This prospective, multicenter, observational study will evaluate on-treatment predictors of response in patients with HBeAg positive or HBeAg negative chronic hepatitis B receiving treatment with peginterferon alfa-2a (PEGASYS®) in accordance with local labeling and the summary of product characteristics. Data will be collected from patients for the duration of their treatment and for up to 24 weeks thereafter.
Study Type
OBSERVATIONAL
Enrollment
141
Peginterferon alfa-2a commercial product (PEGASYS®) was supplied as a solution in prefilled syringes.
Mhat - Pleven; Clinic of Gastroenterology
Pleven, Bulgaria
Umhat St. Georgi; Clinical of Gastroenterology
Plovdiv, Bulgaria
MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases
Sofia, Bulgaria
Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study
Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml).
Time frame: At the end of the study (Week 36)
Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml
Time frame: approximately 3 years
In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive
Time frame: approximately 3 years
Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment
Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml) separately for participants who were hepatitis B envelope antigen (HBeAg) positive and HBeAg negative.
Time frame: At the end of treatment (Week 24)
HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative
Time frame: approximately 3 years
Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients
Time frame: approximately 3 years
Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients
Time frame: approximately 3 years
Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio
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UMHAT Alexandrovska EAD; Gastroenterology
Sofia, Bulgaria
Mhat Queenjoanna; Clinic of Gastroenterology
Sofia, Bulgaria
Military Medical Academy; Gastroenterology
Sofia, Bulgaria
Mhat St. Ivan Rilski; Clinic of Gastroenterology
Sofia, Bulgaria
Mhat St. Zagora; Clinical of Gastroenterology
Stara Zagora, Bulgaria
Mhat Sveta Marina; Clinic of Gastroenterology
Varna, Bulgaria
Time frame: approximately 3 years
Safety: Incidence of Adverse Events
Time frame: approximately 3 years