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A Study to Collect Blood Biomarker Samples From Participants With Chronic Hepatitis B (CHB) Who Received Treatment With Pegasys (Peginterferon Alfa-2a) ± Nucleoside/Nucleotide Analogue

A Phase IV, Blood Sample Collection Study For Exploratory Evaluation of the Association of Single Nucleotide Polymorphisms With Treatment Responses From Subjects With HBe-Antigen Positive or Negative Chronic Hepatitis B, Who Received Therapy for Hepatitis B With Peginterferon Alfa-2a 40kD (Peg-IFN) ± Nucleos(t)Ide Analogue

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01855997
Enrollment
1669
Registered
2013-05-17
Start date
2013-08-20
Completion date
2014-11-28
Last updated
2017-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Chronic

Brief summary

This Phase 4 study is designed for the collection of blood biomarker samples from participants who have completed CHB treatment with at least 24 weeks of a pegylated interferon alfa-2a (Peg-IFN alfa-2a) containing regimen and at least 24 weeks post-treatment follow-up. Participants may be enrolled from historical studies supported or sponsored by Roche, ongoing studies supported or sponsored by Roche, or from general medical practice. The follow-up of individuals who choose to participate in this study will be in accordance with the ongoing studies or with the general medical practice of the physician. Data from whole blood deoxyribonucleic acid (DNA) samples collected in the GV28555 study or available from previously collected Roche Clinical Repository (RCR) samples will be used for combined analysis with data from other applicable studies. Procedures will include blood sample collection (not applicable for participants who previously have consented and donated RCR DNA samples) and medical record capture.

Interventions

Participants received Peg-IFN alfa-2a prior to enrollment for at least 24 weeks. Dosing was chosen according to standard of care or at the discretion of the treating physician.

Sponsors

Hoffmann-La Roche
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults greater than or equal to (≥) 18 years of age * CHB * Previously enrolled in a Roche study and treated for CHB for ≥24 weeks with Peg-IFN ± nucleoside analogue (lamivudine or entecavir) or Peg-IFN ± nucleotide analogue (adefovir) and with ≥24 weeks post-treatment follow-up; or * Treated in general practice for CHB with Peg-IFN according to standard of care and in line with the current Summary of Product Characteristics (SmPC)/local labeling who have no contraindication to Peg-IFN therapy as per local label and have been treated with Peg-IFN for ≥24 weeks and have ≥24 week post-treatment response available at the time of blood sample collection

Exclusion criteria

* Hepatitis A, hepatitis C, or human immunodeficiency virus (HIV) infection

Design outcomes

Primary

MeasureTime frameDescription
SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Dominant ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs6592052) was included in the analysis.
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Dominant ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs17037122) was included in the analysis.
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Dominant ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Additive ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs12992677) was included in the analysis.
SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Dominant ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs12992677) was included in the analysis.
SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Additive ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs7549785) was included in the analysis.
SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Dominant ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs7549785) was included in the analysis.
SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Additive ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Single Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive ModelSingle blood sample ≥24 weeks post-treatmentGenome-wide association study (GWAS) approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of the antibody to HBeAg (anti-HBe). HBsAg clearance was defined as the loss of HBsAg, with or without detection of the antibody to HBsAg (anti-HBs). Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
SNPs Associated With HBeAg Seroconversion Plus Undetectable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Additive ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as HBV DNA level below the lower limit of detection (LLD) of 2000 international units per milliliter (IU/mL). HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-East Asian (Non-CN) Population: Additive ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs17037122) was included in the analysis.
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population: Dominant ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs17037122) was included in the analysis.
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Additive ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs2464266) was included in the analysis.
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Dominant ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive ModelSingle blood sample ≥24 weeks post-treatmentGWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.

Other

MeasureTime frameDescription
Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN PopulationSingle blood sample ≥24 weeks post-treatmentSingle blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Non-CN PopulationSingle blood sample ≥24 weeks post-treatmentSingle blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive PopulationSingle blood sample ≥24 weeks post-treatmentSingle blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.
Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN PopulationSingle blood sample ≥24 weeks post-treatmentSingle blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.
Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Non-CN PopulationSingle blood sample ≥24 weeks post-treatmentSingle blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.
Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative PopulationSingle blood sample ≥24 weeks post-treatmentSingle blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN PopulationSingle blood sample ≥24 weeks post-treatmentSingle blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN PopulationSingle blood sample ≥24 weeks post-treatmentSingle blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-TreatmentSingle blood sample ≥24 weeks post-treatmentSingle blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN PopulationSingle blood sample ≥24 weeks post-treatmentSingle blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN PopulationSingle blood sample ≥24 weeks post-treatmentSingle blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-TreatmentSingle blood sample ≥24 weeks post-treatmentSingle blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.
Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN PopulationSingle blood sample ≥24 weeks post-treatmentSingle blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.
Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN PopulationSingle blood sample ≥24 weeks post-treatmentSingle blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.
Number of Participants With HBsAg Clearance ≥24 Weeks Post-TreatmentSingle blood sample ≥24 weeks post-treatmentSingle blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment in CN PopulationSingle blood sample ≥24 weeks post-treatmentSingle blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN PopulationSingle blood sample ≥24 weeks post-treatmentSingle blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive PopulationSingle blood sample ≥24 weeks post-treatmentSingle blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.

Countries

Austria, Bulgaria, China, France, Germany, Greece, Italy, New Zealand, Poland, Portugal, Romania, South Korea, Taiwan, Thailand, United Kingdom

Participant flow

Recruitment details

Participants were enrolled from Roche completed/ongoing pegylated interferon (Peg-IFN) alfa-2a trials (MV22430/NCT00927082, ML21827/NCT00922207, ML18253/NCT01095835) or from clinical practice (GV28855/NCT01855997).

Participants by arm

ArmCount
Adult Participants Treated With Peg-IFN
Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos\[t\]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
1,669
Total1,669

Baseline characteristics

CharacteristicAdult Participants Treated With Peg-IFN
Age, Continuous39.09 years
STANDARD_DEVIATION 0.27
HBeAg Status
Negative
676 participants
HBeAg Status
Not Known
61 participants
HBeAg Status
Positive
932 participants
Sex: Female, Male
Female
471 Participants
Sex: Female, Male
Male
1198 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 1,105
serious
Total, serious adverse events
0 / 1,105

Outcome results

Primary

Single Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Model

Genome-wide association study (GWAS) approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of the antibody to HBeAg (anti-HBe). HBsAg clearance was defined as the loss of HBsAg, with or without detection of the antibody to HBsAg (anti-HBs). Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Positive CN Population: All HBeAg-positive participants whose genetic data passed a protocol-specified quality check and shared common East Asian genetic background as compared to haplotype map (HapMap) version 3.0 reference individuals.

ArmMeasureGroupValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSingle Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Modelrs18761542.1010 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSingle Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Modelrs28123381.8580 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSingle Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Modelrs108248751.8330 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSingle Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Modelrs18315591.8590 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSingle Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Modelrs108512571.8340 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSingle Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Modelrs64923441.8120 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSingle Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Modelrs125845501.7900 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSingle Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Modelrs95557731.8610 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSingle Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Modelrs79834411.8770 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSingle Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Modelrs124468680.5302 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSingle Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Modelrs2478780.5209 beta coefficient
Comparison: rs1876154p-value: 0.00000559t-test, 2 sided
Comparison: rs2812338p-value: 0.00000766t-test, 2 sided
Comparison: rs10824875p-value: 0.00000982t-test, 2 sided
Comparison: rs1831559p-value: 0.00000127t-test, 2 sided
Comparison: rs10851257p-value: 0.00000396t-test, 2 sided
Comparison: rs6492344p-value: 0.00000648t-test, 2 sided
Comparison: rs12584550p-value: 0.00000221t-test, 2 sided
Comparison: rs9555773p-value: 0.00000902t-test, 2 sided
Comparison: rs7983441p-value: 7.7e-7t-test, 2 sided
Comparison: rs12446868p-value: 4.8e-7t-test, 2 sided
Comparison: rs247878p-value: 3.7e-7t-test, 2 sided
Primary

SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model

GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: Genetic Data Quality Check (GT) Population: All participants, regardless of HBeAg status, whose genetic data passed a protocol-specified quality check.

ArmMeasureGroupValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Modelrs92876550.6617 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Modelrs28030731.5160 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Modelrs19375901.7220 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Modelrs29458610.5957 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Modelrs19978940.6814 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Modelrs14954711.5540 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Modelrs93240181.5400 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Modelrs11525371.7800 beta coefficient
Comparison: rs9287655p-value: 0.00000137t-test, 2 sided
Comparison: rs2803073p-value: 0.00000339t-test, 2 sided
Comparison: rs1937590p-value: 0.00000927t-test, 2 sided
Comparison: rs2945861p-value: 0.00000166t-test, 2 sided
Comparison: rs1997894p-value: 0.00000455t-test, 2 sided
Comparison: rs1495471p-value: 0.00000568t-test, 2 sided
Comparison: rs9324018p-value: 0.00000125t-test, 2 sided
Comparison: rs1152537p-value: 0.00000982t-test, 2 sided
Primary

SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model

GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: GT Population.

ArmMeasureGroupValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Modelrs102369060.5664 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Modelrs29458610.5576 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Modelrs70424731.7050 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Modelrs20774150.5732 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Modelrs93240181.6850 beta coefficient
Comparison: rs10236906p-value: 0.00000846t-test, 2 sided
Comparison: rs2945861p-value: 0.00000562t-test, 2 sided
Comparison: rs7042473p-value: 0.00000497t-test, 2 sided
Comparison: rs2077415p-value: 0.00000997t-test, 2 sided
Comparison: rs9324018p-value: 0.00000864t-test, 2 sided
Primary

SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model

GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: CN Population: All participants, regardless of HBeAg status, whose genetic data passed a protocol-specified quality check and shared common East Asian genetic background as compared to HapMap version 3.0 reference individuals; the analysis only included a subset of participants who provided evaluable data.

ArmMeasureGroupValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Modelrs64431441.6780 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Modelrs21894520.6008 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Modelrs93240181.6680 beta coefficient
Comparison: rs6443144p-value: 0.00000686t-test, 2 sided
Comparison: rs2189452p-value: 0.00000596t-test, 2 sided
Comparison: rs9324018p-value: 0.00000489t-test, 2 sided
Primary

SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model

GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: CN Population; the analysis only included a subset of participants who provided evaluable data.

ArmMeasureGroupValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Modelrs21894520.5360 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Modelrs79681700.4869 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Modelrs93240181.8700 beta coefficient
Comparison: rs2189452p-value: 0.00000834t-test, 2 sided
Comparison: rs7968170p-value: 0.00000487t-test, 2 sided
Comparison: rs9324018p-value: 0.00000918t-test, 2 sided
Primary

SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model

GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: Non-CN Population: All participants, regardless of HBeAg status, whose genetic data passed a protocol-specified quality check and did not share common East Asian genetic background as compared to HapMap version 3.0 reference individuals.

ArmMeasureGroupValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Modelrs170371222.9930 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Modelrs104754030.5024 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Modelrs7152430.5078 beta coefficient
Comparison: rs17037122p-value: 0.00000153t-test, 2 sided
Comparison: rs10475403p-value: 0.00000708t-test, 2 sided
Comparison: rs715243p-value: 0.00000727t-test, 2 sided
Primary

SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model

GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs17037122) was included in the analysis.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: Non-CN Population.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model3.1610 beta coefficient
Comparison: rs17037122p-value: 0.00000397t-test, 2 sided
Primary

SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model

GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Positive CN Population.

ArmMeasureGroupValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Modelrs18761542.2030 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Modelrs77537662.1200 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Modelrs6042410.4876 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Modelrs124468680.4501 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Modelrs2478780.4644 beta coefficient
Comparison: rs1876154p-value: 0.00000987t-test, 2 sided
Comparison: rs7753766p-value: 0.00000605t-test, 2 sided
Comparison: rs604241p-value: 0.00000946t-test, 2 sided
Comparison: rs12446868p-value: 7.7e-7t-test, 2 sided
Comparison: rs247878p-value: 0.00000197t-test, 2 sided
Primary

SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model

GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Positive Population: All HBeAg-positive participants whose genetic data passed a protocol-specified quality check.

ArmMeasureGroupValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Modelrs122107612.7870 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Modelrs18315591.7250 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Modelrs79834411.7410 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Modelrs124468680.5740 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Modelrs2478780.5683 beta coefficient
Comparison: rs12210761p-value: 0.00000677t-test, 2 sided
Comparison: rs1831559p-value: 0.00000798t-test, 2 sided
Comparison: rs7983441p-value: 0.00000512t-test, 2 sided
Comparison: rs12446868p-value: 0.00000345t-test, 2 sided
Comparison: rs247878p-value: 0.00000372t-test, 2 sided
Primary

SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model

GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Positive Population.

ArmMeasureGroupValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Modelrs122107613.0040 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Modelrs14112830.4873 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Modelrs124468680.5002 beta coefficient
Comparison: rs12210761p-value: 0.00000459t-test, 2 sided
Comparison: rs1411283p-value: 0.00000925t-test, 2 sided
Comparison: rs12446868p-value: 0.00000772t-test, 2 sided
Primary

SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model

GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: GT Population.

ArmMeasureGroupValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Modelrs92876550.6444 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Modelrs2163120.6621 beta coefficient
Comparison: rs9287655p-value: 0.00000118t-test, 2 sided
Comparison: rs216312p-value: 0.00000531t-test, 2 sided
Primary

SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model

GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: GT Population.

ArmMeasureGroupValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Modelrs23702200.5233 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Modelrs9931470.5210 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Modelrs109784361.7610 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Modelrs22795191.7460 beta coefficient
Comparison: rs993147p-value: 0.00000593t-test, 2 sided
Comparison: rs10978436p-value: 0.00000997t-test, 2 sided
Comparison: rs2370220p-value: 0.00000581t-test, 2 sided
Comparison: rs2279519p-value: 0.00000802t-test, 2 sided
Primary

SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model

GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: CN Population; the analysis only included a subset of participants who provided evaluable data.

ArmMeasureGroupValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Modelrs15501150.5565 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Modelrs96918732.2250 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Modelrs15501160.5565 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Modelrs20828810.5565 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Modelexm22654620.5730 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Modelrs64431441.8390 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Modelrs14030690.5769 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Modelrs80129121.6200 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Modelrs111588271.6200 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Modelrs118703232.1120 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Modelrs48215580.6146 beta coefficient
Comparison: rs1550116p-value: 0.00000805t-test, 2 sided
Comparison: rs1550115p-value: 0.00000702t-test, 2 sided
Comparison: rs2082881p-value: 0.00000702t-test, 2 sided
Comparison: exm2265462p-value: 0.00000743t-test, 2 sided
Comparison: rs6443144p-value: 7.8e-7t-test, 2 sided
Comparison: rs1403069p-value: 0.00000894t-test, 2 sided
Comparison: rs9691873p-value: 0.00000571t-test, 2 sided
Comparison: rs8012912p-value: 0.00000729t-test, 2 sided
Comparison: rs11158827p-value: 0.00000828t-test, 2 sided
Comparison: rs11870323p-value: 0.00000885t-test, 2 sided
Comparison: rs4821558p-value: 0.00000717t-test, 2 sided
Primary

SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model

GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: CN Population; the analysis only included a subset of participants who provided evaluable data.

ArmMeasureGroupValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Modelrs64431441.9800 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Modelrs16924210.5036 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Modelrs16924230.5029 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Modelrs96918732.3190 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Modelrs79681700.4634 beta coefficient
Comparison: rs6443144p-value: 0.00000629t-test, 2 sided
Comparison: rs1692421p-value: 0.00000579t-test, 2 sided
Comparison: rs1692423p-value: 0.00000553t-test, 2 sided
Comparison: rs9691873p-value: 0.00000946t-test, 2 sided
Comparison: rs7968170p-value: 0.0000045t-test, 2 sided
Primary

SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model

GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: Non-CN Population.

ArmMeasureGroupValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Modelrs170371222.8740 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Modelrs7152430.5000 beta coefficient
Comparison: rs17037122p-value: 0.00000368t-test, 2 sided
Comparison: rs715243p-value: 0.00000577t-test, 2 sided
Primary

SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model

GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: Non-CN Population.

ArmMeasureGroupValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Modelrs23025030.3719 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Modelrs60151812.6740 beta coefficient
Comparison: rs2302503p-value: 0.0000095t-test, 2 sided
Comparison: rs6015181p-value: 0.00000741t-test, 2 sided
Primary

SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model

GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Positive CN Population.

ArmMeasureGroupValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Modelrs13840102.6700 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Modelrs13515182.3000 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Modelrs11573223.0120 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Modelrs118683620.3108 beta coefficient
Comparison: rs1384010p-value: 0.00000666t-test, 2 sided
Comparison: rs1351518p-value: 0.00000844t-test, 2 sided
Comparison: rs1157322p-value: 0.00000794t-test, 2 sided
Comparison: rs11868362p-value: 0.0000031t-test, 2 sided
Primary

SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model

GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Positive Population.

ArmMeasureGroupValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Modelrs111393491.8610 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Modelrs11573222.8290 beta coefficient
Comparison: rs11139349p-value: 0.00000207t-test, 2 sided
Comparison: rs1157322p-value: 0.00000899t-test, 2 sided
Primary

SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model

GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Positive Population.

ArmMeasureGroupValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Modelrs13840102.6260 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Modelrs13515182.2220 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Modelrs11573222.9500 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Modelrs6460970.4639 beta coefficient
Comparison: rs1351518p-value: 0.00000946t-test, 2 sided
Comparison: rs1157322p-value: 0.00000731t-test, 2 sided
Comparison: rs646097p-value: 0.00000945t-test, 2 sided
Comparison: rs1384010p-value: 0.00000573t-test, 2 sided
Primary

SNPs Associated With HBeAg Seroconversion Plus Undetectable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Additive Model

GWAS approach was used to evaluate association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as HBV DNA level below the lower limit of detection (LLD) of 2000 international units per milliliter (IU/mL). HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Positive CN Population.

ArmMeasureGroupValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Additive Modelrs64431441.9390 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Additive Modelrs111638051.8610 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Additive Modelrs111393491.8360 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Additive Modelrs18315591.9060 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Additive Modelrs79834411.9240 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBeAg Seroconversion Plus Undetectable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Additive Modelrs118683620.3363 beta coefficient
Comparison: rs11163805p-value: 0.0000047t-test, 2 sided
Comparison: rs6443144p-value: 0.00000674t-test, 2 sided
Comparison: rs11139349p-value: 0.00000952t-test, 2 sided
Comparison: rs1831559p-value: 0.00000608t-test, 2 sided
Comparison: rs7983441p-value: 0.00000404t-test, 2 sided
Comparison: rs11868362p-value: 0.00000407t-test, 2 sided
Primary

SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Additive Model

GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: GT Population; the analysis only included a subset of participants who provided evaluable data.

ArmMeasureGroupValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Additive Modelrs108148340.4571 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Additive Modelrs104917232.1090 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Additive Modelrs65920526.6180 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Additive Modelrs169434702.9650 beta coefficient
Comparison: rs10814834p-value: 0.00000738t-test, 2 sided
Comparison: rs10491723p-value: 0.00000451t-test, 2 sided
Comparison: rs6592052p-value: 0.00000878t-test, 2 sided
Comparison: rs16943470p-value: 0.00000521t-test, 2 sided
Primary

SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Dominant Model

GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs6592052) was included in the analysis.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: GT Population; the analysis only included a subset of participants who provided evaluable data.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Dominant Model7.8720 beta coefficient
Comparison: rs6592052p-value: 0.0000072t-test, 2 sided
Primary

SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Additive Model

GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs7549785) was included in the analysis.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: CN Population.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Additive Model8.2240 beta coefficient
Comparison: rs7549785p-value: 4.8e-7t-test, 2 sided
Primary

SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Dominant Model

GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs7549785) was included in the analysis.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: CN Population.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Dominant Model8.2240 beta coefficient
Comparison: rs7549785p-value: 4.8e-7t-test, 2 sided
Primary

SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model

GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs12992677) was included in the analysis.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: Non-CN Population; the analysis only included a subset of participants who provided evaluable data.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model5.7670 beta coefficient
Comparison: rs12992677p-value: 0.00000558t-test, 2 sided
Primary

SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model

GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs12992677) was included in the analysis.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: Non-CN Population; the analysis only included a subset of participants who provided evaluable data.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model8.6340 beta coefficient
Comparison: rs12992677p-value: 0.0000099t-test, 2 sided
Primary

SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Additive Model

GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs2464266) was included in the analysis.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Negative CN Population: All HBeAg-negative participants whose genetic data passed a protocol-specified quality check and shared common East Asian genetic background as compared to HapMap version 3.0 reference individuals.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Additive Model0.2583 beta coefficient
Comparison: rs2464266p-value: 0.00000879t-test, 2 sided
Primary

SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Dominant Model

GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Negative CN Population.

ArmMeasureGroupValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Dominant Modelrs94961390.1812 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Dominant Modelrs20142385.8110 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Dominant Modelrs29802315.8110 beta coefficient
Comparison: rs9496139p-value: 0.00000452t-test, 2 sided
Comparison: rs2014238p-value: 0.00000497t-test, 2 sided
Comparison: rs2980231p-value: 0.00000497t-test, 2 sided
Primary

SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population: Dominant Model

GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs17037122) was included in the analysis.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Negative Non-CN Population.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population: Dominant Model4.2450 beta coefficient
Comparison: rs17037122p-value: 8.8e-7t-test, 2 sided
Primary

SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-East Asian (Non-CN) Population: Additive Model

GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs17037122) was included in the analysis.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Negative Non-CN Population: All HBeAg-negative participants whose genetic data passed a protocol-specified quality check and did not share common East Asian genetic background as compared to HapMap version 3.0 reference individuals.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-East Asian (Non-CN) Population: Additive Model4.3170 beta coefficient
Comparison: rs17037122p-value: 1.6e-7t-test, 2 sided
Primary

SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Model

GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Negative Population: All HBeAg-negative participants whose genetic data passed a protocol-specified quality check.

ArmMeasureGroupValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Modelrs169240160.3357 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Modelexm22377220.1070 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Modelrs28997232.0360 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Modelrs80271151.9480 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Modelexm22677802.0100 beta coefficient
Comparison: exm2237722p-value: 0.00000748t-test, 2 sided
Comparison: rs16924016p-value: 7.3e-7t-test, 2 sided
Comparison: rs2899723p-value: 0.00000289t-test, 2 sided
Comparison: rs8027115p-value: 0.00000912t-test, 2 sided
Comparison: exm2267780p-value: 0.00000494t-test, 2 sided
Primary

SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model

GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Negative Population.

ArmMeasureGroupValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Modelrs99739540.2975 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Modelexm22377220.1009 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Modelrs10400842.3660 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Modelrs19134842.3610 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Modelrs169240160.3186 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Modelexm10108130.1299 beta coefficient
HBeAg-Positive CN Participants Treated With Peg-IFNSNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Modelrs65764560.4112 beta coefficient
Comparison: rs9973954p-value: 0.00000627t-test, 2 sided
Comparison: exm2237722p-value: 0.00000696t-test, 2 sided
Comparison: rs1040084p-value: 0.00000426t-test, 2 sided
Comparison: rs1913484p-value: 0.00000435t-test, 2 sided
Comparison: rs16924016p-value: 0.00000221t-test, 2 sided
Comparison: exm1010813p-value: 0.00000523t-test, 2 sided
Comparison: rs6576456p-value: 0.00000757t-test, 2 sided
Other Pre-specified

Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment

Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: GT Population.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNNumber of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment669 participants
Other Pre-specified

Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population

Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: CN Population; the analysis only included a subset of participants who provided evaluable data.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNNumber of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population464 participants
Other Pre-specified

Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population

Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: Non-CN Population.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNNumber of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population205 participants
Other Pre-specified

Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population

Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Positive CN Population.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNNumber of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population255 participants
Other Pre-specified

Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Non-CN Population

Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Positive Non-CN Population: All HBeAg-positive participants whose genetic data passed a protocol-specified quality check and did not share common East Asian genetic background as compared to HapMap version 3.0 reference individuals.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNNumber of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Non-CN Population21 participants
Other Pre-specified

Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population

Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Positive Population.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNNumber of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population276 participants
Other Pre-specified

Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment

Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: GT Population.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNNumber of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment586 participants
Other Pre-specified

Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population

Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: CN Population.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNNumber of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population384 participants
Other Pre-specified

Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population

Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: Non-CN Population.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNNumber of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population202 participants
Other Pre-specified

Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population

Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Positive CN Population.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNNumber of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population175 participants
Other Pre-specified

Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Non-CN Population

Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Positive Non-CN Population.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNNumber of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Non-CN Population18 participants
Other Pre-specified

Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population

Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Positive Population.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNNumber of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population193 participants
Other Pre-specified

Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment

Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: GT Population; the analysis only included a subset of participants who provided evaluable data.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNNumber of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment104 participants
Other Pre-specified

Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population

Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: CN Population.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNNumber of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population80 participants
Other Pre-specified

Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population

Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: Non-CN Population; the analysis only included a subset of participants who provided evaluable data.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNNumber of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population24 participants
Other Pre-specified

Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population

Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Negative CN Population.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNNumber of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population209 participants
Other Pre-specified

Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population

Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Negative Non-CN Population.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNNumber of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population184 participants
Other Pre-specified

Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population

Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.

Time frame: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Negative Population.

ArmMeasureValue (NUMBER)
HBeAg-Positive CN Participants Treated With Peg-IFNNumber of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population393 participants

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026