NIH: Officials 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, community-based setting.”
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 capital.”
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 at http://www.niaid.nih.gov.
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):
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.