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• W3196783006 abstract "<h3>Background</h3> We have previously shown in renally impaired (RI) CHB patients, including those with ESRD on HD, that switching to TAF from TDF and/or other OAVs maintains high rates of viral suppression with stable bone and renal safety parameters at Week 48. Here we present the final Week 96 results. <h3>Methods</h3> In this study, virally suppressed CHB patients (HBV DNA <LLOQ x 6 months, <20 IU/mL at screening) with moderate or severe RI or with ESRD on HD at screening while receiving TDF and/or other OAVs for ≥48 weeks were enrolled and switched to TAF for 96 weeks. Safety assessments including adverse events (AEs), changes in bone BMD and renal (eGFR_CG, serum phosphorus serum creatinine - except in ESRD patients) parameters, viral suppression, serological and biochemical responses were serially assessed. <h3>Results</h3> Of 93 patients (mod-severe RI 78; ESRD on HD 15), most (74%) were male and Asian (77%), 51% ≥65 y, 83% HBeAg-negative, 34% cirrhosis, and median ALT 17 U/L. Up to 24% had osteoporosis at hip and/or spine, with most having comorbidities. Twelve (13%; 11 mod-severe RI and 1 ESRD) patients discontinued the study early (5-withdrew consent, 3-deaths [none treatment-related], 2-AE, 2-investigator decision). Viral suppression (HBV DNA<20IU/mL) was maintained in all patients remaining on treatment (i.e. missing equals excluded); a high proportion had target not detected. Overall, TAF was well tolerated with no Grade 3 ,4 or serious AEs related to study treatment. Relative to baseline levels, switching to TAF resulted in small median% increases in hip/spine BMD in those with moderate to severe RI, and small median decreases in ESRD patients. 2 patients with mod-severe RI had a bone fracture (ankle, rib). Median eGFR_CG increased while urinary markers of proximal tubular function progressively decreased in mod-severe RI patients. <h3>Conclusions</h3> Renally-impaired CHB patients, including ESRD patients on HD, who were switched to TAF from TDF and/or other OAVs maintained high rates of viral suppression, and bone and renal parameters remained stable or slightly improved after 2 years of treatment." @default.
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• W3196783006 date "2021-09-01" @default.
• W3196783006 modified "2023-10-16" @default.
• W3196783006 title "IDDF2021-ABS-0078 Switching from tenofovir disoproxil fumarate (TDF) and/or other oral antivirals (OAVS) to tenofovir alafenamide (TAF) in virally suppressed chronic hepatitis B (CHB) patients with moderate or severe renal impairment, or with end-stage renal disease (ESRD)" @default.
• W3196783006 doi "https://doi.org/10.1136/gutjnl-2021-iddf.80" @default.
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