Hepatitis B, Chronic
Conditions
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Dominant Model | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model | Single blood sample ≥24 weeks post-treatment | 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. |
| 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 | Single blood sample ≥24 weeks post-treatment | 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. |
| 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 | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Additive Model | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Dominant Model | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Additive Model | Single blood sample ≥24 weeks post-treatment | 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. |
| 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 | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model | Single blood sample ≥24 weeks post-treatment | 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. |
| 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 | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-East Asian (Non-CN) Population: Additive Model | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population: Dominant Model | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Additive Model | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Dominant Model | Single blood sample ≥24 weeks post-treatment | 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. |
| SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Model | Single blood sample ≥24 weeks post-treatment | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population | Single blood sample ≥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. |
| Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Non-CN Population | Single blood sample ≥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. |
| Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population | Single blood sample ≥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. |
| Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population | Single blood sample ≥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. |
| 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 sample ≥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. |
| Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population | Single blood sample ≥24 weeks post-treatment | 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. |
| Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population | Single blood sample ≥24 weeks post-treatment | 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. |
| Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population | Single blood sample ≥24 weeks post-treatment | 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. |
| Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment | Single blood sample ≥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. |
| Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population | Single blood sample ≥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. |
| Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population | Single blood sample ≥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. |
| Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment | Single blood sample ≥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. |
| 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 sample ≥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. |
| 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 sample ≥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. |
| Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment | Single blood sample ≥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. |
| Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population | Single blood sample ≥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. |
| Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population | Single blood sample ≥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. |
| Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population | Single blood sample ≥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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 1,669 |
Baseline characteristics
| Characteristic | Adult Participants Treated With Peg-IFN |
|---|---|
| Age, Continuous | 39.09 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 type | EG000 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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | 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 | rs1876154 | 2.1010 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | 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 | rs2812338 | 1.8580 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | 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 | rs10824875 | 1.8330 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | 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 | rs1831559 | 1.8590 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | 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 | rs10851257 | 1.8340 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | 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 | rs6492344 | 1.8120 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | 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 | rs12584550 | 1.7900 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | 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 | rs9555773 | 1.8610 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | 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 | rs7983441 | 1.8770 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | 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 | rs12446868 | 0.5302 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | 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 | rs247878 | 0.5209 beta coefficient |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model | rs9287655 | 0.6617 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model | rs2803073 | 1.5160 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model | rs1937590 | 1.7220 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model | rs2945861 | 0.5957 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model | rs1997894 | 0.6814 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model | rs1495471 | 1.5540 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model | rs9324018 | 1.5400 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model | rs1152537 | 1.7800 beta coefficient |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model | rs10236906 | 0.5664 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model | rs2945861 | 0.5576 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model | rs7042473 | 1.7050 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model | rs2077415 | 0.5732 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model | rs9324018 | 1.6850 beta coefficient |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model | rs6443144 | 1.6780 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model | rs2189452 | 0.6008 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model | rs9324018 | 1.6680 beta coefficient |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model | rs2189452 | 0.5360 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model | rs7968170 | 0.4869 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model | rs9324018 | 1.8700 beta coefficient |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model | rs17037122 | 2.9930 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model | rs10475403 | 0.5024 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model | rs715243 | 0.5078 beta coefficient |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model | 3.1610 beta coefficient |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model | rs1876154 | 2.2030 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model | rs7753766 | 2.1200 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model | rs604241 | 0.4876 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model | rs12446868 | 0.4501 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model | rs247878 | 0.4644 beta coefficient |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model | rs12210761 | 2.7870 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model | rs1831559 | 1.7250 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model | rs7983441 | 1.7410 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model | rs12446868 | 0.5740 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model | rs247878 | 0.5683 beta coefficient |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model | rs12210761 | 3.0040 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model | rs1411283 | 0.4873 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model | rs12446868 | 0.5002 beta coefficient |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model | rs9287655 | 0.6444 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model | rs216312 | 0.6621 beta coefficient |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model | rs2370220 | 0.5233 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model | rs993147 | 0.5210 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model | rs10978436 | 1.7610 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model | rs2279519 | 1.7460 beta coefficient |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model | rs1550115 | 0.5565 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model | rs9691873 | 2.2250 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model | rs1550116 | 0.5565 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model | rs2082881 | 0.5565 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model | exm2265462 | 0.5730 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model | rs6443144 | 1.8390 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model | rs1403069 | 0.5769 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model | rs8012912 | 1.6200 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model | rs11158827 | 1.6200 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model | rs11870323 | 2.1120 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model | rs4821558 | 0.6146 beta coefficient |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model | rs6443144 | 1.9800 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model | rs1692421 | 0.5036 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model | rs1692423 | 0.5029 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model | rs9691873 | 2.3190 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model | rs7968170 | 0.4634 beta coefficient |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | 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 | rs17037122 | 2.8740 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | 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 | rs715243 | 0.5000 beta coefficient |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | 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 | rs2302503 | 0.3719 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | 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 | rs6015181 | 2.6740 beta coefficient |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model | rs1384010 | 2.6700 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model | rs1351518 | 2.3000 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model | rs1157322 | 3.0120 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model | rs11868362 | 0.3108 beta coefficient |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model | rs11139349 | 1.8610 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model | rs1157322 | 2.8290 beta coefficient |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model | rs1384010 | 2.6260 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model | rs1351518 | 2.2220 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model | rs1157322 | 2.9500 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model | rs646097 | 0.4639 beta coefficient |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | 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 | rs6443144 | 1.9390 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | 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 | rs11163805 | 1.8610 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | 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 | rs11139349 | 1.8360 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | 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 | rs1831559 | 1.9060 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | 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 | rs7983441 | 1.9240 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | 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 | rs11868362 | 0.3363 beta coefficient |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Additive Model | rs10814834 | 0.4571 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Additive Model | rs10491723 | 2.1090 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Additive Model | rs6592052 | 6.6180 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Additive Model | rs16943470 | 2.9650 beta coefficient |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Dominant Model | 7.8720 beta coefficient |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Additive Model | 8.2240 beta coefficient |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Dominant Model | 8.2240 beta coefficient |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model | 5.7670 beta coefficient |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model | 8.6340 beta coefficient |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Additive Model | 0.2583 beta coefficient |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Dominant Model | rs9496139 | 0.1812 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Dominant Model | rs2014238 | 5.8110 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Dominant Model | rs2980231 | 5.8110 beta coefficient |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population: Dominant Model | 4.2450 beta coefficient |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-East Asian (Non-CN) Population: Additive Model | 4.3170 beta coefficient |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Model | rs16924016 | 0.3357 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Model | exm2237722 | 0.1070 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Model | rs2899723 | 2.0360 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Model | rs8027115 | 1.9480 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Model | exm2267780 | 2.0100 beta coefficient |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model | rs9973954 | 0.2975 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model | exm2237722 | 0.1009 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model | rs1040084 | 2.3660 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model | rs1913484 | 2.3610 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model | rs16924016 | 0.3186 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model | exm1010813 | 0.1299 beta coefficient |
| HBeAg-Positive CN Participants Treated With Peg-IFN | SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model | rs6576456 | 0.4112 beta coefficient |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment | 669 participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population | 464 participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population | 205 participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population | 255 participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Non-CN Population | 21 participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population | 276 participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment | 586 participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population | 384 participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population | 202 participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population | 175 participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Non-CN Population | 18 participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population | 193 participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment | 104 participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population | 80 participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population | 24 participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population | 209 participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population | 184 participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HBeAg-Positive CN Participants Treated With Peg-IFN | Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population | 393 participants |