A Study to Collect Blood Biomarker Samples From Participants With Chronic Hepatitis B (CHB) Who Received Treatment With Pegasys (Peginterferon Alfa-2a) ± Nucleoside/Nucleotide Analogue
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT01855997
Collaborator
(none)
1,669
84
15.3
19.9
1.3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
1669 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
A Phase IV, Blood Sample Collection Study For Exploratory Evaluation of the Association of Single Nucleotide Polymorphisms With Treatment Responses From Subjects With HBe-Antigen Positive or Negative Chronic Hepatitis B, Who Received Therapy for Hepatitis B With Peginterferon Alfa-2a 40kD (Peg-IFN) ± Nucleos(t)Ide Analogue
Actual Study Start Date
:
Aug 20, 2013
Actual Primary Completion Date
:
Nov 28, 2014
Actual Study Completion Date
:
Nov 28, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Adult CHB Participants Treated With Peg-IFN Alfa-2a Adult participants with CHB infection, and who have completed at least 24 weeks of Peg-IFN alfa-2a with/without nucleoside analogue therapy and at least 24 weeks of follow-up, will be included. Participants will be recruited from Roche clinical trials or general practice; no treatment will be administered in this non-interventional study. |
Drug: Peg-IFN alfa-2a
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- 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.
Other Outcome Measures
- 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.
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Adults greater than or equal to (≥) 18 years of age
-
CHB
-
Previously enrolled in a Roche study and treated for CHB for ≥24 weeks with Peg-IFN ± nucleoside analogue (lamivudine or entecavir) or Peg-IFN ± nucleotide analogue (adefovir) and with ≥24 weeks post-treatment follow-up; or
-
Treated in general practice for CHB with Peg-IFN according to standard of care and in line with the current Summary of Product Characteristics (SmPC)/local labeling who have no contraindication to Peg-IFN therapy as per local label and have been treated with Peg-IFN for ≥24 weeks and have ≥24 week post-treatment response available at the time of blood sample collection
Exclusion Criteria:
- Hepatitis A, hepatitis C, or human immunodeficiency virus (HIV) infection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie | Wien | Austria | 1090 | |
| 2 | MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases | Sofia | Bulgaria | 1407 | |
| 3 | Mhat Sveta Marina; Clinic of Gastroenterology | Varna | Bulgaria | 9010 | |
| 4 | Beijing Ditan Hospital | Beijing | China | 100011 | |
| 5 | Beijing 302 Hospital; No. 2 Infectious Disease Section | Beijing | China | 100039 | |
| 6 | Peking University People's Hospital | Beijing | China | 100044 | |
| 7 | Beijing You An Hospital; Digestive Dept | Beijing | China | 100069 | |
| 8 | Xiangya Hospital of Centre-South University | Changsha | China | 410008 | |
| 9 | West China Hospital, Sichuan University | Chengdu | China | 610041 | |
| 10 | The Second Affiliated Hospital, Chongqing Medical University | Chongqing | China | 400010 | |
| 11 | The First Affiliated Hospital of Fujian Medical University | Fu Zhou | China | 350005 | |
| 12 | The Eighth People's Hospital of Guangzhou | Guangzhou | China | 510060 | |
| 13 | Nanfang Hospital, Southern Medical University | Guangzhou | China | 510515 | |
| 14 | Guangdong General Hospital | Guangzhou | China | ||
| 15 | Hangzhou Sixth People's Hospital | Hangzhou | China | ||
| 16 | The 1st Affiliated Hospital of Harbin Medical University | Harbin | China | 150001 | |
| 17 | Jinan Infectious Diseases Hospital | Jinan | China | 250021 | |
| 18 | Nanjing No.2 Hospital; Liver Disease Department | Nanjing | China | 210003 | |
| 19 | The First Affiliate Hospital of Guangxi Medical University | Nanning | China | 530021 | |
| 20 | Shuguang Hospital, Shanghai University of Traditional Chinese Medicine | Shanghai | China | 200021 | |
| 21 | Shanghai Public Health Clinical Center | Shanghai | China | 201508 | |
| 22 | Shenzhen Donghu Hospital | Shen Zhen | China | 518020 | |
| 23 | The Third Hospital of Hebei Medical University | Shi Jiazhuang | China | 050051 | |
| 24 | Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine | Urumqi | China | 830001 | |
| 25 | Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech | Wuhan | China | 430030 | |
| 26 | The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital) | Xi'an | China | 710038 | |
| 27 | General Hospital of Ningxia Medical University | Yinchuan | China | 750004 | |
| 28 | Henan Provincial People's Hospital | Zhengzhou | China | 450003 | |
| 29 | Hopital Beaujon;Hepatologie | Clichy | France | 92118 | |
| 30 | Hopital Henri Mondor; Hepatologie Gastro Enterologie | Creteil | France | 94010 | |
| 31 | Hopital de Pontchaillou; Medicine Interne - Hepatologie | Rennes | France | 35033 | |
| 32 | Institut Arnault Tzanck; Medecine I Gastro Enterologie | Saint Laurent Du Var | France | 06721 | |
| 33 | Praxis Dr. med. Christine John | Berlin | Germany | 10117 | |
| 34 | Praxis Dr. Heyne | Berlin | Germany | 10969 | |
| 35 | Charité Uni.-medizin Berlin, Campus Virchow-Klinikum; Med. Klinik m.S. Hepatologie Gastroenterologie | Berlin | Germany | 13353 | |
| 36 | Ifi- Studien und Projekte GmbH, An der Asklepios Klinik St. Georg | Hamburg | Germany | 20099 | |
| 37 | Medizinische Hochschule Zentrum Innere Medizin Abt.Gastroenterologie, Endokrinologie und Hepatologie | Hannover | Germany | 30625 | |
| 38 | Laiko General Hospital Athen; Uni Clinic of Gastrenterology | Athens | Greece | 115 27 | |
| 39 | University Hospital of Larissa; Pathological Clinic | Larissa | Greece | 41 110 | |
| 40 | Hippokratio Hospital; 4Th Internal Medicine Dpt | Thessaloniki | Greece | 546 42 | |
| 41 | Az. Osp. S. Sebastiano; Divisione Malattie Infettive | Caserta | Campania | Italy | 81100 |
| 42 | Az. Osp. Cardarelli; Unita Operativa A Struttura Complessa Di Epatologia | Napoli | Campania | Italy | 80131 |
| 43 | UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In | Bologna | Emilia-Romagna | Italy | 40138 |
| 44 | Az. Osp. Uni Ria Di Parma; Gastro-Enterology | Parma | Emilia-Romagna | Italy | 43100 |
| 45 | Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia | Milano | Lombardia | Italy | 20122 |
| 46 | Ospedale Maggiore Policlinico; Iii Divisione Medicina Generale | Milano | Lombardia | Italy | 20122 |
| 47 | Azienda Ospedaliera Policlinico Consorziale di Bari; Clinica Malattie Infettive | Bari | Puglia | Italy | 70124 |
| 48 | Ospedale de Bellis; Reparto Medicina Generale | Castellana Grotte | Puglia | Italy | 70013 |
| 49 | Uni Di Cagliari; Dept. Di Scienze Mediche | Cagliari | Sardegna | Italy | 09042 |
| 50 | Istituto Di Clinica Medica 1 A; Divisione Di Medicina Generale E Gastroenterologia | Palermo | Sicilia | Italy | 90127 |
| 51 | Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia | Pisa | Toscana | Italy | 56124 |
| 52 | Az. Osp. Di Padova; Dipart. Scienze Chirurgiche E Gastroent. | Padova | Veneto | Italy | 35128 |
| 53 | Inje University Busan Paik Hospital; Nephrology | Busan | Korea, Republic of | 633-165 | |
| 54 | Chooncheon Sacred Heart Hospital | Chooncheon | Korea, Republic of | 200-060 | |
| 55 | Samsung Medical Center; Gastroenterology | Seoul | Korea, Republic of | 135-710 | |
| 56 | Auckland Hospital; New Zealand Liver Transplant Unit | Auckland | New Zealand | 100 | |
| 57 | Hospital For Infectious Diseases; Infectiology | Bydgoszcz | Poland | 85-030 | |
| 58 | Szpital Specjalistyczny; Oddzial Obserwacyjno - Zakayny | Chorzow | Poland | 41-500 | |
| 59 | Krakowski Szpital Specjalistyczny im. Jana Pawla II; Oddzial Wirusowego Zapalenia Watroby | Krakow | Poland | 31-202 | |
| 60 | Centrum Medyczne | Lancut | Poland | 37-100 | |
| 61 | Wojewodzki Szpital Zakazny; Klinika Chorob Zakaznych | Warszawa | Poland | 01-201 | |
| 62 | Centralny Szpital Kliniczny MSWiA; Oddzial Chorob Wewnetrznych i Hepatologii | Warszawa | Poland | 02-507 | |
| 63 | NZOZ Lubuska Specjalistyczna Poradnia Chorob Watroby | Zielona Góra | Poland | 65-044 | |
| 64 | Specjalistyczny Szpital Wojewódzki im. Biegańskiego; Klinika Chorób Zakaźnych i Hepatologii UM | Łodz | Poland | 91-347 | |
| 65 | Hospital de Santa Maria; Servico de Gastrenterologia e Hepatologia | Lisboa | Portugal | 1649-035 | |
| 66 | Hospital Geral de Santo Antonio; Servico de Gastrenterologia | Porto | Portugal | 4099-001 | |
| 67 | Hospital de Sao Joao; Servico de Gastrenterologia | Porto | Portugal | 4202-451 | |
| 68 | Institutul De Boli Infectioase Matei Bals; Sectia Clinica II Boli Infectioase Adulti | Bucharest | Romania | 021105 | |
| 69 | The Hospital of Tropical and Infectious Disease Victor Babes | Bucharest | Romania | 030303 | |
| 70 | Clinical Infectious Diseases Hospital Victor Babes | Craiova | Romania | 200515 | |
| 71 | Changhua Christian Hospital; Internal Medicine | Changhua | Taiwan | 500 | |
| 72 | Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine | Kaohsiung | Taiwan | 00833 | |
| 73 | Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine | Kaohsiung | Taiwan | 807 | |
| 74 | Chang Gung Medical Foundation - Keelung; Dept. of Hepato-Gastroenterology | Keelung City | Taiwan | 204 | |
| 75 | China Medical University Hospital; Department of Rheumatology | Taichung | Taiwan | 404 | |
| 76 | National Taiwan Uni Hospital; Gastro-Enterology Dept. | Taipei | Taiwan | 100 | |
| 77 | Taipei Veterans General Hospital; Gastroenterology Division | Taipei | Taiwan | 112 | |
| 78 | Tri-Service Hospital; Dept. of Internal Medicine | Taipei | Taiwan | ||
| 79 | Chang Gung Medical Foundation - Linkou; Dept. of Hepato-Gastroenterology | Taoyuan | Taiwan | 333 | |
| 80 | Siriraj Hospital | Bangkok | Thailand | 10700 | |
| 81 | Chiang Mai Uni Hospital; Faculty of Medicine | Chiang Mai | Thailand | 50200 | |
| 82 | Songklanagarind Hospital; Division of Gastroenterology | Songkhla | Thailand | 90112 | |
| 83 | The Royal London Hospital | London | United Kingdom | E1 1BB | |
| 84 | Manchester Royal Infirmary; Department Of Medicine | Manchester | United Kingdom | M13 9WL |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01855997
Other Study ID Numbers:
- GV28855
First Posted:
May 17, 2013
Last Update Posted:
Apr 5, 2017
Last Verified:
Mar 1, 2017
Additional relevant MeSH terms:
Study Results
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). |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Adult Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult participants with hepatitis B envelope antigen (HBeAg)-positive or -negative chronic hepatitis B (CHB) infection who completed greater than or equal to (≥) 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. |
| Period Title: Overall Study | |
| STARTED | 1669 |
| COMPLETED | 1669 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Adult Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 1669 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
39.09
(0.270)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
471
28.2%
|
| Male |
1198
71.8%
|
| HBeAg Status (participants) [Number] | |
| Positive |
932
55.8%
|
| Negative |
676
40.5%
|
| Not Known |
61
3.7%
|
Outcome Measures
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult East Asian participants with HBeAg-positive 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. |
| Measure Participants | 819 |
| rs1876154 |
2.1010
|
| rs2812338 |
1.8580
|
| rs10824875 |
1.8330
|
| rs1831559 |
1.8590
|
| rs10851257 |
1.8340
|
| rs6492344 |
1.8120
|
| rs12584550 |
1.7900
|
| rs9555773 |
1.8610
|
| rs7983441 |
1.8770
|
| rs12446868 |
0.5302
|
| rs247878 |
0.5209
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs1876154 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000559 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs2812338 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000766 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs10824875 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000982 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs1831559 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000127 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs10851257 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000396 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs6492344 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000648 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs12584550 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000221 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs9555773 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000902 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs7983441 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000077 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs12446868 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000048 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs247878 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000037 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| HBeAg-Positive CN Population. |
| Arm/Group Title | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult East Asian participants with HBeAg-positive 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. |
| Measure Participants | 819 |
| rs1876154 |
2.2030
|
| rs7753766 |
2.1200
|
| rs604241 |
0.4876
|
| rs12446868 |
0.4501
|
| rs247878 |
0.4644
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs1876154 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000987 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs7753766 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000605 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs604241 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000946 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs12446868 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000077 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs247878 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000197 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| HBeAg-Positive Population: All HBeAg-positive participants whose genetic data passed a protocol-specified quality check. |
| Arm/Group Title | HBeAg-Positive Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult participants with HBeAg-positive 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. |
| Measure Participants | 907 |
| rs12210761 |
2.7870
|
| rs1831559 |
1.7250
|
| rs7983441 |
1.7410
|
| rs12446868 |
0.5740
|
| rs247878 |
0.5683
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs12210761 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000677 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs1831559 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000798 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs7983441 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000512 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs12446868 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000345 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs247878 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000372 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| HBeAg-Positive Population. |
| Arm/Group Title | HBeAg-Positive Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult participants with HBeAg-positive 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. |
| Measure Participants | 907 |
| rs12210761 |
3.0040
|
| rs1411283 |
0.4873
|
| rs12446868 |
0.5002
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs12210761 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000459 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs1411283 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000925 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs12446868 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000772 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| HBeAg-Positive CN Population. |
| Arm/Group Title | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult East Asian participants with HBeAg-positive 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. |
| Measure Participants | 819 |
| rs11163805 |
1.8610
|
| rs6443144 |
1.9390
|
| rs11139349 |
1.8360
|
| rs1831559 |
1.9060
|
| rs7983441 |
1.9240
|
| rs11868362 |
0.3363
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs11163805 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000470 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs6443144 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000674 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs11139349 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000952 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs1831559 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000608 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs7983441 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000404 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs11868362 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000407 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| HBeAg-Positive CN Population. |
| Arm/Group Title | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult East Asian participants with HBeAg-positive 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. |
| Measure Participants | 819 |
| rs1384010 |
2.6700
|
| rs1351518 |
2.3000
|
| rs1157322 |
3.0120
|
| rs11868362 |
0.3108
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs1384010 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000666 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs1351518 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000844 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs1157322 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000794 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs11868362 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000310 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| HBeAg-Positive Population. |
| Arm/Group Title | HBeAg-Positive Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult participants with HBeAg-positive 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. |
| Measure Participants | 907 |
| rs11139349 |
1.8610
|
| rs1157322 |
2.8290
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs11139349 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000207 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs1157322 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000899 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| HBeAg-Positive Population. |
| Arm/Group Title | HBeAg-Positive Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult participants with HBeAg-positive 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. |
| Measure Participants | 907 |
| rs1384010 |
2.6260
|
| rs1351518 |
2.2220
|
| rs1157322 |
2.9500
|
| rs646097 |
0.4639
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs1384010 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000573 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs1351518 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000946 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs1157322 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000731 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs646097 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000945 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-East Asian (Non-CN) Population: Additive Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | HBeAg-Negative Non-CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult non-East Asian participants with HBeAg-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. |
| Measure Participants | 371 |
| Number [beta coefficient] |
4.3170
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs17037122 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000016 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population: Dominant Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| HBeAg-Negative Non-CN Population. |
| Arm/Group Title | HBeAg-Negative Non-CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult non-East Asian participants with HBeAg-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. |
| Measure Participants | 371 |
| Number [beta coefficient] |
4.2450
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs17037122 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000088 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Additive Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | HBeAg-Negative CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult East Asian participants with HBeAg-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. |
| Measure Participants | 267 |
| Number [beta coefficient] |
0.2583
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs2464266 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000879 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Dominant Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| HBeAg-Negative CN Population. |
| Arm/Group Title | HBeAg-Negative CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult East Asian participants with HBeAg-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. |
| Measure Participants | 267 |
| rs9496139 |
0.1812
|
| rs2014238 |
5.8110
|
| rs2980231 |
5.8110
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs9496139 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000452 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs2014238 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000497 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs2980231 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000497 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| HBeAg-Negative Population: All HBeAg-negative participants whose genetic data passed a protocol-specified quality check. |
| Arm/Group Title | HBeAg-Negative Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult participants with HBeAg-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. |
| Measure Participants | 638 |
| exm2237722 |
0.1070
|
| rs16924016 |
0.3357
|
| rs2899723 |
2.0360
|
| rs8027115 |
1.9480
|
| exm2267780 |
2.0100
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | exm2237722 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000748 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs16924016 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000073 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs2899723 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000289 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs8027115 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000912 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | exm2267780 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000494 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| HBeAg-Negative Population. |
| Arm/Group Title | HBeAg-Negative Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult participants with HBeAg-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. |
| Measure Participants | 638 |
| rs9973954 |
0.2975
|
| exm2237722 |
0.1009
|
| rs1040084 |
2.3660
|
| rs1913484 |
2.3610
|
| rs16924016 |
0.3186
|
| exm1010813 |
0.1299
|
| rs6576456 |
0.4112
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs9973954 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000627 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | exm2237722 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000696 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs1040084 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000426 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs1913484 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000435 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs16924016 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000221 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | exm1010813 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000523 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs6576456 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000757 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Adult Non-CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult non-East Asian 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. |
| Measure Participants | 459 |
| rs17037122 |
2.9930
|
| rs10475403 |
0.5024
|
| rs715243 |
0.5078
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs17037122 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000153 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs10475403 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000708 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs715243 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000727 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Non-CN Population. |
| Arm/Group Title | Adult Non-CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult non-East Asian 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. |
| Measure Participants | 459 |
| Number [beta coefficient] |
3.1610
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs17037122 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000397 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Adult CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult East Asian 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. |
| Measure Participants | 1086 |
| rs6443144 |
1.6780
|
| rs2189452 |
0.6008
|
| rs9324018 |
1.6680
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs6443144 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000686 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs2189452 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000596 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs9324018 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000489 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| CN Population; the analysis only included a subset of participants who provided evaluable data. |
| Arm/Group Title | Adult CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult East Asian 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. |
| Measure Participants | 1086 |
| rs2189452 |
0.5360
|
| rs7968170 |
0.4869
|
| rs9324018 |
1.8700
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs2189452 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000834 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs7968170 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000487 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs9324018 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000918 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Genetic Data Quality Check (GT) Population: All participants, regardless of HBeAg status, whose genetic data passed a protocol-specified quality check. |
| Arm/Group Title | Adult Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 1545 |
| rs9287655 |
0.6617
|
| rs2803073 |
1.5160
|
| rs1937590 |
1.7220
|
| rs2945861 |
0.5957
|
| rs1997894 |
0.6814
|
| rs1495471 |
1.5540
|
| rs9324018 |
1.5400
|
| rs1152537 |
1.7800
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs9287655 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000137 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs2803073 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000339 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs1937590 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000927 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs2945861 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000166 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs1997894 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000455 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs1495471 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000568 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs9324018 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000125 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs1152537 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000982 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| GT Population. |
| Arm/Group Title | Adult Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 1545 |
| rs10236906 |
0.5664
|
| rs2945861 |
0.5576
|
| rs7042473 |
1.7050
|
| rs2077415 |
0.5732
|
| rs9324018 |
1.6850
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs10236906 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000846 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs2945861 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000562 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs7042473 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000497 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs2077415 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000997 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs9324018 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000864 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Non-CN Population. |
| Arm/Group Title | Adult Non-CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult non-East Asian 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. |
| Measure Participants | 459 |
| rs17037122 |
2.8740
|
| rs715243 |
0.5000
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs17037122 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000368 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs715243 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000577 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Non-CN Population. |
| Arm/Group Title | Adult Non-CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult non-East Asian 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. |
| Measure Participants | 459 |
| rs2302503 |
0.3719
|
| rs6015181 |
2.6740
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs2302503 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000950 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs6015181 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000741 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| CN Population; the analysis only included a subset of participants who provided evaluable data. |
| Arm/Group Title | Adult CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult East Asian 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. |
| Measure Participants | 1086 |
| rs1550116 |
0.5565
|
| rs1550115 |
0.5565
|
| rs2082881 |
0.5565
|
| exm2265462 |
0.5730
|
| rs6443144 |
1.8390
|
| rs1403069 |
0.5769
|
| rs9691873 |
2.2250
|
| rs8012912 |
1.6200
|
| rs11158827 |
1.6200
|
| rs11870323 |
2.1120
|
| rs4821558 |
0.6146
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs1550116 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000805 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs1550115 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000702 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs2082881 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000702 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | exm2265462 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000743 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs6443144 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000078 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs1403069 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000894 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs9691873 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000571 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs8012912 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000729 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs11158827 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000828 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs11870323 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000885 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs4821558 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000717 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| CN Population; the analysis only included a subset of participants who provided evaluable data. |
| Arm/Group Title | Adult CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult East Asian 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. |
| Measure Participants | 1086 |
| rs6443144 |
1.9800
|
| rs1692421 |
0.5036
|
| rs1692423 |
0.5029
|
| rs9691873 |
2.3190
|
| rs7968170 |
0.4634
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs6443144 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000629 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs1692421 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000579 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs1692423 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000553 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs9691873 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000946 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs7968170 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000450 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| GT Population. |
| Arm/Group Title | Adult Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 1545 |
| rs9287655 |
0.6444
|
| rs216312 |
0.6621
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs9287655 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000118 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs216312 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000531 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| GT Population. |
| Arm/Group Title | Adult Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 1545 |
| rs993147 |
0.5210
|
| rs10978436 |
1.7610
|
| rs2370220 |
0.5233
|
| rs2279519 |
1.7460
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs993147 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000593 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs10978436 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000997 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs2370220 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000581 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs2279519 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000802 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Non-CN Population; the analysis only included a subset of participants who provided evaluable data. |
| Arm/Group Title | Adult Non-CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult non-East Asian 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. |
| Measure Participants | 408 |
| Number [beta coefficient] |
5.7670
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs12992677 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000558 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Non-CN Population; the analysis only included a subset of participants who provided evaluable data. |
| Arm/Group Title | Adult Non-CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult non-East Asian 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. |
| Measure Participants | 408 |
| Number [beta coefficient] |
8.6340
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs12992677 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000990 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Additive Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| CN Population. |
| Arm/Group Title | Adult CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult East Asian 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. |
| Measure Participants | 1095 |
| Number [beta coefficient] |
8.2240
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs7549785 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000048 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Dominant Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| CN Population. |
| Arm/Group Title | Adult CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult East Asian 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. |
| Measure Participants | 1095 |
| Number [beta coefficient] |
8.2240
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs7549785 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000048 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Additive Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| GT Population; the analysis only included a subset of participants who provided evaluable data. |
| Arm/Group Title | Adult Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 1503 |
| rs10814834 |
0.4571
|
| rs10491723 |
2.1090
|
| rs6592052 |
6.6180
|
| rs16943470 |
2.9650
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs10814834 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000738 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs10491723 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000451 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs6592052 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000878 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs16943470 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000521 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Dominant Model |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| GT Population; the analysis only included a subset of participants who provided evaluable data. |
| Arm/Group Title | Adult Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 1503 |
| Number [beta coefficient] |
7.8720
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|---|
| Comments | rs6592052 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00000720 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| HBeAg-Positive Population. |
| Arm/Group Title | HBeAg-Positive Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult participants with HBeAg-positive 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. |
| Measure Participants | 907 |
| Number [participants] |
276
16.5%
|
| Title | Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| HBeAg-Positive CN Population. |
| Arm/Group Title | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult East Asian participants with HBeAg-positive 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. |
| Measure Participants | 819 |
| Number [participants] |
255
15.3%
|
| Title | Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Non-CN Population |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | HBeAg-Positive Non-CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult non-East Asian participants with HBeAg-positive 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. |
| Measure Participants | 88 |
| Number [participants] |
21
1.3%
|
| Title | Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| HBeAg-Positive Population. |
| Arm/Group Title | HBeAg-Positive Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult participants with HBeAg-positive 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. |
| Measure Participants | 907 |
| Number [participants] |
193
11.6%
|
| Title | Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| HBeAg-Positive CN Population. |
| Arm/Group Title | HBeAg-Positive CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult East Asian participants with HBeAg-positive 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. |
| Measure Participants | 819 |
| Number [participants] |
175
10.5%
|
| Title | Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Non-CN Population |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| HBeAg-Positive Non-CN Population. |
| Arm/Group Title | HBeAg-Positive Non-CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult non-East Asian participants with HBeAg-positive 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. |
| Measure Participants | 88 |
| Number [participants] |
18
1.1%
|
| Title | Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| HBeAg-Negative Population. |
| Arm/Group Title | HBeAg-Negative Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult participants with HBeAg-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. |
| Measure Participants | 638 |
| Number [participants] |
393
23.5%
|
| Title | Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| HBeAg-Negative CN Population. |
| Arm/Group Title | HBeAg-Negative CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult East Asian participants with HBeAg-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. |
| Measure Participants | 267 |
| Number [participants] |
209
12.5%
|
| Title | Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| HBeAg-Negative Non-CN Population. |
| Arm/Group Title | HBeAg-Negative Non-CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult non-East Asian participants with HBeAg-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. |
| Measure Participants | 371 |
| Number [participants] |
184
11%
|
| Title | Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| GT Population. |
| Arm/Group Title | Adult Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 1545 |
| Number [participants] |
669
40.1%
|
| Title | Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| CN Population; the analysis only included a subset of participants who provided evaluable data. |
| Arm/Group Title | Adult CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult East Asian 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. |
| Measure Participants | 1086 |
| Number [participants] |
464
27.8%
|
| Title | Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Non-CN Population. |
| Arm/Group Title | Adult Non-CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult non-East Asian 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. |
| Measure Participants | 459 |
| Number [participants] |
205
12.3%
|
| Title | Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| GT Population. |
| Arm/Group Title | Adult Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 1545 |
| Number [participants] |
586
35.1%
|
| Title | Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| CN Population. |
| Arm/Group Title | Adult CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult East Asian 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. |
| Measure Participants | 1086 |
| Number [participants] |
384
23%
|
| Title | Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Non-CN Population. |
| Arm/Group Title | Adult Non-CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult non-East Asian 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. |
| Measure Participants | 459 |
| Number [participants] |
202
12.1%
|
| Title | Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| GT Population; the analysis only included a subset of participants who provided evaluable data. |
| Arm/Group Title | Adult Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 1503 |
| Number [participants] |
104
6.2%
|
| Title | Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| CN Population. |
| Arm/Group Title | Adult CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult East Asian 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. |
| Measure Participants | 1095 |
| Number [participants] |
80
4.8%
|
| Title | Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Non-CN Population; the analysis only included a subset of participants who provided evaluable data. |
| Arm/Group Title | Adult Non-CN Participants Treated With Peg-IFN |
|---|---|
| Arm/Group Description | Adult non-East Asian 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. |
| Measure Participants | 408 |
| Number [participants] |
24
1.4%
|
Adverse Events
| Time Frame | Single visit at least 24 weeks after completion of treatment (overall sampling period up to 12 months) | |
|---|---|---|
| Adverse Event Reporting Description | Participants who were recruited directly into the study from general practice and who provided a blood sample were observed only for adverse events (AEs) related to the blood sampling procedure. | |
| Arm/Group Title | Adult Participants Treated With Peg-IFN | |
| Arm/Group Description | Adult participants with HBeAg-positive or -negative CHB infection, and who had completed at least 24 weeks of Peg-IFN alfa-2a with/without nucleoside analogue therapy and at least 24 weeks of follow-up, were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study. | |
All Cause Mortality |
||
| Adult Participants Treated With Peg-IFN | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Adult Participants Treated With Peg-IFN | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/1105 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Adult Participants Treated With Peg-IFN | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/1105 (0%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
| Name/Title | Medical Communications |
|---|---|
| Organization | Hoffmann-LaRoche |
| Phone | 800-821-8590 |
| genentech@druginfo.com |
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01855997
Other Study ID Numbers:
- GV28855
First Posted:
May 17, 2013
Last Update Posted:
Apr 5, 2017
Last Verified:
Mar 1, 2017