Research and Policy Recommendations from the TAG Hepatitis C Report
From Seattle Treatment Education Project
Winter 2000
A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!
- The CDC should further investigate the role of HCV sexual transmission in MSM.
- 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 people with HCV. The findings should be widely distributed to people and community physicians in a timely manner.
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- Large natural history studies should be initiated to determine the current natural history of HIV/HCV co-infected individuals in the era of HAART.
- 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 co-infection.
- 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.
- People with HCV 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 co-infected 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 PEG-IFN NDA a "priority review" because of the unmet medical need for therapies for people with HCV-induced cirrhosis.
- HCV treating physicians should fully explain the risk and benefits of IFN/RBV 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.
A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!
This article was provided by Seattle Treatment Education Project. It is a part of the publication STEP Perspective.
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