing the cap back on tightly.
5. Zatvorite bocu tako što ćete na nju ponovno čvrsto staviti zatvarač.
Renal function (creatinine clearance in ml/min)
Bubrežna funkcija (klirens kreatinina u ml/min)
Patients with cirrhosis with decompensation
Bolesnici s cirozom i dekompenzacijom
Rare post-marketing cases of lactic acidosis have been reported with telbivudine.
Pri primjeni telbivudina zabilježeni su rijetki slučajevi laktacidoze nakon stavljanja lijeka u promet.
Assessment of adverse reactions is mainly based on two studies, NV-02B-007 (GLOBE) and NV-02B015, in which 1,699 patients with chronic hepatitis B received double-blind treatment with telbivudine 600 mg/day (n = 847) or lamivudine (n = 852) for 104 weeks.
Procjena nuspojava uglavnom se zasniva na dva dvostruko slijepa ispitivanja, NV-02B-007 (GLOBE) i NV-02B-015, u kojima je 1699 bolesnika s kroničnim hepatitisom B liječeno telbivudinom u dozi od 600 mg/day (n = 847) ili lamivudinom (n = 852) tijekom 104 tjedna.
Sodium starch glycolate Silica, colloidal anhydrous Magnesium stearate
Silicijev dioksid, koloidni, bezvodni Magnezijev stearat
Table 8 Efficacy analysis in pooled data from NV-02B-007 (GLOBE), NV-02B-015 and CLDT600A2303 studies
Tablica 8 Analiza djelotvornosti skupnih podataka iz ispitivanja NV-02B-007 (GLOBE), NV02B-015 i CLDT600A2303
What Sebivo looks like and contents of the pack Sebivo film-coated tablets are white to slightly yellowish, oval, film-coated tablets with “LDT” imprinted on one side.
Sebivo filmom obložene tablete su bijele do blago žućkaste, ovalne, filmom obložene tablete s otisnutom oznakom “LDT” na jednoj strani.
Following once-daily administration of telbivudine 600 mg, steady-state trough plasma concentrations were approximately 0.2-0.3 g/ml.
Nakon primjene 600 mg telbivudina jedanput na dan, najniže koncentracije telbivudina u plazmi u stanju dinamičke ravnoteže iznosile su otprilike 0,2-0,3 g/ml.
The single- and multiple-dose pharmacokinetics of telbivudine were evaluated in healthy subjects and in patients with chronic hepatitis B. The pharmacokinetics of telbivudine were not evaluated with the recommended dose of 600 mg in patients with chronic hepatitis B. However telbivudine pharmacokinetics are similar between both populations.
Kinetika jednokratne i višekratnih doza telbivudina ispitivana je u zdravih ispitanika i u bolesnika s kroničnim hepatitisom B. Farmakokinetika telbivudina nije ispitivana u bolesnika s kroničnim hepatitisom B pri preporučenoj dozi od 600 mg.
Table 6 Histological improvement and change in Ishak Fibrosis Score at week 52 in NV-02B007 (GLOBE) study
Tablica 6 Histološko poboljšanje i promjena prema skoru fibroze po Ishaku u 52. tjednu ispitivanja NV-02B-007 (GLOBE)
Dry the cup with a clean tissue and place it back over the cap of the bottle.
13. Osušite čašu čistom maramicom i vratite je na zatvarač boce.
Among HBeAg-positive patients, therapeutic response (63% vs 48%; p < 0.0001) and key secondary endpoints (mean log10 HBV DNA reduction: -5.74 vs -4.42; p < 0.0001, HBV DNA undetectability: 56% vs 39%; p < 0.0001 and ALT normalisation of 70% vs 62%) demonstrated a widening difference at week 104 between telbivudine and lamivudine, respectively.
Među HBeAg-pozitivnim bolesnicima, terapijski odgovor (63% u odnosu na 48%; p <0,0001) i ključni sekundarni pokazatelji ishoda (srednje smanjenje log10 HBV DNK: -5,74 u odnosu na -4,42; p <0,0001, negativan PCR: 56% u odnosu na 39%; p <0,0001 i normalizacija ALT-a u 70% u odnosu na 62%) pokazali su proširenje razlike između telbivudina odnosno lamivudina u 104. tjednu.
End-stage renal disease patients For patients with ESRD, Sebivo should be administered after haemodialysis (see section 5.2).
U bolesnika s ESRD-om Sebivo treba primjenjivati nakon hemodijalize (vidjeti dio 5.2).
- The other ingredients are: benzoic acid, sodium saccharin, passion fruit flavouring, sodium hydroxide, citrc acid anhydrous, water.
- Drugi sastojci su: benzoatna kiselina; natrijev saharin; okus marakuje; natrijev hidroksid;
Maintained ALT normalisation
Normalizacija ALT
Each film-coated tablet contains 600 mg telbivudine.
Svaka filmom obložena tableta sadrži 600 mg telbivudina.
Immediately rinse the dosing cup with water.
Odmah vodom isperite dozirnu čašu.
Lamivudine
Lamivudin
Genotypic resistance test was performed in study NV-02B-007 (GLOBE; n = 680) in patients with virological rebound (confirmed increase of ≥ 1 log10 copies/ml HBV DNA from nadir).
Ispitivanje genotipske rezistencije provedeno je u ispitivanju NV-02B-007 (GLOBE; n = 680), u bolesnika u kojih je došlo do ponovne pojave virusa (potvrđeno povećanjem HBV DNK ≥1 log10 kopija/ml od najniže vrijednosti).
Response parameter
Pokazatelj odgovora
Continue taking Sebivo every day for as long as your doctor tells you.
Uzimajte Sebivo svakoga dana i nastavite s liječenjem točno onako kako Vam je propisano, osim ako Vam liječnik ne kaže drugačije.
Lamivudine n/N (%)
Lamivudin n/N (%)
Among HBeAg-negative patients, differences in therapeutic response (78% vs 66%) and key secondary endpoints (mean log10 HBV DNA reduction: -5.00 vs -4.17, and HBV DNA undetectability: 82% vs 57%; p < 0.0001) were higher for telbivudine up to week 104.
Među HBeAg-negativnim bolesnicima, razlike u terapijskom odgovoru (78% u odnosu na 66%) i ključnim sekundarnim mjerama ishoda (srednje smanjenje log10 HBV DNK: -5,00 u odnosu na -4,17, te negativan PCR: 82% u odnosu na 57%; p <0,0001) su bile veće za telbivudin do 104. tjedna.
Histological response Improvement No improvement Ishak Fibrosis Score Improvement No change
Bez poboljšanja Skor fibroze po Ishaku Poboljšanje
This study is a phase III, randomised, double-blind study of telbivudine 600 mg once daily compared to lamivudine 100 mg once daily for a treatment period of 104 weeks in 332 nucleosidenaïve chronic hepatitis B HBeAg-positive and HBeAg-negative Chinese patients.
Ovo ispitivanje je randomizirano, dvostruko slijepo ispitivanje faze III u kojem se telbivudin u dozi od 600 mg jedanput na dan uspoređivao s lamivudinom u dozi od 100 mg jedanput na dan u trajanju liječenja od 104 tjedna u 332 HBeAg-pozitivnih i HBeAg-negativnih kineskih bolesnika s kroničnim hepatitisom B, koji dotad nisu primali nukleozide.
Cumulative resistance rates at year 4 were 22.3% for HBeAg-positive patients and 16.0% for HBeAgnegative patients in this analysis.
Takovom analizom ustanovljeno je 22,3% HBeAg-pozitivnih bolesnika i 16,0% HBeAg-negativnih bolesnika u 4. godini.
Telbivudine n/N (%)
Telbivudin n/N (%)
HBeAg seroconversion and loss assessed only in patients with detectable HBeAg at baseline.
Serokonverzija i nestanak HBeAg ispitivani su samo u bolesnika s mjerljivom početnom razinom HBeAg.
Sebivo oral solution contains approximately 47 mg of sodium per 600 mg dose (30 ml).
Sebivo oralna otopina sadrži otprilike 47 mg natrija po dozi od 600 mg (30 ml).
Adults The recommended dose of Sebivo is 30 ml, providing a dose equivalent to 600 mg, once daily.
Odrasli Preporučena doza Sebiva iznosi 30 ml, što odgovara dozi od 600 mg, jednom dnevno.
Out of the 680 telbivudine-treated patients initially included in the pivotal study NV-02B-007 (GLOBE), 517 (76%) enrolled into study CLDT600A2303 for continued telbivudine treatment for up to 208 weeks.
Od ukupno 680 bolesnika liječenih telbivudinom, prvotno uključenih u ispitivanje NV-02B-007 (GLOBE), njih 517 (76%) uključeno je u ispitivanje CLDT600A2303 i nastavak liječenja telbivudinom u trajanju do 208 tjedana.
At week 48 among HBeAg-positive and HBeAg-negative patients, 5% (23/458) and 2% (5/222), respectively, had virological rebound with detectable HBV resistance mutations.
Rezultati dobiveni u 48. tjednu pokazali su da se kod 5% (23/458) HBeAg-pozitivnih i 2% (5/222) HBeAg-negativnih bolesnika koji su primali telbivudin ponovno pojavio virus s mjerljivim HBV mutacijama odgovornima za rezistenciju.
colloidal anhydrous; magnesium stearate; hypromellose; titanium dioxide (E171); talc;
- Drugi sastojci su: mikrokristalinična celuloza; povidon; natrijev škroboglikolat; koloidni bezvodni silicijev dioksid; magnezijev stearat; hipromeloza; titanijev dioksid (E171); talk;
The recommended dose of Sebivo is 30 ml of oral solution (600 mg telbivudine) once a day.
Preporučena doza Sebiva je 30 ml oralne otopine (600 mg telbivudina) jedanput na dan.
Therefore, the combination of telbivudine with pegylated or standard interferon alfa is contraindicated (see section 4.3).
Stoga je primjena kombinacije telbivudina i pegiliranog ili standardnog interferona alfa kontraindicirana (vidjeti dio 4.3).
30 ml oral solution contain 600 mg telbivudine.
30 ml oralne otopine sadrži 600 mg telbivudina.
After 104 weeks of telbivudine therapy, 78% of patients (530/680) from study NV-02B-007 (GLOBE) and 82% (137/167) of patients from study NV-02B-015 enrolled into the extension study CLDT600A2303 (see section 5.1) to continue treatment for up to 208 weeks.
Nakon 104 tjedana terapije telbivudinom, 78% bolesnika /530/680) iz ispitivanja NV-02B-007 (GLOBE) i 82% (137/167) bolesnika iz ispitivanja NV-02B-015, uključeno je u prošireno ispitivanje CLDT600A2303 (vidjeti dio 5.1) i nastavak liječenja tijekom dodatnih 208 tjedana.
The NV-02B-007 (GLOBE) study is a randomised, double-blind, multinational phase III study of telbivudine compared to lamivudine for a treatment period of 104 weeks in 1,367 nucleoside-naïve chronic hepatitis B HBeAg-positive and HBeAg-negative patients.
Ispitivanje NV-02B-007 (GLOBE) je randomizirano, dvostruko slijepo, multinacionalno ispitivanje faze III u kojem se telbivudin uspoređivao s lamivudinom tijekom razdoblja liječenja do 104 tjedna u 1367 HBeAg-pozitivnih i HBeAg-negativnih bolesnika s kroničnim hepatitisom B, koji dotad nisu primali nukleozide.
Adults The recommended dose of Sebivo is 600 mg (one tablet) once daily.
Odrasli Preporučena doza Sebiva iznosi 600 mg (jedna tableta) jedanput na dan.
Some side effects could be serious: - Persistent muscle weakness or muscle pain - Numbness, tingling, pain and/or burning sensation in the arms and/or legs If you experience any of these, call your doctor immediately.
Neke nuspojave mogu biti ozbiljne: - trajna mišićna slabost ili bol u mišićima - obamrlost, trnci, bol i/ili osjećaj pečenja u rukama i/ili nogama
You may need to take Sebivo less frequently if you have kidney problems.
Ako imate problema s bubrezima, možda ćete Sebivo morati uzimati rjeđe.
One tablet contains 600 mg telbivudine.
Jedna tableta sadrži 600 mg telbivudina.
Tell your doctor immediately about any new or unusual symptoms that you notice after stopping treatment (see “If you stop taking Sebivo” in section 3 of this leaflet).
Odmah obavijestite svog liječnika o bilo kojem novom ili neuobičajenom simptomu kojeg ste primijetili nakon prestanka liječenja (vidjeti
In the overall ITT population the cumulative resistance rates at year 4 for HBeAg-positive and HBeAg-negative patients, was 40.8% (131/321) and 18.9% (37/196), respectively.
Unutar cjelokupne ITT populacije kumulativna stopa genotipske rezistencije u 4. godini, iznosila je 40,8% (131/321) za HBeAg-pozitivne i 40,8% (131/321) za HBeAg-negativne bolesnike.
HBV DNA undetectability n/N (%)
Nemjerljivi HBV DNK n/N (%)
ALT flare n/N (%)
ALT porast n/N (%)
Benzoic acid (E210) Sodium saccharin Passion fruit flavouring Sodium hydroxide Citric acid anhydrous Water, purified
Benzoatna kiselina (E210) Natrijev saharin Okus marakuje
The steady-state pharmacokinetics of telbivudine were unaltered following multiple dose administration in combination with lamivudine, adefovir dipivoxil, tenofovir disoproxil fumarate, ciclosporin or pegylated interferon alfa-2a.
Primjena višekratnih doza telbivudina u kombinaciji s lamivudinom, adefovir dipivoksilom, tenofovir dizoproksil fumaratom, ciklosporinom ili pegiliranim interferonom alfa-2a nije utjecala na farmakokinetiku telbivudina u stanju dinamičke ravnoteže.
Do not use this medicine after the expiry date which is stated on the carton after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza oznake „Rok valjanosti“.
Study CLDT600A2303 - Clinical results over 208 weeks Study CLDT600A2303 was an open-label 104-week extension study in patients with compensated chronic hepatitis B who were previously treated with telbivudine for 2 years including patients from studies NV-02B-007 (GLOBE) and NV-02B-015, providing efficacy and safety data after 156 and 208 weeks of continuous telbivudine therapy.
Ispitivanje CLDT600A2303 - klinički rezultati tijekom 208 tjedana Bolesnici s kompenzirajućim kroničnim hepatitisom B koji su prethodno liječeni telbivudinom tijekom 2 godine, uključujući bolesnike iz ispitivanja NV-02B (GLOBE) i NV-02B-015, obuhvaćeni su proširenim, otvorenim ispitivanjem CLDT600A2303 iz kojeg su proizašli podaci o sigurnosti i djelotvornosti terapije telbivudinom tijekom 156 i 208 tjedana.
The combination of telbivudine with any interferon alfacontaining product is contraindicated (see section 4.3).
Kombinacija telbivudina i bilo kojeg lijeka koji sadrži interferon alfa je kontraindicirana (vidjeti dio 4.3).
Outcome for key efficacy end points at 104 weeks based on week 24 results Therapeutic response n/N (%)
Rezultati za ključne pokazatelje djelotvornosti u 104. tjednu temeljeni na rezultatima u 24. tjednu
Virological breakthrough* n/N (%)
Virusni proboj* n/N (%)
Table 2 Adverse reactions
Tablica 2 Nuspojave
No definitive conclusion could be drawn regarding the effects of telbivudine on the pharmacokinetics of pegylated interferon due to high interindividual variability of pegylated interferon alfa-2a concentrations.
Zbog velikih razlika u koncentracijama pegiliranog interferona alfa-2a među bolesnicima ne može se donijeti konačan zaključak o učincima telbivudina na farmakokinetiku pegiliranog interferona.
When considering patients with viral breakthrough by 104 weeks in NV-02B-007 (GLOBE), the rate of resistance was lower in patients with HBV DNA < 300 copies/ml at week 24 than in patients with HBV DNA ≥ 300 copies/ml at week 24.
Tjedna u ispitivanju NV-02B-007 (GLOBE), stopa rezistencije je bila niža u bolesnika s HBV DNK <300 kopija/ml u 24.
Your doctor will monitor your health and do regular blood tests to check your liver after you stop treatment with Sebivo.
Nakon što prekinete liječenje Sebivom Vaš će liječnik pratiti Vaše zdravstveno stanje i redovito obavljati krvne pretrage radi provjere stanja jetre.
For full instructions on how to take Sebivo, see section “Instructions for use” at the end of this leaflet.
“Upute za uporabu” na kraju ove upute.
ALT normalisation assessed only in patients with ALT > ULN at baseline.
Normalizacija ALT-a ispitivana je samo u bolesnika s početnim ALT > GGN.
Do not take Sebivo - if you are allergic to telbivudine or any of the other ingredients of this medicine (listed in section 6).
Nemojte uzimati Sebivo - ako ste alergični na telbivudin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako se liječite pegiliranim ili standardnim interferonom alfa (vidjeti “Uzimanje drugih lijekova sa Sebivom”).
Liver transplant recipients
Bolesnici s presađenom jetrom
The incidence of on treatment alanine aminotransferase (ALT) flares in the two treatment arms according to AASLD (American Association for the Study of Liver Diseases) definition (ALT elevation > 2x baseline and > 10x ULN) are further described in Table 3 below.
American Association for the Study of Liver Diseases) (ALT povišenje >2x početne vrijednosti i >10x GGN) dodatno je prikazana niže u Tablici 3.
Peripheral neuropathy has been uncommonly reported in telbivudine-treated patients.
U bolesnika liječenih telbivudinom manje često je zabilježena periferna neuropatija.
Preparing a dose of medicine using the dosing cup
Priprema doze lijeka korištenjem dozirne čaše 1.
In the pooled analysis from NV-02B-007 (GLOBE) and NV-02B-015, by 104 weeks of treatment grade 3 or4 CK elevations (> 7x ULN) occurred in 12.6% of telbivudine-treated patients (n = 847) and 4.0% of lamivudine-treated patients (n = 846).
U udruženoj analizi ispitivanja NV-02B-007 (GLOBE) i NV-02B-015, do 104. tjedna liječenja, porast kreatin kinaze stupnja 3 ili 4 (>7x GGN) pojavio se u 12,6% bolesnika liječenih telbivudinom te u 4,0% bolesnika liječenih lamivudinom.
Telbivudine 600 mg film-coated tablet
Telbivudin 600 mg filmom obložena tableta
Mean HBV DNA reduction from baseline (log10 copies/ml) ± SEM % Patients HBV DNA undetectable by PCR
HBV DNK od početne vrijednosti (log10 kopija/ml) ± SEM % bolesnika s nemjerljivim HBV
Exacerbations of hepatitis have also been reported in patients who have terminated treatment of hepatitis B. Post-treatment ALT flares are normally associated with increases in serum HBV DNA levels, and the majority of such cases have proven to be self-limiting.
Porast ALT-a nakon prekida liječenja obično je povezan s povišenim razinama HBV DNK u serumu, a pokazalo se da je većina tih slučajeva samolimitirajuća.
Telbivudine 600 mg (n = 199)
Telbivudin 600 mg (n = 199)
In HBeAg-positive patients with HBV DNA < 300 copies/ml at week 24, resistance was 1% (3/203) at 48 weeks and 9% (18/203) at week 104, whilst in patients with HBV DNA ≥ 300 copies/ml resistance was 8% (20/247) at 48 weeks and 39% (97/247) at week 104.
Tjednu i 9% (18/203) u 104. tjednu, dok je u bolesnika s HBV DNK ≥300 kopija/ml rezistencija u 48. tjednu bila 8% (20/247), a u 104. tjednu 39% (97/247).
The recommended dose of Sebivo is one 600 mg tablet once a day.
Preporučena doza Sebiva je jedna tableta od 600 mg jedanput na dan.
These patients had completed ≥ 52 weeks of telbivudine treatment, and had exhibited HBeAg loss for ≥ 24 weeks with HBV DNA < 5 log10 copies/ml at the last on-treatment visit.
Navedeni bolesnici završili su liječenje telbuvidinom tijekom ≥52 tjedana, pri čemu je na dan posljednjeg dolaska radi primjene lijeka uočen gubitak HBeAg tijekom ≥24 tjedana s HBV DNA <5 log10 kopija/ml.
Lamivudine 100 mg (n = 386)
Lamivudin 100 mg (n = 386)
ALT flares
Porast ALT
Lamivudine 100 mg (n = 207)
Lamivudin 100 mg (n = 207)
Tabulated list of adverse reactions
Tabelarna lista nuspojava
Telbivudine 600 mg (n = 222)
Telbivudin 600 mg (n = 222)
Sebivo 20 mg/ml oral solution Telbivudine
Sebivo 20 mg/ml oralna otopina telbivudin
Lamivudine 100 mg (n = 224)
Lamivudin 100 mg (n = 224)
Sebivo 600 mg film-coated tablets
Sebivo 600 mg filmom obložene tablete
Telbivudine absorption and exposure were unaffected when a single 600 mg dose was administered with food.
Kada se jednokratna doza od 600 mg primijenila s hranom nije se promijenila niti apsorpcija telbivudina niti izloženost lijeku.
Malaise
Malaksalost
No adjustment to the recommended dose of Sebivo is necessary in patients with hepatic impairment (see section 5.2).
U bolesnika s oštećenjem jetre nije potrebno prilagođavati preporučenu dozu Sebiva (vidjeti dio 5.2).
Telbivudine 600 mg (n = 458)
Telbivudin 600 mg (n = 458)
Lamivudine 100 mg (n = 463)
Lamivudin 100 mg (n = 463)
Maintained undetectable HBV DNA (< 300 copies/ml) with undetectable HBV DNA at week 24
HBeAg-negativni bolesnici (n = 209*) Održavanje nemjerljive razine HBV DNK (<300 kopija/ml) Održavanje nemjerljive razine HBV DNK (<300 kopija/ml) s nemjerljivom razinom HBV DNK u 24. tjednu
Telbivudine 20 mg/ml oral solution
Telbivudin 20 mg/ml oralna otopina
Always put the dosing cup back onto the cap after use and cleaning.
Nakon uporabe i čišćenja dozirnu čašu uvijek vratite na zatvarač.
ALT normalisation HBeAg seroconversion HBeAg loss
HBeAg serokonverzija
PCR Assay (lower limit of quantification  300 copies/ml).
PCR ispitivanje (donja granica kvantitativnog određivanja