studies

HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 1117A
IU/mL is replacing the Roche COBAS® TaqMan® HCV test
(version 2.0) for use with the High Pure System (CTM/HPS,
LLOQ of 25 IU/mL) in clinical practice. Here we describe,
through parallel testing, the HCV RNA viral decline observed
in the SIRIUS study (NCT01965535) using the two different
assays. Methods: Stored, frozen samples drawn during the first
8 weeks of treatment from 154 patients in the SIRIUS trial were
identified and analyzed in parallel using both assay platforms.
These results were compared with each other and with the
results initially obtained using the CTM/HPS (LLOQ=25) system
at the time of the study conduct (between October 2013 and
April 2014). Results: As previously reported, 97% of patients
in this study achieved SVR12. 765 paired samples drawn
during the first 8 weeks of treatment were analyzed. Compared
to HCV RNA measurements obtained with the CTM/HPS
(LLOQ=25) assay, a higher proportion of patients had quantifiable
HCV RNA at treatment weeks 1, 2, and 4 using the new
CAP/CTM (LLOQ=15) assay (see Table). Using the CAP/CTM
(LLOQ=15) assay, twenty six subjects were >LLOQ at Week 4.
Nevertheless, 25/26 (96%) of these subjects achieved SVR12
after 12 or 24 weeks of treatment. Comparison with the data
obtained at the time of study conduct will be presented. Conclusions:
In this analysis, with the next generation Ampliprep sample
preparation with the COBAS TaqMan® HCV test (version
2.0), as many as 17% of patients had detectable HCV RNA
at week 4; conversely, with the older High Pure System used
to prepare samples, as few as 1% of patients had detectable
HCV RNA at week 4. Notably, however, with either assay, the
likelihood of a sustained viral response did not correlate with
early virologic response. Thus, for LDV/SOF-based therapies,
determination of on-treatment HCV RNA levels is not suitable to
guide treatment decisions.
Disclosures:
Tania M. Welzel - Advisory Committees or Review Panels: Novartis, Janssen,
Gilead, Abbvie, Boehringer-Ingelheim+, BMS
Stanislas Pol - Board Membership: Sanofi, Bristol-Myers-Squibb, Boehringer Ingelheim,
Tibotec Janssen Cilag, Gilead, Glaxo Smith Kline, Roche, MSD, Novartis;
Grant/Research Support: Glaxo Smith Kline, Gilead, Roche, MSD; Speaking and
Teaching: Sanofi, Bristol-Myers-Squibb, Boehringer Ingelheim, Tibotec Janssen
Cilag, Gilead, Glaxo Smith Kline, Roche, MSD, Novartis
Patrick Marcellin - Consulting: Roche, Gilead, BMS, Vertex, Novartis, Janssen,
MSD, Abbvie, Alios BioPharma, Idenix, Akron; Grant/Research Support: Roche,
Gilead, BMS, Novartis, Janssen, MSD, Alios BioPharma; Speaking and Teaching:
Roche, Gilead, BMS, Vertex, Novartis, Janssen, MSD, Boehringer, Pfizer,
Abbvie
Robert H. Hyland - Employment: Gilead Sciences, Inc; Stock Shareholder: Gilead
Sciences, Inc
Deyuan Jiang - Employment: Gilead Sciences
Phillip S. Pang - Employment: Gilead Sciences; Stock Shareholder: Gilead Sciences
Diana M. Brainard - Employment: Gilead Sciences; Stock Shareholder: Gilead
Sciences
Vincent Leroy - Board Membership: Abbvie, BMS, Gilead; Consulting: Janssen,
MSD; Speaking and Teaching: Abbvie, BMS, Gilead, Janssen, MSD
Stefan Zeuzem - Consulting: Abbvie, Bristol-Myers Squibb Co., Gilead, Merck
& Co., Janssen
Marc Bourlière - Advisory Committees or Review Panels: Schering-Plough,
Bohringer inghelmein, Schering-Plough, Bohringer inghelmein, Transgene; Board
Membership: Bristol-Myers Squibb, Gilead, Idenix; Consulting: Roche, Novartis,
Tibotec, Abott, glaxo smith kline, Merck, Bristol-Myers Squibb, Novartis, Tibotec,
Abott, glaxo smith kline; Speaking and Teaching: Gilead, Roche, Merck, Bristol-Myers
Squibb
1861
Expanded eligibility to HCV treatment with novel IFNfree
therapies in a large real-world cohort: The German
Hepatitis C Registry
Dietrich Hueppe 2,6 , Stefan Mauss 2,3 , Klaus H. Boeker 2,13 , Andreas
Schober 2,5 , Gerlinde Teuber 2,4 , Stefan Christensen 2,11 , Uwe
Naumann 2,12 , Claus Niederau 2,10 , Stefan Zeuzem 2,8 , Michael P.
Manns 1,2 , Thomas Berg 2,9 , Peter Buggisch 2,7 , Markus Cornberg 1,2 ,
Christoph Sarrazin 2,8 , Heiner Wedemeyer 2,1 ; 1 Gastroenterology,Hepatology
and Endocrinology, Hannover Medical School,
Hannover, Germany; 2 German Hepatitis C Registry, Hannover,
Germany; 3 MVZ Düsseldorf, Düsseldorf, Germany; 4 IFS Frankfurt,
Frankfurt, Germany; 5 Hepatologische Praxis Göttingen, Göttingen,
Germany; 6 Hepatologische SChwerpunktpraxis Herne, Herne,
Germany; 7 IFI Hamburg, Hamburg, Germany; 8 University of Frankfurt,
Frankfurt, Germany; 9 University of Leipzig, Leipzig, Germany;
10 Hospital Oberhausen, Oberhausen, Germany; 11 CIM Münster,
Münster, Germany; 12 Praxiszentrum Kaiserdamm, Berlin, Germany;
13 Hepatologische Praxis Hannover, Hannover, Germany
The German Hepatitis C Registry is a non-interventional prospective
cohort study aiming to recruit at least 10.000 HCV-infected
patients treated with novel direct acting antivirals
against hepatitis C. Second generation DAAs have been used
in Germany since January 2014 and each drug was available
immediately after EMA approval. The current registry follows
a previous national cohort which recruited more than 37.000
HCV patients since 2002. The aim of this analysis was to investigate
the evolution of patient profiles considered eligible for
antiviral therapy over a period of 13 years with different treatment
options available. Methods: Characteristics of patients
enrolled in the German Hepatitis C registry after approval of
2 nd generation DAAs since February 2014 (n=2247; period
III) were compared with patients recruited 2002-2007 (n=
19,115; period I) and patients recruited during 2011-2012
when 1 st generation PIs were widely prescribed in Germany
(n=1,768; period II). Results: The mean age of patients enrolled
increased over the last 12 years (43.0 period I vs. 47.0 years
period II vs. 51.0 years period III) while the gender distribution
remained largely unchanged (male gender 58.9% vs. 64.8%
vs. 61.2%). A slight shift in HCV genotype distribution became
evident with less genotype 3 infections in period III (20.5%)
than in period I (24.6%) but an increase in genotype 4 (2.9%
vs. 2.5% vs. 5.1%). The proportion of patients with liver cirrhosis
increased from 4.5% to 24.5% in period III while less
patients were treatment naïve in period III compared to period
I (56.3 vs. 86.3). In 2014/15 patient characteristics differed
largely between individuals treated with IFN-based regimens
(n=655) vs. IFN-free DAA combination therapies (n=1,169)
regarding age (46.3 years vs. 54.4 years; patients >70 years
3.1% vs. 9.3%), proportion of patients with liver cirrhosis
(15.4% vs. 37.3%), percentage of patients with platelet counts