FOR IMMEDIATE RELEASE
Friday, March 6, 2015
from the National Institutes of Health and the city of Washington,
D.C., launched a clinical trial 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. The trial, which will involve 600 adult D.C. residents
infected with HCV alone or co-infected with HCV and HIV, also will
examine the long-term effects of the treatment.
The study, called ASCEND, is 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.
More than 3 million people in the United States are infected
with HCV. If left untreated, the infection can lead to cirrhosis (liver
scarring), liver cancer and eventual liver failure. Chronic HCV
infections contribute to thousands of deaths each year, and hepatitis C
is a leading cause of death for people co-infected with HIV. In the
United States, hepatitis C infection is largely centered in urban areas
and disproportionately affects minority, low-income and marginalized
populations, such as the homeless and people who inject drugs.
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. In
October 2014, the U.S. Food and Drug Administration approved a new,
once-daily antiviral drug for treatment of hepatitis C infection that
combines ledipasvir and sofosbuvir (trade name Harvoni). Gilead
Sciences, based in Foster City, California, manufactures the drug and is
providing it free-of-charge for use in the ASCEND study.
“The recent advent of direct-acting antiviral medications has
offered promising new treatment options for people who are chronically
infected with hepatitis C,” said NIAID Director Anthony S. Fauci, M.D.
“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,
Led by principal investigator Henry Masur, M.D., chief of the
NIH Clinical Center’s Critical Care Medicine Department, and lead
associate investigator Sarah Kattakhuzy, M.D., of the University of
Maryland’s Institute of Human Virology, the Phase 4 (post-marketing)
ASCEND study aims to enroll approximately 600 D.C. clinic patients with
HCV infections or HCV and HIV co-infections. Of those enrolled, 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 will help 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.
“This study demonstrates the benefit that research can have on
the community,” Dr. Masur said. “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
More information about the Study to Assess Community-based
Treatment of Chronic Hepatitis C Monoinfection and Coinfection With HIV
in the District of Columbia (ASCEND) can be found at ClinicalTrials.gov
using the identifier NCT02339038
NIAID conducts and supports research—at NIH, throughout the United
States, and worldwide—to study the causes of infectious and
immune-mediated diseases, and to develop better means of preventing,
diagnosing and treating these illnesses. News releases, fact sheets and
other NIAID-related materials are available on the NIAID website
The NIH Clinical Center is the clinical research hospital for
the National Institutes of Health. Through clinical research,
clinician-investigators translate laboratory discoveries into better
treatments, therapies and interventions to improve the nation's health.
More information: http://clinicalcenter.nih.gov
About the National Institutes of Health (NIH):
the nation's medical research agency, includes 27 Institutes and
Centers and is a component of the U.S. Department of Health and Human
Services. NIH is the primary federal agency conducting and supporting
basic, clinical, and translational medical research, and is
investigating the causes, treatments, and cures for both common and rare
diseases. For more information about NIH and its programs, visit www.nih.gov
NIH...Turning Discovery Into Health®
Labels: ASCEND study, community-based treatment program, Washington D.C.