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Comparison of Tenofovir DF and Adefovir Dipivoxil for HBeAg-Negative Chronic Hepatitis B Treatment

This study, GS-US-174-0102, evaluates the efficacy and safety of Tenofovir DF (TDF) compared to Adefovir Dipivoxil (ADV) in the treatment of HBeAg-negative chronic hepatitis B (CHB). Conducted as a randomized, double-blind trial, the study involved 375 participants and measured primary endpoints such as complete response, HBV DNA levels, and histological improvement at week 48. Results demonstrated that TDF was significantly more effective than ADV, with a greater proportion of patients achieving viral suppression without developing resistance.

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Comparison of Tenofovir DF and Adefovir Dipivoxil for HBeAg-Negative Chronic Hepatitis B Treatment

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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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