studies

HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 797A
All DAAs regimen were analyzed together. For TN and TE
patients, 2 analyses evaluated the RBV use (regardless of the
treatment duration and for a fixed 12 weeks treatment duration)
and 3 analyses evaluated the treatment duration (regardless
of, with, or without RBV). Another analysis compared 12
wks with RBV vs. 24 wks without RBV. Meta-analyses were
performed according to the Der Simonian and Laird method
and reported weight-adjusted SVR12 gains. Results: 10 RCTs
(1307 GT1 cirrhotic patients (573 TN, 734 TE)) were selected.
The distribution of DAA combinations was as follows: SIM+SOF
(COSMOS, N=168), 3D Abbvie (TURQUOISE II, N=380),
DCV-TRIO BMS (UNITY 2, N=202), GPV+EBV (C-WOR-
THY, N=253), and LDV+SOF (6 RCTs, N=496). In G1 TN
cirrhotic patients, the use of ribavirin (ΔSVR=+2.45%;95%CI:
-1.27 to +6.16%,NS,N=411) or an extended duration
(ΔSVR=+0.64%;95%CI:-3.03 to +4.32%,NS,N=434) did not
increase SVR12. In GT1 TE cirrhotic patients, the use of ribavirin
did not increase SVR12 (ΔSVR=+0.23%;95%CI:-3.54
to +4.01%,NS,N=494), even in analyses restricted to
12wks treatment duration (ΔSVR=+1.85%;95%CI:-3.75 to
+7.44%, NS,N=267). Conversely, extended duration was
associated with higher SVR rates (ΔSVR=+6.35%;95%CI:
+1.49 to +11.20%,p=0.018,N=532), even with ribavirin
use (ΔSVR=+8.26%;95%CI: +2.29 to +14.23%, p=0.028,
N=278). The magnitude of SVR gain was similar between the
different DAA regimen suggesting that a 18 wks extended
duration (as performed in the C-WORTHY study) would be
sufficient for other combos. Only four studies (229 patients)
compared 12wks +RBV vs. 24wks w/o RBV. Extended duration
was associated with a 5.09% SVR gain that did not reach
significance, probably because of a type II error and the overweight
of the SIRIUS study. Conclusion: In GT1 TN patients with
compensated cirrhosis, RBV as well as extending treatment
duration are useless. In GT1 TE patients with compensated
cirrhosis, RBV does not increase SVR rates but extending treatment
duration (18 or 24 wks) significantly increases SVR rates
Disclosures:
Vincent Di Martino - Advisory Committees or Review Panels: Gilead, France,
Abbvie, BMS France; Board Membership: MSD France; Consulting: Gilead,
France; Speaking and Teaching: Janssen, BMS France, Gilead France
Thong Dao - Board Membership: Schering-Plough, Schering-Plough, Schering-Plough,
Schering-Plough; Speaking and Teaching: Roche, Gilead, Roche,
Gilead, Roche, Gilead, Roche, Gilead
Veronique Loustaud-Ratti - Board Membership: Gilead, Roche, Schering Plough
MSD; Speaking and Teaching: Roche, Schering Plough MSD, Janssen, Bristol
meyers squibb, gilead, Abbvie
Odile Goria - Speaking and Teaching: Gilead, Janssen
Eric Nguyen-Khac - Speaking and Teaching: Gilead, Abbvie, Janssen, Roche,
MSD, BMS
The following authors have nothing to disclose: Carine Richou, Jean Paul Cervoni,
Delphine Weil, Claire Vanlemmens, Anne Minello, Christine Silvain, Thierry
Thevenot
1188
Real World Effectiveness Of Sofosbuvir Based Therapy
In Chronic HCV Infected Patients: The Results From Data
Anlaysis Of 167 Patients In Qatar
Moutaz F. Derbala 1 , Aliaa Amer 2 , Saad R. Alkaabi 1 , Nazeeh
Z. Dweik 1 , Khaleel H. Sultan 1 , Yasser M. Kamel 1 , Khalid Al-Ejji 1 ,
Hamid Wani 1 , Fuad I. Pasic 1 ; 1 GASTROENTEROLOGY & HEPA-
TOLOGY, Hamad Hospitaland Weill Cornell Medical College in
Qatar,Consultant Gastroenterology & Hepatology HMC, Doha,
Qatar; 2 Hematopathology, Laboratory Medicine and pathology,
Hematology Section, Hamad Medical Corporation, Doha, Qatar
Background and Aims: However, limited data were available;
Sofosbuvir (SOF) was approved in Qatar in early 2014. In both
interferon (IFN) based triple therapy and IFN-free combinations,
sofosbuvir have been used to treat different patient populations
with various liver disease severity and comorbidities. Our aim
is to assess the effectiveness of SOF based therapy in a real
world setting. Methods: In the Qatar HCV registry, all patients
who started on the following treatment regimens were included
in the analysis: SOF/ribavirin (RBV), SOF/daclatasvir (DCV),
SOF/simeprevir (SMV), and SOF/PegIFN/RBV. Demographics,
history of liver disease were collected, and laboratory tests
were performed at baseline. Clinic, adverse events and virological
data were collected throughout treatment and post-treatment
follow-up. Results: 167 patients were treated with SOF
based therapy. 36%of the patients had cirrhosis and 52.8%
were previously treated with PR or Protease inhibitor (PI) +PR.
14.1% of the patients underwent liver transplantation.13.8 %
patients were treated with SOF+PegIFN/RBV triple therapy.
The overall SVR4 rate was 96%, 92%, and 87% in patients
treated within genotype 1, 4 and 3 respectively. The overall
SVR4 rate differed according to the prior history and fibrosis.
The SOF based therapy achieved 89% SVR4 rate in cirrhotic
patients and a 97% SVR4 in non-cirrhotic patients. One patient
discontinued all medications due to viral breakthrough with no
discontinuation due to adverse events. The most common side
effects are Anemia and neutropenia, headache and myalgia
in both SOF/RBV and SOF/Peg-IFN/RBV groups. Conclusions:
SOF based Therapy is safe and effective in the treatment of
HCV Genotypes 1, 2, 3 and 4 in a real world setting. However,
both SOF/RBV and SOF/Peg-IFN/RBV regimens are less
reliable in cirrhotic patients and genotype 3
Demographic Data Of The Studied Patients
Disclosures:
The following authors have nothing to disclose: Moutaz F. Derbala, Aliaa Amer,
Saad R. Alkaabi, Nazeeh Z. Dweik, Khaleel H. Sultan, Yasser M. Kamel, Khalid
Al-Ejji, Hamid Wani, Fuad I. Pasic
1189
IFN and/or RBV-Free Therapy (Rx) with Simeprevir+Sofosbuvir
(SMV+SOF) was Well-Tolerated and Effective
for Chronic Hepatitis C Genotype 1 (CHC-1) Including
Post-Liver Transplant (LT) and Decompensated Non-Liver
Transplant (Non-LT) Patients: A Single-Center Experience
Glen A. Lutchman 1 , Nghia H. Nguyen 1,3 , Christine Y. Chang 1 ,
Aijaz Ahmed 1 , Tami Daugherty 1 , Gabriel Garcia 1 , Radhka
Kumari 1 , W. Ray Kim 1 , Soumi Gupta 4 , Dilesh Doshi 2 , Mindie H.
Nguyen 1 ; 1 Division of Gastroenterology and Hepatology, Stanford
University Medical Center, Palo Alto, CA; 2 Health Economics
& Outcomes Research, Janssen Scientific Affairs, Titusville, NJ;
3 Department of Medicine, University of California, San Diego, San
Diego, CA; 4 Medical Affairs, Janssen Scientific Affairs, Titusville,
NJ
Purpose: In the U.S., HCV is the leading cause of liver-related
death and CHC-1 is the most common type. Until recently,
effective and safe Rx options were limited. Our goal is to
evaluate outcomes of SMV+SOF Rx in a diverse single-center
patient cohort from 12/2013/12/2014. Methods: A total of