Primary Outcomes

Measure: Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss & Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels ≤1,000 International Units (IU) Per Milliliter (mL)

Time: End of follow-up (up to 96 weeks)

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Description: The number of AEs includes both AEs and Serious Adverse Events (SAEs). The incidence is calculated as the number of AEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.

Measure: Incidence of Adverse Events (AEs) Per Person-Year

Time: From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)

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Description: The incidence is calculated as the number of SAEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.

Measure: Incidence of Serious Adverse Events (SAEs) Per Person-Year

Time: From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)

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Secondary Outcomes

Measure: Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss

Time: End of treatment (up to 48 weeks)

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Measure: Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss

Time: End of follow-up (up to 96 weeks)

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Measure: Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss

Time: End of treatment (up to 48 weeks)

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Measure: Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss

Time: End of follow-up (up to 96 weeks)

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Measure: Proportion of Participants With HBeAg Seroconversion

Time: End of treatment (up to 48 weeks)

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Measure: Proportion of Participants With HBeAg Seroconversion

Time: End of follow-up (up to 96 weeks)

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Measure: Proportion of Participants With HBsAg Seroconversion

Time: End of treatment (up to 48 weeks)

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Measure: Proportion of Participants With HBsAg Seroconversion

Time: End of follow-up (up to 96 weeks)

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Measure: Proportion of Participants With Alanine Aminotransferase (ALT) ≤ 40 Units (U) Per Liter (L) for Males, ≤ 35 U/L for Females

Time: End of treatment (up to 48 weeks)

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Measure: Proportion of Participants With ALT ≤ 40 U/L for Males, ≤ 35 U/L for Females

Time: End of follow-up (up to 96 weeks)

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Measure: Proportion of Participants With HBV DNA ≤1000 IU/mL

Time: End of treatment (up to 48 weeks)

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Measure: Proportion of Participants With HBV DNA ≤1000 IU/mL

Time: End of follow-up (up to 96 weeks)

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Measure: Proportion of Participants With HBV DNA < 20 IU/mL

Time: End of treatment (up to 48 weeks)

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Measure: Proportion of Participants With HBV DNA < 20 IU/mL

Time: End of follow-up (up to 96 weeks)

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Description: HBV drug resistance variant testing was performed at the CDC laboratory. The sequences of the HBV polymerase spanning nucleotide positions 311-1021 were determined by Sanger sequencing. Drug resistance mutations that were tested in this study included L80VI, L82M, T128N, W153Q, F166L, I169T, V173L, L180M, A181TV, T184ACFGILMS, V191T, A194T, A200V, S202ETV, M204IV, V207I, N236T, M250ILV, and G145R.

Measure: Proportion Without Detectable Antiviral Drug-resistance HBV Mutations

Time: End of treatment (up to 48 weeks)

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Description: A child's Z-score is the number of standard deviations that the child is from the average of children of the same sex and age from a reference population. The reference population is provided in the 2000 Centers for Disease Control and Prevention (CDC) growth charts. Positive Z scores mean the growth measure (weight, height, or body mass index) is above the average, negative Z scores mean the growth measure is below the average.

Measure: Growth Measures: Z-scores Weight, Height, and Body Mass Index

Time: End of treatment (up to 48 weeks)

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Description: A child's Z-score is the number of standard deviations that the child is from the average of children of the same sex and age from a reference population. The reference population is provided in the 2000 Centers for Disease Control and Prevention (CDC) growth charts. Positive Z scores mean the growth measure (weight, height, or body mass index) is above the average, negative Z scores mean the growth measure is below the average.

Measure: Growth Measures: Z-scores Weight, Height, and Body Mass Index

Time: End of follow-up (up to 96 weeks)

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Description: The Tanner Stage questionnaire is only completed by participants 8 years of age and older. The copyrighted form includes pictures and descriptions. Girls selected the picture closest to their self-perceived breast growth from among 5 stages of breast growth and boys did the same for testes, scrotum, and penis growth. Boys: I-prepubertal; II-enlargement of scrotum and testes; III-enlargement of the penis and further growth of testes; IV- increased size of penis with growth in breadth and development of glans, testes, and scrotum larger, scrotum skin darker; V- adult genitalia. Girls: I-prepubertal; II-breast bud stage with the elevation of breast and papilla and enlargement of the areola; III-further enlargement of breast and areola, no separation of their contour; IV-areola and papilla form a secondary mound above the level of the breast; V: mature adult stage. There is no "better" or "worse" outcome. They are self-assessed descriptive measures of physical growth.

Measure: Tanner Stages of Physical Growth

Time: End of treatment (up to 48 weeks)

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Description: The Tanner Stage questionnaire is only completed by participants 8 years of age and older. The copyrighted form includes pictures and descriptions. Girls selected the picture closest to their self-perceived breast growth from among 5 stages of breast growth and boys did the same for testes, scrotum, and penis growth. Boys: I-prepubertal; II-enlargement of scrotum and testes; III-enlargement of the penis and further growth of testes; IV- increased size of penis with growth in breadth and development of glans, testes, and scrotum larger, scrotum skin darker; V- adult genitalia. Girls: I-prepubertal; II-breast bud stage with the elevation of breast and papilla and enlargement of the areola; III-further enlargement of breast and areola, no separation of their contour; IV-areola and papilla form a secondary mound above the level of the breast; V: mature adult stage. There is no "better" or "worse" outcome. They are self-assessed descriptive measures of physical growth.

Measure: Tanner Stages of Physical Growth

Time: End of follow-up (up to 96 weeks)

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Description: The Tanner Stage questionnaire is only completed by participants 8 years of age and older. The copyrighted form includes pictures and descriptions. Participants selected the picture closest to their self-perceived pubic hair growth. Boys and girls: I-prepubertal (no pubic hair at all); II-sparse growth of long, slightly pigmented hair, straight or curled, at base of penis or along labia; III: darker, coarser and more curled hair, spreading sparsely over junction of pubes; IV- hair adult in type, but covering smaller area than in adult; V-adult in type and quantity. There is no "better" or "worse" outcome. They are self-assessed descriptive measures of physical growth.

Measure: Tanner Stages of Pubic Hair Growth

Time: End of treatment (up to 48 weeks)

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Description: The Tanner Stage questionnaire is only completed by participants 8 years of age and older. The copyrighted form includes pictures and descriptions. Participants selected the picture closest to their self-perceived pubic hair growth. Boys and girls: I-prepubertal (no pubic hair at all); II-sparse growth of long, slightly pigmented hair, straight or curled, at base of penis or along labia; III: darker, coarser and more curled hair, spreading sparsely over junction of pubes; IV- hair adult in type, but covering smaller area than in adult; V-adult in type and quantity. There is no "better" or "worse" outcome. They are self-assessed descriptive measures of physical growth.

Measure: Tanner Stages of Pubic Hair Growth

Time: End of follow-up (up to 96 weeks)

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Primary Outcomes

Description: Lack of data was considered to be treatment failure.

Measure: Proportion of Participants With HBeAg Loss (Lack of Detectable HBeAg) AND HBV DNA ≤1,000 IU/mL

Time: End of follow-up (up to 96 weeks)

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Description: The number of AEs includes both AEs and Serious Adverse Events (SAEs). The incidence is calculated as the number of AEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.

Measure: Incidence of Adverse Events (AEs) Per Person-Year of Observation

Time: From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)

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Description: The incidence is calculated as the number of SAEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.

Measure: Incidence of Serious Adverse Events (SAEs) Per Person-Year

Time: From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)

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Secondary Outcomes

Measure: Proportion of Participants With HBeAg Loss

Time: End of treatment (up to 48 weeks)

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Measure: Proportion of Participants With HBeAg Loss

Time: End of follow-up (up to 96 weeks)

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Measure: Proportion of Participants With HBeAg Seroconversion

Time: End of treatment (up to 48 weeks)

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Measure: Proportion of Participants With HBeAg Seroconversion

Time: End of follow-up (up to 96 weeks)

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Measure: Proportion of Participants With HBsAg Loss

Time: End of treatment (up to 48 weeks)

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Measure: Proportion of Participants With HBsAg Loss

Time: End of follow-up (up to 96 weeks)

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Measure: Proportion of Participants With HBsAg Seroconversion

Time: End of treatment (up to 48 weeks)

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Measure: Proportion of Participants With HBsAg Seroconversion

Time: End of follow-up (up to 96 weeks)

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Measure: Proportion of Participants With Alanine Aminotransferase (ALT) <45 U/L for Men, <30 U/L for Women

Time: End of treatment (up to 48 weeks)

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Measure: Proportion of Participants With ALT <45 U/L for Men, <30 U/L for Women

Time: End of follow-up (up to 96 weeks)

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Measure: Proportion of Participants With ALT Normalization (Men <30 U/L, Women <20 U/L)

Time: End of treatment (up to 48 weeks)

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Measure: Proportion of Participants With ALT Normalization (Men <30 U/L, Women <20 U/L)

Time: End of follow-up (up to 96 weeks)

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Measure: Proportion of Participants With HBV DNA ≤1000 IU/mL

Time: End of treatment (up to 48 weeks)

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Measure: Proportion of Participants With HBV DNA ≤1000 IU/mL

Time: End of follow-up (up to 96 weeks)

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Measure: Proportion of Participants With HBV DNA <20 IU/mL

Time: End of treatment (up to 48 weeks)

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Measure: Proportion of Participants With HBV DNA <20 IU/mL

Time: End of follow-up (up to 96 weeks)

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Description: HBV drug resistance variant testing was performed at the CDC laboratory. The sequences of the HBV polymerase spanning nucleotide positions 311-1021 were determined by Sanger sequencing. Drug resistance mutations that were tested in this study included L80VI, L82M, T128N, W153Q, F166L, I169T, V173L, L180M, A181TV, T184ACFGILMS, V191T, A194T, A200V, S202ETV, M204IV, V207I, N236T, M250ILV, and G145R.

Measure: Absence of Detectable Antiviral Drug-resistance HBV Mutations

Time: End of treatment (up to 48 weeks)

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