This study will evaluate HIV-HBV infected individuals who have evidence of HBV replication in the blood after taking 48 weeks of more of the HBV active medication tenofovir in combination with emtricitabine or lamivudine. Eligible participants will be randomized to receive 24 weeks of entecavir (ETV) 1 mg versus continued standard of care antiretroviral therapy. After 24 weeks, individuals on entecavir or who remain HBV viremic on standard of care will receive ETV o for an additional 24 weeks. The hypothesis is that intensification with entecavir will reduce HBV DNA at 24 weeks more than continued antiretroviral therapy without entecavir.
Design: This is a randomized, controlled pilot study of open-label entecavir for the treatment of persistent HBV viremia in HIV-HBV coinfected individuals who have failed to suppress HBV replication after 48 weeks on tenofovir containing therapy. Primary Objective: To evaluate the mean log reduction of HBV DNA with entecavir(ETV) intensification in comparison to continued standard therapy with tenofovir and lamivudine/emtricitabine at 24 weeks of therapy Study Population: HIV-HBV co-infected individuals with detectable HBV DNA after 48 weeks of therapy with tenofovir and lamivudine/emtricitabine whose HIV viremia is well controlled ( \< 75 copies at time of enrollment) Treatment: Subjects will be randomized to continue with standard therapy or to receive intensification with 1 mg daily of open label entecavir for the 24 week duration of the study. Sample Size: 24 subjects will be enrolled. Duration 24 weeks of treatment Primary Endpoint: Mean log10 reduction of HBV DNA at 24 weeks of standard therapy vs. entecavir intensification.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
1 mg by mouth daily
continued standard of care with tenofovir in addition to emtricitabine or lamivudine
San Francisco General HIV Clinical Trials Group
San Francisco, California, United States
Hepatitis B Virus (HBV) DNA
HBV DNA carries the genetic blueprint of the virus. How many HBV DNA "particles" or "copies" are found in the blood indicates how rapidly the virus is reproducing in the liver.
Time frame: week 24
Incidence of Permanent Discontinuation Due to Toxicity
Time frame: 24 weeks
Incidence of New Hepatic Decompensation( Ascites, Variceal Hemorrhage, Encephalopathy)
Time frame: every 4 weeks for 24 weeks
Incidence of ALT Flares
ALT flare: sudden increase in blood level of alanine transaminase (ALT)
Time frame: every 4 weeks for 24 weeks
HIV RNA < 75 Copies/ml
Time frame: entry, week 12, and week 24
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