[O-157] EMTRICITABINE/TENOFOVIR DF (FTC/TDF) FIXED DOSE COMBINATION IN PATIENTS WITH NORMAL AND IMPAIRED RENAL FUNCTION POST ORTHOTOPIC LIVER TRANSPLANT (OLT) FOR PREVENTION OF CHRONIC HEPATITIS B (CHB) RECURRENCE IN THE PRESENCE OR ABSENCE OF HBIG: UPDATED SAFETY ANALYSIS.

Lewis Teperman, James Spivey, Fred Poordad, Thomas Schiano, Derek Coombs, Jane Anderson, David Oldach, Franck Rousseau New York University Medical Center, New York, USA; Emory Healthcare, Atlanta, USA; Cedars-Sinai Medical Center, Los Angeles, USA; Recanati/Miller Transplantation Institute, Mount Sinai Hospital, New York, USA; Gilead Sciences, Durham, USA

Background: This study evaluates the safety and efficacy of FTC/TDF with/without HBIG in preventing recurrence of CHB post-OLT. Methods: Stable patients ≥12 weeks post-OLT with a creatinine clearance ≥40 ml/min and no CHB recurrence post-OLT are eligible. Patients are treated 24 weeks with FTC/TDF plus HBIG and at week (W) 24 randomized to HBIG + FTC/TDF or FTC/TDF alone for an additional 72 weeks. Preliminary safety data are described. Results: Currently 29/50 patients are enrolled with 24 patients through W24. At baseline, median age was 59 years, 83% men, 38% Asian, 24% Black and 31% White; all patients had undetectable HBV DNA and 28/29 had normal ALT. Median time (min, max) since transplant was 3.8 yrs (0.6, 6.0). Creatinine clearance values at baseline include: 15 patients >70 ml/min (5 with normal renal function >80 mL/min); 7 patients ≥50 to 70 ml/min and 7 patients <50 ml/min (moderate renal impairment). Patients with creatinine clearance <50 ml/min are dosed every 48 hours. Among patients treated for 24 weeks, median change from baseline in creatinine clearance was +2.0, -4.0 and +8.0 mL/min and median phosporus values were 2.7, 3.1 and 3.75 mg/dL, respectively. No patient had a confirmed increase in creatinine ≥0.5 mg/dL or phosphorus <2mg/dL.One patient underwent a dose reduction to every 48 hours (creatinine clearance decreased from 50 ml/min at baseline to 43 mL/min at W16). Three serious AEs, all considered unrelated to study medications, have occurred: cytomegalovirus (CMV) hepatitis (liver donor positive), hypertension and diarrhea. The only Grade 3 or 4 laboratory abnormalities included: serum or urine glucose (all history of diabetes) and WBC and bilirubin (CMV patient). To date, no patient has experienced CHB recurrence. Safety data through W48 will be presented. Conclusion: Preliminary safety data through W24 indicate that FTC/TDF is well tolerated in patients with mild to moderate renal impairment post-OLT.

Date: Saturday, July 11, 2009
Session Info: Plenary Session III (8:00 AM-10:00 AM)
Presentation Time: 9:50 AM
Room: Grand Ballroom, Level 3