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  • Hepatitis C is a wide spread, global problem. In the Americas alone, 1.7% of the population is currently living with HCV. Worldwide, over 3% of the population is currently living with HCV. To give this number some perspective, we would all agree that HIV is a tremendous, devastating epidemic. An estimated 38 million people are currently living with HIV. The number of people currently living with HCV is over 4 times higher.
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    1. 1. Providing Hepatitis C treatment to HIV co-infected patients Mauro Guarinieri IHRD, Open Society Institute
    2. 3. Overview—an epidemic <ul><li>An estimated 200 million persons are chronically infected with HCV </li></ul><ul><ul><li>3 to 4 million persons are newly infected each year </li></ul></ul><ul><li>HCV is the leading cause of chronic liver disease and the leading non-AIDS cause of death in co-infected subjects </li></ul><ul><ul><li>Mortality is expected to triple over the next two decades </li></ul></ul><ul><li>Transmission is strongly associated with intravenous and percutaneous drug use. </li></ul>
    3. 4. United States 3-4 M Americas 12-15 M Africa 30-40 M Southeast Asia 30-35 M Australia 0.2 M World Health Organization. Weekly epidemiological record. 1999;74:421-428. Western Europe 5 M 170-200 Million (M) Carriers Worldwide Eastern Europe 10 M Far East Asia 60 M
    4. 5. Hepatitis C transmission <ul><li>Contaminated blood most infectious </li></ul><ul><ul><li>Prior to 1992 via transfusions, now needle-sharing </li></ul></ul><ul><li>Sexual transmission (less than 5%) </li></ul><ul><li>Occupational exposure for healthcare workers </li></ul><ul><li>Perinatal transmission (approx. 5%) </li></ul><ul><ul><li>Dependent on maternal viral load </li></ul></ul><ul><li>91-99% of patients using clotting factor, prior to 1987, are HCV positive </li></ul>
    5. 6. HCV Prevalence by Select Groups, US                       
    6. 7. Natural Course <ul><li>~15% spontaneously clear virus </li></ul><ul><li>~20% develop cirrhosis, usually over many years </li></ul><ul><ul><li>Alcohol, co-morbid HIV, HAV and HBV increase risk </li></ul></ul><ul><ul><li>5% of total-develop HCC </li></ul></ul><ul><ul><li>Survival after HCC Dx – 6 months-2 years </li></ul></ul>
    7. 8. Estimated Increase by 2008 Davis GL. Hepatology . 1998;28:390a. Need for OLTx Decompensation Liver-related Deaths HCC Cirrhosis Future Disease Burden: 2008
    8. 9. Predicted HCV-Related Mortality 5,000 10,000 20,000 30,000 Wong et al. Am J Public Health . 2000;90(10):1562-1569. 1992 1995 1998 2001 2004 2007 2010 2013 2016 2019 Non HCC liver-related HCC 0
    9. 10. HCV Prevalence in HIV (%)
    10. 12. HCV/HIV Co-infection <ul><li>HIV both accelerates and increases risk of HCV progression </li></ul><ul><li>Liver disease is increasing as a cause of death in HIV+ persons </li></ul>
    11. 13. Mortality Among HIV-Infected Patients in France (GERMIVIC Study Group) Rosenthal E et al for the GERMIVIC Joint Study Group. 2nd IAS Conference on HIV Pathogenesis and Treatment; 2003; Paris, France. #87.
    12. 14. Treatment <ul><li>Weekly pegylated interferon with daily oral Ribavirin for 24-48 weeks; </li></ul><ul><li>Side effects: often very debilitating </li></ul><ul><ul><li>Flu-like syndrome </li></ul></ul><ul><ul><li>Thyroid dysfunction </li></ul></ul><ul><ul><li>Depression and other psychiatric disorders </li></ul></ul><ul><ul><li>Anemia, retinal bleeding </li></ul></ul>
    13. 15. Effectiveness of Treatment <ul><li>30-50% have sustained viral response </li></ul><ul><ul><li>Genotypes 2 and 3, up to 80% </li></ul></ul><ul><li>Overall SVR in clinical trials for co-infected people: 27% to 40% </li></ul><ul><li>May also slow progress and reduce risk of liver cancer regardless of SVR </li></ul>
    14. 16. Reasons for non-treatment <ul><li>Non-adherent to appointments: 40% </li></ul><ul><li>Active substance users: 15% </li></ul><ul><li>Active psychiatric conditions: 8% </li></ul><ul><li>Medical contraindications: 37% </li></ul><ul><li>“ A majority of non-candidates had potentially modifiable psychosocial factors leading to non-treatment” </li></ul><ul><li>Restrepo, 2005 </li></ul>
    15. 17. Challenges <ul><li>Successful treatment rate response much lower in the community </li></ul><ul><li>Current standards include presence of progression based on liver biopsy </li></ul><ul><li>Many clinicians still withhold treatment from IDU instead of making case-by-case decisions with each patient </li></ul>
    16. 18. IDUs may be denied Tx because many physicians think: <ul><li>Their adherence will be poor . </li></ul><ul><ul><li>A review of 7 clinical trials found that drug users were similar to controls or comparable groups in adherence and response (Schaefer 2004, Mehta 2005) </li></ul></ul>
    17. 19. IDUs may be denied Tx because many physicians think: <ul><li>They will become re-infected. </li></ul><ul><ul><li>Data suggest that the re-infection rate is not high enough to jeopardize the potential benefit for most patients (Clinical Infectious Diseases 2004;39:1540-1543) </li></ul></ul>
    18. 20. IDUs may be denied Tx because many physicians think: <ul><li>They will relapse. </li></ul><ul><ul><li>Likelihood of relapse not demonstrated and based on anecdotes </li></ul></ul><ul><ul><li>Relapse in drugs use does not imply non-adherence. </li></ul></ul>
    19. 21. European Consensus Conference <ul><li>Active drug use should not be an absolute exclusion criteria since full benefits of HCV therapy are not compromised when active drug users are successfully retained in treatment </li></ul><ul><li>Patients who require treatment should be offered opiate substitution therapy (including heroin maintenance) </li></ul><ul><li>If the patient is not ready to stop drug use, any assessment for initiation of HCV treatment should be made case-by-case </li></ul><ul><li>Journal of Hepatology 42 (2005) 615–624 </li></ul>
    20. 22. <ul><ul><li>“ The only non compliant people are physicians. If the patient doesn’t get better, it’s your own fault. Fix it.” </li></ul></ul><ul><ul><li>P. Farmer </li></ul></ul>