Popis: |
Background 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. Methods In this study, virally suppressed CHB patients (HBV DNA Results 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 Conclusions 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. |