The National Institutes of Health has partnered with the District of Columbia to begin a clinical trial of a new antiviral therapy for hepatitis C.
Co-sponsored by the NIH’s Clinical Center and National Institute of Allergy and Infectious Diseases (NIAID), the ASCEND study will determine whether general doctors, physician assistants, nurse practitioners and other health care professionals can use a new antiviral therapy just as effectively as specialty physicians.
The trial is part of a program to reduce the number of HIV/AIDS and related diseases -- including hepatitis C -- in Washington DC. Hepatitis C is most commonly found in minority, marginalized, low-income populations living in urban areas.
The study involves 600 adults from the DC area. They all have hepatitis C, with some also having HIV.
There are currently more than 3 million people with hepatitis C in the U.S. Untreated hepatitis C infections can cause liver cancer, cirrhosis of the liver and liver failure. The health industry attributes thousands of deaths to hepatitis C infections each year. Co-infections of hepatitis C and HIV are especially dangerous.
Current hepatitis C treatments are complicated and lengthy, consisting of injected and oral medications with negative side effects such as depression and flu-like symptoms. These treatments are typically administered by specialty physicians.
The new antiviral, oral, direct-acting drug, which is a combination of ledipasvir and sofosbuvir, may be a better alternative for a more effective treatment that requires less time and complexity.
“The recent advent of direct-acting antiviral medications has offered promising new treatment options for people who are chronically infected with hepatitis C,” Dr. Anthony Fauci, the NIAID director, said. “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.”