Progress and Future Directions for Management of Hepatitis C

Office of the DirectorOffice of Medical, Applications of ResearchFOR IMMEDIATE RELEASE, NIH Office of Medical, National Institute of Diabetes and

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 research.

Among its recommendations for future research, the panel gave top priority to the development of reliable and reproducible HCV cultures, which will advance the understanding of its biology, mechanisms of drug resistance, and aid vaccine development. The panel urged the establishment of a hepatitis research network that would conduct research into the natural history, prevention, and treatment of hepatitis C. Studies to determine the efficacy of alternative medicines are also needed. 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.

The full text of the panel's statement will be available in draft form following the conference at http://consensus.nih.gov. Statements from past conferences are available at the same Web site, or by calling 1-888-NIH-CONSENSUS (1-888-644-2667).

A summary of the hepatitis C evidence report prepared by the Johns Hopkins University School of Medicine EPC is available at http://www.ahrq.gov/clinic/epcix.htm. Copies are also available from the AHRQ Publications Clearinghouse, by calling 1-800-358-9295.

Note to TV Editors: The news conference at 1:00 p.m. on Wednesday, June 12, 2002 will be broadcast live via satellite on the following coordinates:

C-Band Galaxy 3 R Transponder 5 Downlink Frequency: 95 degrees West Polarity: 3800 Horizontal Audio: 6.2 / 6.8

Test time: 12:30 - 1:00 p.m. Broadcast time 1:00-2:00 p.m.