studies

HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 1189A
yrs:1.07%, p=0.046). HCC development beyond yr-5 was
associated with older age (RH per yr:1.069, 95% CI:0.997-
1.146; p=0.062) or age ≥55 yrs at ETV/TDF start (p=0.029
by log-rank), but not with gender (p=0.340) or presence of
cirrhosis at baseline (p=0.371). Conclusions: The HCC risk
seems to be decreasing after the first 5 yrs of ETV/TDF therapy
in CHB patients, especially in those with compensated cirrhosis
at baseline. Older age at treatment initiation, particularly age
≥55 yrs, appears to represent the main risk factor associated
with late HCC development.
Disclosures:
George V. Papatheodoridis - Advisory Committees or Review Panels: Merck
Sharp & Dohme, Novartis, Abbvie, Boerhinger Ingelheim, Bristol-Meyer Squibb,
Gilead, Roche, Janssen, GlaxoSmith Kleine; Grant/Research Support: Roche,
Gilead, Bristol-Meyer Squibb, Abbvie, Janssen; Speaking and Teaching: Merck
Sharp & Dohme, Bristol-Meyer Squibb, Gilead, Roche, Janssen, Abbvie
Maria Buti - Advisory Committees or Review Panels: Gilead, Janssen, MSD;
Grant/Research Support: Gilead, Janssen; Speaking and Teaching: Gilead,
Janssen, BMS
Florian van Bömmel - Advisory Committees or Review Panels: Gilead Sciences
Inc., Roche Pharmaceutics; Grant/Research Support: Biopredictive; Speaking
and Teaching: Bristol-Myers Squibb, Janssen, Roche Pharmaceutics, Gilead Sciences
Inc., Abbvie
Ioannis Goulis - Consulting: Gilead Sciences, Abbvie, Janssen-Cilag, Janssen-Cilag,
BMS; Grant/Research Support: BMS; Speaking and Teaching: BMS, Gilead
Sciences, Janssen-Cilag
Spilios Manolakopoulos - Advisory Committees or Review Panels: NOVARTIS,
ABBVIE, MSD, BMS, GILEAD, JANNSEN; Consulting: GILEAD, BMS, ABBVIE,
JANNSEN, MSD; Grant/Research Support: BMS, GILEAD; Speaking and Teaching:
ABBVIE, MSD, GILEAD, BMS, GSK, JANNSEN
Cihan Yurdaydin - Advisory Committees or Review Panels: Janssen, Roche,
Merck, Gilead, AbbVie; Speaking and Teaching: BMS
Thomas Berg - Advisory Committees or Review Panels: Gilead, BMS, Roche,
Tibotec, Vertex, Jannsen, Novartis, Abbott, Merck, Abbvie; Consulting: Gilead,
BMS, Roche, Tibotec; Vertex, Janssen; Grant/Research Support: Gilead, BMS,
Roche, Tibotec; Vertex, Jannssen, Merck/MSD, Boehringer Ingelheim, Novartis,
Abbvie; Speaking and Teaching: Gilead, BMS, Roche, Tibotec; Vertex, Janssen,
Merck/MSD, Novartis, Merck, Bayer, Abbvie
Massimo Colombo - Advisory Committees or Review Panels: BRISTOL-MEY-
ERS-SQUIBB, SCHERING-PLOUGH, ROCHE, GILEAD, BRISTOL-MEYERS-SQUIBB,
SCHERING-PLOUGH, ROCHE, GILEAD, Janssen Cilag, Achillion; Grant/
Research Support: BRISTOL-MEYERS-SQUIBB, ROCHE, GILEAD, BRISTOL-MEY-
ERS-SQUIBB, ROCHE, GILEAD; Speaking and Teaching: Glaxo Smith-Kline,
BRISTOL-MEYERS-SQUIBB, SCHERING-PLOUGH, ROCHE, NOVARTIS, GILEAD,
VERTEX, Glaxo Smith-Kline, BRISTOL-MEYERS-SQUIBB, SCHERING-PLOUGH,
ROCHE, NOVARTIS, GILEAD, VERTEX, Sanofi
Rafael Esteban - Speaking and Teaching: MSD, BMS, Novartis, Gilead, Glaxo,
MSD, BMS, Novartis, Gilead, Glaxo, Janssen
Harry L. Janssen - Consulting: AbbVie, Bristol Myers Squibb, GSK, Gilead Sciences,
Innogenetics, Merck, Medtronic, Novartis, Roche, Janssen, Medimmune,
ISIS Pharmaceuticals, Tekmira; Grant/Research Support: AbbVie, Bristol Myers
Squibb, Gilead Sciences, Innogenetics, Merck, Medtronic, Novartis, Roche,
Janssen, Medimmune
Pietro Lampertico - Advisory Committees or Review Panels: Bayer, Bayer; Speaking
and Teaching: Bristol-Myers Squibb, Roche, GlaxoSmithKline, Novartis, Gilead,
Bristol-Myers Squibb, Roche, GlaxoSmithKline, Novartis, Gilead
The following authors have nothing to disclose: Ramazan Idilman, George N.
Dalekos, Heng Chi, José Luís Calleja, Vana Sypsa, Federica Invernizzi, Spyros I.
Siakavellas, Onur Keskin, Nikolaos Gatselis, Bettina E. Hansen, Maria Lehretz,
Juan de la Revilla, Savvoula Savvidou, Anastasia Kourikou, Floriana Facchetti,
Jiannis Vlachogiannakos, Kostas Galanis
2013
Week 24 HBsAg levels predict response to peginterferon
alfa-2b in HBeAg-positive genotype B or C
chronic hepatitis B patients not meeting a week 12 stopping-rule
Milan J. Sonneveld 1 , Jun Cheng 2 , Qing Xie 3 , Bettina E. Hansen 1 ,
Jin-Lin Hou 4 , Fehmi Tabak 5 , Stefan Zeuzem 6 , Harry L. Janssen 1,7 ;
1 Erasmus MC, University Medical Center Rotterdam, Rotterdam,
Netherlands; 2 Capital Medical University, Ditan Hospital, Beijing,
China; 3 Infectious Diseases, Ruijin Hospital, Shanghai, China;
4 Nanfang Hospital, Infectious Diseases, Guangzhou, China;
5 Istanbul Medical School, Hepatology, Istanbul, Turkey; 6 Medical
clinic 1, Goethe University, Frankfurt, Germany; 7 Gastroenterology,
University Health Network, Toronto, ON, Canada
Background & Aims. Serum levels of HBsAg (qHBsAg) predict
response in HBeAg-positive patients with HBV genotypes B
and C treated with peginterferon (PEG-IFN). A stopping-rule
has been proposed based on qHBsAg >20,000 at week
12 or 24. The performance of these stopping-rules has not
been sufficiently validated in patients treated with PEG-IFN
alfa-2b. Similarly, the value of measuring qHBsAg at week 24
in patients not meeting the week 12 stopping-rule is unknown.
Methods. HBeAg-positive patients with HBV genotypes B or
C treated with PEG-IFN alfa-2b monotherapy for one year in
2 global randomized trials (HBV 99-01 and P05170) were
enrolled if they had available qHBsAg and a known therapy
outcome. We assessed (1) the performance of the proposed
stopping-rules based on qHBsAg >20,000 IU/mL and (2)
assessed predictive performance of qHBsAg at week 24 in
patients not meeting the week 12 stopping-rule. Response was
defined as HBeAg loss with HBV DNA 20,000 at week
12 was observed in 53 (26%) patients, of whom 4 (7.5%)
achieved a response (negative predictive value [NPV] 92%).
At week 24, 33 (16%) patients had qHBsAg >20,000, of
whom 0 (0%, NPV 100%) achieved a response (p20,000
IU/mL) at week 12 or 24 of PEG-IFN alfa-2b therapy identifies
genotype B and C patients with a low probability of response.
Among patients not meeting the week 12 stopping-rule, qHBsAg
at week 24 predicts treatment outcome.
Disclosures:
Milan J. Sonneveld - Advisory Committees or Review Panels: Roche; Speaking
and Teaching: Roche, BMS
Stefan Zeuzem - Consulting: Abbvie, Bristol-Myers Squibb Co., Gilead, Merck
& Co., Janssen