natgillin/translations-raw huggingface dataset:
The full EPAR for Zeffix is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zeffix je na voljo tukaj.
Pharmaceutical forms
Farmacevtska oblika
Route of administration Packaging
Pot uporabe Ovojnina
EU/ 1/ 99/ 114/ 001 EU/ 1/ 99/ 114/ 002
EU/ 1/ 99/ 114/ 001 Zeffix EU/ 1/ 99/ 114/ 002 Zeffix
Oral use Blister (Alu/ pvc) Oral use Blister (Alu/ pvc)
pretisni omot (Alu/ pvc) pretisni omot (Alu/ pvc)
28 tablets 84 tablets
28 tablet 84 tablet
EU/ 1/ 99/ 114/ 003
EU/ 1/ 99/ 114/ 003 Zeffix
Oral solution
peroralno
Zeffix film-coated tablets contain 100 mg lamivudine For a full list of excipients see section 6.1.
Zeffix filmsko obložene tablete vsebujejo 100 mg lamivudina Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
Butterscotch coloured, film-coated, capsule shaped, biconvex and engraved “ GX CG5” on one face.
Karamelne barve, filmsko obložene, v obliki kapsule, bikonveksne in imajo na eni strani vtisnjeno oznako “ GX CG5 ”.
Zeffix is indicated for the treatment of chronic hepatitis B in adults with:
Zeffix je indiciran za zdravljenje kroničnega hepatitisa B pri odraslih:
compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis.
• s kompenzirano jetrno boleznijo, z znaki aktivne replikacije virusa, s trajnim povečanjem vrednosti serumske alanin- aminotransferaze (ALT) in histološkimi dokazi aktivnega vnetja in/ ali fibroze jeter,
decompensated liver disease.
• z dekompenzirano jetrno boleznijo.
Therapy with Zeffix should be initiated by a physician experienced in the management of chronic hepatitis B.
Zdravljenje z Zeffixom mora uvesti zdravnik, ki ima izkušnje z zdravljenjem kroničnega hepatitisa B.
Adults: the recommended dosage of Zeffix is 100 mg once daily.
Priporočeni odmerek Zeffixa je 100 mg enkrat dnevno.
Zeffix can be taken with or without food.
Zeffix se lahko vzame s hrano ali brez nje.
• In patients with HBeAg positive chronic hepatitis B (CHB) treatment should be administered for at least 3-6 months after HBeAg seroconversion (HBeAg and HBV DNA loss with HBeAb detection) is confirmed, to limit the risk of virological relapse, or until HBsAg seroconversion.
• Pri HBeAg pozitivnih bolnikih s kroničnim hepatitisom B (CHB) mora zdravljenje trajati še vsaj 3- 6 mesecev po potrditvi serokonverzije HBeAg (izginotje HBeAg in HBV DNA ter detekcija HBeAb) v dveh zaporednih vzorcih seruma z vsaj 3- mesečnim vmesnim presledkom, da se omeji tveganje virusnega relapsa, ali do serokonverzije HBsAg.
This recommendation is based on limited data (see section 5.1). • In patients with HBeAg negative CHB (pre-core mutant), the optimal duration of treatment is unknown.
To priporočilo temelji na omejenih podatkih (glejte poglavje 5. 1). • Pri HBeAg negativnih (pre- core mutanta) bolnikih s CHB optimalno trajanje zdravljenja ni znano.
Treatment discontinuation may be considered following HBsAg seroconversion. • In patients with either HBeAg positive or HBeAg negative CHB, the development of YMDD variant HBV may result in a diminished therapeutic response to lamivudine, indicated by a rise in HBV DNA and ALT from previous on-treatment levels.
O prekinitvi zdravljenja se lahko razmisli po serokonverziji HBsAg. • Pri HBeAg pozitivnih ali HBeAg negativnih bolnikih s CHB, lahko pojav YMDD variante HBV povzroči zmanjšan terapevtski odziv na lamivudin, kar se kaže kot povečanje HBV DNA in ALT v primerjavi s predhodnimi vrednostmi med zdravljenjem.
In patients with extended-duration YMDD variant HBV, a switch to or addition of an alternative agent should be considered (see section 5.1). • In patients with decompensated liver disease and liver transplant recipients, treatment cessation is not recommended.
Pri bolnikih z dolgotrajno prisotnostjo YMDD variante HBV je potrebno razmisliti o zamenjavi zdravila z alternativnim ali uvedbi dodatnega zdravila (glejte poglavje 5. 1). • Pri bolnikih z dekompenzirano jetrno boleznijo in bolnikih s presajenimi jetri prekinitev zdravljenja ni priporočljiva.
If there is a loss of efficacy attributable to the emergence of YMDD variant HBV in these patients, additional or alternative therapies should be considered (see section 5.1).
V primeru izgube učinkovitosti zaradi pojava YMDD variante HBV je potrebno pri teh bolnikih razmisliti o dodatnem ali alternativnem zdravljenju (glejte poglavje 5. 1).
2 If Zeffix is discontinued, patients should be periodically monitored for evidence of recurrent hepatitis (see section 4.4).
2 Če se zdravljenje z Zeffixom prekine, je treba bolnike periodično nadzirati glede dokazov rekurentnega hepatitisa (glejte poglavje 4. 4).
Children (less than 12 years of age) and adolescents (12 to 17 years of age):
Otroci (stari manj kot 12 let) in mladostniki (stari od 12 do 17 let):
Zeffix is not recommended for use in children below age 12 and adolescents age 12 to 17 due to lack of data on safety and efficacy (see section 5.2).
Uporabe zdravila Zeffix otrokom, starim manj kot 12 let, in mladostnikom v starosti od 12 do 17 let zaradi pomanjkanja podatkov o varnosti in učinkovitosti ne priporočamo (glejte poglavje 5. 2).
Renal impairment: lamivudine serum concentrations (AUC) are increased in patients with moderate to severe renal impairment due to decreased renal clearance.
Zaradi zmanjšanega očistka pri bolnikih z zmernim do hudo oslabljenim delovanjem ledvic so serumske koncentracije (AUC) lamivudina zvečane.
The dosage should therefore be reduced for patients with a creatinine clearance of < 50 ml/ minute.
Tako je treba pri bolnikih z očistkom kreatinina < 50 ml/ minuto odmerek zmanjšati.
When doses below 100 mg are required Zeffix oral solution should be used (see Table 1 below).
Če so potrebni odmerki manjši od 100 mg, je treba uporabiti Zeffix peroralno raztopino (glejte tabelo 1 spodaj).
Dosage of Zeffix in patients with decreased renal clearance.
Odmerjanje Zeffixa pri bolnikih z oslabljenim delovanjem ledvic
Creatinine clearance ml/ min
Očistek kreatinina ml/ min
First Dose of Zeffix oral solution *
Začetni odmerek Zeffix peroralne raztopine *
Maintenance Dose Once daily
Vzdrževalni odmerek enkrat dnevno
* Zeffix oral solution containing 5 mg/ ml lamivudine.
* Zeffix peroralna raztopina vsebuje 5 mg/ ml lamivudina.
Data available in patients undergoing intermittent haemodialysis (for less than or equal to 4 hrs dialysis 2-3 times weekly), indicate that following the initial dosage reduction of lamivudine to correct for the patient’ s creatinine clearance, no further dosage adjustments are required while undergoing dialysis.
Razpoložljivi podatki pri bolnikih, ki se zdravijo z intermitentno hemodializo (4 ure ali manj dialize 2 - do 3- krat tedensko), kažejo, da po začetnem zmanjšanju odmerka lamivudina in korekciji glede na bolnikov očistek kreatinina nadaljnje uravnave odmerka med dializo niso potrebne.
Hepatic impairment: data obtained in patients with hepatic impairment, including those with end-stage liver disease awaiting transplant, show that lamivudine pharmacokinetics are not significantly affected by hepatic dysfunction.
Podatki, pridobljeni pri bolnikih z jetrno okvaro, tudi pri tistih s končnim stadijem jetrne bolezni, ki čakajo na transplantacijo, kažejo, da jetrna disfunkcija farmakokinetike lamivudina znatno ne prizadene.
Hypersensitivity to the active substance or to any of the excipients.
Preobčutljivost za zdravilno učinkovino ali za katero koli pomožno snov.
Lamivudine has been administered to children (2 years and above) and adolescents with compensated chronic hepatitis B.
Lamivudin se je uporabljal pri otrocih (2 leti in starejši) in mladostnikih s kompenziranim kroničnim hepatitisom B.
However, due to limitations of the data, the administration of lamivudine to this patient population is not currently recommended (see section 5.1).
Vendar uporaba lamivudina v tej populaciji bolnikov, zaradi omejenih podatkov, trenutno ni priporočljiva (glejte poglavje 5. 1).
The efficacy of lamivudine in patients co-infected with Delta hepatitis or hepatitis C has not been established.
Učinkovitost lamivudina pri bolnikih, ki so sočasno okuženi s hepatitisom delta ali hepatitisom C ni dokazana.
Data are limited on the use of lamivudine in HBeAg negative (pre-core mutant) patients and in those receiving concurrent immunosuppressive regimes, including cancer chemotherapy.
Podatki o uporabi lamivudina pri HBeAg negativnih bolnikih (okuženih s pre- core mutanto) in pri tistih, ki imajo predpisano sočasno imunosupresivno zdravljenje, vključno s kemoterapijo rakavih obolenj, so omejeni.
During treatment with Zeffix patients should be monitored regularly.
Med zdravljenjem z Zeffixom je treba bolnike redno nadzirati.
Serum ALT levels should be monitored at 3 month intervals and HBV DNA and HBeAg should be assessed every 6 months.
Serumske vrednosti ALT je potrebno preveriti vsake 3 mesece, HBV DNA in HBeAg pa vsakih 6 mesecev.
3 Exacerbations of hepatitis
3 Poslabšanja, ponovni pojavi hepatitisa
HBV viral subpopulations with reduced susceptibility to lamivudine (YMDD variant HBV) have been identified with extended therapy.
Z razširitvijo zdravljenja so bile odkrite podskupine virusa HBV (YMDD varianta HBV) z zmanjšano občutljivostjo za lamivudin.
In some patients the development of YMDD variant HBV can lead to exacerbation of hepatitis, primarily detected by serum ALT elevations and re-emergence of HBV DNA.
Pri nekaterih bolnikih lahko pojav YMDD variante HBV vodi do poslabšanja hepatitisa, kar se primarno zazna z zvišanjem serumske ALT in ponovnim pojavom HBV DNA.
In patients who have YMDD variant HBV and worsening liver disease (increasing ALT with or without decompensated cirrhosis) or recurrent hepatitis B after liver transplantation, a switch to or addition of an alternative agent should be considered.
Pri bolnikih z YMDD varianto HBV in poslabšanjem jetrne bolezni (povečanje vrednosti ALT z ali brez dekompenzirane ciroze) ali rekurentnim hepatitisom B po transplantaciji jeter je potrebno razmisliti o zamenjavi zdravila z alternativnim ali uvedbi dodatnega zdravila.
If Zeffix is discontinued or there is a loss of efficacy due to the development of YMDD variant HBV (see section 4.2), some patients may experience clinical or laboratory evidence of recurrent hepatitis.
V primeru prekinitve ali izgube učinkovitosti zaradi pojava YMDD variante HBV (glejte poglavje 4. 2) zdravljenja z Zeffixom se lahko pri nekaterih bolnikih pojavijo klinični ali laboratorijski dokazi rekurentnega hepatitisa.
If Zeffix is discontinued, patients should be periodically monitored both clinically and by assessment of serum liver function tests (ALT and bilirubin levels), for at least four months, and then as clinically indicated.
Če se zdravljenje z Zeffixom prekine, je bolnike treba periodično nadzirati tako klinično kot tudi z oceno serumskih testov jetrne funkcije (aktivnost ALT in koncentracija bilirubina) vsaj štiri mesece, nadalje pa, če je to klinično indicirano.
Exacerbation of hepatitis has primarily been detected by serum ALT elevations, in addition to the re-emergence of HBV DNA.
Poslabšanje hepatitisa se primarno odkrije z zvišanjem serumske ALT in ponovnim pojavom HBV DNA.
See Table 3 in Section 5.1 Clinical experience for more information regarding frequency of post treatment ALT elevations.
Za več informacij o pogostnosti zvišanja ALT po zdravljenju glejte tabelo 3 v poglavju 5. 1 Klinične izkušnje.
Most events have been self- limited, however some fatalities have been observed.
Večina dogodkov ima tendenco samoomejitve, vendar pa je prišlo tudi do nekaj smrtnih primerov.
For patients who develop evidence of recurrent hepatitis post-treatment, there are insufficient data on the benefits of re-initiation of lamivudine treatment.
O koristih ponovnega pričetka zdravljenja z lamivudinom pri bolnikih, pri katerih so se po prekinitvi zdravljenja pojavili dokazi rekurentnega hepatitisa, ni dovolj podatkov.
Transplantation recipients and patients with advanced liver disease are at greater risk from active viral replication.
Prejemniki presajenih organov in bolniki z napredovalo boleznijo jeter so v večji nevarnosti glede aktivne replikacije virusa.
Laboratory parameters to be monitored should include (as a minimum) serum ALT, bilirubin, albumin, blood urea nitrogen, creatinine, and virological status:
Med laboratorijske parametre, ki jih je treba nadzirati, morajo biti vključeni (najmanj) serumski ALT, bilirubin, albumin, dušik sečnine v krvi, kreatinin in virološki status:
HBV antigen/ antibody, and serum HBV DNA concentrations when possible.
HBV antigen/ protitelo in po možnosti koncentracija HBV DNA v serumu.
For the treatment of patients who are co-infected with HIV and are currently receiving or plan to receive treatment with lamivudine or the combination lamivudine-zidovudine, the dose of lamivudine prescribed for HIV infection (usually 150 mg/ twice daily in combination with other antiretrovirals) should be maintained.
Pri zdravljenju bolnikov, ki so sočasno okuženi z virusom HIV in se trenutno že zdravijo ali pa se zanje načrtuje zdravljenje z lamivudinom ali kombinacijo lamivudin- zidovudin, je potreben vzdrževalni odmerek lamivudina, ki je predpisan za okužbo z virusom HIV (običajno 150 mg/ dvakrat dnevno v kombinaciji z drugimi protiretrovirusnimi zdravili).
4 Lamivudine is predominantly eliminated by active organic cationic secretion.
4 Lamivudin se pretežno izloča z aktivno sekrecijo organskih kationov.
The possibility of interactions with other medicinal products administered concurrently should be considered, particularly when their main route of elimination is active renal secretion via the organic cationic transport system e. g. trimethoprim.
Treba je upoštevati možnost interakcij z drugimi zdravili, ki se uporabljajo sočasno, še posebno, če je njihova glavna pot izločanja aktivna renalna sekrecija preko organskega kationskega transportnega sistema, npr. trimetoprim.
Other medicinal products (e. g. ranitidine, cimetidine) are eliminated only in part by this mechanism and were shown not to interact with lamivudine.
Druga zdravila (npr. ranitidin, cimetidin) se le deloma izločajo s pomočjo tega mehanizma in niso kazala interakcij z lamivudinom.
Administration of trimethoprim/ sulphamethoxazole 160 mg/ 800 mg increased lamivudine exposure by about 40%.
Dajanje 160 mg/ 800 mg trimetoprima/ sulfametoksazola je izpostavljenost lamivudinu zvečalo za 40%.
A modest increase in Cmax (28%) was observed for zidovudine when administered with lamivudine, however overall exposure (AUC) was not significantly altered.
Opaženo je bilo zmerno zvečanje Cmax (28%) zidovudina, če se je uporabljal sočasno z lamivudinom, vendar se celotna izpostavljenost (AUC) ni znatno spremenila.
Zidovudine had no effect on the pharmacokinetics of lamivudine (see section 5.2).
Zidovudin ni imel učinka na farmakokinetiko lamivudina (glejte poglavje 5. 2).
There were no observed clinically significant adverse interactions in patients taking lamivudine concurrently with commonly used immunosuppressant medicinal products (e. g. cyclosporin A).
Pri bolnikih, ki so sočasno jemali lamivudin in pogosto uporabljana imunosupresivna zdravila (npr. ciklosporin A), ni bilo opaznih klinično pomembnih neželenih interakcij.
Lamivudine may inhibit the intracellular phosphorylation of zalcitabine when the two medicinal products are used concurrently.
V primeru sočasne uporabe obeh zdravil lahko lamivudin inhibira znotrajcelično fosforilacijo zalcitabina.
Zeffix is therefore not recommended to be used in combination with zalcitabine.
Zato ni priporočljivo uporabljati Zeffixa v kombinaciji z zalcitabinom.
Pregnancy: there are no adequate data from the use of lamivudine in pregnant women.
Na voljo ni ustreznih podatkov o uporabi lamivudina pri nosečih ženskah.
The potential risk to humans is unknown.
Morebitno tovrstno tveganje pri ljudeh ni znano.
Consistent with passive transmission of the substance across the placenta, lamivudine concentrations in infant serum at birth were similar to those in maternal and cord serum at delivery.
Koncentracije lamivudina v serumu novorojenčka so bile podobne tistim v serumu matere in popkovnici ob porodu, kar se sklada s pasivnim prehodom učinkovine preko placente.
Although animal reproductive studies are not always predictive of the human response, administration is not recommended during the first three months of pregnancy (see section 4.4).
Kljub temu, da reproduktivne študije na živalih niso vedno pokazatelj humanega odziva, uporaba med prvim trimesečjem nosečnosti ni priporočljiva (glejte poglavje 4. 4).
Lactation: following oral administration, lamivudine was excreted in breast milk at similar concentrations to those found in serum.
Po peroralnem vnosu se je lamivudin izločal v materino mleko v podobnih koncentracijah, kot so bile ugotovljene v serumu.
It is therefore recommended that mothers taking lamivudine do not breast feed their infants.
Priporočeno je, da matere, ki jemljejo lamivudin, svojih otrok ne dojijo.
In clinical studies of patients with chronic hepatitis B, lamivudine was well tolerated.
V kliničnih študijah so bolniki s kroničnim hepatitisom B lamivudin dobro prenašali.
The incidence of adverse events and laboratory abnormalities (with the exception of elevations of ALT and CPK, see below) were similar between placebo and lamivudine treated patients).
Pojavnost neželenih učinkov in laboratorijskih abnormalnosti (z izjemo zvišanja ALT in CPK, glejte spodaj) je bila podobna pri bolnikih, ki so se zdravili s placebom in pri bolnikih, ki so se zdravili z lamivudinom.
The most common adverse events reported were malaise and fatigue, respiratory tract infections, throat and tonsil discomfort, headache, abdominal discomfort and pain, nausea, vomiting and diarrhoea.
Najpogosteje so poročali o naslednjih neželenih učinkih: slabem počutju in utrujenosti, infekcijah respiratornega trakta, neugodju v predelu grla in tonzil, glavobolu, neugodju in bolečinah v trebuhu, navzei, bruhanju in diareji.
Frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10), uncommon (≥ 1/ 1000, < 1/ 100), rare (≥ 1/ 10,000, < 1/ 1000) and very rare (< 1/ 10,000).
Pogostnost je definirana kot: zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100, < 1/ 10), občasni (≥ 1/ 1. 000, < 1/ 100), redki (≥ 1/ 10. 000, < 1/ 1. 000) in zelo redki (< 1/ 10. 000).
5 The frequency categories assigned to the adverse reactions below are estimates: for most events, suitable data for calculating incidence are not available.
5 Kategorije pogostnosti, omejene na neželene učinke spodaj, so ocenjene: za večino dogodkov ni bilo na voljo ustreznih podatkov za izračun pojavnosti.
Very common and common adverse drug reaction frequency categories were determined from clinical trial data and the background incidence in placebo groups was not taken into account.
Neželeni učinki zdravila iz kategorij zelo pogosti in pogosti so bile dognane iz podatkov kliničnih študij, pri čemer predpostavljena pojavnost pri skupini s placebom ni bila upoštevana.
Adverse drug reactions identified through post-marketing surveillance were categorised as rare or very rare.
Neželeni učinki zdravila, ugotovljeni pri postmarketinškem spremljanju zdravila, so kategorizirani kot redki ali zelo redki.
ALT elevations (see section 4.4).
Zvišanje ALT (glejte poglavje 4. 4)
Exacerbations of hepatitis, primarily detected by serum ALT elevations, have been reported ‘ on- treatment’ and following lamivudine withdrawal.
Po prenehanju zdravljenja pri tistih, ki so se pred tem zdravili z lamivudinom, so poročali o poslabšanjih, ponovnih pojavih hepatitisa, ki ga primarno zaznamo s povečanjem serumske koncentracije ALT.
Most events have been self-limited, however fatalities have been observed very rarely (see section 4.4).
Večina primerov je bilo izoliranih, kljub temu pa so se smrtni primeri pojavili zelo redko (glejte poglavje 4. 4).
Elevations of CPK Muscle disorders, including myalgia, cramps and rhabdomyolysis
Zvišanje CPK Bolezni mišic, vključno z mialgijo, krči in rabdomiolizo
Cases of lactic acidosis, sometimes fatal, usually associated with severe hepatomegaly and hepatic steatosis, have been reported with the use of combination nucleoside analogue therapy in patients with HIV.
Pri zdravljenju bolnikov, okuženih z virusom HIV s kombinacijo nukleozidnih analogov, so poročali o primerih laktacidoze, ki je bila včasih smrtna in navadno povezana s hudo hepatomegalijo in jetrno steatozo.
Pharmacotherapeutic group - nucleoside analogue, ATC Code:
Farmakoterapevtska skupina: nukleozidni analog, Oznaka ATC:
Lamivudine-TP acts as a substrate for the HBV viral polymerase.
Lamivudin- TP deluje kot substrat za HBV virusno polimerazo.
6 Lamivudine-TP does not interfere with normal cellular deoxynucleotide metabolism.
6 Lamivudin- TP blokira nadaljnje nastajanje virusne DNA tako, da se vključi v verigo in s tem povzroči terminacijo verige.
Furthermore, lamivudine-TP has little effect on mammalian cell DNA content.
Lamivudin- TP ima majhen učinek na vsebnost celične DNA pri sesalcih.
Experience in patients with HBeAg positive CHB and compensated liver disease: in controlled studies, 1 year of lamivudine therapy significantly suppressed HBV DNA replication [34-57% of patients were below the assay detection limits (Abbott Genostics solution hybridization assay, LLOD < 1.6pg/ ml)}, normalised ALT level (40-72% of patients), induced HBeAg seroconversion (HBeAg loss and HBeAb detection with HBV DNA loss [by conventional assay], 16-18% of patients), improved histology (38-52% of patients had a ≥ 2 point decrease in the Knodell Histologic Activity Index [HAI]) and reduced progression of fibrosis (in 3-17% of patients) and progression to cirrhosis.
Izkušnje pri HBeAg pozitivnih bolnikih s CHB in kompenzirano jetrno boleznijo: v nadzorovanih študijah je enoletno zdravljenje z lamivudinom znatno zavrlo replikacijo HBV DNA [pri 34 do 57% bolnikov je bila pod mejo dokazljivosti s testom (Abbott Genostics hibridizacijski test v raztopini, LLOD < 1, 6 pg/ ml)], normaliziralo aktivnost ALT (pri 40 do 72% bolnikov), sprožilo serokonverzijo HBeAg (izginotje HBeAg ter pojav protiteles HBeAb z izginotjem HBV DNA [z običajnimi testi] pri 16 do 18% bolnikov), izboljšalo histološko sliko (pri 38 do 52% bolnikov se je Knodell- ov histološki indeks aktivnosti [HAI] znižal za ≥ 2 točki) in zmanjšalo progresijo fibroze (pri 3 do 17% bolnikov) in progresijo v cirozo.
In patients with YMDD variant HBV, 41/ 82 (50%) patients had improvement in liver inflammation and 40/ 56 (71%) patients without YMDD variant HBV had improvement.
Pri 41/ 82 (50%) bolnikov z YMDD varianto HBV in pri 40/ 56 (71%) bolnikov brez YMDD variante HBV je prišlo do izboljšanja vnetnih sprememb jeter.
Improvement in bridging fibrosis occurred in 19/ 30 (63%) patients without YMDD variant and 22/ 44 (50%) patients with the variant.
Pri 19/ 30 (63%) bolnikov brez YMDD variante in 22/ 44 (50%) bolnikov z varianto je prišlo do izboljšanja fibroze.
Five percent (3/ 56) of patients without the YMDD variant and 13% (11/ 82) of patients with YMDD variant showed worsening in liver inflammation compared to pre-treatment.
Pri petih odstotkih (3/ 56) bolnikov brez YMDD variante in 13% (11/ 82) bolnikov z YMDD varianto je prišlo do poslabšanja vnetnih sprememb v primerjavi s stanjem pred zdravljenjem.
Progression to cirrhosis occurred in 4/ 68 (6%) patients with the YMDD variant, whereas no patients without the variant progressed to cirrhosis.
Do progresije v cirozo je prišlo pri 4/ 68 (6%) bolnikov z YMDD varianto in pri nobenem od bolnikov brez YMDD variante.
In an extended treatment study in Asian patients (NUCB3018) the HBeAg seroconversion rate and ALT normalisation rate at the end of the 5 year treatment period was 48% (28/ 58) and 47% (15/ 32), respectively.
V študiji podaljšanega zdravljenja pri bolnikih v Aziji (NUCB3018) je bil ob zaključku 5- letnega zdravljenja odstotek serokonverzije HBeAg 48% (28/ 58), odstotek normalizacije ALT pa 47% (15/ 32).