An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive Chronic Hepatitis B in Vietnam

Study Overview
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Brief Summary
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This prospective, multicenter, observational study will evaluate the sustained response in patients with HBeAg positive chronic hepatitis B who are treated with Pegasys according to standard of care and in line with the current local labeling in routine clinical practice in Vietnam. Eligible patients will be followed for the duration of their treatment and for up to 2 years thereafter.

Official Title
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A Multicenter, Prospective, Observational, Non-Interventional Cohort Study Evaluating Sustained Response in Subjects With HBeAg Positive Chronic Hepatitis B Receiving Therapy With Pegasys (Peginterferon Alfa-2a) in Vietnam

Conditions
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Hepatitis B, Chronic

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients, >/= 18 years of age HBeAg-positive serologically proven chronic hepatitis B with or without cirrhosis Elevated serum ALT > ULN (upper limit of normal) but </= 10 x ULN Patients with no contra-indications to Pegasys therapy as detailed in the label Written informed consent where local regulations allow or require it Exclusion Criteria: Patients should not receive concomitant therapy with telbivudine Co-infection with hepatitis A, hepatitis B or HIV Pregnant or breastfeeding women Patients with depression/mental diseases Neutrophil at baseline > 90.000/mm3 Abnormal T4 or TSH

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL at 6 Months After End of Treatment | A participant was considered to have achieved suppression of Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) to <2,000 International Units Per Milliliter (IU/mL) if the HBV DNA measurement is lower than 2,000 IU/mL. | 6 months | 
| Percentage of Participants Who Become Hepatitis B Envelope Antigen-Negative and Anti-HBe-Positive During Treatment and at 6 and 12 Months After End of Treatment | HBeAg is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people. HBeAg-negative hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL During the Observation Period | A participant was considered to have achieved suppression of HBV DNA to <2,000 IU/mL if the HBV DNA measurement is lower than 2,000 IU/mL. | Up to 24 months | 
| Percentage of Participants With Loss of Hepatitis B Envelope Antigen During the Observation Period | Loss of HBeAg is defined as the absence of HBeAg. A participant was considered to have achieved HBeAg loss if the HBeAg measurement was reported as (a) 'NEGATIVE' or (b) a quantitative result was lower than the reported lower detection limit. | Up to 24 months | 
| Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion and Hepatitis B Virus Deoxyribonucleic Acid Suppression (<2,000 IU/mL) During the Observation Period | HBeAg seroconversion is defined as the absence of HBeAg and the presence of antibody to hepatitis B antigen (anti-HBe) . A participant was considered to have achieved suppression of HBV DNA to <2,000 IU/mL if the HBV DNA measurement is lower than 2,000 IU/mL. | Up to 24 months | 
| Percentage of Participants Who Become Hepatitis B Envelope Antigen Negative During the Observation Period | HBeAg is a protein from the hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people. HBeAg-negative hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. | Up to 24 months | 
| Incidence of Normalization of Serum Alanine Transaminase | Normalization of alanine transaminase (ALT) values means that ALT values out of the normal range returned to within the normal range. | Up to 24 months | 
| Number of Participants With Incidence of Adverse Events | An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product | Up to 24 months |