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)

Chinese Medical Journal
Dae Won JunJi Sung Lee

Abstract

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. 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. 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 <2000...Continue Reading

References

Aug 30, 2001·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·L SerfatyR Poupon
Jul 1, 2005·The New England Journal of Medicine·George K K LauUNKNOWN Peginterferon Alfa-2a HBeAg-Positive Chronic Hepatitis B Study Group
Oct 15, 2005·Journal of Korean Medical Science·Si Hyun BaeMasashi Mizokami
Jul 8, 2009·The Korean Journal of Hepatology·Ji-Hyun ChoHaak-Cheoul Kim
Sep 6, 2014·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Qing XieMianzhi Zhao
Oct 29, 2014·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Willem Pieter BrouwerUNKNOWN ARES Study Group

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Citations

Sep 19, 2020·Journal of Comparative Effectiveness Research·Urbano SbarigiaMaarten Postma
Mar 13, 2019·Expert Opinion on Pharmacotherapy·Hans L Tillmann, Gbeminiyi Samuel

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