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Long-Term Anti-HBV Therapy Considerations

Long-Term Anti-HBV Therapy Considerations. Adrian M. Di Bisceglie , MD, FACP Badeeh A. & Catherine V. Bander Chair in Internal Medicine Chairman and Professor of Internal Medicine Chief of Hepatology Saint Louis University School of Medicine St. Louis, Missouri Tram T. Tran, MD

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Long-Term Anti-HBV Therapy Considerations

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  1. Long-Term Anti-HBV Therapy Considerations Adrian M. Di Bisceglie, MD, FACP Badeeh A. & Catherine V. Bander Chair in Internal Medicine Chairman and Professor of Internal Medicine Chief of Hepatology Saint Louis University School of Medicine St. Louis, Missouri Tram T. Tran, MD Associate Professor of Medicine University of California, Los Angeles School of Medicine Medical Director Liver Transplantation Comprehensive Transplant Center Cedars-Sinai Medical Center Los Angeles, California

  2. Recommended Duration of Nucleos(t)ide Analog Therapy 1. Baraclude [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2010. 2. Viread [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2011. 3. Lok AS, et al. Hepatology. 2009;50:1-36. 4. Keeffe EB, et al. ClinGastroenterolHepatol. 2008;6:1315-1341.

  3. Responses to Anti-HBV Therapies in Treatment-Naive HBsAg(+) Patients Treated for 1 Year *Lamivudine and entecavir – no or short consolidation; adefovir and tenofovir – consolidation for most patients. †Results for week 48 end of treatment/week 72 (24 weeks posttreatment).Abbreviation: NA, not available. Lok AS, et al. Hepatology. 2009;50:1-36.

  4. Responses to Anti-HBV Therapies in Treatment-Naive HBsAg(-) Patients Treated for 1 Year Abbreviation: NA, not available. Lok AS, et al. Hepatology. 2009;50:1-36.

  5. Tenofovir—Regression of Hepatic Fibrosis After 5 Years Year 5 Response • Treatment-naive HBeAg(+) or HBeAg(-) patients treated with tenofovir 300 mg/day (N = 641) • 348 had paired baseline and 5-year biopsies evaluated by Ishak fibrosis score • 98% had undetectable HBV DNA at year 5 • 98% had improved or no worsening of fibrosis • 74% of cirrhotic patients no longer had cirrhosis at year 5 • Conclusion: Long-term tenofovir treatment stabilizes or improves fibrosis in most patients Improvement No Change Worsening Graphic with permission from Marcellin P, et al. Paper presented at: 62nd AASLD; November 4-8, 2011; San Francisco, CA. Hepatology. 2011;54:Abstract 1375. Marcellin P, et al. 62nd AASLD; San Francisco, CA; November 4-8, 2011; Abst. 1375.

  6. Entecavir—Histologic Responses atWeek 48 and Long-Term 41/56 55/57 18/56 50/57 25/43 3/42 Histologic Improvement Ishak Score ≤1-Point Decrease Ishak Score ≤2-Point Decrease *Median time on entecavir at time of long-term biopsy was 6 years (range, 3–7 years). Chang TT, et al. Hepatology. 2010;52:886-893.

  7. Adherence to Anti-HBV Nucleos(t)ide Analogs • Predictors of adherence • Older than 45 years of age (P = .001) • Receipt of adefovir or entecavirvslamivudine (P <.001) • Existing vs new patients (P = .002) Chotiyaputta W, et al. J Hepatol. 2011;54:12-18.

  8. Factors Associated with Adherence Rate >90% Chotiyaputta W, et al. J Hepatol. 2011;54:12-18.

  9. Lamivudinevs Placebo—Clinical Endpoints • Differences between groups for other endpoints were insignificant • Renal insufficiency (lamivudine 0.5%; placebo 0%) • Bleeding varices (lamivudine 0.5%; placebo 0%) • Spontaneous bacterial peritonitis (lamivudine 0%; placebo 0%) • Liver-related death (lamivudine 0%; placebo 0%) Abbreviation: HCC, hepatocellular carcinoma. Liaw YF, et al. N Engl J Med. 2004;351:1521-1531.

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