The cessation criteria for lamivudine treatment vary in published articles and their results are contradictory, especially factors predicting relapse. To clarify these contradictions, this long-term follow-up study of 125 Chinese hepatitis B e antigen (HBeAg)-positive chronic hepatitis B patients was designed with stringent cessation criterion. All patients received lamivudine and achieved HBeAg seroconversion (group A, n = 82) or loss (group B, n = 43) with undetectable hepatitis B virus (HBV) DNA by PCR assay during the treatment. Lamivudine was withdrawn >or=6 months after HBeAg seroconversion/loss occurred. The median treatment durations were 24 (12-54) months and 36 (18-89) months in group A and group B, respectively. Patients were followed up for median 24 (2-84) months. The cumulative relapse (defined as serum HBV DNA >or=10(4) copies/mL) rates in the two groups at months 12, 24, 36 and 48 were 23.4%vs 35.0%, 25.0%vs 37.7%, 25.0%vs 41.1% and 29.4%vs 41.1%, respectively (log-rank test, P = 0.119). For patients whose total treatment duration >or=18 months in group A, the cumulative relapse rates at months 12, 24, 36 and 48 were 18.3%, 20.1%, 20.1% and 25.1%, which was significantly lower than those with a shorter duration (log-rank test, P = 0.002). The mean age and median total duration were statistically different between relapsers and nonrelapsers in group A (33.9 +/- 13.6 vs 23.1 +/- 11.0 years, P < 0.001 and 24 vs 26 months, P = 0.003). Cox regression revealed that age was the only predictive factor for relapse (RR, 1.069; 95% CI, 1.032-1.106, P < 0.001). Patients aged <30 years relapsed less frequently in 5 years (12.3%vs 53.5%, P = 0.001). In conclusion, for patients who maintained HBeAg seroconversion for >or=6 months and total duration for >or=18 months, lamivudine withdrawal is a reasonable option. Prolonged treatment may be required for patients aged greater than 30 years to reduce relapse.
ABSTRACT. This study aimed to determine the relationship between changes in the serum levels of macrophage migratory inhibitory factor (MIF), interleukin (IL) 17, and IL-10 during chronic hepatitis B treatment via Baraclude ® (Bristol-Meyers Squibb). Thirty-six patients with chronic hepatitis B and 24 healthy individuals were selected as the experimental and control groups, respectively, and the serum levels of MIF, IL-17, and IL-10 were measured during the period in which the experimental group was treated with oral Baraclude ® ; meanwhile, the alanine aminotransferase (ALT), hepatitis B virus (HBV) DNA, and HBV marker (M) levels were measured in the experimental group. In the experimental group, the ALT and HBV-DNA levels began to exhibit obvious decreases in week 4, and the MIF and IL-17 levels exhibited obvious increases in week 4 followed by gradual decreases; however, the IL-10 level exhibited an obvious decrease in week 12 and then (2015) increased gradually. These changes were significant when compared with the control group (P < 0.05). In conclusion, Baraclude ® treatment not only actively suppressed HBV but also indirectly balanced the MIF, IL-17, and IL-10 levels and reduced the liver inflammatory response.
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