NIH Panel Recommends Expand Access for HCV Therapy to HIV, IVDUs, children
Excerpts From NIH Press Release
Wednesday, June 12
there are 6 reports from this conference posted on the NATAP website
Progress and Future Directions for Management of Hepatitis C: expand access
to treatment to IVDUs, persons who use alcohol, suffer from co-morbid
conditions such as depression, who are coinfected with HIV, children and
older adults from treatment and research.
A 12-member consensus panel was convened by the NIH to meet in Bethesda, MD
at the NIH campus to discuss and prepare recommendations regarding hepatitis
Substantial advances in treatment for chronic hepatitis C and a decline in
the number of new infections, were highlighted by a panel convened by the
National Institutes of Health (NIH). Nonetheless, a fourfold increase in
persons with chronic hepatitis C infection is projected over the next decade,
as a result of unsuspected infection from contaminated blood and blood
products, occupational exposure, and injection drug use prior to the advent
of routine screening in the early 1990s. These chronic infections are now
leading to significant increases in cirrhosis, end-stage liver disease, liver
cancer, and are the most common causes of liver transplants.
"However, the good news is that new combination therapies are having a
beneficial impact on this disease," noted panel chair Dr. James Boyer, Ensign
Professor of Medicine and Director of the Liver Center at Yale University
School of Medicine. "In addition, preliminary research indicates that this
approach may prove useful in treating important subgroups of patients
including children and injection drug users previously ineligible for
treatment. Up to now, the
majority of studies have focused on what is actually a narrow segment of the
patient population. Thus, we still have a lot to learn."
More than 4 million Americans are infected with hepatitis C, and of this
group, the majority experience chronic infection, defined as detection of the
virus in blood over at least a 6-month period. The hepatitis C virus (HCV) is
the most common blood-borne infection, and transmission now occurs primarily
by injection drug use, high-risk sexual behaviors and occupational exposures
such as accidental needle sticks, and mother-to-infant transmission.
Clinical trials are providing persuasive evidence that treating HCV with a
combination of pegylated interferon and ribavirin produces a considerably
better sustained viral response (SVR) than monotherapy or standard
interferon-ribavirin combination. Unfortunately, patients with genotype 1
HCV, who account for 70-75% of infected persons, require longer duration of
therapy and have a lower SVR.
Although SVR has not yet been correlated with improved survival because of
the need for long-term follow-up, the absence of detectable HCV provides a
significant benefit in terms of resolution of liver injury, reduction of
liver fibrosis, and a lower likelihood of HCV reinfection. The best
treatments are less clear for non-responders and relapsers.
The independent, nonadvocate, non-Federal panel issued its statement at the
conclusion of a two-and-a-half-day NIH Consensus Development Conference on
Management of Hepatitis C: 2002 held on the NIH campus in Bethesda, Maryland.
The meeting was convened to provide an update to a 1997 conference on the
same topic. This consensus panel broke away from its 1997 predecessors by
expanding the scope of patients eligible for treatment to include those who
use injected drugs, consume alcohol, suffer from co-morbid conditions such as
depression, or who are coinfected with HIV. Similarly, panelists cautioned
against the exclusion of children and older adults from treatment and further
The panel urged the establishment of a hepatitis research network that would
conduct research into the natural history, prevention, and treatment of
hepatitis C. The panel also recommended the development of strategies to
better prevent, diagnose, and treat the disease in injection drug users and
the incarcerated population.
The 12-member consensus panel included representation from internal medicine,
gastroenterology, infectious diseases, pediatrics, family practice, oncology
and the public. The panel members heard presentations from 28 hepatitis C
experts, and reviewed an extensive body of medical literature, as well as an
evidence report prepared by the Johns Hopkins University School of Medicine
Evidence-based Practice Center (EPC) under contract to the U.S. Agency for
Healthcare Research and Quality (AHRQ).
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
and the NIH Office of Medical Applications of Research (OMAR) sponsored the
conference. Co-sponsors included the National Cancer Institute (NCI), the
National Center for Complementary and Alternative Medicine (NCCAM), the
National Heart, Lung, and Blood Institute (NHLBI), the National Institute on
Alcohol Abuse and Alcoholism (NIAAA), the National Institute of Allergy and
Infectious Diseases (NIAID), the National Institute of Child Health and Human
Development (NICHD), the National Institute on Drug Abuse (NIDA), the Centers
for Disease Control and Prevention (CDC), the Centers for Medicare and
Medicaid Services (CMS), the U.S. Department of Veterans Affairs (VA), and
the U.S. Food and Drug Administration (FDA).
The panel's statement is an independent report and is not a policy statement
of the NIH or the Federal Government. The NIH Consensus Development Program,
of which this consensus conference was a part, was established in 1977 as a
mechanism to judge in an unbiased, impartial manner controversial topics in
medicine and public health. NIH has conducted 116 consensus development
conferences addressing a wide range of issues.