The National Institutes of Health, in collaboration with officials in Washington, D.C., have launched the ASCEND Study to determine if the specific type of health care provider influences outcomes when administering hepatitis C virus infection treatment to a patient, according to a press release from the NIH.
The ASCEND trial includes 600 adults with HCV or coinfected with HCV and HIV who reside in Washington, D.C. The goal of the trial is to determine if primary care physicians and other health care providers, such as nurse practitioners and physician assistants, are as successful when using an antiviral therapy to treat people with HCV as a specialist physician is.
“The recent advent of direct-acting antiviral medications has offered promising new treatment options for people who are chronically infected with hepatitis C,” Anthony S. Fauci, MD, director of the NIH National Institute of Allergy and Infectious Diseases, said in the release. “These therapies have yielded high cure rates in clinical trials led by specialized care teams. The ASCEND study will help determine whether these medications are similarly effective when administered in an urban, community-based setting.”
Anthony S. Fauci
Henry Masur, MD, chief of the NIH Clinical Center’s Critical Care Medicine Department, Sarah Kattakuzhy, MD, of the University of Maryland’s Institute of Human Virology, and colleagues will recruit the patients and divide them into two groups: one group will consist of 350 patients who will continue HCV therapy with their current specialist and the other group will include 250 patients to be assigned to a primary care physician, physician assistant or nurse practitioner for HCV therapy, according to the release. All patients will be administered an oral tablet of ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) for 2 to 6 months.
The patients will be followed for 10 years to monitor for short-term and long-term treatment outcomes, including viral response to the drug and evidence of liver damage, according to the release. The ASCEND study is expected to be completed in 2025.
“This study demonstrates the benefit that research can have on the community,” Masur said in the release. “NIH, community clinics and the D.C. Department of Health are working collaboratively to reduce the impact of a lethal viral disease, hepatitis C, on the population of our nation’s capital.”
Disclosure: Fauci, Kattakuzhy and Masur report no relevant financial disclosures.