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On‐treatment prediction of sustained response to peginterferon alfa‐2a for HB eAg‐negative chronic hepatitis B patients
Author(s) -
Goulis Ioannis,
Karatapanis Stylianos,
Akriviadis Evangelos,
Deutsch Melanie,
Dalekos George N.,
RaptopoulouGigi Maria,
Mimidis Konstantinos,
Germanidis George,
Drakoulis Christos,
Triantos Christos,
Zintzaras Elias,
Bakalos Georgios,
Papatheodoridis George
Publication year - 2015
Publication title -
liver international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.873
H-Index - 110
eISSN - 1478-3231
pISSN - 1478-3223
DOI - 10.1111/liv.12725
Subject(s) - medicine , hbsag , gastroenterology , chronic hepatitis , hbeag , peginterferon alfa 2a , odds ratio , immunology , hepatitis b virus , virus , ribavirin
Background & Aims We assessed predictors of response in HB eAg‐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 HB sAg. HB sAg decline was more profound in patients with SR . HB sAg 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 HB sAg 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 HB sAg decline of ≥10% at week 24 (12 achieved SR ) and 15 (38%) had HB sAg decline of <10% (1 achieved SR ; negative predictive value: 93%). Conclusions In HB eAg‐negative chronic hepatitis B patients treated with peginterferon alfa‐2a, HB sAg decline >10% at 24 weeks is significantly associated with SR . The combination of the PARC rule and week 24 decline in HB sAg can identify almost two‐thirds of patients who are unlikely to achieve SR . Clinicaltrials.gov identifier: NCT01283074.