Comparison of fibrosis regression of entecavir alone or combined with pegylated interferon alpha2a in patients with chronic hepatitis B.

Abstract

BACKGROUND AND AIMS:

Antiviral treatment with necleos(t)ide analogues contributes to histological improvement and virologic response in chronic hepatitis B (CHB) patients. However, whether adding pegylated interferon alpha2a (Peg-IFN-α-2a) can help additional clinical benefit, particularly on fibrosis regression was still unknown.

METHODS:

Chronic hepatitis B patients with pre-treatment biopsy-proven Ishak fibrosis score 2, 3 or 4 were randomly assigned to entecavir (ETV) alone or ETV plus Peg-IFN-α-2a (Peg-IFN-α-2a add-on) group (1:2 ratio). Post-treatment liver biopsy was performed at week 78. Fibrosis regression was defined as decrease in Ishak fibrosis score by ≥ 1 stage or predominantly regressive categorized by P-I-R score. Serum HBV DNA levels were assessed at baseline and every 26 weeks, while HBsAg and HBeAg were evaluated at baseline and every 52 weeks.

RESULTS:

A total of 218 treatment-naive CHB patients were randomly assigned to ETV alone or Peg-IFN-α-2a add-on group. Totals of 155 patients (ETV alone: Peg-IFN-α-2a add-on, 47:108) were included in statistical analysis. Fibrosis regression rates were 68% (32/47) in the ETV alone and 56% (60/108) in Peg-IFN-α-2a add-on group (p = 0.144). Both groups showed a similar trend of virological suppression during the process of 104-week antiviral therapy (p = 0.132). HBeAg or HBsAg loss or seroconversion rates in the ETV alone group were lower than Peg-IFN-α-2a add-on group though without statistical significance.

CONCLUSIONS:

Peg-IFN-α-2a add-on therapy did not yield additional fibrosis regression and virologic response than ETV alone therapy.

• Authors: Shuyan Chen, Jialing Zhou, Xiaoning Wu, Tongtong Meng, Bingqiong Wang, Hui Liu, Tailing Wang, Xinyan Zhao, Yuanyuan Kong, Shanshan Wu, Xiaojuan Ou, Jidong Jia, Yameng Sun, Hong You
• Journal: Hepatology international (Hepatol Int) Vol. 15 Issue 3 Pg. 611-620 (Jun 2021) ISSN: 1936-0541 [Electronic] United States
• PMID: 33677771 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)
• Copyright: © 2021. Asian Pacific Association for the Study of the Liver.

Chemical References

• Antiviral Agents
• Drug Combinations
• Hepatitis B Surface Antigens
• Hepatitis B e Antigens
• Interferon-alpha
• Recombinant Proteins
• Polyethylene Glycols
• entecavir
• Guanine
• peginterferon alfa-2a

Topics

• Antiviral Agents (therapeutic use)
• Drug Combinations
• Fibrosis
• Guanine (analogs & derivatives, therapeutic use)
• Hepatitis B Surface Antigens
• Hepatitis B e Antigens
• Hepatitis B, Chronic (drug therapy)
• Humans
• Interferon-alpha (therapeutic use)
• Polyethylene Glycols (therapeutic use)
• Recombinant Proteins (therapeutic use)
• Treatment Outcome