Tenofovir Alone Versus Tenofovir With Emtricitabine to Treat Chronic Hepatitis B
Status:
Terminated
Trial end date:
2017-02-16
Target enrollment:
Participant gender:
Summary
This study will test whether the combination of two medications, tenofovir and emtricitabine,
are safer and more effective for treating chronic hepatitis B than tenofovir alone. Chronic
hepatitis B is a liver disease caused by infection with the hepatitis B virus. Several
medications, including standard and pegylated interferon and the anti-viral drugs lamivudine,
adefovir, entecavir and telbivudine, are currently used to treat the disease. Problems are
associated with all of these agents, however, including development of viral resistance with
long-term therapy of the anti-virals. Since many patients require long-term therapy to
prevent their disease from worsening, a major goal of new approaches to treatment is to
prevent the development of viral resistance. Combination treatment has been shown to be an
effective strategy in preventing this resistance.
Tenofovir is an anti-viral drug approved for use in patients with HIV infection. In small
studies in patients infected with both HIV and hepatitis B, tenofovir lowered the level of
hepatitis B virus in the blood, with no viral resistance reported when used for up to 5
years. Emtricitabine is an anti-viral drug similar to lamivudine and is effective at lowering
viral load and improving liver damage.
Patients 18 years of age and older with chronic hepatitis B may be eligible for this study.
Participants are admitted to the NIH Clinical Center for a complete medical history and
examination, including blood and urine tests, chest X-ray, electrocardiogram, abdominal
ultrasound, Fibroscan (ultrasound exam of the liver that measures the amount of scarring),
bone mineral density scan and liver biopsy. They are then randomly assigned to take
combination treatment with tenofovir plus emtricitabine or tenofovir alone for at least 48
weeks. During the treatment period, patients visit the Clinical Center for blood tests and a
physical examination every 2 weeks for the first month and then every 4 to 12 weeks. After 48
weeks, patients are readmitted to the Clinical Center for a complete evaluation that includes
all the tests done at the start of therapy, including a liver biopsy. Patients who seem to
have improved with treatment may continue therapy for up to 192 weeks, when they are again
admitted to the Clinical Center for a complete medical evaluation and liver biopsy. Patients
whose condition has not improved after 48 weeks of treatment have their treatment changed or
stopped and continue to have regular outpatient clinic visits for 24 more weeks.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)