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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update

UNITED STATES: FDA, Academia, and Industry Team up to End Hepatitis C




 

University of Florida News (08.29.2013)
 
A partnership between the US Food and Drug Administration (FDA), the Hepatitis C Therapeutic Registry and Research Network (HCV-TARGET), and the pharmaceutical industry could facilitate better treatment for hepatitis C virus (HCV)-infected people and improve HCV drug development programs. The collaboration will allow the partners to share HCV-TARGET’s national data that reveal how hepatitis medications actually are used and managed in routine practice. A goal of this data sharing is providing patients and clinicians with better information about HCV therapies. A project priority is aligning data elements to enable comparison of clinical trial data gathered by FDA and real-world observational data gathered by HCV-TARGET.

The collaboration is timely since CDC recently recommended hepatitis C testing for all baby boomers, who account for 75 percent of the estimated 3 million hepatitis C-infected Americans. In addition, the first all-oral HCV drug is in the final stages of FDA approval. As this new medication moves into use, new questions about side effects and drug combinations will emerge.

HCV-TARGET includes 103 academic sites and follows approximately 2,500 HCV-infected patients in 31 states, Puerto Rico, Canada, and Europe. Many HCV-TARGET study participants—patients with cirrohosis, African Americans, and patients over age 65—are underrepresented in clinical trials. Since the project’s inception in 2011, HCV-TARGET has been studying treatment with boceprevir and telaprivir; observational studies will expand this year to include all antiviral HCV therapies.

The University of Florida (UF) is the HCV-TARGET clinical coordinating center, and the University of North Carolina (UNC) is the HCV-TARGET data coordinating center. Co-principal investigators include Dr. David R. Nelson, director of the UF Clinical and Translational Science Institute and a professor of medicine at UF Health, and Dr. Michael W. Fried, professor of medicine at the UNC School of Medicine. HCV-TARGET receives ongoing industry support from Merck, Genentech, Kadmon, and Vertex.



 


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Information in this article was accurate in August 30, 2013. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.