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ISSN 1001-5256 (Print)
ISSN 2097-3497 (Online)
CN 22-1108/R
Issue 7
Jul.  2016
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Article Contents

Criteria for withdrawal of nucleos( t) ide analogues and their clinical significance in treatment of chronic hepatitis B

DOI: 10.3969/j.issn.1001-5256.2016.07.013
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  • Received Date: 2016-01-21
  • Published Date: 2016-07-20
  • Objective To investigate the association of virologic relapse after withdrawal of nucleos( t) ide analogues( NAs) with HBs Ag quantitation and HBV DNA load at withdrawal in patients with chronic hepatitis B( CHB). Methods A total of 205 CHB patients who were treated with NAs in the outpatient service of Jining Infectious Diseases Hospital from January 2010 to June 2014,met the criteria for drug withdrawal in Guidelines for Prevention and Treatment of Chronic Hepatitis B( version 2010),and planned to stop the drugs were enrolled.HBs Ag and HBV DNA load were measured before drug withdrawal,and COBAS Taq Man 480 Ⅱ PCR was performed for patients with HBV DNA < 103 IU / ml to measure highly sensitive HBV DNA load. The patients were followed up for 1 year after drug withdrawal and HBV DNA > 103 IU / ml was defined as virologic relapse. The chi- square test and Fisher' s exact test were used for comparison of categorical data between groups. Results At 1 year after drug withdrawal,the overall virologic relapse rate in all CHB patients was 65. 9%( 135 /205),and 20%( 41 /205) had HBV DNA >103 IU / ml. In the patients with HBs Ag quantitation ≤100 IU / ml or >100 IU / ml,the virologic relapse rate was23. 9%( 11 /46) and 78. 0%( 124 /159),respectively,with a significant difference between the two groups( χ2= 46. 4,P < 0. 000 1). In the patients with highly sensitive HBV DNA load < 20 IU / ml or ≥20 IU / ml,the virologic relapse rate was 56. 4%( 62 /110) and 76. 8%( 73/95),respectively,with a significant difference between the two groups( χ2= 9. 5,P = 0. 002). The patients with HBs Ag quantitation ≤100IU / ml and highly sensitive HBV DNA load < 20 IU / ml had a relapse rate of 14. 3%( 5 /35),and the other patients had a relapse rate of76. 5%( 130 /170); the relapse rate showed a significant difference between the two groups( χ2= 49. 9,P <0. 000 1). Conclusion After the patients meet the criteria for drug withdrawal in Guidelines for Prevention and Treatment of Chronic Hepatitis B( version 2010) and stop the antiviral therapy,the relapse of CHB is associated with HBs Ag quantitation and HBV DNA load at withdrawal. With reference to HBs Ag quantitation and / or highly sensitive HBV DNA load as the criteria for withdrawal of antiviral therapy,such as HBs Ag quantitation ≤100 IU / ml and highly sensitive HBV DNA load < 20 IU / ml,patients can achieve the safest drug withdrawal.

     

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