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Efficacy of Pegylated Interferon Monotherapy versus Sequential Therapy of Entecavir and Pegylated Interferon in Hepatitis B e Antigen-Positive Hepatitis B Patients: A Randomized, Multicenter, Phase IIIb Open-Label Study (POTENT Study)
- Source :
- Chinese Medical Journal, Vol 131, Iss 14, Pp 1645-1651 (2018)
- Publication Year :
- 2018
- Publisher :
- Wolters Kluwer, 2018.
-
Abstract
- Background: Until now, various types of combined therapy with nucleotide analogs and pegylated interferon (Peg-INF) in patients with hepatitis B patients have been tried. However, studies regarding the benefits of de novo combination, late-add on, and sequential treatment are very limited. The objective of the current study was to identify the efficacy of sequential treatment of Peg-INF after short-term antiviral treatment. Methods: Between June 2010 and June 2015, hepatitis B e antigen (HBeAg)-positive patients (n = 162) received Peg-IFN for 48 weeks (mono-treatment group, n = 81) and entecavir (ETV) for 12 weeks with a 48-week course of Peg-IFN starting at week 5 of ETV therapy (sequential treatment group, n = 81). The primary endpoint was HBeAg seroconversion at the end of follow-up period after the 24-week treatment. The primary endpoint was analyzed using Chi-square test, Fisher's exact test, and regression analysis. Results: HBeAg seroconversion rate (18.2% vs. 18.2%, t = 0.03, P = 1.000) and seroclearance rate (19.7% vs. 19.7%, t = 0.03, P = 1.000) were same in both mono-treatment and sequential treatment groups. The rate of alanine aminotransferase (ALT) normalization (45.5% vs. 54.5%, t = 1.12, P = 0.296) and serum hepatitis B virus (HBV)-DNA
- Subjects :
- Entecavir
Hepatitis B
Peginterferon Alfa-2a
Medicine
Subjects
Details
- Language :
- English
- ISSN :
- 03666999
- Volume :
- 131
- Issue :
- 14
- Database :
- Directory of Open Access Journals
- Journal :
- Chinese Medical Journal
- Publication Type :
- Academic Journal
- Accession number :
- edsdoj.4375db57a3ec44e8accc6010238eafd9
- Document Type :
- article
- Full Text :
- https://doi.org/10.4103/0366-6999.235880