Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01855997
Recruitment Status : Completed
First Posted : May 17, 2013
Results First Posted : April 8, 2016
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Other
Condition Hepatitis B, Chronic
Intervention Drug: Peg-IFN alfa-2a
Enrollment 1669
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 Details  
Arm/Group Title Adult Participants Treated With Peg-IFN
Hide 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
Arm/Group Title Adult Participants Treated With Peg-IFN
Hide 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 Number of Baseline Participants 1669
Hide Baseline Analysis Population Description
All Enrolled Population: All participants for whom genotype data were available.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1669 participants
39.09  (0.270)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1669 participants
Female
471
  28.2%
Male
1198
  71.8%
HBeAg Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1669 participants
Positive 932
Negative 676
Not Known 61
1.Primary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 819
Measure Type: Number
Unit of Measure: beta coefficient
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
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000559
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000766
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000982
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000127
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000396
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 6 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000648
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 7 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000221
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 8 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000902
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 9 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000077
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 10 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000048
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 11 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000037
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
HBeAg-Positive CN Population.
Arm/Group Title HBeAg-Positive CN Participants Treated With Peg-IFN
Hide 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.
Overall Number of Participants Analyzed 819
Measure Type: Number
Unit of Measure: beta coefficient
rs1876154 2.2030
rs7753766 2.1200
rs604241 0.4876
rs12446868 0.4501
rs247878 0.4644
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000987
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000605
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000946
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000077
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000197
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Primary Outcome
Title SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 907
Measure Type: Number
Unit of Measure: beta coefficient
rs12210761 2.7870
rs1831559 1.7250
rs7983441 1.7410
rs12446868 0.5740
rs247878 0.5683
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HBeAg-Positive Participants Treated With Peg-IFN
Comments rs12210761
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000677
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HBeAg-Positive Participants Treated With Peg-IFN
Comments rs1831559
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000798
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection HBeAg-Positive Participants Treated With Peg-IFN
Comments rs7983441
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000512
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection HBeAg-Positive Participants Treated With Peg-IFN
Comments rs12446868
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000345
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection HBeAg-Positive Participants Treated With Peg-IFN
Comments rs247878
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000372
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Primary Outcome
Title SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
HBeAg-Positive Population.
Arm/Group Title HBeAg-Positive Participants Treated With Peg-IFN
Hide 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.
Overall Number of Participants Analyzed 907
Measure Type: Number
Unit of Measure: beta coefficient
rs12210761 3.0040
rs1411283 0.4873
rs12446868 0.5002
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HBeAg-Positive Participants Treated With Peg-IFN
Comments rs12210761
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000459
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HBeAg-Positive Participants Treated With Peg-IFN
Comments rs1411283
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000925
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection HBeAg-Positive Participants Treated With Peg-IFN
Comments rs12446868
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000772
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Primary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
HBeAg-Positive CN Population.
Arm/Group Title HBeAg-Positive CN Participants Treated With Peg-IFN
Hide 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.
Overall Number of Participants Analyzed 819
Measure Type: Number
Unit of Measure: beta coefficient
rs11163805 1.8610
rs6443144 1.9390
rs11139349 1.8360
rs1831559 1.9060
rs7983441 1.9240
rs11868362 0.3363
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000470
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000674
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000952
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000608
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000404
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 6 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000407
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Primary Outcome
Title SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
HBeAg-Positive CN Population.
Arm/Group Title HBeAg-Positive CN Participants Treated With Peg-IFN
Hide 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.
Overall Number of Participants Analyzed 819
Measure Type: Number
Unit of Measure: beta coefficient
rs1384010 2.6700
rs1351518 2.3000
rs1157322 3.0120
rs11868362 0.3108
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000666
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000844
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000794
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000310
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Primary Outcome
Title SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
HBeAg-Positive Population.
Arm/Group Title HBeAg-Positive Participants Treated With Peg-IFN
Hide 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.
Overall Number of Participants Analyzed 907
Measure Type: Number
Unit of Measure: beta coefficient
rs11139349 1.8610
rs1157322 2.8290
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HBeAg-Positive Participants Treated With Peg-IFN
Comments rs11139349
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000207
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HBeAg-Positive Participants Treated With Peg-IFN
Comments rs1157322
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000899
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Primary Outcome
Title SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
HBeAg-Positive Population.
Arm/Group Title HBeAg-Positive Participants Treated With Peg-IFN
Hide 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.
Overall Number of Participants Analyzed 907
Measure Type: Number
Unit of Measure: beta coefficient
rs1384010 2.6260
rs1351518 2.2220
rs1157322 2.9500
rs646097 0.4639
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HBeAg-Positive Participants Treated With Peg-IFN
Comments rs1384010
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000573
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HBeAg-Positive Participants Treated With Peg-IFN
Comments rs1351518
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000946
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection HBeAg-Positive Participants Treated With Peg-IFN
Comments rs1157322
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000731
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection HBeAg-Positive Participants Treated With Peg-IFN
Comments rs646097
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000945
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
9.Primary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 371
Measure Type: Number
Unit of Measure: beta coefficient
4.3170
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HBeAg-Negative Non-CN Participants Treated With Peg-IFN
Comments rs17037122
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000016
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
10.Primary Outcome
Title SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population: Dominant Model
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
HBeAg-Negative Non-CN Population.
Arm/Group Title HBeAg-Negative Non-CN Participants Treated With Peg-IFN
Hide 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.
Overall Number of Participants Analyzed 371
Measure Type: Number
Unit of Measure: beta coefficient
4.2450
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HBeAg-Negative Non-CN Participants Treated With Peg-IFN
Comments rs17037122
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000088
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
11.Primary Outcome
Title SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Additive Model
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 267
Measure Type: Number
Unit of Measure: beta coefficient
0.2583
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HBeAg-Negative CN Participants Treated With Peg-IFN
Comments rs2464266
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000879
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
12.Primary Outcome
Title SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Dominant Model
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
HBeAg-Negative CN Population.
Arm/Group Title HBeAg-Negative CN Participants Treated With Peg-IFN
Hide 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.
Overall Number of Participants Analyzed 267
Measure Type: Number
Unit of Measure: beta coefficient
rs9496139 0.1812
rs2014238 5.8110
rs2980231 5.8110
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HBeAg-Negative CN Participants Treated With Peg-IFN
Comments rs9496139
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000452
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HBeAg-Negative CN Participants Treated With Peg-IFN
Comments rs2014238
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000497
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection HBeAg-Negative CN Participants Treated With Peg-IFN
Comments rs2980231
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000497
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
13.Primary Outcome
Title SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Model
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 638
Measure Type: Number
Unit of Measure: beta coefficient
exm2237722 0.1070
rs16924016 0.3357
rs2899723 2.0360
rs8027115 1.9480
exm2267780 2.0100
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HBeAg-Negative Participants Treated With Peg-IFN
Comments exm2237722
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000748
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HBeAg-Negative Participants Treated With Peg-IFN
Comments rs16924016
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000073
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection HBeAg-Negative Participants Treated With Peg-IFN
Comments rs2899723
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000289
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection HBeAg-Negative Participants Treated With Peg-IFN
Comments rs8027115
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000912
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection HBeAg-Negative Participants Treated With Peg-IFN
Comments exm2267780
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000494
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
14.Primary Outcome
Title SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
HBeAg-Negative Population.
Arm/Group Title HBeAg-Negative Participants Treated With Peg-IFN
Hide 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.
Overall Number of Participants Analyzed 638
Measure Type: Number
Unit of Measure: beta coefficient
rs9973954 0.2975
exm2237722 0.1009
rs1040084 2.3660
rs1913484 2.3610
rs16924016 0.3186
exm1010813 0.1299
rs6576456 0.4112
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HBeAg-Negative Participants Treated With Peg-IFN
Comments rs9973954
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000627
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HBeAg-Negative Participants Treated With Peg-IFN
Comments exm2237722
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000696
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection HBeAg-Negative Participants Treated With Peg-IFN
Comments rs1040084
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000426
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection HBeAg-Negative Participants Treated With Peg-IFN
Comments rs1913484
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000435
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection HBeAg-Negative Participants Treated With Peg-IFN
Comments rs16924016
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000221
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection HBeAg-Negative Participants Treated With Peg-IFN
Comments exm1010813
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000523
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection HBeAg-Negative Participants Treated With Peg-IFN
Comments rs6576456
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000757
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
15.Primary Outcome
Title SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 459
Measure Type: Number
Unit of Measure: beta coefficient
rs17037122 2.9930
rs10475403 0.5024
rs715243 0.5078
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adult Non-CN Participants Treated With Peg-IFN
Comments rs17037122
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000153
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adult Non-CN Participants Treated With Peg-IFN
Comments rs10475403
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000708
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adult Non-CN Participants Treated With Peg-IFN
Comments rs715243
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000727
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
16.Primary Outcome
Title SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Non-CN Population.
Arm/Group Title Adult Non-CN Participants Treated With Peg-IFN
Hide 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.
Overall Number of Participants Analyzed 459
Measure Type: Number
Unit of Measure: beta coefficient
3.1610
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adult Non-CN Participants Treated With Peg-IFN
Comments rs17037122
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000397
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
17.Primary Outcome
Title SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 1086
Measure Type: Number
Unit of Measure: beta coefficient
rs6443144 1.6780
rs2189452 0.6008
rs9324018 1.6680
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adult CN Participants Treated With Peg-IFN
Comments rs6443144
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000686
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adult CN Participants Treated With Peg-IFN
Comments rs2189452
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000596
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adult CN Participants Treated With Peg-IFN
Comments rs9324018
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000489
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
18.Primary Outcome
Title SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 1086
Measure Type: Number
Unit of Measure: beta coefficient
rs2189452 0.5360
rs7968170 0.4869
rs9324018 1.8700
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adult CN Participants Treated With Peg-IFN
Comments rs2189452
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000834
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adult CN Participants Treated With Peg-IFN
Comments rs7968170
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000487
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adult CN Participants Treated With Peg-IFN
Comments rs9324018
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000918
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
19.Primary Outcome
Title SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 1545
Measure Type: Number
Unit of Measure: beta coefficient
rs9287655 0.6617
rs2803073 1.5160
rs1937590 1.7220
rs2945861 0.5957
rs1997894 0.6814
rs1495471 1.5540
rs9324018 1.5400
rs1152537 1.7800
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adult Participants Treated With Peg-IFN
Comments rs9287655
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000137
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adult Participants Treated With Peg-IFN
Comments rs2803073
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000339
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adult Participants Treated With Peg-IFN
Comments rs1937590
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000927
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Adult Participants Treated With Peg-IFN
Comments rs2945861
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000166
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Adult Participants Treated With Peg-IFN
Comments rs1997894
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000455
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Adult Participants Treated With Peg-IFN
Comments rs1495471
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000568
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Adult Participants Treated With Peg-IFN
Comments rs9324018
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000125
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Adult Participants Treated With Peg-IFN
Comments rs1152537
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000982
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
20.Primary Outcome
Title SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
GT Population.
Arm/Group Title Adult Participants Treated With Peg-IFN
Hide 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 Number of Participants Analyzed 1545
Measure Type: Number
Unit of Measure: beta coefficient
rs10236906 0.5664
rs2945861 0.5576
rs7042473 1.7050
rs2077415 0.5732
rs9324018 1.6850
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adult Participants Treated With Peg-IFN
Comments rs10236906
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000846
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adult Participants Treated With Peg-IFN
Comments rs2945861
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000562
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adult Participants Treated With Peg-IFN
Comments rs7042473
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000497
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Adult Participants Treated With Peg-IFN
Comments rs2077415
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000997
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Adult Participants Treated With Peg-IFN
Comments rs9324018
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000864
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
21.Primary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Non-CN Population.
Arm/Group Title Adult Non-CN Participants Treated With Peg-IFN
Hide 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.
Overall Number of Participants Analyzed 459
Measure Type: Number
Unit of Measure: beta coefficient
rs17037122 2.8740
rs715243 0.5000
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adult Non-CN Participants Treated With Peg-IFN
Comments rs17037122
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000368
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adult Non-CN Participants Treated With Peg-IFN
Comments rs715243
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000577
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
22.Primary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Non-CN Population.
Arm/Group Title Adult Non-CN Participants Treated With Peg-IFN
Hide 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.
Overall Number of Participants Analyzed 459
Measure Type: Number
Unit of Measure: beta coefficient
rs2302503 0.3719
rs6015181 2.6740
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adult Non-CN Participants Treated With Peg-IFN
Comments rs2302503
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000950
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adult Non-CN Participants Treated With Peg-IFN
Comments rs6015181
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000741
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
23.Primary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 1086
Measure Type: Number
Unit of Measure: beta coefficient
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
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adult CN Participants Treated With Peg-IFN
Comments rs1550116
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000805
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adult CN Participants Treated With Peg-IFN
Comments rs1550115
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000702
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adult CN Participants Treated With Peg-IFN
Comments rs2082881
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000702
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Adult CN Participants Treated With Peg-IFN
Comments exm2265462
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000743
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Adult CN Participants Treated With Peg-IFN
Comments rs6443144
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000078
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Adult CN Participants Treated With Peg-IFN
Comments rs1403069
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000894
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Adult CN Participants Treated With Peg-IFN
Comments rs9691873
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000571
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Adult CN Participants Treated With Peg-IFN
Comments rs8012912
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000729
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Adult CN Participants Treated With Peg-IFN
Comments rs11158827
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000828
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Adult CN Participants Treated With Peg-IFN
Comments rs11870323
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000885
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Adult CN Participants Treated With Peg-IFN
Comments rs4821558
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000717
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
24.Primary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 1086
Measure Type: Number
Unit of Measure: beta coefficient
rs6443144 1.9800
rs1692421 0.5036
rs1692423 0.5029
rs9691873 2.3190
rs7968170 0.4634
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adult CN Participants Treated With Peg-IFN
Comments rs6443144
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000629
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adult CN Participants Treated With Peg-IFN
Comments rs1692421
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000579
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adult CN Participants Treated With Peg-IFN
Comments rs1692423
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000553
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Adult CN Participants Treated With Peg-IFN
Comments rs9691873
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000946
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Adult CN Participants Treated With Peg-IFN
Comments rs7968170
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000450
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
25.Primary Outcome
Title SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
GT Population.
Arm/Group Title Adult Participants Treated With Peg-IFN
Hide 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 Number of Participants Analyzed 1545
Measure Type: Number
Unit of Measure: beta coefficient
rs9287655 0.6444
rs216312 0.6621
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adult Participants Treated With Peg-IFN
Comments rs9287655
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000118
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adult Participants Treated With Peg-IFN
Comments rs216312
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000531
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
26.Primary Outcome
Title SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
GT Population.
Arm/Group Title Adult Participants Treated With Peg-IFN
Hide 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 Number of Participants Analyzed 1545
Measure Type: Number
Unit of Measure: beta coefficient
rs993147 0.5210
rs10978436 1.7610
rs2370220 0.5233
rs2279519 1.7460
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adult Participants Treated With Peg-IFN
Comments rs993147
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000593
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adult Participants Treated With Peg-IFN
Comments rs10978436
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000997
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adult Participants Treated With Peg-IFN
Comments rs2370220
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000581
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Adult Participants Treated With Peg-IFN
Comments rs2279519
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000802
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
27.Primary Outcome
Title SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 408
Measure Type: Number
Unit of Measure: beta coefficient
5.7670
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adult Non-CN Participants Treated With Peg-IFN
Comments rs12992677
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000558
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
28.Primary Outcome
Title SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 408
Measure Type: Number
Unit of Measure: beta coefficient
8.6340
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adult Non-CN Participants Treated With Peg-IFN
Comments rs12992677
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000990
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
29.Primary Outcome
Title SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Additive Model
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
CN Population.
Arm/Group Title Adult CN Participants Treated With Peg-IFN
Hide 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.
Overall Number of Participants Analyzed 1095
Measure Type: Number
Unit of Measure: beta coefficient
8.2240
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adult CN Participants Treated With Peg-IFN
Comments rs7549785
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000048
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
30.Primary Outcome
Title SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Dominant Model
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
CN Population.
Arm/Group Title Adult CN Participants Treated With Peg-IFN
Hide 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.
Overall Number of Participants Analyzed 1095
Measure Type: Number
Unit of Measure: beta coefficient
8.2240
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adult CN Participants Treated With Peg-IFN
Comments rs7549785
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000048
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
31.Primary Outcome
Title SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Additive Model
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 1503
Measure Type: Number
Unit of Measure: beta coefficient
rs10814834 0.4571
rs10491723 2.1090
rs6592052 6.6180
rs16943470 2.9650
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adult Participants Treated With Peg-IFN
Comments rs10814834
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000738
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adult Participants Treated With Peg-IFN
Comments rs10491723
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000451
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adult Participants Treated With Peg-IFN
Comments rs6592052
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000878
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Adult Participants Treated With Peg-IFN
Comments rs16943470
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000521
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
32.Primary Outcome
Title SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Dominant Model
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 1503
Measure Type: Number
Unit of Measure: beta coefficient
7.8720
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adult Participants Treated With Peg-IFN
Comments rs6592052
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000720
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
33.Other Pre-specified Outcome
Title Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
HBeAg-Positive Population.
Arm/Group Title HBeAg-Positive Participants Treated With Peg-IFN
Hide 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.
Overall Number of Participants Analyzed 907
Measure Type: Number
Unit of Measure: participants
276
34.Other Pre-specified Outcome
Title Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
HBeAg-Positive CN Population.
Arm/Group Title HBeAg-Positive CN Participants Treated With Peg-IFN
Hide 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.
Overall Number of Participants Analyzed 819
Measure Type: Number
Unit of Measure: participants
255
35.Other Pre-specified Outcome
Title Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Non-CN Population
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 88
Measure Type: Number
Unit of Measure: participants
21
36.Other Pre-specified Outcome
Title Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
HBeAg-Positive Population.
Arm/Group Title HBeAg-Positive Participants Treated With Peg-IFN
Hide 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.
Overall Number of Participants Analyzed 907
Measure Type: Number
Unit of Measure: participants
193
37.Other Pre-specified Outcome
Title Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
HBeAg-Positive CN Population.
Arm/Group Title HBeAg-Positive CN Participants Treated With Peg-IFN
Hide 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.
Overall Number of Participants Analyzed 819
Measure Type: Number
Unit of Measure: participants
175
38.Other Pre-specified Outcome
Title Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Non-CN Population
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
HBeAg-Positive Non-CN Population.
Arm/Group Title HBeAg-Positive Non-CN Participants Treated With Peg-IFN
Hide 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.
Overall Number of Participants Analyzed 88
Measure Type: Number
Unit of Measure: participants
18
39.Other Pre-specified Outcome
Title Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
HBeAg-Negative Population.
Arm/Group Title HBeAg-Negative Participants Treated With Peg-IFN
Hide 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.
Overall Number of Participants Analyzed 638
Measure Type: Number
Unit of Measure: participants
393
40.Other Pre-specified Outcome
Title Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
HBeAg-Negative CN Population.
Arm/Group Title HBeAg-Negative CN Participants Treated With Peg-IFN
Hide 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.
Overall Number of Participants Analyzed 267
Measure Type: Number
Unit of Measure: participants
209
41.Other Pre-specified Outcome
Title Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
HBeAg-Negative Non-CN Population.
Arm/Group Title HBeAg-Negative Non-CN Participants Treated With Peg-IFN
Hide 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.
Overall Number of Participants Analyzed 371
Measure Type: Number
Unit of Measure: participants
184
42.Other Pre-specified Outcome
Title Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
GT Population.
Arm/Group Title Adult Participants Treated With Peg-IFN
Hide 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 Number of Participants Analyzed 1545
Measure Type: Number
Unit of Measure: participants
669
43.Other Pre-specified Outcome
Title Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 1086
Measure Type: Number
Unit of Measure: participants
464
44.Other Pre-specified Outcome
Title Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Non-CN Population.
Arm/Group Title Adult Non-CN Participants Treated With Peg-IFN
Hide 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.
Overall Number of Participants Analyzed 459
Measure Type: Number
Unit of Measure: participants
205
45.Other Pre-specified Outcome
Title Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
GT Population.
Arm/Group Title Adult Participants Treated With Peg-IFN
Hide 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 Number of Participants Analyzed 1545
Measure Type: Number
Unit of Measure: participants
586
46.Other Pre-specified Outcome
Title Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
CN Population.
Arm/Group Title Adult CN Participants Treated With Peg-IFN