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Telbivudine, New HBV Drug: Early Viral Response Predicts Outcomes
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Reported by Jules Levin
EASL Annual Meeting April 28th, 2006
Vienna, Austria
"OPTIMAL VIROLOGIC AND CLINICAL EFFICACY AT ONE YEAR IS ASSOCIATED WITH MAXIMAL EARLY HBV SUPPRESSION IN NUCLEOSIDE-TREATED HEPATITIS B PATIENTS"
S Zeuzem, CL Lai, E Gane, YF Liaw, S Thongsawat, Y Wang, Y Chen, J Heathcote, J Rasenack, N Bzowej, N Naoumov, G Chao, B Fielman, N Brown,
and the GLOBE Study Group
BACKGROUND
Maximizing and maintaining HBV suppression is emerging as a key milestone leading to long-lasting improvement in chronic hepatitis B.
Better early viral suppression has been linked to improved therapeutic outcomes in several reports.
Previous results with lamivudine and adefovir suggest that the best early viral suppression (at 6 or 12 months) predicts the highest efficacy and lowest resistance subsequently1,2
1 Yuen et al., Hepatol. 2001
2 Locarnini et al., J Hepatol. 2005 (abstr)
Understanding the quantitative relationships between early viral suppression and subsequent therapeutic responses may help optimize patient management.
AUTHOR CONCLUSIONS
The magnitude of early HBV suppression (24wks) is linked to clinical efficacy outcomes and resistance at 1 year
- Best early viral suppression: Useful positive predictive values for 1-year outcomes
- Weaker early viral suppression: More variable negative predictive values for 1-year outcomes
- Same pattern of relationship for telbivudine and lamivudine.
- However telbivudine is superior to lamivudine at week 52, regardless of HBV DNA response at week 24 due to greater antiviral effect
The GLOBE Study Design
Entry criteria:
- Chronic hepatitis B with compensated liver disease
- HBeAg positive or negative
- Serum HBV DNA > 106 by COBAS PCR assay
- ALT >/= 1.3 xULN and < 10 xULN
Relationship Between Early Viral Suppression
and Efficacy Outcomes at 1 Year: Methods
Efficacy and resistance outcomes at 1 year were assessed according to Week 24 viral load categories
- HBV DNA negative by PCR
- Serum ALT
- HBeAg seroconversion
- Viral breakthrough
(Definition in GLOBE: rebound above 5 logs, for pts with viral load initially suppressed to below that level, or, rebound to within 1 log of baseline, for pts with viral load initially suppressed by ≥
2 logs)
Patients were categorized in 4 groups according to serum HBV DNA levels (copies/mL) at week 24:
- PCR-undetectable *, QL-103 copies/mL, 103-104, >104
* COBAS Amplicor; quantitation limit (QL) = 300 copies/mL
Viral Load Achieved by Week 24:
Telbivudine vw. Lamivudine
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