studies

762A AASLD ABSTRACTS HEPATOLOGY, October, 2015
fixed dose Ledipasvir (LDV) and Sofosbuvir (SOF) (90/400mg)
regimen November 2014- May 2015 at Hawaii’s single tertiary
referral center. We collected data on demographics,
adverse events, laboratory values, and SVR (sustained virological
response). Statistical analysis was performed with R
version 3.1.0. Results: Baseline characteristics: 42% cirrhotic
(23.8% of those Child-Pugh Class B/C), 47.7% Caucasian,
30.1% Asian, 9.2% Pacific Islander, 65.3% male, mean age
60 ±10.5, mean BMI 27.1 ±5.8, 11% diabetic, 60.1% GT1a.
Interim analysis data are presented. Viral load was negative
in 100% of patients at the end of treatment (EOT). Main side
effects: headache 14.4%, weight gain 7.8%, nausea 5.9%,
and diarrhea 3.9%. Headache was more frequent in cirrhotics
versus non-cirrhotics (19 vs 11%). In patients with baseline
abnormal ALT (>30 U/L), 84/99 showed normal ALT levels
(15 IU/cc) at 4 weeks post treatment.
Conclusions: 12-week treatment was highly effective and well
tolerated in a multiethnic cohort of patients including patients
with advanced liver disease. Interim analysis indicates SVR
rates comparable to ION trials despite higher proportion (42%)
of cirrhotics in our cohort. Early improvement in albumin levels
in cirrhotic patients may indicate improvement in synthetic function.
Complete data on SVR4 and SVR12 will be available on
all patients by October 2015.
reduced toxicities, the new Direct Acting Antivirals (DAA) could
be attractive therapeutic options for HCV treatment after KT.
The approach of safe HCV treatment post KT, could allow the
use of organs from HCV +ve donors, thus reducing organ discard
rates the wait-list time for KT. Methods: 15 HCV +ve KT
recipients were prospectively enrolled in the study at the time
of initiation of DAA. We report the data from 8 recipients who
had completed HCV treatment till now. Results: From the 8
adult (Mean age 58.5 years; Male: Female=6:2) KT recipients,
4 received HCV +ve grafts. 2 completed Sofosbuvir 400
mg and Simeprevir 150 mg daily combination and 6 completed
Sofosbuvir/Ledipasvir 150mg/90 mg daily 12 weeks
regimen. All achieved End Treatment Response. Data is being
collected for Sustained Virologic Responses (SVR). There were
no episodes of graft rejection and none required modification
in immunosuppression. There were no adverse events requiring
cessation of therapy. All KT recipients had stable renal and
liver function during and after the completion of therapy. Conclusion:
In our cohort of KT recipients, DAAs showed excellent
safety profile and good virologic response.
Study population characteristics and treatment responses of each
subject.
(KT) Kidney Transplant
(IFN) Interferon
(R) Ribavirin
(PI) Protease Inhibitor
(T) Tacrolimus
(M) Mycophenolate
(P) Prednisone
Disclosures:
Marina Roytman - Advisory Committees or Review Panels: Gilead; Speaking and
Teaching: Gilead
Leena K. Hong - Advisory Committees or Review Panels: Gilead Sciences; Speaking
and Teaching: Gilead Sciences, Abbvie
Naoky CS C. Tsai - Advisory Committees or Review Panels: Bristol-Myers Squibb,
Gilead, AbbVie; Consulting: BMS, Gilead; Grant/Research Support: BMS,
Gilead, AbbVie; Speaking and Teaching: Bristol-Myers Squibb, Gilead, Salix,
Bayer, AbbVie
The following authors have nothing to disclose: Alister L. Tang, Christina Wu, Joy
I. Piotrowski, Ruby Trujillo, Leslie Huddleston, Isabel Hung Wan, Peter Poerzgen,
Sumodh Kalathil
(Sof) Sofosbuvir
(Sim) Simeprevir
(Led) Ledipasvir
(EOT) End of Treatment
(SVR) Sustained Virologic Response
1122
Treatment of Chronic Hepatitis C Infection in Kidney
Transplant Recipients with Direct Acting Antiviral Medications
– Initial Experience
Sushrut Trakroo 1 , Sirish Sanaka 1 , Hawah Musa 1 , Mohammed
Eyad Yaseen Alsabbagh 2 , Mythili Ghanta 1 , Swati Rao 1 , Lee Peng 2 ,
Antonio Di Carlo 1 , Abdullah M. Al-Osaimi 2 , Kamran Qureshi 2 ;
1 Temple University Hospital, Philadelphia, PA; 2 Gastroenterology
and Hepatology, Temple University School of Medicine, Philadelphia,
PA
Background: Chronic Hepatitis C infection (HCV) is the leading
cause of liver disease after Kidney Transplant (KT). HCV positive
(+ve) KT recipients have worse overall and graft survival
compared with HCV negative KT recipients. Treatment of HCV
before KT with Interferon (IFN) based therapies showed poor
response rates and tolerability. IFN use is relatively contraindicated
after KT due to increased risk of allograft rejection
and organ failure. Because of the shown greater efficacy and
Disclosures:
Abdullah M. Al-Osaimi - Advisory Committees or Review Panels: Abbvie, Gilead,
Intercept Pharmaceuticals; Grant/Research Support: Chronic Liver Disease
Foundation (CLDF), Beckman Coulter Inc., Conatus Pharmaceuticals, BioPharma
Alliance, Bayer HealthCare Pharmaceuticals, Inc., Vital Therapies Inc., Roche
Molecular Systems, Inc., Abbvie