Lamivudine and Adefovir to Treat Chronic Hepatitis B
Status:
Completed
Trial end date:
2013-08-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the safety and effectiveness of lamivudine plus adefovir versus
adefovir alone to treat chronic hepatitis B infection. The Food and Drug Administration has
approved lamivudine for the treatment of hepatitis B. However, the drug is not effective in
all patients, and many of those in whom it initially works develop resistance after 1 to 3
years. Adefovir is an experimental drug that inhibits replication of the hepatitis B virus
(HBV). Adefovir used alone may be adequate to provide sustained suppression of the virus and
improvement in liver disease. However combining two anti-viral agents may be superior to
using one alone, similar to the strategy employed for the treatment of AIDS. This study will
test whether the combination of lamivudine and adefovir is better than adefovir alone for the
treatment of chronic hepatitis B.
Patients 18 years of age and older, who have been infected with HBV for at least 6 months,
may be eligible for this study. Candidates may not have received lamivudine treatment in the
past 6 months or prior treatment with adefovir and must not be taking other anti-viral
treatments for their hepatitis. They will have a blood test to confirm HBV infection.
Participants will be admitted to the NIH Clinical Center for 2 to 3 days for a medical
evaluation. One to 2 weeks after the evaluation, patients will be randomized to begin taking
lamivudine and adefovir, or adefovir alone. Therapy will continue for at least 12 months.
Follow-up clinic visits will be scheduled weekly for the first month, then every 4 to 8 weeks
for the rest of the treatment period. Patients will be evaluated at the end of 1 year.
Patients who have not improved with treatment will stop taking the treatment and will be
evaluated in the clinic once every 4 weeks for another 6 months. Patients who show an
improvement in their liver injury may continue taking lamivudine and adefovir or adefovir
alone for 4 more years, as long as they continue to improve with the medication. Progress
will be evaluated. If the test results show no continued improvement or are negative for
hepatitis B antigens, therapy will be stopped.
Patients who continue treatment for 5 years will be readmitted at year 4 for another medical
evaluation to assess the effects of treatment at that time. After the 5 years all patients
will stop therapy at and be followed with regular clinic visits for at least 6 months.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)