Safety and Efficacy at 4 Years in Post-Liver Transplant Patients with Chronic Kidney Disease Receiving Tenofovir Alafenamide (TAF) for HBV Prophylaxis
1Auckland City Hospital and University of Auckland, Auckland, New Zealand, 2Gilead Sciences, Inc., Foster City, CA
Meeting: 2022 American Transplant Congress
Abstract number: 561
Keywords: Efficacy, Hepatitis B, Infection, Liver transplantation
Topic: Clinical Science » Infection Disease » 27 - Non-Organ Specific: Viral Hepatitis
Session Information
Session Time: 5:30pm-7:00pm
Presentation Time: 6:50pm-7:00pm
Location: Hynes Room 312
*Purpose: Recommended antiviral prophylaxis to prevent recurrent HBV infection after liver transplantation includes tenofovir disoproxil fumarate (TDF). However, given risks of bone/renal toxicity associated with TDF, safer yet equally effective alternatives needed. Previously reported TAF monotherapy for 48 weeks was similar in efficacy to TDF-containing regimens with improved bone and renal safety. Long-term results presented here.
*Methods: In a Phase 2 open-label study (NCT02862548) in New Zealand, 51 liver transplant recipients on HBV antiviral prophylaxis TDF ± lamivudine, ≥Stage 2 CKD were randomized 1:1 to TAF 25 mg/day or continued TDF-containing treatment for 48 weeks, after which all received TAF through Week 192 (i.e. TAF vs. TDF→TAF). At Week 192, the efficacy endpoint was HBV DNA <20 IU/mL; secondary safety endpoints included treatment-emergent serious adverse events (SAEs), changes in estimated glomerular filtration rate by the CKDEPI creatinine method, (eGFR), and changes in bone mineral density (BMD) at spine and hip by DXA.
*Results: Baseline characteristics included: mean age 60 years, 75% males, 53% Pacific Islander; median eGFR 50 mL/min/1.73m2. Overall, 46/51 (90%) patients completed 192 weeks of treatment (TAF: 2 deaths, 1 D/C for AE; TDF→TAF: 1 death, 1 D/C for investigator discretion). All patients had sustained viral suppression through Week 192. During extension phase, SAEs occurred at similar frequency between groups (TAF 31%; TDF→TAF 33%), and no treatment related; 1 TAF patient D/C due to AKI not related to treatment. Median (Q1, Q3) eGFR increased in both groups at Week 192: TAF: 3.5 (-1.2, 7.7), and TDF→TAF 1.1 (-6.3, 9.0) mL/min/1.73m2. Increases in baseline spine and hip BMD observed in TAF treatment (mean [SD]% change at Week 192: 4.26% [7.034] and 1.60% [2.384], respectively); while TDF→TAF group decreases occurred in randomized phase, increases in BMD seen switching to TAF at Week 48 (mean [SD]% change at Week 192: 4.26% [6.289] and 1.81% [3.703] for spine and hip, respectively).
*Conclusions: Long-term results in liver transplant recipients switched from TDF-containing regimens to TAF monotherapy demonstrated prevention of viral relapse, with sustained improvements in bone and renal safety parameters.
To cite this abstract in AMA style:
Gane E, George B, Ray-Chaudhuri D, Mules T, Holt CD, Wang H, Suri V, Gaggar A, Osinusi A, Flaherty J. Safety and Efficacy at 4 Years in Post-Liver Transplant Patients with Chronic Kidney Disease Receiving Tenofovir Alafenamide (TAF) for HBV Prophylaxis [abstract]. Am J Transplant. 2022; 22 (suppl 3). https://atcmeetingabstracts.com/abstract/safety-and-efficacy-at-4-years-in-post-liver-transplant-patients-with-chronic-kidney-disease-receiving-tenofovir-alafenamide-taf-for-hbv-prophylaxis/. Accessed November 21, 2024.« Back to 2022 American Transplant Congress