HEPATOLOGY, VOLUME 60, NUMBER 4 (SUPPL)
AASLD ABSTRACTS
1 BPAR (Biopsy Proven Acute Rejection) During Protocolized Immunosuppression Withdrawal (ISW) is Readily Reversed in Pediatric Liver Transplant (Tx) Recipients
197A
Table 1: Characteristics of the 1st 20 Subjects With BPAR
Veena L. Venkat1, George V. Mazariegos2, John Bucuvalas3, Anthony J. Demetris4, Steven J. Lobritto5, John C. Magee6, Mercedes Martinez5, Yumirle P. Turmelle7, Katharine Spain8, Sandy Feng9; 1Pediatrics, Children’s Hospital of Pittsburgh of UPMC, Pittsburgh, PA; 2Hillman Center for Pediatric Transplantation, Children’s Hospital of Pittsburgh of UPMC, Pittsburgh, PA; 3Pediatric Liver Care Center, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH; 4Pathology, University of Pittsburgh Medical Center, Pittsburgh, PA; 5Pediatrics, New York-Presbyterian Hospital/ Columbia, New York, NY; 6Surgery, University of Michigan, Ann Arbor, MI; 7Pediatrics, St. Louis Children’s Hospital, St. Louis, MO; 8Rho Inc., Chapel Hill, NC; 9Surgery, University of California, San Francisco, San Francisco, CA
Background: iWITH (NCT101638559) is an NIH funded trial that aims to determine the efficacy and safety (1° and 2° objectives) of ISW. We describe the timing, severity, and treatment response in the 1st 20 subjects with BPAR. Methods: Between 9/1/12 and 3/1/14, 74 subjects (42% male; 31% living donor; 59% biliary atresia) 4 yrs post-tx, with ALT and GGT 2 were excluded. ISW proceeded in 8 steps (75, 56, 40, 32, 24, 16, 8 and 0% of the pre-ISW dose) over 36-48 wks. Biopsy was mandated for ALT or GGT >100 IU/L and graded using Banff criteria by a central pathologist. BPAR was treated according to standard of care at each site. Results: As of 3/31/14, 31(42%) subjects were off IS for a median(range) of 12(0.7, 39.9) wks, 23(31%) were still undergoing ISW and 20(27%) subjects had BPAR, as described in Table 1. 15/20 BPAR episodes occurred at pre-ISW; 5 to max dose ≤pre-ISW); none required antibody therapy. One subject had concurrent biliary stricture. ALT and GGT were
AASLD ABSTRACTS
1 BPAR (Biopsy Proven Acute Rejection) During Protocolized Immunosuppression Withdrawal (ISW) is Readily Reversed in Pediatric Liver Transplant (Tx) Recipients
197A
Table 1: Characteristics of the 1st 20 Subjects With BPAR
Veena L. Venkat1, George V. Mazariegos2, John Bucuvalas3, Anthony J. Demetris4, Steven J. Lobritto5, John C. Magee6, Mercedes Martinez5, Yumirle P. Turmelle7, Katharine Spain8, Sandy Feng9; 1Pediatrics, Children’s Hospital of Pittsburgh of UPMC, Pittsburgh, PA; 2Hillman Center for Pediatric Transplantation, Children’s Hospital of Pittsburgh of UPMC, Pittsburgh, PA; 3Pediatric Liver Care Center, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH; 4Pathology, University of Pittsburgh Medical Center, Pittsburgh, PA; 5Pediatrics, New York-Presbyterian Hospital/ Columbia, New York, NY; 6Surgery, University of Michigan, Ann Arbor, MI; 7Pediatrics, St. Louis Children’s Hospital, St. Louis, MO; 8Rho Inc., Chapel Hill, NC; 9Surgery, University of California, San Francisco, San Francisco, CA
Background: iWITH (NCT101638559) is an NIH funded trial that aims to determine the efficacy and safety (1° and 2° objectives) of ISW. We describe the timing, severity, and treatment response in the 1st 20 subjects with BPAR. Methods: Between 9/1/12 and 3/1/14, 74 subjects (42% male; 31% living donor; 59% biliary atresia) 4 yrs post-tx, with ALT and GGT 2 were excluded. ISW proceeded in 8 steps (75, 56, 40, 32, 24, 16, 8 and 0% of the pre-ISW dose) over 36-48 wks. Biopsy was mandated for ALT or GGT >100 IU/L and graded using Banff criteria by a central pathologist. BPAR was treated according to standard of care at each site. Results: As of 3/31/14, 31(42%) subjects were off IS for a median(range) of 12(0.7, 39.9) wks, 23(31%) were still undergoing ISW and 20(27%) subjects had BPAR, as described in Table 1. 15/20 BPAR episodes occurred at pre-ISW; 5 to max dose ≤pre-ISW); none required antibody therapy. One subject had concurrent biliary stricture. ALT and GGT were
