natgillin/translations-raw huggingface dataset:
De mest almindelige bivirkninger med, som minimum, en mulig relation til telbivudin var grad 3/ 4 forhøjelser af kreatininkinase i blodet (6, 8%), træthed (4, 4%), hovedpine (3, 0%) og kvalme (2, 6%).
The most common adverse events with at least a possible relation to telbivudine were grade 3/ 4 blood creatine kinase elevations (6.8%), fatigue (4.4%), headache (3.0%) and nausea (2.6%).
Meget almindelig (≥1/ 10); almindelig (≥1/ 100 til < 1/ 10); ikke almindelig (≥1/ 1. 000 til < 1/ 100); sjælden (≥1/ 10. 000 til < 1/ 1. 000); meget sjælden (< 1/ 10. 000).
Table 2 lists the adverse reactions recorded in the pooled 104-week NV-02B-007 GLOBE and NV- 02B-015 studies by system organ class and by frequency using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000).
6 Tabel 2
6 Table 2
Kliniske bivirkninger hos patienter med kronisk hepatitis B, behandlet med telbivudin 600 mg i de samlede 104 ugers studier NV- 02B- 007 (GLOBE) og NV- 02B - 015 *
Clinical adverse reactions in patients with chronic hepatitis B, treated with telbivudine 600 mg in the pooled 104-week NV-02B-007 (GLOBE) and NV-02B-015 studies*
Svimmelhed, hovedpine Perifer neuropati, smagsforstyrrelse, nedsat følsomhed, paræstesi, iskias
Dizziness, headache Peripheral neuropathy, dysgeusia, hypoaesthesia, paresthesia, sciatica
Forhøjet s- amylase, diarré, forhøjet s- lipase, kvalme, mavesmerter
Blood amylase increased, diarrhoea, blood lipase increased, nausea, abdominal pain
subkutane væv Almindelig
Common
Forhøjet kreatinfosfokinase Artralgi, myalgi, myopati/ myositis, smerte i ekstremiteterne, rygsmerter, muskelspasmer, smerter i nakken, smerter i siden
Blood creatine phosphokinase increased Arthralgia, myalgia, myopathy/ myositis, pain in the extremities, back pain, muscle spasm, neck pain, flank pain
Forhøjet alaninaminotransferase Forhøjet aspartataminotransferase
Blood alanine aminotransferase increased Aspartate aminotransferase increased
* Antallet af patienter i den samlede analyse (NV- 02B- 007 (GLOBE) og NV- 02B- 015) er for lille til at detektere sjældne og meget sjældne bivirkninger.
* Due to the sample size of the pooled analysis (NV-02B-007 [GLOBE] and NV-02B-015), there are insufficient numbers of telbivudine-treated patients to detect rare and very rare events.
Kreatinkinaseforhøjelser af grad 3/ 4 (> 7x ULN) forekom i den samlede analyse af 104 ugers behandlingsvarighed hos 12, 6% af de telbivudin- behandlede patienter og hos 4, 0% af de lamivudin - behandlede patienter ved uge 52.
In the pooled analysis, by 104 weeks of treatment Grade 3/ 4 creatine kinase elevations (> 7x ULN) occurred in 12.6% of telbivudine-treated patients and 4.0% of lamivudine-treated patients.
De fleste kreatinkinaseforhøjelser var ikke- symptomgivende, og kreatinkinaseværdierne faldt typisk inden det næste besøg på fortsat behandling.
Most creatine kinase elevations were asymptomatic and creatine kinase values typically decreased by the next visit on continued treatment.
I pivotalstudiet NV - 02B- 007 (GLOBE) blev høje CK- værdier før behandlingen og kaukasisk race identificeret i begge behandlingsgrupper som prædikative faktorer for grad 3/ 4- forhøjelser ved 104 uger.
In the pivotal study NV-02B-007 (GLOBE), higher pre-treatment CK values and Caucasian race were identified in both treatment groups as predictive factors for Grade 3/ 4 elevations by 104 weeks.
Hyppigheden af forhøjede ALT- niveauer under behandling i de to behandlingsgrupper ifølge AASLD (American Association for the Study of Liver Diseases) definition (ALT- stigning > 2x udgangsværdi og > 10x ULN) er yderligere beskrevet i tabel 3 herunder.
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.
Tabel 3
7 Table 3
Opsummering af ALT (IE/ L) niveauer under 015 sammenlagt
Summary of on treatment ALT (IU/ L) flare – Pooled NV-02B-007/ NV-02B-015
ALT- niveau:
ALT flare:
Lamivudin Telbivudin
Lamivudine Telbivudine
ALT stigning > 2x udgangsværdi og > 10x ULN
ALT elevation > 2x baseline and > 10x ULN
Ialt Baseline til uge 24 Uge 24 til slutningen af studiet
Overall Baseline to week 24 Week 24 to end of study
4. 4).
Periodic monitoring of hepatic function is recommended during treatment (see section 4.4).
4. 4).
Exacerbations of hepatitis B after discontinuation of treatment Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti- hepatitis B therapy including telbivudine (see section 4.4).
Hyppigheden af ALT- niveauer efter behandlingsstop i to behandlingsgrupper er yderligere beskrevet i tabel 4 herunder.
The incidence of post-treatment alanine aminotransferase (ALT) flares in the two treatment arms are further described in Table 4 below.
Opsummering af ALT- niveauer efter behandling – NV- 02B- 007/ NV- 02B- 015
Summary of post-treatment ALT flares – Pooled NV-02B-007/ NV-02B-015
Lamivudine
Lamivudine
Telbivudine
Telbivudine
ALT- niveauer
ALT flare
ALT- stigning > 2x udgangsværdi og > 10x ULN
ALT elevation > 2x baseline and > 10x ULN
Testede doser op til 1. 800 mg/ dag, 3 gange højere end den anbefalede daglige dosis, er blevet tålt godt.
Tested doses up to 1,800 mg/ day, three times greater than the recommended daily dose, have been well tolerated.
Hæmmere af nukleosid - og nukleotid- revers- transkriptase, ATC - kode:
Nucleoside and nucleotide reverse transcriptase inhibitors, ATC code:
Telbivudin er en syntetisk tymidinnukleosidanalog med aktivitet rettet mod HBV- DNA- polymerase.
Telbivudine is a synthetic thymidine nucleoside analogue with activity against HBV DNA polymerase.
Telbivudin- 5 '- trifosfat hæmmer HBV- DNA- polymerase (revers transkriptase) ved at konkurrere med det naturlige substrat, tymidin 5' - trifosfat.
Telbivudine-5'-triphosphate inhibits HBV DNA polymerase (reverse transcriptase) by competing with the natural substrate, thymidine 5'-triphosphate.
Inkorporering af telbivudin- 5 '- trifosfat i viralt DNA medfører DNA- kæde- terminering, hvilket resulterer i hæmning af HBV- replikation.
Incorporation of telbivudine-5'-triphosphate into viral DNA causes DNA chain termination, resulting in inhibition of HBV replication.
Telbivudin er en hæmmer af syntesen af både HBV' s første streng (EC50 = 0, 4- 1, 3 μM) og anden streng (EC50 = 0, 12- 0, 24 μM) og viser en klar præference for at hæmme produktionen af anden streng.
Telbivudine is an inhibitor of both HBV first strand (EC50 = 0.4-1.3 μ M) and second strand (EC50 = 0.12-0.24 μ M) synthesis, and shows a distinct preference for inhibiting second strand production.
Derimod hæmmede telbivudin- 5 '- trifosfat i koncentrationer på op til 100 μM ikke de cellulære DNA- polymeraser α, β og γ.
By contrast, telbivudine-5'-triphosphate at concentrations up to 100 μ M did not inhibit cellular DNA polymerases α, β, or γ.
Telbivudin forøgede ikke produktionen af mælkesyre in vitro.
In assays relating to mitochondrial structure, function and DNA content, telbivudine lacked appreciable toxic effect at concentrations up to at 10 μ M and did not increase lactic acid production in vitro.
Den antivirale aktivitet af telbivudin in vitro blev vurderet i den HBV- eksprimerende humane hepatoma- cellelinje 2. 2. 15.
8 The in vitro antiviral activity of telbivudine was assessed in the HBV-expressing human hepatoma cell line 2.2.15.
0, 2 μM.
The concentration of telbivudine that effectively inhibited 50% of viral synthesis (EC50) was approximately 0.2 μ M.
Telbivudins antivirale aktivitet er specifik for hepatitis B- virus og relaterede hepadnavira.
The antiviral activity of telbivudine is specific to the hepatitis B virus and related hepadnaviruses.
Fravær af aktivitet af telbivudin mod HIV er ikke blevet undersøgt i kliniske forsøg.
The absence of activity of telbivudine against HIV has not been evaluated in clinical trials.
Klinisk erfaring Sikkerhed og effekt af langtidsbehandling (104 uger) med Sebivo blev evauleret i to aktivt kontrollerede kliniske forsøg, hvori der blev inkluderet 1. 699 patienter med kronisk hepatitis B (NV - 02B- 007 GLOBE og NV- 02B- 015).
Clinical experience The safety and efficacy of long-term (104 weeks) Sebivo treatment were evaluated in two active- controlled clinical studies that included 1,699 patients with chronic hepatitis B (NV-02B-007 GLOBE and NV-02B-015).
I studiet indgik 1. 367 nukleosidnaive HBeAg- positive og HBeAg- negative patienter med kronisk hepatitis B.
NV-02B-007 GLOBE study 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.
Størstedelen af de inkluderede patienter var asiater.
The majority of the population enrolled was Asian.
De mest almindelige HBV- genotyper var b (26%) og c (51%).
The most common HBV genotypes were B (26%) and C (51%).
HBeAg- positive patienter:
HBeAg-positive patients:
Patienternes gennemsnitsalder var 32 år, 74% var mænd, 82% var asiater, 12% var kaukasere og 6% havde tidligere fået behandling med alfa- interferon.
The mean age of patients was 32 years, 74% were male, 82% were Asian, 12% were Caucasian, and 6% had previously received alfa-interferon therapy.
HBeAg- negative patienter:
HBeAg-negative patients:
Patienternes gennemsnitsalder var 43 år, 79% var mænd, 65% var asiater, 23% var kaukasere og 11% havde tidligere fået behandling med alfa- interferon.
The mean age of patients was 43 years, 79% were male, 65% were Asian, 23% were Caucasian, and 11% had previously received alfa-interferon therapy.
Kliniske resultater ved uge 52 Kliniske og virologiske effekt- endepunkter blev vurderet separat i de HBeAg- positive og HBeAg - negative patientpopulationer.
Clinical results at week 52 Clinical and virological efficacy endpoints were evaluated separately in the HBeAg-positive and HBeAg-negative patient populations.
Det primære endepunkt for terapeutisk respons var et sammensat serologisk endepunkt, omfattende suppression af HBV- DNA til < 5 log10 kopier/ ml sammen med enten tab af serum- HBeAg eller normaliseret ALT.
The primary endpoint of therapeutic response was a composite serological endpoint requiring suppression of HBV DNA to < 5 log10 copies/ ml in conjunction with either loss of serum HBeAg or ALT normalised.
De sekundære endepunkter omfattede histologisk respons, ALT- normalisering og forskellige parametre for antiviral effekt.
Secondary endpoints included histological response, ALT normalisation, and various measures of antiviral efficacy.
Udgangsniveauer for ALT > 2 x ULN og udgangsværdier for HBV- DNA < 9 log10 kopier/ ml var ledsaget af en større grad af eAg serokonvertering blandt HBeAg- positive- patienter.
Baseline ALT levels > 2 x ULN and baseline HBV DNA < 9 log10 copies/ ml were associated with higher rates of eAg seroconversion in HBeAg-positive patients.
Patienter, der opnåede HBV- DNA- niveauer < 3 log10 kopier/ ml inden uge 24, havde optimalt respons på behandlingen; omvendt havde patienter med HBV- DNA- niveauer > 4 log10 kopier/ ml ved uge 24 mindre favorable resultater ved uge 52.
Patients who achieve HBV DNA levels< 3 log10 copies/ml by week 24 had optimal responses to treatment; conversely patients with HBV DNA levels> 4 log10 copies/ ml at 24 weeks had less favourable outcomes at week 52.
67, 0% respondenter; p = 0, 0047).
In HBeAg-positive patients, telbivudine was superior to lamivudine in therapeutic response (75.3% vs 67.0% responders; p = 0.0047).
Blandt HBeAg- negative patienter var telbivudin ikke dårligere end lamivudin (75, 2% og 77, 2% respondenter; p = 0, 6187).
In HBeAg-negative patients, telbivudine was non-inferior to lamivudine (75.2% and 77.2% responders; p = 0.6187).
Kaukasisk etnicitet var forbundet med lavere behandlingsrespons for begge antivirale midler anvendt i GLOBE undersøgelsen; den kaukasiske patientpopulation var dog meget begrænset (n = 98).
Caucasian ethnicity was associated with lower treatment response to both antiviral agents used in the GLOBE trial; however the Caucasian patient population was very limited (n = 98).
I uge 24 havde 203 HBeAg- positive og 178 HBeAg- negative forsøgspersoner opnået ikke - detekterbare HBV- DNA- niveauer.
At week 24, 203 HBeAg-positive and 178 HBeAg-negative subjects achieved non-detectable HBV DNA levels.
Af disse HBeAg- positive personer havde 95% stadig ikke - detekterbart HBV- DNA, 39% havde opnået HBeAg- serokonvertering og 90% havde opnået ALT - normalisering i uge 52.
Of those HBeAg positive subjects, 95% achieved non-detectable HBV DNA, 39% achieved HBeAg seroconversion, 90% achieved ALT normalisation at week 52 and 0.5% exhibited resistance at week 48.
0% udviste resistens i uge 48.
Similarly of those HBeAg-negative subjects, 96% achieved non-detectable HBV DNA, 79% achieved ALT normalisation at week 52 and 0% exhibited resistance at week 48.
9 Tabel 5
9 Table 5
Virologiske, biokemiske og serologiske endepunkter i uge 52 undersøgelsen)
Virological, biochemical and serological endpoints at week 52 (NV-02B-007 GLOBE study)
HBeAg- negativ (n = 446)
HBeAg-positive (n = 921) HBeAg-negative (n = 446)
Gennemsnitlig HBV - DNA- reduktion ift. udgangsværdi (log10 kopier/ ml) ± SEM1, 2, 3
Mean HBV DNA reduction from baseline (log10 copies/ ml) ± SEM1,2,3
(0, 11)
-5.54 (0.11)
- 5, 23 (0, 13) *
-5.23 (0.13) *
% patienter HBV - DNA- negative ved PCR
% Patients HBV DNA negative by PCR
ALT- normalisering4 HBeAg - serokonvertering4
ALT normalisation4 HBeAg seroconversion4
HBeAg- tab5 1
HBeAg loss5 1
Standard error of mean 2 Roche COBAS Amplicor® PCR- analyse (nedre kvantificeringsgrænse ≤ 300 kopier/ ml).
Standard error of mean 2 Roche COBAS Amplicor® PCR Assay (lower limit of quantification ≤ 300 copies/ ml).
3 HBeAg- positive n = 443 og 444, HBeAg- negative n = 219 og 219 for henholdsvis telbivudin - og lamivudingruppen.
3 HBeAg-positive n = 443 and 444, HBeAg-negative n = 219 and 219, for both telbivudine and lamivudine groups, respectively.
Forskellen i populationer er forårsaget af patientfrafald fra undersøgelsen og manglende HBV- DNA- undersøgelser ved uge 52.
The difference in populations is due to patient discontinuation from the study and missing HBV DNA assessment at week 52.
4 HBeAg- positive n = 440 og 446, HBeAg- negative n = 203 og 207 for henholdsvis telbivudin - og lamivudingruppen.
4 HBeAg-positive n = 440 and 446, HBeAg-negative n = 203 and 207, for telbivudine and lamivudine groups, respectively.
ALT- normalisering kun vurderet hos patienter med ALT > ULN ved forsøgsstart.
ALT normalisation assessed only in patients with ALT > ULN at baseline.
5 n = 432 og 442 for henholdsvis telbivudin - og lamivudingruppen.
5 n = 432 and 442, for telbivudine and lamivudine groups, respectively.
HBeAg- serokonvertering og - tab kun vurderet hos patienter med detekterbart HBeAg ved forsøgsstart. * p < 0, 0001
HBeAg seroconversion and loss assessed only in patients with detectable HBeAg at baseline. *p < 0.0001
Histologisk bedring og ændring ved Ishaks fibrosescore GLOBE- undersøgelsen)
Histological improvement and change in Ishak Fibrosis Score at week 52 (NV-02B- 007 GLOBE study)
HBeAg- negativ (n = 446) Telbivudin Lamivudin 600 mg 100 mg
HBeAg-positive (n = 921) HBeAg-negative (n = 446) Telbivudine Lamivudine Telbivudine Lamivudine 600 mg 100 mg 600 mg 100 mg (n = 384)1 (n = 386)1 (n = 199)1 (n = 207)1
(n = 199) 1 (n = 207) 1
Histological response2
Bedring Ingen bedring
Improvement No improvement
Ishaks fibrosescore3
Ishak Fibrosis Score3
Bedring Ingen ændring Forværring
Improvement No change Worsening
Manglende biopsi i uge 52 1
Missing week 52 biopsy 1
Patienter med > én dosis testmedicin med vurderbare leverbiopsier ved forsøgsstart og Knodells histologiske aktivitetsindeks (HAI) - score > 3 ved forsøgsstart.
Patients with ≥ one dose of study drug with evaluable baseline liver biopsies and baseline Knodell Histological Activity Index (HAI) score > 3.
3 Vedr.
2 Histological response defined as a ≥ 2 point decrease in Knodell Necroinflammatory Score from baseline with no worsening of the Knodell Fibrosis Score.
Bedring målt som > 1 points reduktion ved Ishaks fibrosescore fra forsøgsstart til uge 52. * p = 0, 0024
3 For Ishak Fibrosis Score, improvement measured as ≥ 1 point reduction in Ishak Fibrosis Score from baseline to week 52. *p = 0.0024
10 Kliniske resultater ved uge 104 Der blev demonstreret varig effekt hos patienter i fortsat telbivudinbehandling, idet kliniske resultater, i uge 104 hos patienter behandlet med telbivudin, var i overensstemmelse med dem, der blev observeret efter 52 uger
10 Clinical results at week 104 Overall, clinical results at week 104 in telbivudine-treated patients were consistent with those at week 52, demonstrating durability of efficacy responses for telbivudine-treated patients with continued treatment.
Blandt HBeAg- positive patienter var der i uge 104 tiltagende forskel i terapeutisk respons (63% vs 48%; p < 0, 0001) og vigtigste sekundære endepunkter (middel log10 HBV DNA reduktion; - 5, 74 vs - 4, 42: p < 0, 0001, PCR negativitet:
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, PCR negativity:
56% vs 39%: p < 0, 0001 og ALT normalisering på 70% vs 62%) mellem henholdsvis telbuvidin og lamivudin.
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.
Der var også en tendens mod højere hyppighed af HBeAg tab (35% vs 29%) og serokonvertering (30% vs 25%) for telbivudin.
A trend towards higher rates of HBeAg loss (35% vs 29%) and seroconversion (30% vs 25%) was also observed for telbivudine.
I undergruppen af patienter med baseline ALT- niveauer ≥ 2x ULN (320), var der yderligere en signifikant højere andel af telbivudin- patienter i forhold til lamivudin- patienter, der modtog HBeAg serokonvertering i uge 104 (henholdsvis 36% og 28%).
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).
66%) og i vigtigste sekundære endepunkter (middel log10 HBV DNA reduktion: - 5, 00 vs. - 4, 17, og PCR negativitet:
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 PCR negativity:
57%: p < 0, 0001) høj for telbivudin op til uge 104.
82% vs 57%; p < 0.0001) were higher for telbivudine up to week 104.
70%) vedblev at være højere i uge 104.
ALT normalisation rates (78% vs 70%) continued to be higher by week 104.
Forudsigelighed ved uge 24 I uge 24 havde 203 HBeAg- positive (44%) og 177 HBeAg- negative (80%) telbivudinbehandlede patienter opnået HBV DNA- niveauer, der ikke kunne måles.
Predictability at week 24 At week 24, 203 HBeAg-positive (44%) and 177 HBeAg-negative (80%) telbivudine-treated subjects achieved non-detectable HBV DNA levels.
For både HBeAg- positive og negative patienter var HBV DNA resultaterne i uge 24 en prædiktor for et farvorabelt langtidsresultat.
For both HBeAg positive and negative patients, week 24 HBV DNA results were a predictor of long- term favourable outcomes.
Telbivudinbehandlede patienter, som opnåede PCR negativitet i uge 24, havde højest forekomst af PCR negativitet og HBeAg serokonvertering (hos HBeAg- positive patienter), og den laveste samlede forekomst af virologisk gennembrud i uge 104.
Telbivudine-treated patients who achieved PCR negativity by week 24 had the highest rates of PCR negativity and HBeAg seroconversion (in HBeAg-positive patients), and the lowest overall rates of virological breakthrough at week 104.
Resultater i uge 104 baseret på HBV DNA niveau i uge 24 for henholdsvis HBeAg- positive og HBeAg- negative patienter er vist i tabel 7.
Outcome results at week 104, based on level of HBV DNA at week 24, for either HBeAg-positive or HBeAg-negative patients are presented in Table 7.
Vigtigste effekt endepunkter i uge 104 baseret på serum HBV DNA niveau uge 24, telbivudinbehandlede patienter (NV- 02B- 007 GLOBE)
Key efficacy endpoints at week 104 by serum HBV DNA levels at week 24, telbivudine patients (NV-02B-007 GLOBE)
HBV DNA uge 24
HBV DNA at week 24
Resultat af vigtigste endepunkter uge 104 baseret på Terapeutisk PCR- negativ HBeAg serokon -
Outcome for key efficacy end points at 104 weeks based on week 24 results Therapeutic PCR-negative HBeAg ALT Virological response HBV DNA seroconversion normalisation breakthrough* n/ N (%) n/ N (%) n/ N (%) n/ N (%) n/ N (%)
resultat i uge 24 ALT Virologisk
HBeAg-positive < 300 copies/ ml 300 copies/ ml to < 3 log10 copies/ ml
normalisering n/ N (%)
172/ 203 (85) 36/ 57 (63)
172/ 203 (85) 166/ 203 (82) 36/ 57 (63) 35/ 57 (61)
166/ 203 (82) 35/ 57 (61)
≥ 3 log10 kopier/ ml HBeAg- negativ
≥ 3 log10 copies/ ml
82/ 190 (43) 54/ 190 (28)
54/ 190 (28)
< 300 kopier/ ml 300 kopier/ ml til < 3 log10 kopier/ ml
< 300 copies/ ml 300 copies/ ml to < 3 log10 copies/ ml
146/ 177 (82) 156/ 177 (88) 13/ 18 (72) 14/ 18 (78)
156/ 177 (88) 14/ 18 (78)
≥ 3 log10 kopier/ ml N/ A = Ikke relevant
≥ 3 log10 copies/ ml N/ A = not applicable
13/ 26 (50) 12/ 26 (46)
12/ 26 (46)
* Virologisk gennembrud: ” 1 log over nadir ” definition fastsat uge 104
* Virological breakthrough: “ 1 log above nadir” definition assessed at week 104
11 NV- 02B- 015 studiet Resultaterne af effekt og sikkerhed fra 007 GLOBE studiet blev bekræftet i NV- 02B- 015 studiet.
11 Study NV-02B-015 The efficacy and safety results of the 007 GLOBE study were confirmed in study NV-02B-015.
Dette studie er et fase- III, randomiseret, dobbeltblindet studie af telbivudin 600 mg givet én gang daglig sammenlignet med lamivudin 100 mg givet én gang daglig i en behandlingsperiode på 104 uger i 332 nukleosid- naive kroniske hepatitis B HBeAg- positive og HBeAg- negative kinesiske patienter.
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 nucleoside-naïve chronic hepatitis B HBeAg-positive and HBeAg-negative Chinese patients.
Varighed af HBeAg- serokonvertering Varigheden af HBeAg- serokonvertering blev vurderet ud fra de samlede data opnået i studierne NV - 02B- 007 og NV- 02B- 015.
Durability of HBeAg-seroconversion Durability of HBeAg-seroconversion was assessed from pooled data from studies NV-02B-007 and NV-02B-015.
Kaplan- Meier estimaterne for andelen af patienter, der opretholdt HBeAg serokonvertering i minimum 52 uger efter seponering af behandlingen, var 86, 2% for telbivudin og 92, 8% for lamivudin.
The Kaplan-Meier estimates of the proportion of patients who maintained HBeAg seroconversion for at least 52 weeks following treatment discontinuation were 86.2% for telbivudine and 92.8% for lamivudine.
Patienter, der var med i denne analyse, havde gennemført ≥ 52 ugers behandling med studiemedicin og vist HBeAg tab i ≥ 24 uger, med HBV DNA < 5 log10 kopier/ ml ved sidste besøg eller havde, hvis de var HBeAg- negative ved baseline, gennemført ≥ 52 ugers behandling med studiemedicin OG havde et dokumenteret HBeAg tab på ≥ 2 på hinanden følgende studiebesøg.
Patients included in this analysis had completed ≥ 52 weeks of study drug treatment and exhibited HBeAg loss for ≥ 24 weeks, with HBV DNA < 5 log10 copies/ ml at the last visit, or, if they were HBeAg-negative at entry, completed ≥ 52 weeks of study drug treatment AND had HBsAg loss documented on ≥ 2 consecutive study visits.