Abstract
Background The recently updated EASL Guidelines for Management of HBV Infection (2017) recommend the use of TAF as an alternative to TDF in patients with risk factors unfavourable to TDF use. We, therefore, performed an evaluation of the efficacy and safety of TAF compared with TDF in patients considered to be at risk for adverse bone and/or renal effects from TDF. Methods In two Phase 3 studies, patients (HBeAg-positive [n=873] and HBeAg-negative [n=425]) were randomised 2:1 to TAF or TDF. Antiviral efficacy (HBV DNA 60 years, osteoporosis of hip or spine by t-score, eGFRCG 30 mg/g, or serum phosphorus Results Of 1298 patients randomised and treated in the 2 studies, 239 (18%; 151 TAF and 88 TDF) patients had at least 1 risk factor for TDF use. Baseline demographics were similar between groups. At Week 96, similar antiviral efficacy (HBV DNA Conclusions In CHB patients considered to be at risk for TDF toxicity, TAF showed significantly less impact on bone and renal parameters while efficacy was maintained in this subgroup through 96 weeks.
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