Treatment cessation of entecavir in Asian patients with hepatitis B e antigen negative chronic hepatitis B: a multicentre prospective study.

Abstract

BACKGROUND AND OBJECTIVE:

The off-treatment durability of nucleos(t)ide analogue therapy in Asian hepatitis B e antigen (HBeAg) negative chronic hepatitis B (CHB) and the role of hepatitis B surface antigen (HBsAg) levels in predicting off-treatment durability has not been well investigated.

METHODS:

Following Asia-Pacific Association for the Study of the Liver guidelines, entecavir was stopped in Asian HBeAg negative patients treated for ≥ 2 years with undetectable HBV DNA levels on ≥ 3 separate occasions 6 months apart before treatment cessation. HBsAg and HBV DNA levels were prospectively monitored every 6-12 weeks for 48 weeks. Entecavir was restarted if there was virologic relapse (defined as HBV DNA >2000IU/mL).

RESULT:

184 patients (mean age 53.9 years, 67.9% male) were recruited. The cumulative rate of virologic relapse at 24 and 48 weeks was 74.2% and 91.4%, respectively. The median HBV DNA level at virologic relapse was 11000 (range 2115 to >1.98×10(8)) IU/mL. 42 (25.8%) patients had elevated alanine aminotransferase (median level 97 U/L, range 37-1058 U/L) during virologic relapse. Mean rate of off-treatment HBsAg decline was 0.018 (± 0.456) log IU/mL/year. No patients cleared HBsAg. There was no correlation between off-treatment serial HBsAg and HBV DNA levels (r=-0.026, p=0.541). HBsAg levels at the time of entecavir commencement, entecavir cessation and the subsequent rate of HBsAg reduction were not associated with virologic relapse (all p>0.05).

CONCLUSIONS:

Entecavir cessation in Asian HBeAg negative CHB resulted in high rates of virologic relapse, suggesting nucleos(t)ide analogue therapy should be continued indefinitely until the recognised treatment endpoint of HBsAg seroclearance.

• Authors: Wai-Kay Seto, Aric Josun Hui, Vincent Wai-Sun Wong, Grace Lai-Hung Wong, Kevin Sze-Hang Liu, Ching-Lung Lai, Man-Fung Yuen, Henry Lik-Yuen Chan
• Journal: Gut (Gut) Vol. 64 Issue 4 Pg. 667-72 (Apr 2015) ISSN: 1468-3288 [Electronic] England
• PMID: 24833635 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Chemical References

• Antiviral Agents
• Hepatitis B Surface Antigens
• Hepatitis B e Antigens
• entecavir
• Guanine

Topics

• Antiviral Agents (administration & dosage)
• Asian People
• Female
• Guanine (administration & dosage, analogs & derivatives)
• Hepatitis B Surface Antigens
• Hepatitis B e Antigens (blood)
• Hepatitis B, Chronic (blood, drug therapy)
• Humans
• Male
• Middle Aged
• Predictive Value of Tests
• Prospective Studies
• Recurrence
• Withholding Treatment