A Study of Switch From Nucleotide to Peginterferon Alfa-2a in CHB Patients Achieving HBeAg Loss and HBV DNA <200IU/ml

Summary

A Randomized, open-label, multicenter study. The patients after 1-3 years NAs treatment and having achieved HBeAg loss and HBV DNA \<200IU/ml will be switched to Pegasys for 48 or 96 weeks (with a 12 weeks period of overlap with the NA for safety reasons). The subjects will be randomized into 2 groups: Group 1 : 48-week standard treatment by Peginterferon alfa 2a 180µg/week Group 2 : 96-week prolonged treatment by Peginterferon alfa 2a 180µg/week. All the patients will be followed up for 48 weeks after discontinuation of the study medication. Note: NAs will be stratified LAM, ETV and ADV, with the ratio 1:1:1.

Timeline

Start

2011-10

Primary completion

2016-06

Completion

2016-12

Publications

• Hu P, Shang J, Zhang WH, Gong GZ, Li YG, Chen XY, Jiang JN, Xie Q, Dou XG, Sun YT, Li YF, Liu YX, Liu GZ, Ma DW, Chi XL, Tang H, Li XO, Xie Y, Chen XP, Jiang JJ, Zha P, Hou JL, Gao ZL, Fan HM, Ding JG, Zhang DZ, Ren H. [HBsAg loss with Pegylated-interferon alfa-2a in hepatitis B patients with partial response to nucleos(t)-ide analog: new switch study]. Zhonghua Gan Zang Bing Za Zhi. 2018 Oct 20;26(10):756-764. doi: 10.3760/cma.j.issn.1007-3418.2018.10.005. Chinese.
• Hu P, Shang J, Zhang W, Gong G, Li Y, Chen X, Jiang J, Xie Q, Dou X, Sun Y, Li Y, Liu Y, Liu G, Mao D, Chi X, Tang H, Li X, Xie Y, Chen X, Jiang J, Zhao P, Hou J, Gao Z, Fan H, Ding J, Zhang D, Ren H. HBsAg Loss with Peg-interferon Alfa-2a in Hepatitis B Patients with Partial Response to Nucleos(t)ide Analog: New Switch Study. J Clin Transl Hepatol. 2018 Mar 28;6(1):25-34. doi: 10.14218/JCTH.2017.00072. Epub 2018 Mar 17.

Drugs

Indications