None listed
Conditions
Brief summary
The aim of this study is to focus on the clinical utility of hepatitis B surface antigen (HBsAg) quantitation by assessing on-treatment serum HBsAg kinetics in newly diagnosed HBeAg-negative and positive chronic hepatitis B (CHB) patients who will be treated with pegylated interferon-based therapies or nucleos(t)ide analogues as endicated in our Hepatology Clinic. We suggest that approximately 100 eligible CHB patients will participate and be followed up during 3 years in this prospective analysis. Serum hepatitis B virus (HBV) DNA, liver chemistry tests and HBsAg (Abbott Architect HBsAg QT assay) will be assessed at baseline and during treatment (weeks 0, 4, 8, 12, 24, 36, 48, 52, 64, 72, 84, 100). Decline in HBsAg and HBV DNA over time will be determined, results will be stratified according to treatment groups and baseline characteristics and then analyzed with regard to our primary and secondary outcomes.
Interventions
1, Arm- Newly diagnosed chronic hepatitis B patients starting to receive pegylated interferon (PEG-IFN in a dose of 1.5 mcg per kg subcutaneously once weekly or 180 mcg subcutaneously once weekly, for 48 weeks) based therapies in our Hepatology Clinic.
2, Arm- Newly diagnosed chronic hepatitis B patients starting to receive nucleos(t)ide analogues (NAs:lamivudine 100 mg orally once daily, telbivudine 600 mg orally once daily, tenofovir 245 mg orally once daily, entecavir 0.5 mg orally once dail
1, Arm- Newly diagnosed chronic hepatitis B patients starting to receive pegylated interferon (PEG-IFN in a dose of 1.5 mcg per kg subcutaneously once weekly or 180 mcg subcutaneously once weekly, for 48 weeks) based therapies in our Hepatology Clinic. 2, Arm- Newly diagnosed chronic hepatitis B patients starting to receive nucleos(t)ide analogues (NAs:lamivudine 100 mg orally once daily, telbivudine 600 mg orally once daily, tenofovir 245 mg orally once daily, entecavir 0.5 mg orally once daily, until the HBe seroconversion occurs in HBeAg positive patients or until the HBs seroconversion occurs in Anti HBe antibody positive patients) in our Hepatology Clinic.
Sponsors
Gastroenterology Institute of Marmara University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Treatment-naive-hepatitis B virus infection patients for whom a treatment plan has been made by the hepatology outpatient clinic. (Indication for treatment is the presence of HBs Ag in serum for more than 6 months, and by liver biopsy showing histological features of chronic hepatitis compatible with HBV infection.)
Exclusion criteria
- Prior antiviral therapy - Immunosuppressive therapy within the previous 6 months - Presence of viral coinfections,with hepatitis C, hepatitis D, or human immunodeficiency virus; - Presence of other acquired or inherited causes of liver disease
Outcome results
None listed