The roadmap concept suggests the use of on-treatment HBV DNA to guide treatment strategy of chronic hepatitis B patients treated by telbivudine. Our aim was to validate the roadmap approach of entecavir switch therapy in patients with incomplete response to telbivudine.
Methods
Consecutive chronic hepatitis B patients on telbivudine monotherapy were studied. Incomplete virological response was defined as detectable HBV DNA after 6–12 months of treatment. Maintained virological response was defined as undetectable HBV DNA until the last follow-up.
Results
Among the 79 patients on telbivudine, 39 (49%) had undetectable HBV DNA after 6–12 months of telbivudine treatment and 40 (51%) had incomplete virological response. In total, 33 incomplete responders switched to entecavir at 11 months (6–23), and 26 (79%) achieved maintained virological response after 25 months (4–46). Low HBV DNA level before switch therapy was the independent factor associated with maintained virological response to entecavir (P=0.01). A total of 24 of 25 (96%) patients with HBV DNA<2,000 IU/ml, versus 2 of 8 (25%) patients with HBV DNA≥2,000 IU/ml, had maintained virological response after switching to entecavir. Although rtM204I and/or rtL180M was detected in 3 of 7 patients with incomplete virological response to entecavir, none of the patients with HBV DNA<2,000 IU/ml during telbivudine treatment harboured these amino acid substitutions.
Conclusions
Roadmap approach using entecavir switch at month 6–12 among incomplete responders to telbivudine is recommended if the HBV DNA is <2,000 IU/ml at the time of switching.
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