Safety and Efficacy at 4 Years in Post-Liver Transplant Patients with Chronic Kidney Disease Receiving Tenofovir Alafenamide (TAF) for HBV Prophylaxis

E. Gane¹, B. George¹, D. Ray-Chaudhuri¹, T. Mules¹, C. D. Holt², H. Wang², V. Suri², A. Gaggar², A. Osinusi², J. Flaherty²

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 Name: Viral Hepatitis

Session Type: Rapid Fire Oral Abstract

Date: Tuesday, June 7, 2022

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 May 9, 2025.

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