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On-treatment prediction of sustained response to peginterferon alfa-2a for HBeAg-negative chronic hepatitis B patients
Ioannis Goulis1, Stylianos Karatapanis2, Evangelos Akriviadis1, Melanie Deutsch3, George N. Dalekos4, Maria Raptopoulou-Gigi5, Konstantinos Mimidis6, George Germanidis7, Christos Drakoulis8, Christos Triantos9, Elias Zintzaras10,11,12, Georgios Bakalos13,† andGeorge Papatheodoridis3,‡,*
Article first published online: 20 NOV 2014
DOI: 10.1111/liv.12725
© 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Issue
Liver International
Volume 35, Issue 5, pages 1540–1548, May 2015
Article has an altmetric score of 1
Additional Information(Show All)
1 4th Department of Internal Medicine, Αristotle University of Thessaloniki Medical School, Hippokration General Hospital, Thessaloniki, Greece
2 1st Department of Internal Medicine, General Hospital of Rhodes, Rhodes Island, Greece
3 2nd Department of Internal Medicine, Athens University Medical School, Hippokration General Hospital, Athens, Greece
4 Department of Medicine and Research Laboratory of Internal Medicine, University of Thessaly School of Medicine, Larissa, Greece
5 2nd Department of Internal Medicine, Αristotle University of Thessaloniki Medical School, Hippokration General Hospital, Thessaloniki, Greece
6 1st Department of Internal Medicine, Democritus University of Thrace Medical School, Alexandroupolis, Greece
7 1st Internal Medicine Clinic, Αristotle University of Thessaloniki Medical School, AHEPA Hospital, Thessaloniki, Greece
8 2nd Department of Internal Medicine, General Hospital of Nikaia, Athens, Greece
9 Gastroenterology Department, University of Patras Medical School, Patra, Greece
10 BECRO, Pharmaceutical services, Athens, Greece
11 Department of Biomathematics, University of Thessaly School of Medicine, Larissa, Greece
12 The Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA
13 Roche Hellas, Athens, Greece
† F. Hoffmann-La Roche Ltd, Basel, Switzerland
‡ Academic Department of Gastroenterology, Laiko General Hospital, Athens, Greece
* Correspondence
George Papatheodoridis, MD, PhD, Academic Department of Gastroenterology, Athens University Medical School, Laiko General Hospital, 17 Agiou Thoma street, 11527 Athens, Greece
Tel: +30 2107456315
Fax: +30 2107462601
e-mail: [email protected]
Abstract
Background & Aims
We assessed predictors of response in HBeAg-negative chronic hepatitis B patients treated with peginterferon alfa-2a in routine clinical practice.
Methods
Ninety-five HBeAg-negative patients received peginterferonalfa-2a for 48 weeks and were followed-up for 48 weeks post-treatment. Serum HBsAg and HBV DNA levels were monitored during and after therapy with valid commercial assays. Sustained response (SR) was defined as HBV DNA <2000 IU/ml at study week 96.
Results
Twenty-two patients (23%) achieved SR and nine (9.5%) lost HBsAg. HBsAg decline was more profound in patients with SR. HBsAg decline ≥10% from baseline to week 24 was significantly associated with SR [81% (17/21) vs 37% (21/57); Odds ratio: 7.286 (2.162–24.552), P = 0.001]. The PARC rule (no decrease in HBsAg and <2 log drop in HBV DNA at week 12) was evaluated in a subset of 47 patients. Among eight patients who fulfilled the PARC rule, none achieved SR. Of the 39 patients who did not fulfil the PARC rule, 24 (62%) had HBsAg decline of ≥10% at week 24 (12 achieved SR) and 15 (38%) had HBsAg decline of <10% (1 achieved SR; negative predictive value: 93%).
Conclusions
In HBeAg-negative chronic hepatitis B patients treated with peginterferon alfa-2a, HBsAg decline >10% at 24 weeks is significantly associated with SR. The combination of the PARC rule and week 24 decline in HBsAg can identify almost two-thirds of patients who are unlikely to achieve SR. Clinicaltrials.gov identifier: NCT01283074.
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发表于 2015-4-19 21:42
