studies

310A AASLD ABSTRACTS HEPATOLOGY, October, 2015
Disclosures:
Douglas Dieterich - Advisory Committees or Review Panels: Gilead, BMS, Abbvie,
Janssen, Merck, Achillion
Zobair M. Younossi - Advisory Committees or Review Panels: Salix, Janssen,
Vertex; Consulting: Gilead, Enterome, Coneatus
Aijaz Ahmed - Consulting: Bristol-Myers Squibb, Gilead Sciences Inc., Roche,
AbbVie, Salix Pharmaceuticals, Janssen pharmaceuticals, Vertex Pharmaceuticals,
Three Rivers Pharmaceuticals; Grant/Research Support: Gilead Sciences
Inc.
The following authors have nothing to disclose: Ryan B. Perumpail, Andy Liu,
Channa R. Jayasekera, Robert J. Wong
the 300 mg/kg arm compared to 8 (29%) reinfections in the
control. Conclusions: The majority of LT recipients have CP B or
C cirrhosis pre-LT and frequent renal dysfunction early post-LT.
Despite these medical complexities, preliminary results suggest
that Civacir is well-tolerated in the peri-transplant setting and
effective (at the 300 mg/kg dose) in preventing HCV reinfection.
200
Prevention of Recurrent Hepatitis C in Liver Transplant
(LT) Recipients with Civacir ® : Preliminary Results on
Safety and Efficacy, Including Patients with Renal/Liver
Dysfunction
Norah Terrault 1 , Roshan Shrestha 2 , Sanjaya K. Satapathy 3 , Sher
Linda 4 , Jens Rosenau 5 , Jacqueline G. O’Leary 6 , Thomas D. Schiano
7 , Lewis W. Teperman 8 , James Spivey 9 , Jeffrey Campsen 10 ,
John M. Vierling 11 , Elizabeth C. Verna 12 , David W. Victor 13 ,
George Therapondos 14 , Kalyan R. Bhamidimarri 15 , Seraphin
Kuate 16 , Gregory Osgood 16 , Judith Blacklidge 16 , Nicole
Daelken 16 , Shailesh Chavan 16 ; 1 University of California San Francisco,
San Francisco, CA; 2 Piedmont Transplant Institute, Atlanta,
GA; 3 University of Tennessee Health Sciences Center, Memphis,
TN; 4 University of Southern California, Los Angeles, CA; 5 University
of Kentucky, Lexington, KY; 6 Baylor University Medical Center,
Dallas, TX; 7 Mount Sinai Medical Center, New York, NY;
8 New York University, New York, NY; 9 Emory University, Atlanta,
GA; 10 University of Utah, Salt Lake City, UT; 11 Baylor College of
Medicine, Houston, TX; 12 Columbia University, New York, NY;
13 Houston Methodist Hospital, Houston, TX; 14 Ochsner Clinic
Foundations, New Orleans, LA; 15 University of Miami, Miami, FL;
16 Biotest Pharmaceuticals Corporation, Boca Raton, FL
Background and Aims: Prevention of hepatitis C virus (HCV)
recurrence post-LT is important as it eliminates the risk of severe
or progressive disease and reduces the complexity of post-LT
management. Treatment in the peri-transplant period is especially
difficult in patients with severe renal impairment, which
often restricts antiviral therapy (AVT). Safe use of hepatitis B
immune globulin for the prevention of hepatitis B recurrence
in post-LT patients is well established with >30 years of experience.
Civacir ® a hepatitis C immune globulin contains a broad
variety of antibodies against HCV and may offer a safe prophylactic
approach in the peri-transplant period. Methods: Study
988 is an ongoing open-label, randomized phase III clinical
trial evaluating Civacir 200 or 300 mg/kg vs. standard of care
(no AVT treatment post-LT) in HCV-infected patients (any genotype)
awaiting LT. Wait-listed patients receiving pre-LT AVT for
≤24 weeks and with HCV RNA