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A Randomized, Open-Label Clinical Study of Combined Pegylated Interferon Alfa-2a (40KD) and Entecavir Treatment for Hepatitis B \e\ Antigen–Positive Chronic Hepatitis B
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A Randomized, Open-Label Clinical Study of Combined Pegylated Interferon Alfa-2a (40KD) and Entecavir Treatment for Hepatitis B \e\ Antigen–Positive Chronic Hepatitis B
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A Randomized, Open-Label Clinical Study of Combined Pegylated Interferon Alfa-2a (40KD) and Entecavir Treatment for Hepatitis B \e\ Antigen–Positive Chronic Hepatitis B
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Journal Article
A Randomized, Open-Label Clinical Study of Combined Pegylated Interferon Alfa-2a (40KD) and Entecavir Treatment for Hepatitis B \e\ Antigen–Positive Chronic Hepatitis B
2014
Overview
Background. Treatment with pegylated interferon (peg-IFN) alfa-2a (40KD) results in hepatitis B \"e\" antigen (HBeAg) seroconversion 6 months after treatment in up to 36% of HBeAg-positive chronic hepatitis B patients. This study explored the efficacy of a novel combination of peg-IFN alfa-2a and entecavir (ETV), a potent nucleoside analogue. Methods. In total, 218 treatment-naive Chinese HBeAg-positive patients were randomized to peg-IFN alfa-2a (180 μg/week) for 48 weeks, either as monotherapy (n = 72), or with 24 weeks of ETV (0.5 mg/daily) added at week 13 (ETV add-on, n = 73), or pretreatment with a 24-week course of ETV, starting peg-IFN alfa-2a at week 21 (ETV pretreatment, n = 73). The primary endpoint was reduction in quantitative HBeAg from baseline to 24 weeks posttreatment. Results. Significant reductions in HBeAg from baseline were achieved in all treatment groups 24 weeks posttreatment; reductions were comparable across treatment arms (shown as log10 Paul Ehrlich international units [PEIU]/mL): monotherapy: −1.4 (SD, 1.8); ETV add-on: −1.6 (SD, 1.8); ETV pretreatment: −1.3 (SD, 1.7). Rates of HBeAg seroconversion were similar across treatment groups posttreatment (monotherapy: 22 [31%]; ETV add-on: 18 [25%]; ETV pretreatment: 19 [26%]). Significantly greater reductions of hepatitis B virus DNA were achieved with ETV add-on while on treatment, but were not sustained posttreatment. Safety profiles were comparable between treatment groups; adverse events were experienced by 62 (86%) monotherapy, 65 (89%) ETV add-on, and 58 (81%) ETV pretreatment patients. Conclusions. Neither ETV add-on nor ETV pretreatment demonstrated superiority compared with 48 weeks of peg-IFN alfa-2a monotherapy. The optimal treatment strategy using nucleos(t)ide analogues and peg-IFN alfa-2a remains to be determined.
Publisher
Oxford University Press
Subject
/ Antibiotics. Antiinfectious agents. Antiparasitic agents
/ Antigens
/ Antiviral Agents - therapeutic use
/ Biological and medical sciences
/ DNA
/ Female
/ Guanine - analogs & derivatives
/ Hepatitis B e Antigens - blood
/ Hepatitis B, Chronic - blood
/ Hepatitis B, Chronic - drug therapy
/ Hepatitis B, Chronic - immunology
/ Humans
/ Interferon-alpha - therapeutic use
/ Liver
/ Male
/ Pharmacology. Drug treatments
/ Polyethylene Glycols - therapeutic use
/ Recombinant Proteins - therapeutic use
/ Viruses
