studies

738A AASLD ABSTRACTS HEPATOLOGY, October, 2015
John G. McHutchison - Employment: Gilead Sciences; Stock Shareholder: Gilead
Sciences
Gamal E. Esmat - Advisory Committees or Review Panels: MSD &BMS companies,
MSD &BMS companies, Abbvie; Grant/Research Support: Gilead Sc;
Speaking and Teaching: Roche & GSK companies, Roche & GSK companies
The following authors have nothing to disclose: Wahid H. Doss, Gamal Shiha,
Dani Ain, Reham Soliman, Marwa Khairy, Joseph Riad, Waleed Samir, Rabab
F. Omar, Raymond Meshrekey, Mostafa Gamil
1077
The TOSCAR Study: Sofosbuvir and Daclatasvir Therapy
for Decompensated HCV Cirrhosis with MELD scores ≥
15: What is the point of no return?
Geoff McCaughan 1 , Stuart K. Roberts 2 , Simone I. Strasser 1 , Paul
Gow 3 , Alan J. Wigg 4 , Caroline Tallis 5 , Gary P. Jeffrey 6 , Jacob
George 7 , Alex J. Thompson 8 , Susan Mason 9 , Joanne Mitchell 2 ,
Peter W. Angus 3 ; 1 ANLTU, Royal Prince Alfred Hospital/Univeristy
of Sydney, Sydney, NSW, Australia; 2 Alfred Health, Melbourne,
VIC, Australia; 3 VLTU, Melbourne, VIC, Australia; 4 SALTU, Adelaide,
SA, Australia; 5 QLTU, Brisbane, QLD, Australia; 6 WALTU,
Perth, WA, Australia; 7 Westmead Hospital, Sydney, NSW, Australia;
8 St Vincent’s Hospital, Melbourne, VIC, Australia; 9 AW Morrow
Gastroenterology & Liver Centre, Royal Prince Alfred Hospital,
Sydney, NSW, Australia
Background: Interferon free therapies for chronic HCV have
resulted in greater than 95% SVRs. However, there are few
data that examine the efficacy in patients with decompensated
chronic liver disease due to HCV. We report such data in a
well defined patient population. Aims: To examine virological
responses in patients with decompensated HCV liver disease
treated with an interferon free regime To examine the effect of
viral clearance on severity and outcomes of liver disease. Methods:
A compassionate access Australia-wide protocol using
Sofosbuvir and Daclatasvir for 24 weeks without Ribavirin to
treat patients with HCV decompensated liver disease with a
MELD score of ≥ 15 was introduced in November 2014. Data
was collected from multiple sites at tertiary level liver centres
throughout Australia. Results: 92 patients have been analysed.
The average age was 55 years. 73% were male. 39% had
genotype 1a, 9% genotype1b and 27% genotype 3. The average
Child Pugh Score (CPS) was 9.5 with an average MELD
of 17.4. 23 patients (25%) had MELD scores > 20 (maximum
29). 76% of patients had ascites and 65% had encephalopathy.
35 patients were listed and 10 underwent liver transplantation
during this period .6 patients died before transplantation
(5 within 8 weeks of starting treatment). End of treatment (EOT)
data was available in 15 patients. All but 1 patient was HCV
PCR negative. The single patient who remained positive had
undergone a surgical procedure with treatment disruption. This
patient had also had a previous relapse from a 12 week course
of Sofosbuvir and Ledipasvir. 8 of 15 patients (approx 50%)
had a ≥ 2 improvement in MELD scores whilst 4 (approx 25%)
had an increase in MELD score of ≥ 2. Improvement in MELD
≥ 2 was only seen in patients with a pre-treatment MELD of <
20. The improvements in CPS ≥ 2 were seen in 6/15 (40%).
SVR12 data and post-transplant HCV RNA status for all patients
will be presented. Conclusion: Sofosbuvir/Daclatasvir therapy
in patients with significantly decompensated HCV liver disease
results in on-treatment virological control in almost all patients.
Despite this, EOT improvements in MELD scores were only seen
in 50% of patients. Improvements were limited to patients with
MELD scores < 20. SVRs and further assessment of liver disease
severity are currently being analysed.
Disclosures:
Geoff McCaughan - Advisory Committees or Review Panels: Gilead
Stuart K. Roberts - Board Membership: AbbVie, Gilead
Simone I. Strasser - Advisory Committees or Review Panels: Janssen, AbbVie,
Roche Products Australia, MSD, Bristol-Myers Squibb, Gilead, Norgine, Bayer
Healthcare; Speaking and Teaching: Bayer Healthcare, Bristol-Myers Squibb,
MSD, Roche Products Australia, Gilead, Janssen, Abbvie
Jacob George - Advisory Committees or Review Panels: Roche, BMS, MSD,
Gilead, Janssen, Abbvie; Grant/Research Support: MSD
Alex J. Thompson - Advisory Committees or Review Panels: Gilead, Abbvie,
BMS, Merck, Spring Bank Pharmaceuticals, Arrowhead, Roche; Grant/Research
Support: Gilead, Abbvie, BMS, Merck; Speaking and Teaching: Roche, Gilead,
Abbvie, BMS
Susan Mason - Advisory Committees or Review Panels: Janssen, MSD, BMS;
Grant/Research Support: Janssen, MSD; Speaking and Teaching: ASHM
Peter W. Angus - Advisory Committees or Review Panels: Gilead Sciences, BMS;
Grant/Research Support: Gilead sciences
The following authors have nothing to disclose: Paul Gow, Alan J. Wigg, Caroline
Tallis, Gary P. Jeffrey, Joanne Mitchell
1078
(THE SOFGER TRIAL) Sofosbuvir-based treatment under
real life conditions in Germany
Peter Buggisch 1 , Christoph Sarrazin 2 , Stefan Mauss 3 , Holger
Hinrichsen 4 , Karl-Georg Simon 5 , Dietrich Hueppe 6 , Johannes Vermehren
2 , Barbara Seegers 4 , Joerg Petersen 1 ; 1 IFI, Liver Center
Hamburg, Hamburg, Germany; 2 1 Medizinische Klinik, Johann
Wolfgang Goethe University Hospital, Frankfurt, Germany; 3 Zentrum
für HIV und Hepatogastroenterologie, Duesseldorf, Germany;
4 Gastroenterolgische Praxis, Kiel, Germany; 5 Gastroenterologisch-hepatologisches
Zentrum, Leverkusen, Germany; 6 Gastroenterologische
Gemeinschaftspraxis, Herne, Germany
Background and Aims: After the approval of direct-acting antivirals
(DAA) in Germany 2014 starting with Sofosbuvir(SOF)
Jan., Simeprevir(SIM) May, Daclatasvir(DCV) August and Ledipasvir(LDV)
November, recommendations in Germany (BNG/
DGVS) were rapidly changed accordingly. Rules for reimbursement
changed over time,too, but there was no limitation to
advanced fibrosis stages. Aim of this study was to evaluate
the change of treatment modalities following availability of
treatment options, implementation of recommendation/reimbursement
rules as well as the safety and efficacy of the SOF
based therapies under real life conditions. Methods: In this
non-interventional, prospective, multi-center study conducted
by the Association of German Gastroenterologists in private
practice (BNG) (5 center) and one academic based center
(Frankfurt), SOF-based therapies from Jan.2014 to February
2015 are being evaluated in Germany. Demographic, clinical,
virology data and adverse events are collected throughout
treatment and post-treatment. This interim analysis shows data
about pts.with SOF-based treatments. Results: 790 patients
(471 male, 318 female) received SOF-based treatments. 553
pts.with genotype 1(275 1a, 278 1b), 61 genotype 2, 128
genotype 3, 48 genotype 4. 393 (49,8% had previous treatment
(65 with DAAs), 417 of pat.had fibrosis F3-4. In 118 pat.
no exact fibosis stage was evalueted, but 45% of those were
clinically cirrhotic. 93 pat. received SOF/Riba (84% Genotype
2(12 w) and 3(24 w) 160 received PEG/RIBA/SOF 12 w
(all before Sep.2014) 118 SIM/SOF, 221 SOF+DCV ±Riba
(75% F3/4, 198 SOF/LDV (58% F0-2). No IFN-based treatment
started after 9/2014. SVR 4 for SIM/SOF (116 pat.) is
87% SVR 12 (90 pat.) 86 %. SVR 4 for PEG/RIBA/SOF (157
pat.) is 83%, SVR 12 (144 pat.)79%. SVR 4 for SOF/RIBA is
78%(88 pat.) SVR 12 75% (82 pat). SVR 4 for SOF/DCV is
85% (163 pat.) SVR 12 (97 pat.) 87%. SVR 4 for SOF/LDV
is 96% (110 pat.). There was a clear trend to use SOF/LDV
in lower fibrosis stages (8 or 12 weeks). Anemia (Riba-based
therapy),headache, sleeping disorders and fatigue were the
most reported AEs. No severe side effects occurred. 6 deaths
were reported due to complications of cirrhosis. More SVR