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A prospective clinical study in hepatitis B e antigen-negative chronic hepatitis B patients with stringent cessation
Minghao Ha1, Guotong Zhang, Shu Diao
1Department of Infectious Diseases and Hepatology, Shanghai No 7 hospital, Shanghai 200137, China. hmh_1021@sina.com
Insights
Adefovir treatment for chronic hepatitis B (CHB) shows limited long-term effectiveness after cessation in HBeAg-negative patients. Relapse is common, particularly within 12 months, with younger age being a factor in lower relapse rates.
Area of Science:
- Hepatology
- Virology
- Pharmacology
Background:
- Adefovir is a common treatment for chronic hepatitis B (CHB).
- The long-term effectiveness of adefovir after treatment cessation is not well understood.
- Strict cessation criteria are often used to guide treatment discontinuation.
Purpose of the Study:
- To evaluate the sustained effectiveness of adefovir in HBeAg-negative CHB patients after treatment cessation.
- To identify factors influencing relapse rates post-adefovir therapy.
- To determine the significance of HBsAg seroconversion as a treatment endpoint.
Main Methods:
- A cohort of 145 HBeAg-negative CHB patients meeting strict adefovir cessation criteria were followed.
- Patients were monitored for hepatitis B virus (HBV) DNA levels post-cessation.
- Relapse was defined as HBV DNA ≥10(4) copies/mL.
- Cox regression analysis was used to identify factors associated with relapse.
Main Results:
- 95 out of 145 patients (65.5%) relapsed during follow-up.
- Over 93% of relapses occurred within 12 months of adefovir cessation.
- Younger age (≤25 years) was associated with significantly lower relapse rates.
- Hepatitis B surface antigen (HBsAg) seroconversion occurred in 12 patients, with no subsequent relapses.
Conclusions:
- Adefovir treatment effectiveness wanes after cessation in HBeAg-negative CHB patients, even with strict criteria.
- Younger patients (≤25 years) may have a better prognosis after adefovir cessation.
- HBsAg seroconversion represents an ideal and sustained treatment endpoint for adefovir therapy in CHB.
Abstract:
Adefovir is usually applied for therapy of chronic hepatitis B (CHB), but its effectiveness after cessation is still unknown. This study was to evaluate the effectiveness of adefovir treatment with strict cessation criteria in hepatitis B e antigen (HBeAg)-negative patients and to identify potentially important factors. One hundred forty-five HBeAg-negative CHB patients who had received adefovir treatment for at least 24 months and for whom serum hepatitis B virus (HBV) DNA had remained undetectable for at least 18 months before cessation were included. They were followed up monthly during the first four months and at 3-month or 6-month intervals thereafter. Patients with ≥10(4) copies of HBV DNA per mL were defined as relapsed. In total, 95 patients relapsed within the follow-up time, and more than 93% relapsed within 12 months after adefovir cessation. Cumulative relapse rates at months 6, 12, 24, 36, 48 and 60 were 53.8%, 61.4%, 65.5%, 65.5%, 65.5% and 65.5%, respectively. Age was the only factor associated with relapse, with lower relapse rates in younger patients shown by Cox regression analysis. HBsAg seroconversion occurred in 12 patients, and none of them relapsed during follow-up. The effectiveness of adefovir therapy does not persist in HBeAg-negative CHB patients, even when strict cessation criteria are applied, except for patients aged ≤ 25 years. HBsAg seroconversion is the ideal endpoint of adefovir treatment.
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