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August 2000

by Michael Marco and Jeffrey Schouten

  1. The CDC should further investigate the role of HCV sexual transmission in men who have sex with men.
  2. The CDC should update its 1998 HCV recommendations to suggest HCV testing for all persons with HIV/AIDS.
  3. More research should be conducted to completely understand the immunologic responses associated with control of HCV infection.
  4. The NIAAA should commence studies on the effects of alcohol in patients with HCV. The findings should be widely distributed to patients and community physicians in a timely manner.
  5. Large natural history studies should be initiated to determine the current natural history of HIV/HCV coinfected individuals.
  6. The NIH ICDs (i.e., NIAID, NIDDK, NHLBI) should issue multiple RFAs for cross-training of fellows in hepatology and infectious disease/HIV research.
  7. The NIH’s Office of AIDS Research should make available some of its discretionary funding for basic and clinical research on HIV/HCV coinfection.
  8. The NIH should explore the desirability and feasibility of a Hepatitis Clinical Trials Network. The network would carry out Phase I to IV clinical studies with nested basic science research.
  9. Future HCV treatment trials should stratify for HIV serostatus and enroll both HIV-positive and HIV-negative people in order to gather these critical data.
  10. HCV treatment should be mandated in all state and federal prison systems.
  11. Transplant centers in the U.S. should consider HIV-positive people for liver transplantation.
  12. HCV patients must have access to their HCV RNA levels at timely intervals (e.g., week 24) while on HCV treatment studies.
  13. Schering Plough must unbundle Rebetron so that ribavirin can be purchased separately.
  14. Research should be conducted to determine the lowest effective dose of ribavirin to minimize unnecessary toxicity.
  15. All 50 U.S. states should add ribavirin to their Medicaid and ADAP formularies.
  16. Industry should conduct drug interaction studies of anti-HIV drugs in HIV/HCV coinfected people while drugs are in development so that potential hepatotoxicity and drug interactions are defined prior to approval.
  17. The FDA should grant Hoffmann-La Roche’s pegylated interferon NDA a “priority review” because of the unmet medical need for therapies for HCV patients with cirrhosis.
  18. HCV treating physicians should fully explain the risk and benefits of interferon/ribavirin combination therapy with their patients as well as estimates of treatment response according to host and viral characteristics.
  19. Industry must actively recruit African Americans in all phases of HCV clinical trials. These studies should have the statistical power to assess racial differences in viral clearance and response rates.
  20. Hepatitis treatment advocates should be included in all facets of NIH decision making about hepatitis clinical and basic science research, including protocol development, scientific agenda committees and grant reviews.

CDC= Centers for Disease Control and Prevention; NIAAA= National Institute on Alcohol Abuse and Alcoholism; NIAID= National Institutes of Allergy and Infectious Disease; NIDDK=National Institute of Diabetes, Digestive and Kidney Diseases; NHLBI=National Heart, Lung, Blood Institute; RFA= Request for Applications; ADAP= AIDS Drug Assistance Program; NDA= New Drug Application

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