A Randomized Trial of Telbivudine (LdT) vs. Adefovir for HBeAg-Positive Chronic

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AASLD 2006

#1005. A Randomized Trial of Telbivudine (LdT) vs. Adefovir for

HBeAg-Positive Chronic Hepatitis B: Final Week 52 Results

N. Bzowe; H. Chan; C. Lai; M. Cho; Y. Moon; Y. Chao; E. J. Heathcote; R.

Myers; G. Minuk; P. Marcellin; L. Jeffers; Sievert; R. Kaiser; G. Harb; G.

C. Chao; N. A. Brown; S. The 018

Background:

Telbivudine (LdT) demonstrated greater antiviral efficacy vs lamivudine in

Phase II and III trials. Adefovir dipivoxil (ADV) was superior to placebo in

Phase III but has not been evaluated in active-comparator trials. Here we

report final results at week 52 (W52) of a randomized trial of LdT vs ADV in

adults with HBeAg-positive chronic hepatitis B (CHB), including the primary

antiviral efficacy analysis at week 24 and the results of a randomized

switch from ADV to LdT.

Methods:

The study enrolled 135 adults with HBeAg-positive compensated CHB with HBV

DNA >6 log10 copies/mL by COBAS Amplicor PCR assay (LLOQ = 300 copies/mL),

serum ALT 1.3-10 x ULN. Patients were initially randomized (2:1) to ADV 10

mg/d or LdT 600 mg/d for 24 weeks, with a secondary randomization (1:1) of

ADV recipients to either continue ADV or switch to LdT after Week 24. The

primary endpoint is HBV DNA reduction at Week 24, with secondary efficacy

and safety endpoints assessed at Week 24 and Week 52.

Results:

Treatment groups were matched at baseline. At Week 24 mean HBV DNA reduction

from baseline was significantly greater with LdT vs ADV (-6.30 vs. -4.97

log10 copies/mL; p<0.01). Compared with 52 wks of ADV treatment, patients

treated with or switched to LdT (1) achieved greater HBV DNA reductions; (2)

were significantly more likely to achieve HBV <5log10 (91% and 87% vs 66%,

p<0.05); and (3) achieved proportionally greater PCR-negativity (58% and

54%, vs 39%) and HBeAg loss (31% and 26%, vs 21%). In the ADV/LdT switch

group, mean viral load decreased rapidly following Week 24; by Week 40 the

mean viral load was similar to the group receiving LdT from baseline

(Figure). All regimens were well-tolerated. Resistance is being analyzed and

will be presented.

Conclusion:

At 24 wks, LdT produced significantly greater and more consistent antiviral

efficacy than ADV. At one year, patients treated continuously with LdT, or

switched from ADV to LdT, showed proportionally better results on all

measures of antiviral efficacy compared to continuous ADV.

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