New Delhi, 19 Mar, 2015: National Institute Of Health and the city of Washington DC jointly launched a clinical trial called ASCEND to examine whether primary care physicians and other health care providers, such as nurse practitioners and physician assistants, can use a new antiviral therapy as effectively as specialist physicians to treat people with hepatitis C virus (HCV) infection. More than 3 million people in the United States are infected with HCV and lead to thousands of deaths each year. Hepatitis C is a leading cause of death for people co-infected with HIV
The trial will be co-sponsored by the NIH’s Clinical Center and National Institute of Allergy and Infectious Diseases (NIAID), with additional support from the NIH Office of AIDS Research. The study is being conducted as part of the D.C. Partnership for HIV/AIDS Progress, a program that aims to reduce the burden of HIV/AIDS and associated diseases, such as hepatitis C, in the District of Columbia.
600 adult patients from Washington DC infected with HCV alone or co-infected with HCV and HIV will be enrolled in the trial to see the long term effects of the treatment.350 participants will continue treatment with their current specialist, and 250 participants will be assigned to a primary care physician, physician assistant or nurse practitioner for treatment. All participants will take a daily pill of combination ledipasvir (90 milligrams) and sofosbuvir (400 milligrams) for two to six months. Study volunteers will be treated at 11 D.C.-based clinics operated by Unity Health Care, Inc., and one D.C. clinic run by Family and Medical Counseling Services. Both D.C. health care organizations are active collaborators in the D.C. Partnership for HIV/AIDS Progress.
Participants will be monitored over a 10-year period for short-term and long-term treatment outcomes, including viral response to the drug and evidence of liver damage. The researchers aim to determine whether the type of health care provider administering the treatment influences outcomes. They also will assess the safety of the drug, how well it is tolerated and whether there are differences in outcomes for people infected with both HCV and HIV compared with those with HCV alone. According to the investigators, this study willhelp advance scale-up of the use of direct-acting antivirals for elimination of chronic HCV infections in certain at-risk groups. The ASCEND study is expected to be completed in 2025.
In the past, hepatitis C treatment involved long-term use of oral and injectable medications, some of which had unpleasant side effects, including flu-like symptoms and depression. Because of the complexity of these regimens, hepatitis C treatment has largely been provided by specialist physicians, such as infectious disease specialists and hepatologists. New oral direct-acting antiviral drugs may offer more effective, shorter-duration, curative treatments.IGMPI
