August 30, 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.