Chronic hepatitis B is a disease of the liver caused by the hepatitis B virus. It affects
nearly 1 million Americans. Approximately 25% of patients with chronic hepatitis B will
develop liver cirrhosis and 5% of patients will develop liver cancer.
Presently, two medications have been shown effective in the treatment of hepatitis B:
lamivudine and alpha interferon. Alpha interferon (an antiviral drug that acts through the
immune system) is given by injection once daily or three times a week for four to six months.
Lamivudine (also known as 3-thiacytidine: 3TC) is an antiviral medication given as a pill
once a day for twelve months. These treatments have been known to provide long-term
improvement in one third of patients receiving them.
In previous research, the drug lamivudine was shown to stop the growth of the hepatitis B
virus and to lead marked decreases in the levels of hepatitis B virus and to improvements in
the disease in 50 to 70% of patients. However, once lamivudine therapy was discontinued the
virus returned to levels noted before the therapy began. In those studies lamivudine was
given for 3 to 12 months then discontinued. This study will investigate the safety and
effectiveness of long-term therapy with lamivudine.
This study will select 60 patients diagnosed with hepatitis B. After a thorough medical
examination and liver biopsy, subjects will be given lamivudine. The drug will be taken by
mouth in tablet form (100 mg) once a day for up to 5 years. Subjects will undergo regular
check-ups and after 1 year of therapy be admitted to the Clinical Center for another medical
examination and liver biopsy to assess progress. Patients who have benefitted from the
therapy will continue taking the medication for up to 5 years. A third liver biopsy will be
done during the last year of treatment. The effectiveness of lamivudine will be determined by
whether levels of hepatitis B virus decrease in the blood, whether liver enzymes improve, and
whether inflammation and scarring decreases in the liver biopsies.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)