Case Control Study
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Dec 14, 2016; 22(46): 10210-10218
Published online Dec 14, 2016. doi: 10.3748/wjg.v22.i46.10210
Effect of switching from treatment with nucleos(t)ide analogs to pegylated interferon α-2a on virological and serological responses in chronic hepatitis B patients
Li-Ting He, Xiao-Guang Ye, Xiao-Yuan Zhou
Li-Ting He, Xiao-Guang Ye, Xiao-Yuan Zhou, Department of Infectious Diseases, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou 510260, Guangdong Province, China
Author contributions: Ye XG designed the research and critically reviewed the manuscript for important intellectual content; He LT performed the search, analyzed the data and wrote the manuscript; Zhou XY collected the cases.
Institutional review board statement: The study was reviewed and approved by the Second Affiliated Hospital of Guangzhou Medical University Institutional Review Board.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent before study enrollment.
Conflict-of-interest statement: The authors declare no conflicts.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Dr. Xiao-Guang Ye, Department of Infectious Diseases, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou 510260, Guangdong Province, China. yexiaoguang@126.com
Telephone: +86-20-34152236 Fax: +86-20-34153982
Received: June 20, 2016
Peer-review started: June 22, 2016
First decision: July 29, 2016
Revised: August 25, 2016
Accepted: September 28, 2016
Article in press: September 28, 2016
Published online: December 14, 2016
Processing time: 175 Days and 1.5 Hours
Abstract
AIM

To investigate the efficacy of switching to pegylated interferon-α-2a (PegIFNα-2a) treatment in nucleos(t)ide analog (NA)-treated chronic hepatitis B (CHB) responder patients.

METHODS

A 48-wk prospective and retrospective treatment trial of NA-treated CHB patients who had received entecavir (ETV) for at least 48 wk and had serum hepatitis B virus (HBV)-DNA < 500 IU/mL, serum hepatitis B envelope antigen (HBeAg) < 100 S/CO, serum alanine aminotransferase, and aspartate aminotransferase levels < 2 × the upper limit of normal of 40 IU/L was performed. The effects on virological and serological responses and adverse reactions to 0.5 mg daily ETV for 48 wk vs switching to PegIFNα-2a were compared. Forty-four patients were randomized to be switched from NA treatment to the PegIFNα-2a group, and 44 patients were simultaneously randomized to the ETV group.

RESULTS

After 48 wk of therapy, the decrease in hepatitis B surface antigen (HBsAg) levels was greater in the PegIFNα-2a group than in the ETV group (3.1340 log10 IU/mL vs 3.6950 log10 IU/mL, P = 0.00). Seven patients who were anti-HBs-positive at baseline achieved HBsAg loss when switched to PegIFNα-2a (15.91% vs 0%, P = 0.018). The HBeAg serological conversion rate was higher in the PegIFNα-2a group than in the ETV group; however, the difference was not significant because of the small sample sizes (34.38% vs 21.88%, P = 0.232). In the PegIFNα-2a group, patients with HBsAg levels < 1500 IU/mL at baseline had higher HBeAg seroconversion and HBsAg loss rates at week 48 than those with HBsAg levels ≥ 1500 IU/mL (HBeAg seroconversion: 17.86% vs 62.5%, P = 0.007; HBsAg loss: 41.67% vs 6.25%, P = 0.016). Moreover, patients with HBsAg levels < 1500 IU/mL at week 24 had higher HBsAg loss rates after therapy than those with HBsAg levels ≥ 1500 IU/mL (36.84% vs 0%, P = 0.004). However, there were no statistically significant differences in HBeAg seroconversion rates (47.06% vs 25.93%, P = 0.266).

CONCLUSION

NA-treated CHB patients switched to sequential PegIFNα-2a achieved highly potent treatment termination safely.

Keywords: Chronic hepatitis B; Entecavir; pegylated interferon-α-2a; Sequential therapy; Effect

Core tip: It is necessary to achieve termination safely with minimal risk of long-term resistance in nucleos(t)ide analog (NA)-treated chronic hepatitis B (CHB) patients. We studied NA-treated CHB patients who stopped NAs safely and achieved sustained virological and immunological responses after treatment. We clarified the efficacy and safety of sequential 48-wk pegylated interferon-α-2a (PegIFNα-2a) in NA-treated CHB patients during and after treatment termination. Patients were selected based on the initial serum hepatitis B surface antigen (HBsAg) level. PegIFNα-2a was adjusted based on HBsAg levels at 24 wk of treatment, an important and significant factor in achieving treatment termination safely with immune control.