eGFR IMPROVEMENT IN CHRONIC HEPATITIS B PATIENTS WITH TELBIVUDINE TREATMENT IS INDEPENDENT OF ANTIVIRAL ACTIVITY
Journal of Hepatology(2013)
Abstract
POSTERSvs. 32% (p = 0.015), and prior ADV 14% vs. 25% (p = 0.044).Tenofovir (TFV) PK parameters (AUC t , C max , T max ) in MRI were comparable to historical data in NRF, and there was no correlation between steady-state TFV exposures (AUC t ) and BL CrCL.TDF was well tolerated overall; 3 patients (1.1%) discontinued the study early for an AE (2-MRI and 1-NRF).No patients had a confirmed increase in serum creatinine of ≥0.5 mg/dL, and 1% (2-NRF) had transient PO 4 <2 mg/dL.Nine MRI patients had CL Cr <50 mL/min (pre-treatment range: 49-61 mL/min) that stabilized with dose adjustment.No differences were observed in % change in spine or hip BMD over 96 weeks, and no clinically relevant bone loss was noted in either group.At Week 96 there was no significant difference (missing=failure) in % with HBV DNA <400 copies/mL, or rates of ALT normalization or HBeAg loss/seroconversion.Conclusions: The safety, PK, and efficacy of patients with MRI receiving TDF were similar to NRF patients; in MRI patients there was no evidence of increased risk for renal-or bone-related complications.
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Key words
telbivudine treatment,egfr improvement,antiviral activity
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