A Multicenter, Prospective, Observational, Non-Interventional Cohort Study Evaluating On-Treatment Predictors of Response in Subjects With HBeAg Positive and HBeAg Negative Chronic Hepatitis B Receiving Therapy With PEGASYS(R) (Peginterferon Alfa-2a 40KD)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hepatitis B, Chronic
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 1842
- Locations
- 249
- Primary Endpoint
- Percentage of Participants With Hepatitis B Virus Surface Antigen Clearance
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This observational, non-interventional cohort study will evaluate predictors of response in patients with chronic hepatitis B receiving standard of care Pegasys therapy. Efficacy and safety parameters will also be evaluated. Patients included in the study will be followed for the duration of their treatment and for up to 3 years thereafter.
Investigators
Eligibility Criteria
Inclusion Criteria
- •adult patient, \>/= 18 years of age
- •chronic hepatitis B
- •treatment with peginterferon alfa-2A
Exclusion Criteria
- •coinfection with HAV, HCV and HIV
Outcomes
Primary Outcomes
Percentage of Participants With Hepatitis B Virus Surface Antigen Clearance
Time Frame: Up to 276 Weeks
Percentage of participants who became Hepatitis B Virus Surface Antigen (HBsAg) negative by the end of the observation period. A participant was considered to have achieved HBsAg clearance if the HBsAg measurement was reported as: (a) 'Negative' or (b) a quantitative result lower than the reported lower limit of detection. An observational period was upto 3 years post-treatment. The analysis was performed by 2 methods: Analysis A and Analysis B. For analysis A, all participants included in the analyzed population were used (participants with missing measurement for calculation of the endpoint were considered non-responders regarding the endpoint). For analysis B method, only participants in the analyzed population without missing measurements for calculation of the endpoint were used (analysis "as observed").
Predictive Values of Early on Treatment Response for Hepatitis B Surface Antigen Clearance 3 Years Post-Treatment- Hepatitis B Virus e Antigen Positive Participants
Time Frame: Up to 276 Weeks
The probability that the participant who develops an early virological/serological response would achieve Hepatitis B Surface Antigen (HBsAg) clearance 3 years post-treatment is called the positive predictive value (PPV) of the early virological/serological response. The probability that the participant who fails to develop an early virological/serological response also would fail to achieve HBsAg clearance 3 years post-treatment is called the negative predictive value (NPV) of the early virological/serological response. The positive and negative predictive values of early response at Weeks 12 and 24 on achievement of HBsAg clearance at 3 years post-treatment were examined. The following evidence of early response was explored (giving both NPV and PPV): For HBeAg positive participant, HBsAg \<1,500 International Units Per Milliliter (IU/mL) and HBsAg \<20,000 IU/mL at Weeks 12 and 24.
Predictive Values of Early on Treatment Response for Hepatitis B Surface Antigen Clearance 3 Years Post-Treatment- Hepatitis B Virus e Antigen Negative Participants
Time Frame: Up to 276 Weeks
The probability that the participant who develops an early virological/serological response would achieve HBsAg clearance 3 years post-treatment is called the PPV of the early virological/serological response. The probability that the participant who fails to develop an early virological/serological response also would fail to achieve HBsAg clearance 3 years post-treatment is called the NPV of the early virological/serological response. The positive and negative predictive values of early response at Weeks 12 and 24 on achievement of HBsAg clearance at 3 years post-treatment were examined. The following evidence of early response was explored (giving both NPV and PPV): For HBeAg negative patients, any decline in HBsAg from baseline to Week 12 and 24 and at least a 10% decline in HBsAg from baseline to Weeks 12 and 24.
Secondary Outcomes
- Number of Participants With Non-Serious Adverse Drug Reactions(Up to 276 Weeks)
- Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion in Hepatitis B Virus e Antigen Positive Participants(Up to 276 Weeks)
- Percentage of Participants With Hepatitis B Virus e Antigen Loss in Hepatitis B Virus e Antigen Positive Participants(Up to 276 Weeks)
- Quantitative Hepatitis B Surface Antigen(Up to 276 Weeks)
- Number of Participants With Chronic Hepatitis B - Associated Clinical Endpoints- Liver Transplantation, Hepatocellular Carcinoma, and Liver Decompensation(Up to 276 Weeks)
- Percentage of Participants With Hepatitis B Surface Antigen Seroconversion(Up to 276 Weeks)
- Alanine Transaminase Ratio Over Time by Hepatitis B Virus e Antigen Status(Up to 276 Weeks)
- Number of Participants With Adverse Events and Serious Adverse Events(Up to 276 Weeks)
- Percentage of Participants With Normalization of Alanine Transaminase(Up to 276 Weeks)
- Number of Participants With Chronic Hepatitis B Associated Clinical Endpoints- Liver Cirrhosis(Up to 276 Weeks)
- Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid to <2,000 International Units Per Milliliter(Up to 276 Weeks)
- Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion and Hepatitis B Virus Deoxyribonucleic Acid <2000IU/mL in Hepatitis B Virus e Antigen Positive Participants(Up to 276 Weeks)
- Number of Participants With Serious Adverse Drug Reactions(Up to 276 Weeks)
- Number of Deaths During Observation Period(Up to 276 Weeks)