It worked as well as combination of drugs used to treat the disease
By Amanda Gardner
HealthDay Reporter
FRIDAY, Jan. 7 (HealthDayNews) -- A drug that has been used for several years to treat hepatitis C is emerging as a strong alternative for treating chronic hepatitis B, a new study finds.
Administering peginterferon alfa-2b alone worked just as well as adding one of the more traditional drugs used to treat the liver disease. Researchers also found the particular type of virus influenced responses to peginterferon.
The findings of the worldwide trial appear in the Jan. 8 issue of The Lancet.
"The data is pretty persuasive," said Dr. Eugene Schiff, chief of the division of hepatology and a professor of medicine at the University of Miami School of Medicine. "This will influence physicians who take care of hepatitis B patients. More people who weren't using interferon will think about it a lot harder, although they won't use it exclusively."
Dr. Adrian M. Di Bisceglie, chief of hepatology at Saint Louis University School of Medicine, added, "Pegylated interferon is likely to take over as the type of interferon used to treat hepatitis B."
Neither Schiff nor Di Bisceglie were involved in the study.
The drug is not without its problems, however, including various side effects such as flu-like symptoms and fatigue. "It's good news, but we still don't have a real knock-out killer punch against hepatitis B," Di Bisceglie said.
A previous study had shown that pegylated interferon was superior to standard interferon.
Chronic hepatitis B is caused by a virus that attacks the liver. The virus, called hepatitis B virus, can cause lifelong infection, scarring of the liver, liver cancer, liver failure and death. The disease affects about 400 million people worldwide. The virus can be spread from mother to fetus, as well as through sex and intravenous drug use.
According to Di Bisceglie, interferon, in one form or another, has been used to treat chronic hepatitis B for about two decades. Two other drugs are also approved in the United States to treat the disease: lamivudine and adefovir.
"The arena right now in treating someone for hepatitis B allows you many choices," Schiff explained. "The big decision certainly in the United States is, do we give somebody interferon where it has to be injected and where there are side effects, or do you give one of the oral agents adefovir or lamivudine."
Pegylated interferon can be given less often that standard interferon, Di Bisceglie said.
Lamivudine and adefovir are given in pill form and produce fewer side effects, but they have to be taken indefinitely. When the drugs are stopped, the virus can return, Di Bisceglie explained. Interferon is usually given for a year, during which time about 30 percent to 40 percent of patients show no signs of the e antigen, a marker for liver disease.
The new trial involved about 300 people and was carried out at 52 centers in 15 countries in Europe, North America and Asia. All participants had chronic hepatitis B and were randomly assigned to receive either pegylated interferon alfa 2b with lamivudine, or pegylated interferon with a placebo for one year. They were then followed for an additional six months after the therapies were stopped. The pharmaceutical firms Schering-Plough and GlaxoSmithKline provided the drugs.
At the end of the year, 44 percent of those in the combination therapy group and 29 percent of those in the single therapy group had no signs of the e antigen. But at the end of the six-month follow-up period, 36 percent of the patients on pegylated interferon alone and 35 percent of those receiving the combination therapy had cleared the antigen.
There were differences in success rates, depending on the genetics of the virus, the study found.
While the study authors suggested that pegylated interferon would become the first-line treatment, Schiff was less sure.
"I don't think it will be first line in the United States," he said. "In the U.S., interferon, lamivudine or adefovir are all on the same level and the physician has a choice. You can then refine that and give the pros and cons for specific clinical situations."
SOURCES: Adrian M. Di Bisceglie, M.D., chief, hepatology, Saint Louis University School of Medicine, St. Louis; Eugene Schiff, M.D., chief, division of hepatology and professor of medicine, University of Miami School of Medicine, Miami; Jan. 8, 2005, The Lancet
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