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Background/Aims: A large proportion of patients fail lamivudine treatment andguidelines recommend switching to nucleotides or add-on therapy. The aim ofthis report is to evaluate the efficacy and safety of the switch to adefovir (ADV)monotherapy versus telbivudine (LDT) plus adefovir in CHB patients withconfirmed YMDD mutation with prior lamivudine treatment.Methods: 150 HBeAg positive patients were planned to be included into an openlabel randomized 96-week trial evaluating ADV versus ADV + LDT. The studywas terminated early due to difficulties enrolling patients into the ADV monotherapyarm. However, 42 patients were randomized 1:1 (91% Korean).Results: Median treatment duration was 48 weeks and 20 patients per armcompleted 48 weeks of treatment. HBV DNA decline at week 24 was higher inthe combination arm versus ADV monotherapy arm: -6.7 versus -5.0log10 copies/ml (baseline ADV + LDT:10.3; ADV:10.1 log10 copies/ml). Atweek 48, HBV DNA decline by -7.4 (ADV + LDT) and -4.9 (ADV)log10 copies/ml, with 38.5% (5/13) and 0% (0/9) of patients, respectively,achieving undetectable HBV DNA (300 copies/ml). Virologic breakthroughoccurred in 0% (0/21) of ADV + LDT and 9.6% (2/21) of ADV patients. HBeAgloss was achieved in one patient per arm at week 24 and in 23.1% (3/13) and 0%(0/9) at week 48 in the ADV+LDT versus ADV groups. The safety profile wassimilar in both treatment arms with 16 AEs reported per group. ALT flares(AASLD criteria) occurred in one patient per arm, increased creatine phosphokinasewas reported in 3/21 patients ADV + LDT and 1/21 ADV arm, but allwere grade 1/2. One case of musculoskeletal pain and parasthesia each occurredin the combination arm.Conclusion: In these 42 patients with established YMDD resistance on lamivudinetreatment, the switch to the combination of telbivudine and adefovir showedbetter outcomes compared with adefovir alone, and both had a similar safetyprofile

The 20th Conference of the Asian Pacific Association for the Study of the Liver Poster Presentation