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Hepatitis B Treatment

Hepatitis B Treatment. Dr R.V.S.N.Sarma., M.D., Consultant Physician & Chest Specialist. TREATMENT OF CHRONIC HEPATITIS B. Review of trials and meta-analysis of RCT of Interferon (IFN) and Lamivudine (LAM) Clinical Practice Guidelines Issues for future clinical trials.

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Hepatitis B Treatment

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  1. Hepatitis B Treatment Dr R.V.S.N.Sarma., M.D., Consultant Physician & Chest Specialist

  2. TREATMENT OF CHRONIC HEPATITIS B • Review of trials and meta-analysis of RCT of Interferon (IFN) and Lamivudine (LAM) • Clinical Practice Guidelines • Issues for future clinical trials

  3. Goals of Antiviral Treatment of Chronic Hepatitis B 1. Sustained suppression of HBV replication Decrease in serum HBV DNA to <105 copies/ml HBeAg to anti-HBe seroconversion HBsAg to anti-HBs seroconversion 2. Remission of liver disease Normalization of serum ALT levels Decreased necroinflammation in liver 3. Improvement in clinical outcome Decreased risks of developing cirrhosis, liver failure and HCC Increased survival

  4. Lamivudine Rx of HBeAg+ CHB HBeAg seroconversion at week 52 Placebo Lam x 52 wk IFN x 16 wk Lam x 24 wk +IFN x 16 wk Lai et al., NEJM 1998 Dienstag et al., NEJM 1999 Schalm et al., Gut 2000 13

  5. Lamivudine Rx of HBeAg+ CHB Histologic response at week 52 Placebo Lam x 52 wk IFN x 16 wk Lam x 24 wk . +IFN x 16 wk Lai et al., NEJM 1998 Dienstag et al., NEJM 1999 Schalm et al., Gut 2000 14

  6. LAM PLA LAM & IFN IFN Lamivudine Rx of HBeAg+ CHB Normal ALT at Week 52

  7. Lamivudine Rx of HBeAg- CHB ALT (xULN) HBV DNA (pg/mL) Lamivudine Treatment (0-52 Weeks) Normal ALT Tassopoulos et al., Hepatology 1999; 29:889

  8. Treatment of HBeAg - CHB

  9. Treatment of Decompensated Cirrhosis Measurements of Response • Viral suppression  • Biochemical improvement  • Decrease in CTP score  (Alb, bil, PT, ascites, encephalopathy) • Decrease clinical complications + • Decrease need for transplant + • Decrease HCC ? • Improve survival +

  10. Clinical Practice Guidelines • Who to treat • What treatment • When to stop treatment

  11. AASLD Practice Guidelines • Current therapy has limited long-term efficacy • Careful balance of benefits and risks before treatment is initiated • patients’ age • severity of liver disease • likelihood of response • potential adverse events Lok and McMahon, Hepatology 2001;34:1225

  12. AASLD Practice Guidelines: Rx Strategies HBeAg HBV DNA* ALT Treatment + + <2x ULN Both IFN and Lam low efficacy Observe + + >2x ULN IFN or Lam IFN NR or contraindications  Lam – + >2x ULN IFN or Lam Long-term Rx required – – normal No Rx required +/ – + cirrhosis Compensated: IFN low dose or Lam Decompensated: Lam, optimal timing unknown - Transplant +/ – – cirrhosis Compensated: observe Decompensated: Transplant *HBV DNA in serum >105 copies/ml Lok and McMahon, Hepatology 2001;34:1225

  13. Treatment of Chronic Hepatitis B Interferon Lamivudine Pros • Finite duration of Rx • More durable response • Resistant mutants not • reported • Oral administration • Negligible side effects • Lower costs? Cons • Expensive • Frequent side effects • Long/indefinite duration of Rx • Resistant mutants

  14. AASLD Practice GuidelinesTreatment Regimen - IFN Dose 5 MU QD or 10 MU tiw SC Duration e + CHB - 16 wk e – CHB - 12 months Lok and McMahon, Hepatology 2001;34:1225

  15. AASLD Practice GuidelinesTreatment Regimen - Lamivudine Dose 100mg daily po (Lamivir HBV – 100 mg Cipla) HIV Coinfection – 150mg bid + other HIV Rx Duration e+ CHB – 1yr... HBeAg seroconversion – Stop Rx? DNA suppression, HBeAg+ - Continue Rx? Breakthrough infection – continue Rx if clinically stable? Stop Rx if clinical deterioration e- CHB > 1yr, optimal duration? Lok and McMahon, Hepatology 2001;34:1225

  16. Impact of HBeAg Clearanceon Long-Term Clinical Outcome 1.0 0.8 0.6 0.4 0.2 0.0 Clearance of HBeAg IFN No Rx Proportion with complication free survival No Clearance of HBeAg 0 12 24 36 48 60 72 84 96 Month Niederau et al., NEJM 1996;334:1422-7

  17. IFN Treatment of HBeAg- Patients Hadziyannis S, et al., J Hepatology 1990; 11(Suppl 1):513 Fattovich G, Hepatology 1992; 15:584 Pastore G, J Hepatology 1992; 14;221 Lampertico p, Hepatology 1997; 26:1621

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