studies

786A AASLD ABSTRACTS HEPATOLOGY, October, 2015
patients. Cox analyses showed that SVR was associated with
reduced occurrence of cirrhosis-related complications (adjusted
HR 0.19, 95%CI 0.10-0.35). The overall 5-year event rate was
22.4% (95%CI 18.3-26.5) among those without SVR. With
95% SVR the NNT to prevent 1 cirrhosis-related complication
in 5 years was 27, 14, 9 or 7 at a 5-year complication rate of
5, 10, 15 or 20%, respectively. With 85% SVR this was 30,
15, 10 or 8, respectively. CONCLUSION The clinical efficacy
of interferon-free therapy among patients with advanced but
compensated liver disease is high, especially in case of an
increased risk of cirrhosis-related complications. Small differences
in the high SVR rates of these regimens have only limited
effect on the clinical efficacy
Disclosures:
Adriaan J. van der Meer - Consulting: Gilead; Speaking and Teaching: MSD,
Gilead
Raoel Maan - Consulting: AbbVie
Jordan J. Feld - Advisory Committees or Review Panels: Merck, Janssen, Gilead,
AbbVie, Theravance, Bristol Meiers Squibb; Grant/Research Support: AbbVie,
Boehringer Ingelheim, Janssen, Gilead, Merck
Heiner Wedemeyer - Advisory Committees or Review Panels: Transgene, MSD,
Roche, Gilead, Abbott, BMS, Falk, Abbvie, Novartis, GSK, Roche Diagnostics;
Grant/Research Support: MSD, Novartis, Gilead, Roche, Abbott, Roche Diagnostics;
Speaking and Teaching: BMS, MSD, Novartis, ITF, Abbvie, Gilead
Jean-Francois Dufour - Advisory Committees or Review Panels: Bayer, BMS, Gilead,
AbbVie, Novartis, Sillagen, Genfit
Andres Duarte-Rojo - Advisory Committees or Review Panels: Gilead Sciences;
Grant/Research Support: Vital Therapies; Speaking and Teaching: Roche
Michael P. Manns - Consulting: Roche, BMS, Gilead, Boehringer Ingelheim,
Novartis, Idenix, Achillion, GSK, Merck/MSD, Janssen, Medgenics; Grant/
Research Support: Merck/MSD, Roche, Gilead, Novartis, Boehringer Ingelheim,
BMS; Speaking and Teaching: Merck/MSD, Roche, BMS, Gilead, Janssen, GSK,
Novartis
Stefan Zeuzem - Consulting: Abbvie, Bristol-Myers Squibb Co., Gilead, Merck
& Co., Janssen
Robert J. de Knegt - Advisory Committees or Review Panels: Roche, Norgine,
Janssen Cilag, AbbVie; Grant/Research Support: Roche, Janssen Cilag, BMS,
AbbVie; Speaking and Teaching: Gilead, Roche, Janssen Cilag, AbbVie
Bart J. Veldt - Board Membership: GSK, Janssen Therapeutics
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
The following authors have nothing to disclose: Giovanna Fattovich, Frank Lammert,
Wolf P. Hofmann, Donatella Ieluzzi, Bettina E. Hansen
1167
Early response and efficacy of dual oral therapy with
asunaprevir and daclatasvir for elderly patients with
hepatitis C
Takashi Honda, Masatoshi Ishigami, Yoji Ishizu, Teiji Kuzuya,
Kazuhiko Hayashi, Yoshiki Hirooka, Hidemi Goto; Gastroenterology
and Hepatology, Nagoya University Graduate School of
Medicine, Nagoya, Japan
Background and aim: In Japan, patients with hepatitis C virus
(HCV)-associated liver disease including hepatocellular carcinoma
(HCC) are getting older and many patients die of such
disease. The efficacy of dual oral therapy by using asunaprevir
(NS3 protease inhibitor) and daclatasvir (NS5A replication
complex inhibitor) for elderly patients with HCV genotype 1b
has not been clarified. The aim of this study was to evaluate
the early response and efficacy of dual oral therapy in such
patients. Methods: Four hundred forty two consecutive chronic
patients with HCV genotype 1b including compensated cirrhosis
were treated with dual oral therapy with asunaprevir
and daclatasvir in our hospital and affiliated hospital. These
patients were divided into two groups according to age:
elderly patients (aged ≥ 70 years, n = 240) and non-elderly
patients (aged < 70 years, n = 202). Clinical characteristics,
the rapid virological response (RVR) and the sustained virological
response at post-treatment week 4 (SVR4) obtained
by intention-to-treat analysis were compared between the two
groups. Biochemical response and α-fetoprotein were compared
at the start point and 4weeks later. Results: The ratio of
female and compensated cirrhosis was significantly higher in
elderly patients than in non-elderly patients (p = 0.006, 0.003,
respectively). ALT, gGTP and hemoglobin level was significantly
lower in elderly patients than that in non-elderly patients
(P =0.0001, 0.010, 0.0001, respectively). However, other
clinical characteristics of patients were not significantly different
between two groups. The RVR and SVR4 rates didn’t differ
significantly between elderly patients and non-elderly patients
(RVR: 94.3 % vs 97.0 %, SVR4: 84.6 % vs 92.1 %). According
to multivariate analysis, only RVR proved to be significantly
associated with SVR4 while patient age did not affect SVR4.
Multivariate analysis also indicated there is no significant factor
associated with SVR4 in elderly patients. HCVRNA, ALT,
γGTP and α-fetoprotein was rapidly and significantly reduced
from start point to 4 weeks later in both elderly patients and
non-elderly patients. Conclusions: Treatment of chronic hepatitis
C including compensated cirrhosis with dual oral therapy was
comparably effective between elderly patients and non-elderly
patients. This dual oral therapy rapidly reduced ALT, γGTP and
α-fetoprotein and may reduce incidence of HCC even in elderly
patients.
Disclosures:
Hidemi Goto - Grant/Research Support: MSD, Roche, Bayer, Bristol-Myers, Eisai,
Ajinomoto, Otsuka, Astra, Tanabe, Takeda
The following authors have nothing to disclose: Takashi Honda, Masatoshi Ishigami,
Yoji Ishizu, Teiji Kuzuya, Kazuhiko Hayashi, Yoshiki Hirooka