Trial Outcomes & Findings for 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 (NCT NCT01855997)

NCT ID: NCT01855997

Last Updated: 2017-04-05

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 1669 participants
• Primary outcome timeframe: Single blood sample ≥24 weeks post-treatment
• Results posted on: 2017-04-05

Participant Flow

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).

Participant milestones

Measure	Adult Participants Treated With Peg-IFN 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.
Overall Study STARTED	1669
Overall Study COMPLETED	1669
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Adult Participants Treated With Peg-IFN n=1669 Participants 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.
Age, Continuous	39.09 years STANDARD_DEVIATION 0.270 • n=5 Participants
Sex: Female, Male Female	471 Participants n=5 Participants
Sex: Female, Male Male	1198 Participants n=5 Participants
HBeAg Status Positive	932 participants n=5 Participants
HBeAg Status Negative	676 participants n=5 Participants
HBeAg Status Not Known	61 participants n=5 Participants

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

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

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.

Outcome measures

Measure	HBeAg-Positive CN Participants Treated With Peg-IFN n=819 Participants 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.
Single Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Model rs1876154	2.1010 beta coefficient
Single Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Model rs2812338	1.8580 beta coefficient
Single Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Model rs10824875	1.8330 beta coefficient
Single Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Model rs1831559	1.8590 beta coefficient
Single Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Model rs10851257	1.8340 beta coefficient
Single Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Model rs6492344	1.8120 beta coefficient
Single Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Model rs12584550	1.7900 beta coefficient
Single Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Model rs9555773	1.8610 beta coefficient
Single Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Model rs7983441	1.8770 beta coefficient
Single Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Model rs12446868	0.5302 beta coefficient
Single Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Model rs247878	0.5209 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Positive CN Population.

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.

Outcome measures

Measure	HBeAg-Positive CN Participants Treated With Peg-IFN n=819 Participants 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.
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model rs1876154	2.2030 beta coefficient
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model rs7753766	2.1200 beta coefficient
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model rs604241	0.4876 beta coefficient
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model rs12446868	0.4501 beta coefficient
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model rs247878	0.4644 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

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

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.

Outcome measures

Measure	HBeAg-Positive CN Participants Treated With Peg-IFN n=907 Participants 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.
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model rs12210761	2.7870 beta coefficient
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model rs1831559	1.7250 beta coefficient
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model rs7983441	1.7410 beta coefficient
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model rs12446868	0.5740 beta coefficient
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model rs247878	0.5683 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Positive Population.

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.

Outcome measures

Measure	HBeAg-Positive CN Participants Treated With Peg-IFN n=907 Participants 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.
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model rs12210761	3.0040 beta coefficient
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model rs1411283	0.4873 beta coefficient
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model rs12446868	0.5002 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Positive CN Population.

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.

Outcome measures

Measure	HBeAg-Positive CN Participants Treated With Peg-IFN n=819 Participants 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.
SNPs Associated With HBeAg Seroconversion Plus Undetectable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Additive Model rs11163805	1.8610 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Additive Model rs6443144	1.9390 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Additive Model rs11139349	1.8360 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Additive Model rs1831559	1.9060 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Additive Model rs7983441	1.9240 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Additive Model rs11868362	0.3363 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Positive CN Population.

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.

Outcome measures

Measure	HBeAg-Positive CN Participants Treated With Peg-IFN n=819 Participants 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.
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model rs1384010	2.6700 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model rs1351518	2.3000 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model rs1157322	3.0120 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model rs11868362	0.3108 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Positive Population.

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.

Outcome measures

Measure	HBeAg-Positive CN Participants Treated With Peg-IFN n=907 Participants 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.
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model rs11139349	1.8610 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model rs1157322	2.8290 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Positive Population.

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.

Outcome measures

Measure	HBeAg-Positive CN Participants Treated With Peg-IFN n=907 Participants 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.
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model rs1384010	2.6260 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model rs1351518	2.2220 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model rs1157322	2.9500 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model rs646097	0.4639 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

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

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.

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=371 Participants 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.

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

4.3170 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Negative Non-CN Population.

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.

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=371 Participants 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.

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

4.2450 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

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

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.

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=267 Participants 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.

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

0.2583 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Negative CN Population.

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.

Outcome measures

Measure	HBeAg-Positive CN Participants Treated With Peg-IFN n=267 Participants 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.
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Dominant Model rs9496139	0.1812 beta coefficient
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Dominant Model rs2014238	5.8110 beta coefficient
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Dominant Model rs2980231	5.8110 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

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

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.

Outcome measures

Measure	HBeAg-Positive CN Participants Treated With Peg-IFN n=638 Participants 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.
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Model exm2237722	0.1070 beta coefficient
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Model rs16924016	0.3357 beta coefficient
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Model rs2899723	2.0360 beta coefficient
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Model rs8027115	1.9480 beta coefficient
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Model exm2267780	2.0100 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Negative Population.

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.

Outcome measures

Measure	HBeAg-Positive CN Participants Treated With Peg-IFN n=638 Participants 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.
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model rs9973954	0.2975 beta coefficient
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model exm2237722	0.1009 beta coefficient
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model rs1040084	2.3660 beta coefficient
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model rs1913484	2.3610 beta coefficient
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model rs16924016	0.3186 beta coefficient
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model exm1010813	0.1299 beta coefficient
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model rs6576456	0.4112 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

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

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.

Outcome measures

Measure	HBeAg-Positive CN Participants Treated With Peg-IFN n=459 Participants 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.
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model rs17037122	2.9930 beta coefficient
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model rs10475403	0.5024 beta coefficient
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model rs715243	0.5078 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: Non-CN Population.

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.

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=459 Participants 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.

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

3.1610 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

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

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.

Outcome measures

Measure	HBeAg-Positive CN Participants Treated With Peg-IFN n=1086 Participants 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.
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model rs6443144	1.6780 beta coefficient
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model rs2189452	0.6008 beta coefficient
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model rs9324018	1.6680 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

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

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.

Outcome measures

Measure	HBeAg-Positive CN Participants Treated With Peg-IFN n=1086 Participants 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.
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model rs2189452	0.5360 beta coefficient
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model rs7968170	0.4869 beta coefficient
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model rs9324018	1.8700 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

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

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.

Outcome measures

Measure	HBeAg-Positive CN Participants Treated With Peg-IFN n=1545 Participants 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.
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model rs9287655	0.6617 beta coefficient
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model rs2803073	1.5160 beta coefficient
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model rs1937590	1.7220 beta coefficient
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model rs2945861	0.5957 beta coefficient
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model rs1997894	0.6814 beta coefficient
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model rs1495471	1.5540 beta coefficient
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model rs9324018	1.5400 beta coefficient
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model rs1152537	1.7800 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: GT Population.

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.

Outcome measures

Measure	HBeAg-Positive CN Participants Treated With Peg-IFN n=1545 Participants 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.
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model rs10236906	0.5664 beta coefficient
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model rs2945861	0.5576 beta coefficient
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model rs7042473	1.7050 beta coefficient
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model rs2077415	0.5732 beta coefficient
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model rs9324018	1.6850 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: Non-CN Population.

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.

Outcome measures

Measure	HBeAg-Positive CN Participants Treated With Peg-IFN n=459 Participants 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.
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model rs17037122	2.8740 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model rs715243	0.5000 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: Non-CN Population.

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.

Outcome measures

Measure	HBeAg-Positive CN Participants Treated With Peg-IFN n=459 Participants 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.
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model rs2302503	0.3719 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model rs6015181	2.6740 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

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

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.

Outcome measures

Measure	HBeAg-Positive CN Participants Treated With Peg-IFN n=1086 Participants 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.
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model rs1550116	0.5565 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model rs1550115	0.5565 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model rs2082881	0.5565 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model exm2265462	0.5730 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model rs6443144	1.8390 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model rs1403069	0.5769 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model rs9691873	2.2250 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model rs8012912	1.6200 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model rs11158827	1.6200 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model rs11870323	2.1120 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model rs4821558	0.6146 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

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

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.

Outcome measures

Measure	HBeAg-Positive CN Participants Treated With Peg-IFN n=1086 Participants 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.
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model rs6443144	1.9800 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model rs1692421	0.5036 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model rs1692423	0.5029 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model rs9691873	2.3190 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model rs7968170	0.4634 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: GT Population.

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.

Outcome measures

Measure	HBeAg-Positive CN Participants Treated With Peg-IFN n=1545 Participants 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.
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model rs9287655	0.6444 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model rs216312	0.6621 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: GT Population.

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.

Outcome measures

Measure	HBeAg-Positive CN Participants Treated With Peg-IFN n=1545 Participants 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.
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model rs993147	0.5210 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model rs10978436	1.7610 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model rs2370220	0.5233 beta coefficient
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model rs2279519	1.7460 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

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

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.

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=408 Participants 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.

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

5.7670 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

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

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.

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=408 Participants 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.

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

8.6340 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: CN Population.

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.

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=1095 Participants 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.

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

8.2240 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: CN Population.

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.

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=1095 Participants 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.

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

8.2240 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

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

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.

Outcome measures

Measure	HBeAg-Positive CN Participants Treated With Peg-IFN n=1503 Participants 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.
SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Additive Model rs10814834	0.4571 beta coefficient
SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Additive Model rs10491723	2.1090 beta coefficient
SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Additive Model rs6592052	6.6180 beta coefficient
SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Additive Model rs16943470	2.9650 beta coefficient

PRIMARY outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

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

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.

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=1503 Participants 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.

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

7.8720 beta coefficient

OTHER_PRE_SPECIFIED outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Positive Population.

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

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=907 Participants 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.

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

276 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Positive CN Population.

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

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=819 Participants 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.

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

255 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

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

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.

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=88 Participants 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.

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

21 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Positive Population.

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

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=907 Participants 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.

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

193 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Positive CN Population.

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

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=819 Participants 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.

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

175 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Positive Non-CN Population.

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

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=88 Participants 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.

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

18 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Negative Population.

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

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=638 Participants 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.

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

393 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Negative CN Population.

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

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=267 Participants 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.

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

209 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: HBeAg-Negative Non-CN Population.

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

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=371 Participants 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.

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

184 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: GT Population.

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

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=1545 Participants 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.

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

669 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

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

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.

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=1086 Participants 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.

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

464 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: Non-CN Population.

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

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=459 Participants 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.

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

205 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: GT Population.

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

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=1545 Participants 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.

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

586 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: CN Population.

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

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=1086 Participants 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.

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

384 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: Non-CN Population.

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

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=459 Participants 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.

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

202 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

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

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

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=1503 Participants 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.

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

104 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

Population: CN Population.

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

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=1095 Participants 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.

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

80 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Single blood sample ≥24 weeks post-treatment

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

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

Outcome measures

Measure

HBeAg-Positive CN Participants Treated With Peg-IFN n=408 Participants 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.

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

24 participants

Adverse Events

Adult Participants Treated With Peg-IFN

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Medical Communications

Hoffmann-LaRoche

Phone: 800-821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER