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Hepatitis C: The Next Tsunami

Hepatitis C: The Next Tsunami. Danny Jenkins Cri-Help Common Ground – The Westside HIV Community Center We Write the Grants www.wewritethegrants.com. Prevalence 1999 World: 40-175 million USA: ~4 million (1.8%) Primary Modes of Transmission Injection > sexual Occupational Perinatal.

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Hepatitis C: The Next Tsunami

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  1. Hepatitis C:The Next Tsunami Danny Jenkins Cri-Help Common Ground – The Westside HIV Community Center We Write the Grants www.wewritethegrants.com

  2. Prevalence 1999 World: 40-175 million USA: ~4 million (1.8%) Primary Modes of Transmission Injection > sexual Occupational Perinatal Prevalence 1999 World: 40 million USA: ~1 million (0.4%) Primary Modes of Transmission Sexual > injection Occupational Perinatal Prevalence and Transmission of HCV and HIV HCV HIV Lee W, et al. Drugs. 2004;64:693-700.

  3. Overall Prevalence of HCV Among HIV-Infected Persons in the United States HIV Monoinfected HCV/HIV Coinfected 30% 70% Thomas D. Hepatology. 2002;36:S201-S209.

  4. Hospital Admissions Among HIV-Infected Patients 5-fold increase in liver complications from 1995 to 2000 IDU-related complications Liver-related complications Opportunistic infections 35 32 30 25 22 20 20 Hospitalizations Per Patient-Year Follow-Up 15 15 12 11 11 10 8 8 8 8 8 8 8 7 7 5 5 5 0 1995 1996 1997 1998 1999 2000 Gebo K, et al. J Acquir Immune Defic Syndr. 2003;34:165-173.

  5. HCV/HIV Coinfected Patients and End-Stage Liver Disease • Clinical HCV is accelerated in HIV/HCV coinfection • Faster disease progression with an increased risk of cirrhosis and decompensated liver disease • More patients develop cirrhosis within given timeframe • Alcohol has an additional aggravating effect • Graham C, et al. Clin Infect Dis. 2001;33:562-569. • Lee W, et al. Drugs. 2004;64:693-700.

  6. HCV/HIV Coinfection:An Area of High Medical Need • One third of HIV patients are coinfected with HCV1 • Among HIV-infected IDU, this rises to 50%-90%2 • HCV viral load higher in HCV/HIV vs. HCV patients3 • HIV accelerates clinical course of HCV-related liver disease • Time to cirrhosis significantly reduced4 • Liver disease is now the leading cause of death in hospitalized AIDS patients5 • HCV may also impact the course of HIV disease 1. Thomas D. Hepatology. 2002;36:S201-S209. 2.Sulkowski M, et al. Ann Intern Med. 2003;138:197-207. 3. Soriano V, et al. J Hep. 2006:44;S44-S48. 4. Soto B, et al. J Hep. 1997:26;1-5. 5. Bica I, et al. Clin Infect Dis. 2001;32:492-497. 6. Sulkowski M, et al. Hepatology. 2002;35:182-189. 7. Greub G, et al. Lancet. 2000;356:1800-1805.

  7. Hepatitis C (HCV) Basics • Blood-borne virus (formerly non-A/non-B hepatitis) • Six major genotypes: 1a, 1b, 2a, 2b, 3, 4, 5 & 6 • 1a and 1b = most common in US & difficult to treat

  8. Hepatitis C (HCV) Basics • Enters body through direct blood exposure • Attacks liver -> multiples (replicates) • Causes liver inflammation and kills liver cells

  9. Natural History of HCV Infection Exposure (Acute phase) HIV 15% 85% Resolved Chronic 2-12 Wks Alcohol 20% 80% Stable Cirrhosis 10-40 Yrs 75% 25% Slowly Progressive Liver Cancer Transplant Death Alter MJ. Semin Liver Dis. 1995;15:5-14. Management of Hepatitis C NIH Consensus Statement 1997; March 24-26:15(3).

  10. Transmission • Blood to bloodstream • Syringes, cookers, tattooing, piercing, razors, toothbrushes • Sexual transmission (very) rare • Perinatal 5%

  11. Nausea Fatigue Fever Headaches Loss of appetite Abdominal pain Muscle/joint pain Flu-like symptoms Jaundice Dark urine Typical Symptoms

  12. Some HCV Numbers • Likely that >4M Americans infected • 8-10K Americans die annually • This is expected to triple in 10-20 years • Alcohol & drugs are like HCV fuel • Hepatitis A & B Vaccines are a must

  13. Age > 50 years Duration of infection Male gender Iron overload Steatosis Alcohol Co-infection with HBV Co-infection with HIV Not associated: HCV “viral load” HCV genotype Serum ALT ? Smoking Factors Associated with Disease Progression in HCV Infected Patients

  14. HCV Tests • Antibody tests: Elisa & RIBA • Viral Load • Predict Medical TX Response • Measure Rx Effectiveness • NOT to measure disease progression • Genotype Tests • Liver Biochem/function Tests • Biopsies – gold standard

  15. HCV Treatments • Pegylated Interferon + Ribavirin are only FDA approved Rx • Interferon injected weekly • Ribavirin boosts effect, daily pills • Sustained Virological Response (SVR): • Genotype 1: 40-50% • Genotypes 2 & 3: 75+%

  16. “Follow the Leader”Themes in Which HCV Has Lagged Significantly Behind HIV

  17. Unmet Needs and Challenges

  18. Many others including immune stimulants gene therapy Hepatitis C Drug Development: 2005 Stage

  19. Protease InhibitorsExample: VX-950 or Telapravir • Recent US Study – 250 patients • 60% cleared virus (vs 40% standard TX only) • 67% on 1yr TX = no signs of infection • 2X “both” patients stopped TX -> side effects • Recent European Study – 334 Patients • After 6 mos, 69% “both” -> undetectable • (vs 46% on standard TX only)

  20. Conclusions • Despite advances in therapy, many needs remain unmet • Hard-to-treat patients • Nonresponders • Patients excluded from current therapies • New antivirals with innovative mechanisms of action may help meet those needs • Monotherapy • In combination with PEG IFN +/- RBV • In combination with new antivirals with different targets • Now is the opportunity to develop pipeline therapies toward these many unmet needs

  21. Hepatitis C Task Forcefor Los Angeles County www.hepctaskforcela.org

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