Effect of Entecavir in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) Infection
Effect of Entecavir in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) Infection
The purpose of this clinical research study is to develop observational clinical experience
 with the use of entecavir in participants who are either of Black/African-American race or of
 Hispanic ethnicity.
Inclusion Criteria:

 -  Chronic HBV infection, with either HBeAg-positive (HBeAb-negative) or HBeAg-negative
 (HBeAb-positive) disease

 -  Black/African American Race and/or Hispanic ethnicity

 -  Nucleoside/tide-naive

 -  Males or females ≥ 16 years of age (or minimum age required in a given country)

 -  Compensated liver function

 -  ALT of 1.3 to 10 x upper limit of normal (ULN)

 -  No Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or
 hepatitis D virus (HDV)

 Exclusion Criteria

 -  Women of childbearing potential (WOCBP) who are unwilling or unable to use an
 acceptable method to avoid pregnancy for the entire study period and for up to 6 weeks
 after study medication has been discontinued

 -  Women who are pregnant or breastfeeding

 -  Women with a positive pregnancy test on enrollment or prior to study drug
 administration

 -  Evidence of decompensated cirrhosis including but not limited to: variceal bleeding;
 hepatic encephalopathy; or ascites requiring management with diuretics or paracentesis

 -  Recent history of pancreatitis (resolution of any recent pancreatitis must be
 documented by normal lipase at least 12 weeks prior to the first dose of study
 medication)

 -  Currently abusing illegal drugs or alcohol sufficient, in the investigator's opinion,
 to prevent adequate compliance with study therapy or to increase the risk of
 hepatotoxicity or pancreatitis

 -  Other serious medical conditions that might preclude completion of this study or that
 require chronic administration of prohibited medications

 -  Serum creatinine > 1.5 mg/dL

 -  Hemoglobin < 10.0 g/dL

 -  Platelet count < 70,000/mm3

 -  Absolute neutrophil count < 1200 cells/mm3

 -  Serum alpha fetoprotein (AFP) level > 100 ng/mL. If the AFP level is between 21 and
 100 ng/mL, it must be repeated. If the repeat AFP level is between 21 and 100 ng/mL
 and if ultrasonography or computerized tomography (CT) of the liver performed prior to
 the first dose of study medication does not demonstrate a focal lesion suggestive of
 carcinoma, the subject may be dosed in the study

 -  Known history of allergy to nucleoside analogues

 -  Any prior therapy with Entecavir

 -  Any prior or concomitant use of nucleoside or nucleotide analogue antiviral agents
 with activity against hepatitis B (e.g., ETV, lamivudine (LVD), tenofovir [TDF],
 emtricitabine (FTC), clevudine, telbivudine [LdT], famciclovir), or any other
 experimental anti-HBV antiviral agent

 -  Therapy with interferon, thymosin alpha or other immunostimulators within 24 weeks of
 enrollment (i.e., dosing) into this study

 -  Subjects who require chronic administration of concomitant medications which cause
 immunosuppression or which are associated with a high rate of nephrotoxicity or
 hepatotoxicity, or which affect renal excretion, should not be enrolled in this study

 -  Unable to tolerate oral medication

 -  Poor peripheral venous access

 -  Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
 treatment of either a psychiatric or physical (e.g., infectious disease) illness must
 not be enrolled into this study