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Marcellin P et al., AASLD 2007, LB2

A Randomized, Double-Blind, Comparison of Tenofovir DF (TDF) versus Adefovir Dipivoxil (ADV) for the Treatment of HBeAg-Negative Chronic Hepatitis B (CHB): Study GS-US-174-0102.

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Marcellin P et al., AASLD 2007, LB2

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  1. A Randomized, Double-Blind, Comparison of Tenofovir DF (TDF) versus Adefovir Dipivoxil (ADV) for the Treatment of HBeAg-Negative Chronic Hepatitis B (CHB): Study GS-US-174-0102 P Marcellin1, M Buti2, Z Krastev3, G Germanidis4, K Kaita5, I Kotzev6, P Buggisch7, F Weilert8, H Trinh9, J Sorbel10, J Anderson10, E Mondou10, F Rousseau10 1Hospital Beaujon, Clichy France; 2Hebron Hospital, Barcelona Spain; 3University Hospital “St Ivan Rilsky”, Sofia, Bulgaria; 4General Hospital of Thessaloniki, Thessaloniki, Greece; 5John Buhler Research Centre, University of Manitoba, Winnipeg MB Canada; 6University Hospital “Sveta Marina”, Varna Bulgaria; 7Medizinische Universitatsklinik Eppendorf, Hamburg Germany; 8Waikato Hospital, Hamilton, New Zealand; 9San Jose Gastroenterology, San Jose, CA; 10Gilead Sciences, Durham NC. Marcellin P et al., AASLD 2007, LB2

  2. Studiendesign 5 Jahre doppelblind offen Tenofovir 300 mg Tenofovir 300 mg (n =250) Randomisierung 2:1 Adefovir 10 mg (n = 125) Woche 240 Leberbiopsie Woche 48 Leberbiopsie Leberbiopsie Vor Therapie Marcellin P et al., AASLD 2007, LB2

  3. Endpunkte (Woche 48) Primärer Endpunkt: • Komplettes Ansprechen: HBV DNA <400 K/ml und histologische Besserung (mindestens Reduktion des Knodell-Scores um 2 Punkte ohne Verschlechterung der Fibrose) Sekundäre Endpunkte: • HBV DNA <400 K/ml • Normale GPT • Histologische Besserung • Resistenz Marcellin P et al., AASLD 2007, LB2

  4. Patienten Charakteristika Marcellin P et al., AASLD 2007, LB2

  5. Primäre und sekundäre Endpunkte TDF 100 93 ADV P>0.05 p<0.001 P<0.001 90 80 72 71 69 70 63 60 % Patienten 49 50 40 30 20 10 0 HBV DNA <400 Kopien/ml Histologische Besserung Komplettes Ansprechen Marcellin P et al., AASLD 2007, LB2

  6. 8 7 T r e a t m e n t T D F 6 A D V 5 Mean (95% CI) HBV DNA (Log10 Copies/mL) p<0.001 4 3 2 LLOQ 1 0 4 8 1 2 1 6 2 0 2 4 2 8 3 2 3 6 4 0 4 4 4 8 W e e k s o n S t u d y A D V n = 1 1 1 2 2 2 5 5 5 1 1 1 2 2 2 3 3 3 1 1 1 2 2 2 1 1 1 1 1 1 1 1 1 7 7 7 1 1 1 1 1 1 7 7 7 T D F n = 2 2 2 5 5 5 0 0 0 2 2 2 4 4 4 2 2 2 2 2 2 3 3 3 9 9 9 2 2 2 4 4 4 2 2 2 2 2 2 4 4 4 1 1 1 Verlauf der HBV-DNA (log10Kopien/ml) Marcellin P et al., AASLD 2007, LB2

  7. % HBV-DNA <400 Kopien/ml (Missing=Failure) 100 93% Treatment 90 TDF (N=250) 93% von LAM-vorbehandelt ADV (N=125) 80 p<0.001 70 63% 60 50 Prozent (%) 40 30 20 10 0 0 4 8 12 16 20 24 28 32 36 40 44 48 Wochen Marcellin P et al., AASLD 2007, LB2

  8. %Patienten mit normaler GPT (Missing=Failure) 100 Therapie 90 TDF (N=250) ADV (N=125) 80 77% 70 60 50 Prozent (%) 40 30 20 10 0 0 4 8 12 16 20 24 28 32 36 40 44 48 Wochen Marcellin P et al., AASLD 2007, LB2

  9. Ausgewählte AE im Labor – Grad 3 / 4 Marcellin P et al., AASLD 2007, LB2

  10. Resistenz • Alle TPF-Patienten mit HBV-DNA ≥ 400 K/ml zu Woche 48 ausgewertet (8 Patienten) • In keinem Fall TDF-assoziierte Resistenzmutationen Marcellin P et al., AASLD 2007, LB2

  11. Zusammenfassung (HBeAg-negative Patienten) • TDF war ADV überlegen: 93% HBV-DNA <400 Kopien/ml • Kein Patient entwickelte mit TDF-Resistenz assoziierte Mutation • TDF wurde gut vertragen Marcellin P et al., AASLD 2007, LB2

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