studies

HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 737A
1075
Sofosbuvir, Ledipasvir in IBD treated patients with
advanced biologics including Ribavirin eradicating
Chronic Hepatitis C: SOLATAIRE C Trial. A multi-center
clinical prospective pilot study
Patrick Basu 1,2 , Niraj J. Shah 3 , Nimy John 2 , M. Aloysius 2 , Robert
Brown 4 ; 1 Columbia University School of Physicians and Surgeons,
Forest hills, NY; 2 King’s County Hospital Medical Center, NY,
New York, NY; 3 James J. Peters VA Medical Center, Icahn School
of Medicine at Mount Sinai, NY, New York, NY; 4 Weill Cornell
Medical College, New York, NY
Background: The prevalence and concomitant treatment of
chronic HCV and IBD has not been elucidated. IBD and CHC
of >20 years duration may have more fibrosis due to immune
suppression. Treatment of IBD often requires biological therapies
to achieve longer disease-free remission, which further
accelerates higher HCV replication. Thus effective therapy for
IBD patients requiring immunosuppressive therapy is needed
Aim: To evaluate the role and efficacy of new NS5A + NS5B
inhibitors with and without RBV in treating CHC in moderate
to severe IBD requiring biologic therapy Methods: 35 patients
were recruited from the Kings County Hospital Medical Center,
Brooklyn. Inclusion criteria CHC with IBD, Age: >18, HCV Viral
Load: > 400,000IU/mL, Genotype 1. Fibrotic Score: Metavir
F1 to F4 Primary End Point: SVR12 Secondary End Point: IBD
activity index, sustained control of symptoms SVR 24 and complete
IBD remission at 30 weeks (endoscopy at 30 weeks)
The patients were divided into two groups: Group A (n=17)-
RBV 1000 mg + LDV and SOF; for 8 weeks Group B (n=18):
LDV and SOF; for 12 weeks All will have base line RAV and
ETRAV’s and SVR 24. RAVs 5A polymorphism by Quest. Viral
loads 0, 7, 14 days; 4 th , 8 th , 12 th and 24 th weeks Patient characteristics:
list to follow in the poster/oral presentation Results:
See table. 24 th week RAV- results are pending Conclusion: This
study demonstrates that DAA’s for HCV appear to have similar
efficacy and safety in the presence of active IBD therapy with-
TNF Alfa antagonists while keeping the IBD in uninterrupted
remission
Results
Disclosures:
The following authors have nothing to disclose: Patrick Basu, Niraj J. Shah, Nimy
John, M. Aloysius, Robert Brown
1076
Sofosbuvir plus Ribavirin in the Treatment of Egyptian
Patients with Chronic Genotype 4 HCV Infection
Wahid H. Doss 1 , Peter J. Ruane 2 , Gamal Shiha 3 , Dani Ain 2 ,
Reham Soliman 3 , Marwa Khairy 4 , Mohamad Hassany 1 , Joseph
Riad 2 , Waleed Samir 3 , Rabab F. Omar 4 , Radi Hammad 1 , Raymond
Meshrekey 2 , Mostafa Gamil 4 , Deyuan Jiang 5 , Benedetta
Massetto 5 , Steven J. Knox 5 , Kathryn Kersey 5 , John G. McHutchison
5 , Gamal E. Esmat 4 ; 1 National Hepatology and Tropical Medicine
Research Institute, Cairo, Egypt; 2 Ruane Medical and Liver
Health Institute, Los Angeles, CA; 3 Egyptian Liver Research Institute
and Hospital, Mansoura, Egypt; 4 University of Cairo, Cairo,
Egypt; 5 Gilead Sciences, Inc., Foster City, CA
Background: HCV infection is a major public health burden in
Egypt, with an estimated 6 million people chronically infected.
The combined safety and efficacy data for sofosbuvir (SOF)
plus ribavirin (RBV) from 2 studies in Egyptian patients with
chronic genotype (GT) 4 HCV infection are summarized here.
Methods: An integrated analysis was conducted of data from
treatment-naïve and treatment-experienced patients enrolled in
Study GS-US-334-0114 in the USA (n=60) and Study GS-US-
334-0138 in Egypt (n=103). In each study, subjects were randomized
1:1 to receive either 12 or 24 weeks of SOF (400
mg daily) + RBV (1000-1200 mg daily). Exact logistic regression
analyses were used to explore the relationships between
SVR12 rates and baseline characteristics in the combined dataset.
Results: Overall, 67% of patients were male, mean age
(range) was 49 years (19-75), 42% had BMI ≥30 kg/m 2 , 19%
had cirrhosis, 82% had IL28B non-CC genotype, 56% had
HCV RNA ≥800,000 IU/mL at baseline, and 53% were treatment-experienced.
SVR12 rates were 73% (61/83) and 91%
(73/80) for SOF+RBV administered for 12 and 24 weeks,
respectively. Multivariate logistic regression analysis identified
male sex, IL28B non-CC genotype, and baseline HCV RNA
≥800,000 IU/mL as statistically significant factors associated
with worse treatment outcome while 24 weeks of treatment
increased the likelihood of achieving SVR12. In treatment-naïve
patients without cirrhosis, SOF+RBV for 12 or 24 weeks
resulted in SVR12 rates of 88% (29/33) and 94% (30/32),
respectively. The most common adverse events were headache,
fatigue, insomnia, cough and pruritus. Most AEs were mild or
moderate in severity and none resulted in treatment discontinuation;
5 patients experienced SAEs of which 1 (dyspnea)
was considered treatment-related. Conclusions: Integrated data
from these 2 studies show SOF+RBV was well tolerated with
an AE profile consistent with that of RBV. SOF+RBV for 24
weeks resulted in a 91% SVR12 rate in Egyptian patients with
HCV GT4 infection. The combined safety and efficacy data
support the use of this interferon-free regimen. In addition, the
data suggest a shorter treatment duration of 12 weeks may be
of benefit for some patients, such as treatment naïve patients
without cirrhosis.
Disclosures:
Peter J. Ruane - Advisory Committees or Review Panels: BMS; Consulting: Gilead,
Abbvie, Janssen; Grant/Research Support: BMS, Gilead, Merck, Abbvie, Idenix,
Idenix, Janssen, Viiv; Speaking and Teaching: Gilead, Merck, Abbvie, Abbvie,
Janssen; Stock Shareholder: Gilead, Gilead
Mohamad Hassany - Grant/Research Support: Gilead Sc
Radi Hammad - Grant/Research Support: Gilead Sciences,Inc, Janssen Pharmaceuticals,
Inc.
Deyuan Jiang - Employment: Gilead Sciences
Benedetta Massetto - Employment: Gilead Sciences, Inc.; Stock Shareholder:
Gilead Sciences, Inc
Steven J. Knox - Employment: Gilead Sciences
Kathryn Kersey - Employment: Gilead Sciences, Inc; Stock Shareholder: Gilead
Sciences, Inc