By Cheryl Lathrop
BOSTON -- November 2, 2009 -- In patients with lamivudine (LMV)-resistant chronic hepatitis B virus (HBV), a combination of adefovir (ADV) and LMV is more effective than ADV alone in virologic response and virologic breakthrough, according to a study presented here at the Liver Meeting 2009, the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).
Woo Young Park, MD, Internal Medicine, Keimyung University Dongsan Medical Center, Daegu, South Korea, and colleagues reported findings from their study in a poster session here on October 31.
In patients with chronic HBV who are resistant to LMV, add-on adefovir strategy is superior to a switch strategy, as ADV monotherapy carries a significant risk of resistance in the long term. However, there is little data on ADV plus LMV (add-on therapy) compared with ADV monotherapy (switch therapy) in this patient population.
Therefore, Dr. Park and colleagues compared ADV plus LMV with ADV monotherapy in 1,003 Korean patients. Patients received ADV/LMV (n = 292) or ADV monotherapy (n = 711) for at least 6 months.
The biochemical response (alanine aminotransferase <40 U/L), virologic response (HBV DNA <2,000 copies/mL), and virologic breakthrough (1 log10 increase in HBV DNA compared with ongoing treatment nadir, confirmed on 2 occasions) were compared in both groups. Virologic response was evaluated according to HBV DNA reduction at 4 weeks of treatment and according to basal HBV DNA level.
Virologic response at 12 weeks was 32% for the LMV/ADV group and 22% for the ADV monotherapy group. At 24 weeks, this was 44% and 33%, respectively; at 48 weeks this was 57% and 45%; and at 72 weeks virologic response was 67% and 45%.
Biochemical response at 4 weeks was 15% in the LMV/ADV group and 11% in the ADV monotherapy group. At 12 weeks, this was 45% and 47%, respectively, and 59% and 61% at 24 weeks. Virologic breakthrough was 2.5% in the combination group and 25.0% in the monotherapy group (P < .0001).
The authors added that the higher HBV DNA reduction at 4 weeks of treatment was a good predictor of maintained virologic response to treatment.
[Presentation title: Comparison of Adefovir and Lamivudine Combination Therapy With Adefovir Monotherapy in Lamivudine-Resistant Chronic Hepatitis B. Abstract 479]
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