Stringent cessation criterion results in better durability of lamivudine
treatment: a prospective clinical study in hepatitis B e antigen-positive
chronic hepatitis B patients
L. Wang 1 , F. Liu 2 , Y.-D. Liu 3 , X.-Y. Li 4 , J.-B. Wang 4 , Z.-H. Zhang 4
and Y.-Z. Wang 4
1 Department of Infectious Diseases and Hepatology, the Second Hospital of
Shandong University, Shandong University, Jinan, China ; 2 Department of
Infectious Disease, Ruijin Hospital, Shanghai Jiao Tong University School of
Medicine, Shanghai, China ; 3 Yantai Infectious Disease Hospital, Yantai,
China ; and 4 Jinan Infectious Disease Hospital, Jinan, China
Correspondence to Wang Lei, Department of Infectious Diseases and Hepatology,
the Second Hospital of Shandong University, 247 Beiyuan Road, Jinan 250033,
China. E-mail: [email protected]
ABSTRACT
Summary. 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 Lamivudine was withdrawn ≥6 months after HBeAg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 ≥104 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 ≥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 ≥6 months and total duration for ≥18 months,
lamivudine withdrawal is a reasonable option. Prolonged treatment may be
required for patients aged greater than 30 years to reduce relapse.
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Received March 2009; accepted for publication May 2009
DIGITAL OBJECT IDENTIFIER (DOI)
10.1111/j.1365-2893.2009.01178作者: bear2009 时间: 2010-3-24 22:03