Defining virologic relapse in XXXX .

@entity1 @entity97 @entity6194
BACKGROUND AND AIMS: Different definitions of virologic relapse (VR) are being used. One way of defining VR is "reappearance of @entity97 DNA in the serum," while another definition is an "increase in @entity97 DNA level greater than 1 log in two determinations at least 4 weeks apart." The aim of this study was to see the effectiveness of these two definitions METHODS: Forty-five HBeAg-positive @entity6194 @entity1 with a virologic response [negative PCR (<12 IU/ml)] who had discontinued therapy were analyzed retrospectively for VR, HBeAg reversion and biochemical flare. RESULTS: @entity97 DNA reappeared in the serum (>= 12 IU/ml) of all 45 @entity1 (100%). An increase in @entity97 DNA level greater than 1 log in two determinations at least 4 weeks apart was identified in 20 of 25 @entity1 (80%). Biochemical flare and HBeAg reversion were observed in 18 (40%) and 14 (31%) @entity1 , respectively. Peak off-therapy @entity97 DNA level was significantly associated with biochemical flare (r=0.758, P<0.001) and HBeAg reversion (r=0.645, P<0.001). Two @entity1 with high initial off-therapy @entity97 DNA levels (>= 4.0 log(10) IU/ml) were reassessed at 4 weeks, and both experienced a biochemical flare and HBeAg reversion. Two @entity1 had an increase in @entity97 DNA level greater than 1 log at a very low level (1 log to 2 or 3 log), but did not experience biochemical flare or HBeAg reversion during follow-up. CONCLUSIONS: Reappearance of @entity97 DNA was universal when sensitive @entity97 DNA assay was used. Waiting 4 weeks to confirm VR may be harmful for @entity1 with a high @entity97 DNA level, and was ineffective to indicate re-therapy for @entity1 with increase in @entity97 DNA at a very low level. There is a need for improved and standardized definitions of VR.
