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Clinical Trial
. 2008;13(5):705-13.

Comparison of the antiviral activity of adefovir and tenofovir on hepatitis B virus in HIV-HBV-coinfected patients

Karine Lacombe  1 , Joël Gozlan, Anders Boyd, Pierre-Yves Boelle, Philippe Bonnard, Jean-Michel Molina, Patrick Miailhes, Caroline Lascoux-Combe, Lawrence Serfaty, Fabien Zoulim, Pierre-Marie Girard
Affiliations
Clinical Trial

Comparison of the antiviral activity of adefovir and tenofovir on hepatitis B virus in HIV-HBV-coinfected patients

Karine Lacombe et al. Antivir Ther. 2008.

Abstract

Background: Characteristics and factors influencing viral decay under tenofovir (TDF) and adefovir (ADV) need to be determined in HIV-HBV-coinfected patients.

Methods: This open-label study compared the HBV dynamics in 85 HIV-HBV-coinfected patients initiating an antiretroviral regimen, either including TDF or associated with ADV. The first 6-month change in viral load was analysed using mixed linear models. The adjusted hazards ratio, comparing the rates of undetectable HBV DNA between treatments, was calculated using a Cox proportional hazard model.

Results: The HBV DNA decay, adjusted for baseline HBV viral load was more pronounced in patients treated with TDF than with ADV at 12 months (66% versus 53%, P=0.0001). Patients in the TDF group presented a steeper slope of decline at 1.1 (95% confidence interval [CI] 0.9-1.3), compared with 0.8 (95% CI 0.6-1.0) in the ADV group (P=0.036). The mean time to HBV DNA undetectability was 19.3 months (95% CI 16.7-22.0) with TDF and 25.9 months (95% CI 21.1-30.7) with ADV. When adjusted for hepatitis B virus e antigen, HBV DNA and alanine aminotransferase levels at baseline, the influence of treatment on time to HBV DNA undetectability remained in favour of TDF versus ADV (hazard ratio=2.79, 95% CI 1.05-7.40, P=0.039)

Conclusions: TDF influenced more strongly the early-phase HBV DNA kinetics than ADV. This is associated with a sustained antiviral activity in the TDF group, in which patients reached the threshold of HBV undetectability at a faster rate and in a larger proportion than those taking ADV.

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Figures

Figure 1
Figure 1. Time course of HBV-DNA during the first 12 months of treatment with TDF (upper line) or ADV (lower line)
Plain lines are the smooth estimates of the mean HBV load at each time point according to treatment. Undetectable viral loads are shown as green spots and thresholds as blue spots.
Figure 2
Figure 2
Modelling of HBV-DNA dynamics between inclusion and month 6 according to treatment.
Figure 3
Figure 3
Success curves representing time-to-undetectability (HBV-DNA < 200 copies/mL) according to treatment group.
See this image and copyright information in PMC

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