Research demonstrating dramatic improvements in treatment options for the more than 3 million people in the United States living with hepatitis C was recognized today, April 10, as one of the Clinical Research Forum’s Top 10 Clinical Research Achievements of 2013.
The Clinical Research Forum presented the award to David R. Nelson, M.D., a University of Florida Health researcher. Nelson served as senior author on a May 2013 New England Journal of Medicine article reporting the results of two randomized phase 3 trials of a new antiviral treatment for hepatitis C, a virus that causes chronic liver disease.
The studies found therapy combining sofosbuvir, a new antiviral drug, with ribavirin — both taken orally — eliminated the hepatitis C virus in 78 percent of patients for whom interferon was not an option and for 50 percent to 73 percent of patients with prior treatment failure (New antiviral drugs clear hepatitis C in patients without treatment options). For patients with genotype 2 infection, cure rates were above 90 percent. Gilead, the maker of the drug sofosbuvir, sponsored the trials.
The research contributed to the U.S. Food and Drug Administration’s approval in December 2013 of using sofosbuvir with ribavirin as the first interferon-free therapy for hepatitis C — giving patients a new reason for optimism as Hepatitis Awareness Month approaches in May.
“Clinical research is the culmination of years of basic and translational science to bring new treatments to patients, and I’m always excited to see the groundbreaking clinical research recognized every year by the Clinical Research Forum,” said National Institutes of Health Director Francis S. Collins, M.D., Ph.D. “This is just the tip of the iceberg of the incredible work coming out in the field, much of it funded by the NIH.”
First discovered in 1989, the hepatitis C virus leads to more deaths in the U.S. than HIV, according to the Centers for Disease Control and Prevention. Since three out of four hepatitis C cases in the U.S. involve people born between 1945 and 1965, both the CDC and the U.S. Preventive Services Task Force recommend one-time hepatitis C screening for baby boomers.
Thanks to public and private investments in hepatitis C research over the last three decades, the cure rates of hepatitis C therapies have improved from approximately 10 percent in 1991 with the introduction of standard interferon — which requires injections and often causes toxic side effects — to more than 90 percent today with oral regimens that include sofosbuvir and other antiviral agents. Treatment that used to last up to 12 months now takes approximately 12 weeks and is associated with minimal side effects.
Led by Nelson, the liver research group at UF Health has played a major role in hepatitis C research. With extensive public and private research funding, the group has conducted more than 100 clinical trials related to hepatitis C and contributed to more than 200 publications. In 2011, Nelson and a colleague at the University of North Carolina at Chapel Hill created the international Hepatitis C Therapeutic Registry and Research Network, or HCV-TARGET, which in 2013 partnered with the FDA to share national data on how newly approved treatments for hepatitis C are used and managed in routine practice. As the clinical coordinating center for HCV-TARGET, UF Health will continue to lead global research that provides real-world data on the safety, management and comparative effectiveness of hepatitis C therapies.
In addition to Nelson, the team contributing to the research honored by the Clinical Research Forum includes first author Ira M. Jacobson, M.D., at Weill Cornell Medical College, and 21 individuals from 16 institutions in the U.S., Canada and Australia.
“I am honored to accept this award on behalf of the many researchers, clinicians and patients who took part in these clinical trials,” said Nelson, an assistant vice president for research at UF and director of the UF Clinical and Translational Science Institute. “I look forward to continuing our research to help doctors and patients navigate a rapidly changing treatment landscape for hepatitis C.”
A nonprofit organization, the Clinical Research Forum created its annual Top 10 Clinical Research Achievement Awards to highlight major advances resulting from the nation¹s investment in research.
Nelson receives public grant support from the NIH and private grant support from Bristol-Myers-Squibb, Genentech, Kadmon, Merck, Vertex, Gilead, Boehringer Ingelheim and Abbott/Abbvie. He receives payment for developing educational presentations from Clinical Care Options, Rush University Medical Center, Practice Point Communications and the Chronic Liver Disease Foundation.