effect of entecavir in blacks/african americans and hispanics with chronic hepatitis b virus (hbv) infection

Conditions: Hepatitis B Infection

Summary: 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.


Eligibility criteria:
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