Chronic Hepatitis B Clinical Trial
Official title:
Lamivudine for Chronic Hepatitis B
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.
To assess the safety, antiviral activity and clinical benefit of lamivudine (3-thiacytidine: 3TC) in chronic hepatitis B, we will treat 60 patients with oral lamivudine in a dose of 100 mg daily for up to five years. Lamivudine is a nucleoside analogue which is used extensively in patients with HIV infection and is being studied in controlled trials in chronic hepatitis B. In this study, we will evaluate lamivudine in patients with four different forms of chronic hepatitis B: (A) Atypical serology (HBeAg negative), (B) extra-hepatic manifestations, (C) chronic delta hepatitis, (D) typical HBeAg- positive chronic hepatitis B. After evaluation and liver biopsy, patients will receive lamivudine, 100 mg orally once daily for 1 year, being monitored at regular intervals for symptoms of liver disease, side effects of lamivudine, serum biochemical and hematologic indices, and serologic markers of hepatitis B (and D) virus replication. At one year, patients will have a repeat medical evaluation and liver biopsy. If there is virologic, biochemical or histologic evidence of benefit, therapy will be continued thereafter for up to 5 years. Patients who develop viral resistance to lamivudine may be offered therapy with higher doses of lamivudine (300 mg per day). The activity of lamivudine will be assessed by changes in levels of HBV DNA or HDV RNA during treatment and its efficacy by loss of viral markers and improvements in aminotransferases and liver histology. ;
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
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