Hepatitis C

FDA Consumer, July, 2001 by Linda Bren

Despite many years of chronic infection, the majority of people infected with hepatitis C virus do not develop severe liver disease, and some may not need treatment.

It's often portrayed as a virus causing an incurable disease--a killer with few outward warning signs that lurks inside the body and slowly ravages the liver.

For some, the hepatitis C virus (HCV) is deadly, but for most of the nearly 4 million Americans infected with the virus, it is not life-threatening.

"Some cases are mild," says Leonard Seeff, M.D., a hepatologist at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), "and people can go through their whole lives and never have a problem. For others who develop severe liver disease, it is a terribly serious problem."

HCV is responsible for 8,000 to 10,000 deaths per year in the United States, according to the Centers for Disease Control and Prevention (CDC). The virus is spread mainly through contact with the blood of an infected person. Most people don't know they carry the virus because they have either no symptoms or vague ones--extreme tiredness is the most common. Other common symptoms are "flu-like": muscle and joint pain, nausea, poor appetite, and mild stomach pain.

Only about 15 percent of those infected with HCV have a short-term infection that goes away by itself and never returns. The other 85 percent become chronically infected, meaning the virus stays in the liver, replicates, and may slowly attack the organ over a period of decades.

Despite many years of chronic infection, the majority of people infected with HCV do not develop severe liver disease, and some may not need treatment, says William Schwieterman, M.D., chief of the immunology and infectious diseases branch in the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER). Most studies report that cirrhosis (advanced liver scarring) develops in 10 percent to 20 percent of people with chronic HCV infection over a period of 20 to 30 years. Liver cancer develops in 1 percent to 5 percent.

Those who do need treatment have more and better therapies today than were available just a few years ago. Although treatments come with the risk of serious side effects, many individuals with HCV infection are benefiting from them.

Disease in Decline

"The number of new cases is going down precipitously," says Jay Hoofnagle, M.D., director of the division of digestive diseases and nutrition at the NIDDK. During the 1980s, an average of 230,000 new infections occurred each year in the United States, according to CDC estimates. But between 1989 and 1996, the annual number of new infections declined by more than 80 percent, to 36,000 reported cases. This decrease is explained by the introduction of routine blood screening for HCV antibodies in 1991 and improved testing for the virus in 1992--lowering significantly the risk of transmitting the virus through blood transfusions.

Individuals who have the virus and are otherwise healthy may be at less risk for severe liver damage than previously thought. Several studies led by Seeff have shown that serious illness and death from liver disease in people infected with HCV is by no means inevitable.

In a study published in the Jan. 18, 2000, issue of Annals of Internal Medicine, Seeff examined the records of more than 8,000 U.S. military recruits. Seventeen who had tested positive for HCV 45 years earlier had similar hospital admission rates over the 45-year period as those who were HCV-negative. After 45 years, only two of the 17 (11.8 percent) showed evidence of liver disease; one of these died from liver disease 42 years after initial testing.

In Seeff's more recent study, published in the Feb. 2001 issue of Hepatology, he reported on nearly 600 people who had received blood transfusions in the 1970s. Approximately 67 percent of the 222 people infected with HCV had died 25 years later, compared with 56 percent of the 377 non-infected people who had died. Although these numbers reflect deaths from all causes, a liver-related cause for death was more common among the HCV-infected persons.

Treatments and Their Success

For some people with mild hepatitis C, the only treatment needed may be eating a nutritious diet, avoiding alcohol, exercising regularly, and visiting a doctor regularly to monitor the disease. But for others with hepatitis C, drug therapy may be appropriate.

The FDA has approved two different treatment regimens for chronic hepatitis C: monotherapy (using a single drug, interferon) and combination therapy (using two drugs, interferon and ribavirin). Interferon, which is injected into the bloodstream, works by bolstering the immune response to HCV. Ribavirin, which is taken orally, may work by preventing the virus from reproducing (viral replication). Taken alone, ribavirin does not effectively suppress levels of the virus in the bloodstream. But studies have shown that the interferon and ribavirin combination, approved in 1998, is more effective than interferon alone.