studies

806A AASLD ABSTRACTS HEPATOLOGY, October, 2015
Michael Trauner - Advisory Committees or Review Panels: MSD, Janssen, Gilead,
Abbvie; Consulting: Phenex; Grant/Research Support: Intercept, Falk Pharma,
Albireo; Patent Held/Filed: Med Uni Graz (norUDCA); Speaking and Teaching:
Falk Foundation, Roche, Gilead
Markus Peck-Radosavljevic - Advisory Committees or Review Panels: Bayer, Gilead,
Janssen, BMS, AbbVie; Consulting: Bayer, Boehringer-Ingelheim, Jennerex,
Eli Lilly, AbbVie; Grant/Research Support: Bayer, Roche, Gilead, MSD, AbbVie;
Speaking and Teaching: Bayer, Roche, Gilead, MSD, Eli Lilly, AbbVie, Bayer
Thomas Reiberger - Consulting: Xtuit; Grant/Research Support: Roche, Gilead,
MSD, Phenex; Speaking and Teaching: Roche, Gilead, MSD
The following authors have nothing to disclose: Bernhard Scheiner, Philipp
Schwabl, Sebastian Steiner, David Chromy, Theresa Bucsics, Berit A. Payer,
Maximilian C. Aichelburg, Armin Rieger, Katharina Grabmeier-Pfistershammer
1205
Real-world effectiveness of ledipasvir/sofosbuvir 8
weeks chronic hepatitis C treatment
Peter Buggisch 1 , Karsten Wursthorn 1 , Albrecht Stoehr 1 , Aline
Gauthier 2 , Petar K. Atanasov 2 , Joerg Petersen 1 ; 1 Asklepios Klinik
St. Georg Haus L, IFI Institut für Interdisziplinäre Medizin, Hamburg,
Germany; 2 Amaris Consulting, London, United Kingdom
Background and Aims: Ledipasvir/Sofosbuvir (LDV/SOF) single
tablet regimen (STR) is approved in Europe for chronic
hepatitis C (CHC) patients with genotypes (GT) 1, 3 and 4. In
the ION-3 study 8 weeks (8w) of LDV/SOF was non-inferior
to 12w in previously untreated GT1 patients without cirrhosis
with no benefit for the addition of ribavirin (RBV). According
to the summary of product characteristics (SmPC) 8w may
be considered in treatment naïve, non-cirrhotic patients with
HCV RNA< 6million IU/mL. The aim of the present analysis
is to characterise the population receiving 8w LDV/SOF and
to describe outcomes in clinical practice. Methods: The first
CHC patients treated with 8w LDV/SOF in a single centre in
Germany, and for whom SVR12 will be available for presentation,
were included. Baseline characteristics, prior treatment
history, safety and effectiveness were investigated. Analysis
was performed using descriptive statistics. Results: 86 patients
met the inclusion criteria and initiated 8w treatment with LDV/
SOF between 21/11/2014 to 07/04/2015. No patient
had ribavirin added to the STR. The mean (SD) age was 49.8
(12.1) years and 44.2% were males. Genotype distribution
was 52.3%, 45.4% and 2.3% for GT1a, GT1b and GT4. The
METAVIR stage distribution at baseline was 51.2%, 26.7%,
17.4% and 4.7% for F0, F1, F2 and F3. No patients had cirrhosis.
Median HCV RNA at baseline was 794,328 (Q1-Q3:
169,824-2,041,738, Min-Max: 11 -18,620,871) IU/ml, two
patients had HCV RNA ≥ 6 million IU/mL (11,481,536 and
18,620,871 IU/ml, both METAVIR stage F0). 4.7% of patients
were HIV co-infected and no patients were HBV co-infected.
Overall, 99% of the patients were treatment-naïve. One patient
had relapsed after previous interferon (INF)/RBV therapy. To
date, one patient discontinued therapy due to lack of adherence.
Two patients experienced adverse events: one assessed
as unrelated and one as possibly related to treatment. Among
patients for whom data is available, SVR4 was 100% (69/69)
and SVR12 was 100% (14/14). Complete results for SVR12,
adverse events and discontinuations will be available at the
time of presentation. Conclusion: 8w LDV/SOF is predominantly
prescribed according to the SmPC for treatment-naïve
non-cirrhotic CHC patients with HCV RNA