On-treatment prediction of sustained response to peginterferon alfa-2a for HBeAg-negative chronic hepatitis B patients
Ioannis Goulis 1,
Stylianos Karatapanis 2,
Evangelos Akriviadis 1,
Melanie Deutsch 3,
George N. Dalekos 4,
Maria Raptopoulou-Gigi 5,
Konstantinos Mimidis 6,
George Germanidis 7,
Christos Drakoulis 8,
Christos Triantos 9,
Elias Zintzaras 10,11,12,
Georgios Bakalos 13,14 and
George Papatheodoridis 3,15,*
DOI: 10.1111/liv.12725
This article is protected by copyright. All rights reserved.
Vol. 34 Issue 10
Liver International
Accepted Article (Accepted, unedited articles published online and citable. The final edited and typeset version of record will appear in future.)
Abstract
Background & Aims
We assessed predictors of response in HBeAg-negative chronic hepatitis B patients treated with peginterferonalfa-2a in routine clinical practice.
Methods
Ninety-five HBeAg-negative patients receivedpeginterferonalfa-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 <2,000 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 fulfill 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.