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Most Patients with Low Baseline HBV Viral Load Can Safely Discontinue Lamivudine (Epivir-HBV) after Achieving Virological Suppression
Most chronic hepatitis B patients with low pre-treatment HBV DNA levels (< 108 copies/mL) can maintain virological suppression after discontinuing treatment with lamivudine (Epivir-HBV), but relapse of hepatitis B "e" antigen (HBeAg) negative hepatitis remains a concern, according to a study published in the June 2009 Journal of Clinical Virology.
Lamivudine effectively suppresses HBV viral load, but it is unclear how long treatment should be continued to achieve optimal long-term outcomes.
The ACT-HBV clinical trials Asia-Pacific Steering Committee recommended withdrawal of lamivudine after patients achieve sustained virological suppression. Chau-Ting Yeh and colleagues from Taiwan analyzed outcomes among patients treated according to this guideline.
The study included 71 initially chronic hepatitis B patients who maintained virological suppression and achieved HBeAg seroconversion while on lamivudine monotherapy. Lamivudine was discontinued if undetectable HBV DNA was documented on 2 separate occasions at least 6 months apart.
Participants were followed for a median of 15 months (range 6-72 months). The researchers analyzed the effect of pre-treatment clinical and virological factors on time to HBV relapse.
Results
Of the 71 patients, 19 (27%) experienced HBV relapse.
Of these, 5 exhibited reappearance of HBeAg, while 14 had recurring HBeAg negative hepatitis.
Pre-treatment HBV DNA level was the only significant predictor of time to relapse (hazard ratio 1.023; P = 0.020).
15 of 34 patients (44.1%) with pre-treatment viral load > 108 copies/mL relapsed during follow-up, compared with 4 of 37 patients (10.8%) with pre-treatment HBV DNA < 108 copies/mL.
This difference in cumulative relapse rates between the 2 groups was statistically significant (P = 0.003).
Based on these findings, the researchers concluded, "In patients with pretreatment HBV DNA levels < 108 copies/mL, lamivudine could be withdrawn after achieving effective maintained virological suppression.
However, they added, "Relapse of HBeAg negative hepatitis remained a major problem."
Liver Research Unit, Chang Gung Memorial Hospital, Taipei, Taiwan; Liver Cancer Research Center, Chang Gung University, Taoyuan, Taiwan
10/09/09
Reference
C-T Yeh, C-W Hsu, Y-C Chen, and others. Withdrawal of lamivudine in HBeAg-positive chronic hepatitis B patients after achieving effective maintained virological suppression. Journal of Clinical Virology 45(2): 114-118. June 2009. (Abstract). |
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