The strategy of finite nucleos(t)ide analogue (Nuc) therapy in hepatitis B virus (HBV) suppressed hepatitis B e antigen (HBeAg)-negative patients has been considered as feasible and reasonably safe. 1,2 The strategy is increasingly accepted 3 and included, at least as an option, in recent American and European guidelines. 4,5 Of note is that clinical relapse (CR), defined as HBV relapse with alanine aminotransferase (ALT) elevation over two times upper limit of normal (ULN), may occur more frequently and earlier in those who stopped
Background
Off-therapy hepatitis flare may be detrimental or, conversely, facilitate hepatitis B surface antigen (HBsAg) decline. Retreatment decisions are crucial.
Methods
HBsAg was quantified before and during flares, at peak/retreatment start and at Months 6 and 12 in 336 entecavir/tenofovir-retreated and 105 non-retreated hepatitis B e antigen (HBeAg)-negative patients. Increasing HBsAg during ALT flare defined a ‘virus-dominating flare’ and decreasing HBsAg a ‘host-dominating flare’.
Results
Two hundred and eighty-eight retreated patients with a virus-dominating flare showed greater 1 year HBsAg decline (−1.0 versus −0.01 log10 IU/mL; P < 0.0001), more frequent rapid decline (69.8% versus 8.3%; P < 0001) and higher 3 year incidence of HBsAg < 100 IU/mL (32% versus 12%; P = 0.026) than 48 patients with a host-dominating flare, of whom 16 (33.3%) showed 3.8-fold (2 to 52-fold) HBsAg rebound on retreatment (versus 2/288; P < 0.0001). Compared with non-retreated controls, 1 year HBsAg decline was greater (−1.0 versus −0.47 log10 IU/mL; P < 0.0001) and faster (69.8% versus 42.5%; P < 0.0001) in patients with a virus-dominating flare, whereas 1 year HBsAg decline (−0.01 versus −0.16 log10 IU/mL) and 3 year HBsAg loss rate (0% versus 21%; P = 0.009) were lower in patients with a host-dominating flare.
Conclusions
Entecavir/tenofovir retreatment effectively decreases HBsAg level in patients with a virus-dominating flare but is ineffective/worse in patients with a host-dominating flare. These results support the use of combined HBsAg/ALT kinetics for the decision to retreat patients with a virus-dominating flare and withhold retreatment for patients with a host-dominating flare.
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