Hepatitis B Infection
Conditions
Brief 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.
Interventions
DRUGEntecavir
Tablets, Oral, 0.5 mg, once daily, up to 52 weeks
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) < 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 48 | Week 48 of ETV treatment | HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay. HBV DNA \< 50 IU/mL = approximately \<300 copies/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48 | Week 48 | HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. |
| Percentage of Participants With HBV DNA by PCR Category at Week 48 | Week 48 | HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay. |
| Percentage of Participants With Virologic Rebound Through Week 48 While on Continued Dosing With ETV | through Week 48 | Virologic rebound is defined as a confirmed increase of ≥ 1 log10 in HBV DNA from the participant's nadir value (2 sequential HBV DNA measurements or last on-treatment measurement) |
| Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 | Week 48 | ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 U/L. |
| Percentage of Participants With Confirmed HBeAg Loss at Week 48 (for HBeAg-positive Participants Only) | Week 48 | HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week |
| Percentage of Participants With HBeAg Seroconversion at Week 48 (for HBeAg-positive Participants Only) | Week 48 | HBeAg is a hepatitis B viral protein. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb). |
| Percentage of Participants With HBV DNA < Other IU Cut-off Points That May be Clinically Relevant at the Time of Data Analysis | Week 48 | — |
| Percentage of Participants With HBsAg Seroconversion at Week 48 | Week 48 | HBsAg = a part of the hepatitis B virus that, when in the blood, is a of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb. |
| Mean log10 Reduction From Baseline in HBV DNA at Week 48 | baseline, Week 48 | HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan TaqMan AmpliPrep assay. Reduction in log10 HBV count=reduced viral load. |
| Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events | From enrollment through Week 52 + 5 days | AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. |
| Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology | OT: From start of study therapy through Week 52 + 5 days; OF= End of OT period + 24-week follow-up | Criteria for hematology abnormalities were graded using the modified WHO grading system. Hemoglobin: \<=11.0 g/dL; White Blood Cells: \<4000/mm\^3; Absolute Neutrophils (includes absolute bands): \<1500/mm\^3; Platelets: \<=99,000/mm\^3; International Normalized Ratio: ≥ 1.5 and ≥ 0.5 from baseline. |
| Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | OT: From start of study therapy through Week 52 + 5 days; OF= End of OT period + 24-week follow-up | The modified World Health Oranization(WHO)grading system was used to grade the abnormalities. ULN=upper limit of normal. Alanine aminotransferase:\>1.25xULN, Aspartate aminotransferase:\>1.25xULN, Alkaline Phosphatase:\>1.25xULN, Total Bilirubin:\>1.1xULN, Serum Lipase:\>1.10xULN, Creatinine:\>1.1xULN, Blood Urea Nitrogen:1.25xULN, Hyperglycemia:\>116 mg/dL, Hypoglycemia:\<64 mg/dL, Hyponatremia:\<132meq/L, Hypokalemia:\<3.4 meq/L, Albumin:≥1g/dL decrease from baseline, \<3 g/dL; Hypernatremia:\>148 meq/L, Hyperkalemia:\>5.6 meq/L, Hypokalemia:\<3.4 meq/L, Hyperchloremia:\>113 meq/L, Hypochloremia:\<93 meq/L |
| Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48 | Week 48 | HBsAg = a part of the hepatitis B virus that, when in the blood, is a marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week. |
Countries
Brazil, Mexico, Puerto Rico, South Africa, United States
Participant flow
Recruitment details
A total of 131 participants were enrolled at 27 sites.
Pre-assignment details
Of the 131 participants enrolled, 85 were never treated (82 no longer met study criteria, 2 withdrew consent, and 1 had other reason).
Participants by arm
| Arm | Count |
|---|---|
| Black/ African American Entecavir (ETV) tablets, Oral, 0.5 mg, once daily, up to 52 weeks | 40 |
| Hispanic ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks | 6 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 |
Baseline characteristics
| Characteristic | Total | Black/ African American | Hispanic |
|---|---|---|---|
| Age Continuous | 40.0 years | 39.0 years | 48.0 years |
| Alanine Aminotransferase (ALT) | 107 U/L | 106 U/L | 113 U/L |
| Albumin | 4.3 g/dL | 4.3 g/dL | 4.3 g/dL |
| Hepatitis B e antibody (HBeAb) at baseline Negative | 25 participants | 21 participants | 4 participants |
| Hepatitis B e antibody (HBeAb) at baseline Positive | 21 participants | 19 participants | 2 participants |
| Hepatitis B e antigen (HBeAg) status at baseline Negative | 20 participants | 18 participants | 2 participants |
| Hepatitis B e antigen (HBeAg) status at baseline Positive | 26 participants | 22 participants | 4 participants |
| Hepatitis B surface antigen (HBsAg) status at baseline Missing | 2 participants | 0 participants | 2 participants |
| Hepatitis B surface antigen (HBsAg) status at baseline Negative | 0 participants | 0 participants | 0 participants |
| Hepatitis B surface antigen (HBsAg) status at baseline Positive | 44 participants | 40 participants | 4 participants |
| Race/Ethnicity, Customized Black/ African American | 40 participants | 40 participants | 0 participants |
| Race/Ethnicity, Customized Hispanic / Latino | 6 participants | 0 participants | 6 participants |
| Race/Ethnicity, Customized Missing | 22 participants | 22 participants | 0 participants |
| Race/Ethnicity, Customized Not Hispanic / Latino | 18 participants | 18 participants | 0 participants |
| Race/Ethnicity, Customized White | 6 participants | 0 participants | 6 participants |
| Region of Enrollment Brazil | 21 participants | 21 participants | 0 participants |
| Region of Enrollment Mexico | 2 participants | 0 participants | 2 participants |
| Region of Enrollment South Africa | 3 participants | 3 participants | 0 participants |
| Region of Enrollment United States | 20 participants | 16 participants | 4 participants |
| Sex: Female, Male Female | 11 Participants | 9 Participants | 2 Participants |
| Sex: Female, Male Male | 35 Participants | 31 Participants | 4 Participants |
| Total Bilirubin | 0.6 mg/dL | 0.6 mg/dL | 0.5 mg/dL |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 21 / 46 |
| serious Total, serious adverse events | 4 / 46 |
Outcome results
Primary
Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) < 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 48
HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay. HBV DNA \< 50 IU/mL = approximately \<300 copies/mL.
Time frame: Week 48 of ETV treatment
Population: All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Black / African American | Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) < 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 48 | 72.5 percentage of participants |
| Total | Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) < 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 48 | 69.6 percentage of participants |
Secondary
Mean log10 Reduction From Baseline in HBV DNA at Week 48
HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan TaqMan AmpliPrep assay. Reduction in log10 HBV count=reduced viral load.
Time frame: baseline, Week 48
Population: All treated participants. The participants who discontinued prior to Week 48 were counted as failure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Black / African American | Mean log10 Reduction From Baseline in HBV DNA at Week 48 | Baseline | 7.1 log10 IU/mL | Standard Error 0.26 |
| Black / African American | Mean log10 Reduction From Baseline in HBV DNA at Week 48 | HBV DNA at Week 48 | 1.88 log10 IU/mL | Standard Error 0.1 |
| Black / African American | Mean log10 Reduction From Baseline in HBV DNA at Week 48 | Change from baseline | -5.22 log10 IU/mL | Standard Error 0.249 |
| Total | Mean log10 Reduction From Baseline in HBV DNA at Week 48 | Baseline | 7.0 log10 IU/mL | Standard Error 0.25 |
| Total | Mean log10 Reduction From Baseline in HBV DNA at Week 48 | HBV DNA at Week 48 | 1.87 log10 IU/mL | Standard Error 0.091 |
| Total | Mean log10 Reduction From Baseline in HBV DNA at Week 48 | Change from baseline | -5.18 log10 IU/mL | Standard Error 0.231 |
Secondary
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events
AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.
Time frame: From enrollment through Week 52 + 5 days
Population: All treated participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Black / African American | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events | SAEs | 3 participants |
| Black / African American | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events | Grade 3 - 4 AEs | 5 participants |
| Black / African American | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events | Any AE | 33 participants |
| Black / African American | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events | Deaths | 0 participants |
| Black / African American | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events | Grade 2 - 4 Related AEs | 5 participants |
| Black / African American | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events | Related AEs | 16 participants |
| Black / African American | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events | Discontinuations Due to AEs | 0 participants |
| Total | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events | Any AE | 5 participants |
| Total | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events | Deaths | 0 participants |
| Total | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events | SAEs | 1 participants |
| Total | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events | Discontinuations Due to AEs | 0 participants |
| Total | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events | Grade 3 - 4 AEs | 1 participants |
| Total | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events | Related AEs | 0 participants |
| Total | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events | Grade 2 - 4 Related AEs | 0 participants |
| Total | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events | Grade 3 - 4 AEs | 6 participants |
| Total | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events | SAEs | 4 participants |
| Total | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events | Grade 2 - 4 Related AEs | 5 participants |
| Total | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events | Related AEs | 16 participants |
| Total | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events | Any AE | 38 participants |
| Total | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events | Discontinuations Due to AEs | 0 participants |
| Total | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events | Deaths | 0 participants |
Secondary
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology
Criteria for hematology abnormalities were graded using the modified WHO grading system. Hemoglobin: \<=11.0 g/dL; White Blood Cells: \<4000/mm\^3; Absolute Neutrophils (includes absolute bands): \<1500/mm\^3; Platelets: \<=99,000/mm\^3; International Normalized Ratio: ≥ 1.5 and ≥ 0.5 from baseline.
Time frame: OT: From start of study therapy through Week 52 + 5 days; OF= End of OT period + 24-week follow-up
Population: All treated participants. n = number of participants in the OF period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology | Hemoglobin-OT | 1 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology | Hemoglobin-OF; n=26 , 29 | 0 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology | White Blood Cells-OT | 15 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology | White Blood Cells-OF; n=26 , 29 | 7 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology | Neutrophils -OT | 13 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology | Neutrophils-OF; n=26 , 26 | 4 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology | Platelets-OT | 4 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology | Platelets-OF; n=26 , 29 | 0 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology | International Normalized Ratio-OT | 18 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology | International Normalized Ratio-OF; n=26 , 29 | 4 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology | Platelets-OF; n=26 , 29 | 0 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology | Hemoglobin-OT | 2 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology | Neutrophils-OF; n=26 , 26 | 4 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology | Hemoglobin-OF; n=26 , 29 | 0 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology | International Normalized Ratio-OF; n=26 , 29 | 4 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology | White Blood Cells-OT | 18 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology | Platelets-OT | 4 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology | White Blood Cells-OF; n=26 , 29 | 8 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology | International Normalized Ratio-OT | 23 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology | Neutrophils -OT | 13 participants |
Secondary
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
The modified World Health Oranization(WHO)grading system was used to grade the abnormalities. ULN=upper limit of normal. Alanine aminotransferase:\>1.25xULN, Aspartate aminotransferase:\>1.25xULN, Alkaline Phosphatase:\>1.25xULN, Total Bilirubin:\>1.1xULN, Serum Lipase:\>1.10xULN, Creatinine:\>1.1xULN, Blood Urea Nitrogen:1.25xULN, Hyperglycemia:\>116 mg/dL, Hypoglycemia:\<64 mg/dL, Hyponatremia:\<132meq/L, Hypokalemia:\<3.4 meq/L, Albumin:≥1g/dL decrease from baseline, \<3 g/dL; Hypernatremia:\>148 meq/L, Hyperkalemia:\>5.6 meq/L, Hypokalemia:\<3.4 meq/L, Hyperchloremia:\>113 meq/L, Hypochloremia:\<93 meq/L
Time frame: OT: From start of study therapy through Week 52 + 5 days; OF= End of OT period + 24-week follow-up
Population: All treated participants. n = number of participants in the OF period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Total Bilirubin-OT | 7 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Alanine aminotransferase-OF; n=26 , 29 | 3 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Aspartate aminotransferase-OT | 33 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Aspartate aminotransferase-OF; n=26 , 29 | 2 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Alkaline Phosphatase-OT | 3 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Alkaline Phosphatase-OF; n=26 , 29 | 1 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Albumin-OT | 3 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Albumin-OF; n=26 , 29 | 0 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Alanine aminotransferase-OT | 37 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Total Bilirubin-OF; n=26 , 29 | 3 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Serum Lipase-OT | 12 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Serum Lipase-OF; n=26 , 29 | 1 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Creatinine-OT | 3 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Creatinine-OF; n=26 , 29 | 0 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Blood Urea Nitrogen-OT | 2 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Blood Urea Nitrogen-OF; n=26 , 29 | 0 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hyperglycemia-OT | 14 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hyperglycemia-OF; n=26 , 29 | 5 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hypoglycemia-OT | 5 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hypoglycemia-OF; n=26 , 29 | 1 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hypernatremia-OT | 0 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hypernatremia-OF; n=26 , 29 | 0 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hyponatremia-OT | 3 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hyponatremia-OF; n=26 , 29 | 0 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hyperkalemia-OT | 0 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hyperkalemia-OF; n=26 , 29 | 0 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hypokalemia-OT | 3 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hypokalemia-OF; n=26 , 29 | 0 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hyperchloremia-OT | 0 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hyperchloremia-OF; n=26 , 29 | 0 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hypochloremia-OT | 0 participants |
| Black / African American | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hypochloremia-OF; n=26 , 29 | 0 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hypochloremia-OF; n=26 , 29 | 0 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Alanine aminotransferase-OT | 43 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hyperglycemia-OT | 15 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Alanine aminotransferase-OF; n=26 , 29 | 4 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hyperkalemia-OT | 0 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Aspartate aminotransferase-OT | 38 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hyperglycemia-OF; n=26 , 29 | 5 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Aspartate aminotransferase-OF; n=26 , 29 | 3 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hyperchloremia-OT | 0 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Alkaline Phosphatase-OT | 3 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hypoglycemia-OT | 5 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Alkaline Phosphatase-OF; n=26 , 29 | 1 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hypokalemia-OF; n=26 , 29 | 0 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Albumin-OT | 5 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hypoglycemia-OF; n=26 , 29 | 1 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Albumin-OF; n=26 , 29 | 0 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hyperkalemia-OF; n=26 , 29 | 0 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Total Bilirubin-OT | 7 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hypernatremia-OT | 0 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Total Bilirubin-OF; n=26 , 29 | 4 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hypochloremia-OT | 0 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Serum Lipase-OT | 14 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hypernatremia-OF; n=26 , 29 | 0 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Serum Lipase-OF; n=26 , 29 | 1 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hypokalemia-OT | 3 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Creatinine-OT | 3 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hyponatremia-OT | 3 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Creatinine-OF; n=26 , 29 | 0 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hyperchloremia-OF; n=26 , 29 | 0 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Blood Urea Nitrogen-OT | 2 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Hyponatremia-OF; n=26 , 29 | 1 participants |
| Total | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | Blood Urea Nitrogen-OF; n=26 , 29 | 0 participants |
Secondary
Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48
HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection.
Time frame: Week 48
Population: All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Black / African American | Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48 | 12.5 percentage of participants |
| Total | Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48 | 13.0 percentage of participants |
Secondary
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48
ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 U/L.
Time frame: Week 48
Population: All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Black / African American | Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 | 67.5 percentage of participants |
| Total | Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 | 67.4 percentage of participants |
Secondary
Percentage of Participants With Confirmed HBeAg Loss at Week 48 (for HBeAg-positive Participants Only)
HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week
Time frame: Week 48
Population: Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Black / African American | Percentage of Participants With Confirmed HBeAg Loss at Week 48 (for HBeAg-positive Participants Only) | 50.0 percentage of participants |
| Total | Percentage of Participants With Confirmed HBeAg Loss at Week 48 (for HBeAg-positive Participants Only) | 53.8 percentage of participants |
Secondary
Percentage of Participants With HBeAg Seroconversion at Week 48 (for HBeAg-positive Participants Only)
HBeAg is a hepatitis B viral protein. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb).
Time frame: Week 48
Population: Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Black / African American | Percentage of Participants With HBeAg Seroconversion at Week 48 (for HBeAg-positive Participants Only) | 40.9 percentage of participants |
| Total | Percentage of Participants With HBeAg Seroconversion at Week 48 (for HBeAg-positive Participants Only) | 46.2 percentage of participants |
Secondary
Percentage of Participants With HBsAg Seroconversion at Week 48
HBsAg = a part of the hepatitis B virus that, when in the blood, is a of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb.
Time frame: Week 48
Population: All treated participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Black / African American | Percentage of Participants With HBsAg Seroconversion at Week 48 | 2.5 percentage of participants |
| Total | Percentage of Participants With HBsAg Seroconversion at Week 48 | 4.3 percentage of participants |
Secondary
Percentage of Participants With HBV DNA by PCR Category at Week 48
HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay.
Time frame: Week 48
Population: All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Black / African American | Percentage of Participants With HBV DNA by PCR Category at Week 48 | 50 to <172 IU/mL (300 to < 103 copies/mL) | 0 percentage of participants |
| Black / African American | Percentage of Participants With HBV DNA by PCR Category at Week 48 | 1720 to <17200 IU/mL (104 to < 105 copies/mL) | 5.0 percentage of participants |
| Black / African American | Percentage of Participants With HBV DNA by PCR Category at Week 48 | <50 IU/mL (< 300 copies/mL) | 72.5 percentage of participants |
| Black / African American | Percentage of Participants With HBV DNA by PCR Category at Week 48 | ≥17,200 IU/mL (≥105 copies/mL) | 0 percentage of participants |
| Black / African American | Percentage of Participants With HBV DNA by PCR Category at Week 48 | 172 to <1720 IU/mL (103 to < 104 copies/mL) | 10.0 percentage of participants |
| Black / African American | Percentage of Participants With HBV DNA by PCR Category at Week 48 | Missing | 12.5 percentage of participants |
| Total | Percentage of Participants With HBV DNA by PCR Category at Week 48 | Missing | 15.2 percentage of participants |
| Total | Percentage of Participants With HBV DNA by PCR Category at Week 48 | <50 IU/mL (< 300 copies/mL) | 69.6 percentage of participants |
| Total | Percentage of Participants With HBV DNA by PCR Category at Week 48 | 50 to <172 IU/mL (300 to < 103 copies/mL) | 0 percentage of participants |
| Total | Percentage of Participants With HBV DNA by PCR Category at Week 48 | 172 to <1720 IU/mL (103 to < 104 copies/mL) | 10.9 percentage of participants |
| Total | Percentage of Participants With HBV DNA by PCR Category at Week 48 | 1720 to <17200 IU/mL (104 to < 105 copies/mL) | 4.3 percentage of participants |
| Total | Percentage of Participants With HBV DNA by PCR Category at Week 48 | ≥17,200 IU/mL (≥105 copies/mL) | 0 percentage of participants |
Secondary
Percentage of Participants With HBV DNA < Other IU Cut-off Points That May be Clinically Relevant at the Time of Data Analysis
Time frame: Week 48
Population: Since there were no other cut-off points other than those at the time of data analysis, this outcome was not analysed.
Secondary
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48
HBsAg = a part of the hepatitis B virus that, when in the blood, is a marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week.
Time frame: Week 48
Population: All treated participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Black / African American | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48 | 5.0 percentage of participants |
| Total | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48 | 6.5 percentage of participants |
Secondary
Percentage of Participants With Virologic Rebound Through Week 48 While on Continued Dosing With ETV
Virologic rebound is defined as a confirmed increase of ≥ 1 log10 in HBV DNA from the participant's nadir value (2 sequential HBV DNA measurements or last on-treatment measurement)
Time frame: through Week 48
Population: All treated participants. The participants who discontinued prior to Week 48 were counted as failure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Black / African American | Percentage of Participants With Virologic Rebound Through Week 48 While on Continued Dosing With ETV | 0 percentage of participants |
| Total | Percentage of Participants With Virologic Rebound Through Week 48 While on Continued Dosing With ETV | 0 percentage of participants |