Simvastatin for the Treatment of Chronic Hepatitis B
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
The investigators have shown robust in vitro anti-hepatitis B activity of simvastatin alone
and synergistic activity with all four FDA-approved anti-hepatitis B oral drugs tested. The
investigators propose phase 1 studies in 48 chronic hepatitis B human carriers who have never
been treated before. Doses of drugs will remain at or below FDA-approved dosage levels for
cholesterol lowering (simvastatin) or hepatitis B (tenofovir or entecavir). Arm 1 will have
simvastatin monotherapy only. Arm 2 will combine simvastatin with tenofovir. Arm 3 will
combine simvastatin with entecavir. For maximum safety, the 3 arms and the dose groups in
each arm will be filled consecutively and not concurrently. The definition of efficacy for
simvastatin alone will be a 1 log drop of hepatitis B virus in 14 days. Efficacy for
combination of drugs will require a 2 log drop of hepatitis B virus in 14 days. Numerous
safety tests and stop rules are noted in the protocol.