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Background: A 2-year roadmap study was conducted to evaluate the efficacy and safety of tenofovir intensification at Week 24 in patients with chronic hepatitis B (CHB) receiving telbivudine. Scope: A prospective multicenter study was conducted in treatment-naive patients with hepatitis B e antigen (HBeAg)- positive CHB. All patients received telbivudine (600 mg/day) until Week 24. Thereafter, patients with detectable hepatitis B virus (HBV) DNA (≥300 copies/mL) were administered tenofovir (300 mg/day) plus telbivudine, and patients with undetectable HBV DNA continued telbivudine monotherapy until Week 104. The primary endpoint was the proportion of patients with undetectable HBV DNA (

Background/Aims In two identically-designed double-blind, randomized (2:1), phase 3 studies, the safety and efficacy of tenofovir alafenamide (TAF) vs tenofovir disoproxil fumarate (TDF) was evaluated in subjects treated for 3 years. Methods One thousand two hundred ninety-eight HBeAg(-) and HBeAg(+) chronic hepatitis B patients were randomized and treated with TAF25 mg or TDF300 mg QD. Included in this analysis, were 1,118 patients (759 HBeAg(+)and 359 HBeAg(-)); 866 of whom received TAF and 252 who received TDF for 3 years. Efficacy analyses included virologic, biochemical, and serologic responses, and pooled safety assessments included changes in bone mineral density (BMD), serum creatinine, and estimated glomerular filtration rate (eGFR) by Cockcroft-Gault method. Results Baseline characteristics were similar between two groups: mean age, 39 years; 63% males; 78% Asian mostly genotypes C (48%) and D (26%); mean hepatitis B virus DNA was 7 log IU/mL and 25% previously treated with nucleos(t)ides. At week 144, high rate of virologic control were maintained in TAF versus TDF subjects; a greater proportion of TAF versus TDF patients achieved alanine aminotransferase normalization (Table 1). Overall, adverse events (AEs) and serious AEs were similar between groups. At week 144, greater median declines in eGFR were observed with TDF treatment; similarly, hip and spine BMD declines in the TDF group were larger than in TAF group (Table 1). Conclusions After 3 years of treatment, high and similar rate of virologic suppression were achieved and maintained and continued improvements in renal and bone safety were observed in patients receiving TAF compared to TDF. [ABSTRACT FROM AUTHOR]

Background/Aims Tenofovir alafenamide (TAF), a novel prodrug of tenofovir (TFV), has greater plasma stability and reduced circulating levels of TFV compared to tenofovir disoproxil fumarate (TDF) at approved doses. TAF has shown efficacy noninferior to TDF with improved renal and bone safety in viremic chronic hepatitis B (CHB) patients. We evaluated efficacy and safety in stable, virally-suppressed patients who were switched from TDF to TAF versus continued TDF for an additional year. Methods In this phase 3 study (NCT02979613), CHB patients on TDF for 348w with hepatitis B virus (HBV) DNA