Off‐therapy durability of response to entecavir therapy in hepatitis B e antigen‐negative chronic hepatitis B patients
The optimal duration of nucelos(t)ide analog (Nuc) treatment in hepatitis B e antigen (HBeAg)‐negative patients with chronic hepatitis B virus (HBV) infection is unknown. The Asian Pacific Association for the Study of the Liver (APASL) guidelines recommend that treatment can be discontinued if undet...
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| Published in | Hepatology (Baltimore, Md.) Vol. 58; no. 6; pp. 1888 - 1896 |
|---|---|
| Main Authors | , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Wolters Kluwer Health, Inc
01.12.2013
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| Subjects | |
| Online Access | Get full text |
| ISSN | 0270-9139 1527-3350 1527-3350 |
| DOI | 10.1002/hep.26549 |
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| Abstract | The optimal duration of nucelos(t)ide analog (Nuc) treatment in hepatitis B e antigen (HBeAg)‐negative patients with chronic hepatitis B virus (HBV) infection is unknown. The Asian Pacific Association for the Study of the Liver (APASL) guidelines recommend that treatment can be discontinued if undetectable HBV‐DNA has been documented on three occasions ≥6 months apart. This study aimed to test this stopping rule in HBeAg‐negative chronic hepatitis B (CHB) patients treated with entecavir (ETV). Ninety‐five patients (39 cirrhosis) were treated with ETV for a median of 721 (395‐1,762) days before stopping therapy and were then monitored with serum HBV DNA and alanine aminotransferase (ALT) at least every 3 months. Within 1 year after stopping ETV therapy, “clinical relapse” (an episode of ALT elevation >2 × upper limit of normal plus HBV‐DNA >2,000 IU/mL) occurred in 43 (45.3%) of the 95 patients. Of the 39 cirrhosis patients, 17 (43.6%) relapsed and one (2.6%) developed decompensation. The median duration until relapse was 230 days (74.4% >6 months). Logistic regression analysis showed that baseline HBV‐DNA ≤2 × 105 IU/mL was the only significant independent factor for sustained response. The 1‐year relapse rate was 29% in patients with a baseline HBV DNA ≤2 × 105 IU/mL versus 53% in those with HBV DNA >2 × 105 IU/mL (P = 0.027). For the latter, consolidation therapy >64 weeks reduced the relapse rate to 33.3% in patients without cirrhosis. Conclusion: With an overall 1‐year relapse rate of 45% and 29% in those with a baseline serum HBV DNA ≤2 × 105 IU/mL, the APASL stopping rule for HBeAg‐negative CHB patients with proper off‐therapy monitoring is adequate even in patients with cirrhosis. Consolidation therapy >64 weeks seems more appropriate for those with higher baseline HBV DNA. (Hepatology 2013; 58:1888–1896) |
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| AbstractList | The optimal duration of nucelos(t)ide analog (Nuc) treatment in hepatitis B e antigen (HBeAg)‐negative patients with chronic hepatitis B virus (HBV) infection is unknown. The Asian Pacific Association for the Study of the Liver (APASL) guidelines recommend that treatment can be discontinued if undetectable HBV‐DNA has been documented on three occasions ≥6 months apart. This study aimed to test this stopping rule in HBeAg‐negative chronic hepatitis B (CHB) patients treated with entecavir (ETV). Ninety‐five patients (39 cirrhosis) were treated with ETV for a median of 721 (395‐1,762) days before stopping therapy and were then monitored with serum HBV DNA and alanine aminotransferase (ALT) at least every 3 months. Within 1 year after stopping ETV therapy, “clinical relapse” (an episode of ALT elevation >2 × upper limit of normal plus HBV‐DNA >2,000 IU/mL) occurred in 43 (45.3%) of the 95 patients. Of the 39 cirrhosis patients, 17 (43.6%) relapsed and one (2.6%) developed decompensation. The median duration until relapse was 230 days (74.4% >6 months). Logistic regression analysis showed that baseline HBV‐DNA ≤2 × 105 IU/mL was the only significant independent factor for sustained response. The 1‐year relapse rate was 29% in patients with a baseline HBV DNA ≤2 × 105 IU/mL versus 53% in those with HBV DNA >2 × 105 IU/mL (P = 0.027). For the latter, consolidation therapy >64 weeks reduced the relapse rate to 33.3% in patients without cirrhosis. Conclusion: With an overall 1‐year relapse rate of 45% and 29% in those with a baseline serum HBV DNA ≤2 × 105 IU/mL, the APASL stopping rule for HBeAg‐negative CHB patients with proper off‐therapy monitoring is adequate even in patients with cirrhosis. Consolidation therapy >64 weeks seems more appropriate for those with higher baseline HBV DNA. (Hepatology 2013; 58:1888–1896) The optimal duration of nucelos(t)ide analog (Nuc) treatment in hepatitis B e antigen (HBeAg)-negative patients with chronic hepatitis B virus (HBV) infection is unknown. The Asian Pacific Association for the Study of the Liver (APASL) guidelines recommend that treatment can be discontinued if undetectable HBV-DNA has been documented on three occasions ≥6 months apart. This study aimed to test this stopping rule in HBeAg-negative chronic hepatitis B (CHB) patients treated with entecavir (ETV). Ninety-five patients (39 cirrhosis) were treated with ETV for a median of 721 (395-1,762) days before stopping therapy and were then monitored with serum HBV DNA and alanine aminotransferase (ALT) at least every 3 months. Within 1 year after stopping ETV therapy, "clinical relapse" (an episode of ALT elevation >2 × upper limit of normal plus HBV-DNA >2,000 IU/mL) occurred in 43 (45.3%) of the 95 patients. Of the 39 cirrhosis patients, 17 (43.6%) relapsed and one (2.6%) developed decompensation. The median duration until relapse was 230 days (74.4% >6 months). Logistic regression analysis showed that baseline HBV-DNA ≤2 × 105 IU/mL was the only significant independent factor for sustained response. The 1-year relapse rate was 29% in patients with a baseline HBV DNA ≤2 × 105 IU/mL versus 53% in those with HBV DNA >2 × 105 IU/mL (P = 0.027). For the latter, consolidation therapy >64 weeks reduced the relapse rate to 33.3% in patients without cirrhosis. Conclusion: With an overall 1-year relapse rate of 45% and 29% in those with a baseline serum HBV DNA ≤2 × 105 IU/mL, the APASL stopping rule for HBeAg-negative CHB patients with proper off-therapy monitoring is adequate even in patients with cirrhosis. Consolidation therapy >64 weeks seems more appropriate for those with higher baseline HBV DNA. (Hepatology 2013; 58:1888-1896) [PUBLICATION ABSTRACT] The optimal duration of nucelos(t)ide analog (Nuc) treatment in hepatitis B e antigen (HBeAg)-negative patients with chronic hepatitis B virus (HBV) infection is unknown. The Asian Pacific Association for the Study of the Liver (APASL) guidelines recommend that treatment can be discontinued if undetectable HBV-DNA has been documented on three occasions ≥ 6 months apart. This study aimed to test this stopping rule in HBeAg-negative chronic hepatitis B (CHB) patients treated with entecavir (ETV). Ninety-five patients (39 cirrhosis) were treated with ETV for a median of 721 (395-1,762) days before stopping therapy and were then monitored with serum HBV DNA and alanine aminotransferase (ALT) at least every 3 months. Within 1 year after stopping ETV therapy, "clinical relapse" (an episode of ALT elevation >2 × upper limit of normal plus HBV-DNA >2,000 IU/mL) occurred in 43 (45.3%) of the 95 patients. Of the 39 cirrhosis patients, 17 (43.6%) relapsed and one (2.6%) developed decompensation. The median duration until relapse was 230 days (74.4% >6 months). Logistic regression analysis showed that baseline HBV-DNA ≤ 2 × 10(5) IU/mL was the only significant independent factor for sustained response. The 1-year relapse rate was 29% in patients with a baseline HBV DNA ≤ 2 × 10(5) IU/mL versus 53% in those with HBV DNA >2 × 10(5) IU/mL (P = 0.027). For the latter, consolidation therapy >64 weeks reduced the relapse rate to 33.3% in patients without cirrhosis. With an overall 1-year relapse rate of 45% and 29% in those with a baseline serum HBV DNA ≤ 2 × 10(5) IU/mL, the APASL stopping rule for HBeAg-negative CHB patients with proper off-therapy monitoring is adequate even in patients with cirrhosis. Consolidation therapy >64 weeks seems more appropriate for those with higher baseline HBV DNA. The optimal duration of nucelos(t)ide analog (Nuc) treatment in hepatitis B e antigen (HBeAg)-negative patients with chronic hepatitis B virus (HBV) infection is unknown. The Asian Pacific Association for the Study of the Liver (APASL) guidelines recommend that treatment can be discontinued if undetectable HBV-DNA has been documented on three occasions ≥ 6 months apart. This study aimed to test this stopping rule in HBeAg-negative chronic hepatitis B (CHB) patients treated with entecavir (ETV). Ninety-five patients (39 cirrhosis) were treated with ETV for a median of 721 (395-1,762) days before stopping therapy and were then monitored with serum HBV DNA and alanine aminotransferase (ALT) at least every 3 months. Within 1 year after stopping ETV therapy, "clinical relapse" (an episode of ALT elevation >2 × upper limit of normal plus HBV-DNA >2,000 IU/mL) occurred in 43 (45.3%) of the 95 patients. Of the 39 cirrhosis patients, 17 (43.6%) relapsed and one (2.6%) developed decompensation. The median duration until relapse was 230 days (74.4% >6 months). Logistic regression analysis showed that baseline HBV-DNA ≤ 2 × 10(5) IU/mL was the only significant independent factor for sustained response. The 1-year relapse rate was 29% in patients with a baseline HBV DNA ≤ 2 × 10(5) IU/mL versus 53% in those with HBV DNA >2 × 10(5) IU/mL (P = 0.027). For the latter, consolidation therapy >64 weeks reduced the relapse rate to 33.3% in patients without cirrhosis.UNLABELLEDThe optimal duration of nucelos(t)ide analog (Nuc) treatment in hepatitis B e antigen (HBeAg)-negative patients with chronic hepatitis B virus (HBV) infection is unknown. The Asian Pacific Association for the Study of the Liver (APASL) guidelines recommend that treatment can be discontinued if undetectable HBV-DNA has been documented on three occasions ≥ 6 months apart. This study aimed to test this stopping rule in HBeAg-negative chronic hepatitis B (CHB) patients treated with entecavir (ETV). Ninety-five patients (39 cirrhosis) were treated with ETV for a median of 721 (395-1,762) days before stopping therapy and were then monitored with serum HBV DNA and alanine aminotransferase (ALT) at least every 3 months. Within 1 year after stopping ETV therapy, "clinical relapse" (an episode of ALT elevation >2 × upper limit of normal plus HBV-DNA >2,000 IU/mL) occurred in 43 (45.3%) of the 95 patients. Of the 39 cirrhosis patients, 17 (43.6%) relapsed and one (2.6%) developed decompensation. The median duration until relapse was 230 days (74.4% >6 months). Logistic regression analysis showed that baseline HBV-DNA ≤ 2 × 10(5) IU/mL was the only significant independent factor for sustained response. The 1-year relapse rate was 29% in patients with a baseline HBV DNA ≤ 2 × 10(5) IU/mL versus 53% in those with HBV DNA >2 × 10(5) IU/mL (P = 0.027). For the latter, consolidation therapy >64 weeks reduced the relapse rate to 33.3% in patients without cirrhosis.With an overall 1-year relapse rate of 45% and 29% in those with a baseline serum HBV DNA ≤ 2 × 10(5) IU/mL, the APASL stopping rule for HBeAg-negative CHB patients with proper off-therapy monitoring is adequate even in patients with cirrhosis. Consolidation therapy >64 weeks seems more appropriate for those with higher baseline HBV DNA.CONCLUSIONWith an overall 1-year relapse rate of 45% and 29% in those with a baseline serum HBV DNA ≤ 2 × 10(5) IU/mL, the APASL stopping rule for HBeAg-negative CHB patients with proper off-therapy monitoring is adequate even in patients with cirrhosis. Consolidation therapy >64 weeks seems more appropriate for those with higher baseline HBV DNA. The optimal duration of nucelos(t)ide analog (Nuc) treatment in hepatitis B e antigen (HBeAg)-negative patients with chronic hepatitis B virus (HBV) infection is unknown. The Asian Pacific Association for the Study of the Liver (APASL) guidelines recommend that treatment can be discontinued if undetectable HBV-DNA has been documented on three occasions greater than or equal to 6 months apart. This study aimed to test this stopping rule in HBeAg-negative chronic hepatitis B (CHB) patients treated with entecavir (ETV). Ninety-five patients (39 cirrhosis) were treated with ETV for a median of 721 (395-1,762) days before stopping therapy and were then monitored with serum HBV DNA and alanine aminotransferase (ALT) at least every 3 months. Within 1 year after stopping ETV therapy, "clinical relapse" (an episode of ALT elevation >2 upper limit of normal plus HBV-DNA >2,000 IU/mL) occurred in 43 (45.3%) of the 95 patients. Of the 39 cirrhosis patients, 17 (43.6%) relapsed and one (2.6%) developed decompensation. The median duration until relapse was 230 days (74.4% >6 months). Logistic regression analysis showed that baseline HBV-DNA less than or equal to 2 10 super(5) IU/mL was the only significant independent factor for sustained response. The 1-year relapse rate was 29% in patients with a baseline HBV DNA less than or equal to 2 10 super(5) IU/mL versus 53% in those with HBV DNA >2 10 super(5) IU/mL (P = 0.027). For the latter, consolidation therapy >64 weeks reduced the relapse rate to 33.3% in patients without cirrhosis. Conclusion: With an overall 1-year relapse rate of 45% and 29% in those with a baseline serum HBV DNA less than or equal to 2 10 super(5) IU/mL, the APASL stopping rule for HBeAg-negative CHB patients with proper off-therapy monitoring is adequate even in patients with cirrhosis. Consolidation therapy >64 weeks seems more appropriate for those with higher baseline HBV DNA. (Hepatology 2013; 58:1888-1896) |
| Author | Chen, Yi‐Cheng Liaw, Yun‐Fan Chu, Chia‐Ming Chien, Rong‐Nan Sheen, I‐Shyan Hsu, Chao‐Wei Jeng, Wen‐Juei |
| Author_xml | – sequence: 1 givenname: Wen‐Juei surname: Jeng fullname: Jeng, Wen‐Juei organization: Chang Gung University – sequence: 2 givenname: I‐Shyan surname: Sheen fullname: Sheen, I‐Shyan organization: Chang Gung University – sequence: 3 givenname: Yi‐Cheng surname: Chen fullname: Chen, Yi‐Cheng organization: Chang Gung University – sequence: 4 givenname: Chao‐Wei surname: Hsu fullname: Hsu, Chao‐Wei organization: Chang Gung University – sequence: 5 givenname: Rong‐Nan surname: Chien fullname: Chien, Rong‐Nan organization: Chang Gung Memorial Hospital – sequence: 6 givenname: Chia‐Ming surname: Chu fullname: Chu, Chia‐Ming organization: Chang Gung University – sequence: 7 givenname: Yun‐Fan surname: Liaw fullname: Liaw, Yun‐Fan organization: Chang Gung University |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/23744454$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Copyright | 2013 by the American Association for the Study of Liver Diseases 2013 by the American Association for the Study of Liver Diseases. |
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| Notes | Potential conflict of interest: The authors have no financial and personal relationships with other people or organizations that could inappropriately influence (bias) their work. Y.F. Liaw has been involved in clinical trials or served as a global advisory board member of Roche, BMS, Novartis, and Gilead Sciences. Long‐term grant support provided by Chang Gung Medical Research Fund (SMRPG1005, OMRPG380061, CMRPG3A0901) and the Prosperous Foundation, Taipei, Taiwan. See Editorial on Page 1885 ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 |
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| PublicationTitle | Hepatology (Baltimore, Md.) |
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hepatitis B e antigen-negative chronic hepatitis B patients with stringent cessation criteria for adefovir publication-title: Arch Virol doi: 10.1007/s00705-011-1163-0 – volume: 381 start-page: 468 year: 2013 ident: 10.1002/hep.26549-BIB0023|hep26549-cit-0023 article-title: Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: a 5-year open-label follow-up study publication-title: Lancet doi: 10.1016/S0140-6736(12)61425-1 – volume: 47 start-page: 458 year: 2005 ident: 10.1002/hep.26549-BIB0011|hep26549-cit-0011 article-title: Estimation of the Youden Index and its associated cutoff point publication-title: Biomed J – volume: 6 start-page: 531 year: 2012 ident: 10.1002/hep.26549-BIB0002|hep26549-cit-0002 article-title: Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2012 update publication-title: Hepatol Int doi: 10.1007/s12072-012-9365-4 – volume: 206 start-page: 1521 year: 2012 ident: 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publication-title: Gastroenterology doi: 10.1053/j.gastro.2012.01.044 – volume: 19 start-page: 138 year: 2012 ident: 10.1002/hep.26549-BIB0021|hep26549-cit-0021 article-title: Serial HBV DNA levels in patients with persistently normal transaminase over 10 years following spontaneous HBeAg seroconversion publication-title: J Viral Hepat doi: 10.1111/j.1365-2893.2011.01450.x – volume: 11 start-page: 947 year: 2006 ident: 10.1002/hep.26549-BIB0006|hep26549-cit-0006 article-title: Short-term lamivudine therapy in HBeAg-negative chronic active hepatitis B in Taiwan publication-title: Antivir Ther doi: 10.1177/135965350601100715 – volume: 2 start-page: 263 year: 2008 ident: 10.1002/hep.26549-BIB0007|hep26549-cit-0007 article-title: Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2008 update publication-title: Hepatol Int doi: 10.1007/s12072-008-9080-3 – volume: 354 start-page: 1011 year: 2006 ident: 10.1002/hep.26549-BIB0010|hep26549-cit-0010 article-title: 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volume: 15 start-page: 1159 year: 2012 ident: 10.1002/hep.26549-BIB0014|hep26549-cit-0014 article-title: Adherence, persistence, healthcare utilization, and cost benefits of guideline-recommended hepatitis B pharmacotherapy publication-title: J Med Econ doi: 10.3111/13696998.2012.710690 – reference: 24037945 - Hepatology. 2013 Dec;58(6):1885-7 |
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| Snippet | The optimal duration of nucelos(t)ide analog (Nuc) treatment in hepatitis B e antigen (HBeAg)‐negative patients with chronic hepatitis B virus (HBV) infection... The optimal duration of nucelos(t)ide analog (Nuc) treatment in hepatitis B e antigen (HBeAg)-negative patients with chronic hepatitis B virus (HBV) infection... |
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| SubjectTerms | Adult Aged Aged, 80 and over Alanine Transaminase - blood Cohort Studies Consolidation Deoxyribonucleic acid DNA DNA, Viral - blood Female Guanine - administration & dosage Guanine - analogs & derivatives Hepatitis Hepatitis B Hepatitis B e Antigens - blood Hepatitis B virus Hepatitis B virus - genetics Hepatitis B, Chronic - drug therapy Hepatology Humans Liver cirrhosis Liver Cirrhosis - drug therapy Male Middle Aged Prospective Studies Recurrence Retrospective Studies Treatment Outcome |
| Title | Off‐therapy durability of response to entecavir therapy in hepatitis B e antigen‐negative chronic hepatitis B patients |
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