August 2000
by Michael Marco and Jeffrey Schouten
- The CDC should further investigate the role of HCV sexual transmission in men who have sex with men.
- The CDC should update its 1998 HCV recommendations to suggest HCV testing for all persons with HIV/AIDS.
- More research should be conducted to completely understand the immunologic responses associated with control of HCV infection.
- 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.
- Large natural history studies should be initiated to determine the current natural history of HIV/HCV coinfected individuals.
- The NIH ICDs (i.e., NIAID, NIDDK, NHLBI) should issue multiple RFAs for cross-training of fellows in hepatology and infectious disease/HIV research.
- The NIH’s Office of AIDS Research should make available some of its discretionary funding for basic and clinical research on HIV/HCV coinfection.
- 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.
- 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.
- HCV treatment should be mandated in all state and federal prison systems.
- Transplant centers in the U.S. should consider HIV-positive people for liver transplantation.
- HCV patients must have access to their HCV RNA levels at timely intervals (e.g., week 24) while on HCV treatment studies.
- Schering Plough must unbundle Rebetron so that ribavirin can be purchased separately.
- Research should be conducted to determine the lowest effective dose of ribavirin to minimize unnecessary toxicity.
- All 50 U.S. states should add ribavirin to their Medicaid and ADAP formularies.
- 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.
- 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.
- 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.
- 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.
- 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