Pegylated Interferon Alfa-2b Add-on Treatment in Hepatitis B Virus Envelope Antigen-Positive Chronic Hepatitis B Patients Treated with Nucleos(t)ide Analogue: A Randomized, Controlled Trial (PEGON).

Autor:	Heng Chi, Hansen, Bettina E., Simin Guo, Ning Ping Zhang, Xun Qi, Liang Chen, Qing Guo, Arends, Pauline, Ji-Yao Wang, Verhey, Elke, de Knegt, Robert J., Qing Xie, Janssen, Harry L. A., Chi, Heng, Guo, Simin, Zhang, Ning Ping, Qi, Xun, Chen, Liang, Guo, Qing, Wang, Ji-Yao
Předmět:	CHRONIC hepatitis B INTERFERONS RANDOMIZED controlled trials NUCLEOSIDES ANTIGENS THERAPEUTICS ANTIVIRAL agents COMBINATION drug therapy COMPARATIVE studies DNA HEPATITIS viruses RESEARCH methodology MEDICAL cooperation POLYETHYLENE glycol PROTEINS PURINES RECOMBINANT proteins RESEARCH STATISTICAL sampling VIRAL antigens LOGISTIC regression analysis EVALUATION research TREATMENT effectiveness
Zdroj:	Journal of Infectious Diseases; 4/1/2017, Vol. 215 Issue 7, p1085-1093, 9p
Abstrakt:	Background: We studied whether 48 weeks of pegylated interferon alfa-2b (peginterferon) add-on therapy increases serological response in hepatitis B virus (HBV) envelope antigen (HBeAg)-positive patients receiving nucleos(t)ide analogue (NA) therapy, compared with continued NA monotherapy.Methods: This randomized trial included HBeAg-positive patients with compensated liver disease who were treated with entecavir/tenofovir for >12 months and had an HBV DNA load of <2000 IU/mL. Patients were randomly assigned in a 1:1 ratio to 48 weeks of peginterferon add-on therapy (n = 39) or continued NA monotherapy (n = 38). Response (defined as HBeAg seroconversion with an HBV DNA load of <200 IU/mL) was assessed at week 48, with responders discontinuing NA therapy at week 72.Results: The primary end point (response at week 96) was achieved in 18% of patients who were assigned peginterferon add-on therapy versus 8% of patients assigned NA monotherapy (P = .31). Among 58 interferon-naive patients, add-on therapy led to a greater frequency of HBeAg seroconversion (30% vs 7%; P = .034) and response (26% vs 7%; P = .068) at week 96, compared with monotherapy. Among 8 responders at week 48 who discontinued NA therapy at week 72, 6 patients (75%) maintained a response until week 96 (4 of 6 [67%] in the add-on therapy group vs 2 of 2 [100%] in the monotherapy group; P = 1.00). Adverse events were mainly related to peginterferon.Conclusion: The primary end point was negative, but peginterferon add-on therapy appeared to result in a greater frequency of HBeAg seroconversion, compared with NA monotherapy, in interferon-naive patients receiving NA therapy.Clinical Trials Registration: NCT01532843. [ABSTRACT FROM AUTHOR]
Databáze:	Complementary Index
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