Back to Search
Start Over
Adding pegylated interferon to entecavir for hepatitis B e antigen-positive chronic hepatitis B: A multicenter randomized trial (ARES study).
- Source :
-
Hepatology (Baltimore, Md.) [Hepatology] 2015 May; Vol. 61 (5), pp. 1512-22. Date of Electronic Publication: 2015 Feb 27. - Publication Year :
- 2015
-
Abstract
- Unlabelled: Entecavir (ETV) is a potent inhibitor of hepatitis B viral replication, but long-term therapy may be required. We investigated whether adding on pegylated interferon (Peg-IFN) to ETV therapy enhances serological response rates. In this global investigator-initiated, open-label, multicenter, randomized trial, hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) patients with compensated liver disease started on ETV monotherapy (0.5 mg/day) and were randomized in a 1:1 ratio to either Peg-IFN add-on therapy (180 µg/week) from week 24 to 48 (n = 85) or to continue ETV monotherapy (n = 90). Response was defined as HBeAg loss with HBV DNA <200 IU/mL at week 48. Responders discontinued ETV at week 72. All patients were followed until week 96. Response was achieved in 16 of 85 (19%) patients allocated to the add-on arm versus 9 of 90 (10%) in the monotherapy arm (P = 0.095). Adjusted for HBV DNA levels before randomized therapy, Peg-IFN add-on was significantly associated with response (odds ratio: 4.8; 95% confidence interval: 1.6-14.0; P = 0.004). Eleven (13%) of the add-on-treated patients achieved disease remission after ETV cessation versus 2 of 90 (2%) of those treated with monotherapy (P = 0.007), which was 79% (11 of 14) versus 25% (2 of 8) of those who discontinued ETV (P = 0.014). At week 96, 22 (26%) patients assigned add-on versus 12 (13%) assigned monotherapy achieved HBeAg seroconversion (P = 0.036). Peg-IFN add-on led to significantly more decline in hepatitis B surface antigen, HBeAg, and HBV DNA (all P < 0.001). Combination therapy was well tolerated.<br />Conclusion: Although the primary endpoint was not reached, 24 weeks of Peg-IFN add-on therapy led to a higher proportion of HBeAg response, compared to ETV monotherapy. Add-on therapy resulted in more viral decline and appeared to prevent relapse after stopping ETV. Hence, Peg-IFN add-on therapy may facilitate the discontinuation of nucleos(t)ide analogs.<br /> (© 2014 by the American Association for the Study of Liver Diseases.)
- Subjects :
- Adult
Drug Therapy, Combination
Female
Guanine administration & dosage
Humans
Interferon alpha-2
Male
Recombinant Proteins administration & dosage
Antiviral Agents administration & dosage
Guanine analogs & derivatives
Hepatitis B e Antigens blood
Hepatitis B, Chronic blood
Hepatitis B, Chronic drug therapy
Interferon-alpha administration & dosage
Polyethylene Glycols administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1527-3350
- Volume :
- 61
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Hepatology (Baltimore, Md.)
- Publication Type :
- Academic Journal
- Accession number :
- 25348661
- Full Text :
- https://doi.org/10.1002/hep.27586