Background and Aim

Tenofovir disoproxil fumarate (TDF) is a first-line treatment for chronic hepatitis B virus (HBV) infection for its high potency and a low rate of drug resistance. This study investigated the efficacy and safety of TDF in Chinese patients with chronic hepatitis B (CHB) infection after treatment failure with multiple nucleos(t)ide analogues (NAs).

Methods

Patients included were: aged 18-65 years, with treatment failure with multiple NAs (serum HBV DNA >200 IU/mL after ≥2 different NA treatments). The primary endpoint was proportion of patients with serum HBV DNA <20 IU/mL at Week 144 of TDF monotherapy. Secondary endpoints and safety were also assessed.

Results

Overall, 213 patients were enrolled. At Week 144, mean HBV DNA decreased significantly from baseline (4.4 vs 1.4 log10IU/mL), with 77.0% patients (95% CI: 71.1, 82.9) achieving serum HBV DNA <20 IU/mL. Three (1.4%) patients experienced virological breakthrough during TDF monotherapy, without hepatitis flare. At Week 144, 15.3% and 4.7% patients (HBeAg-positive at baseline) experienced hepatitis B e antigen (HBeAg) loss and HBeAg seroconversion, respectively; 68.3% patients achieved normalized alanine aminotransferase levels. Overall, 58.7% patients experienced ≥1 AE. Most common AEs were upper respiratory tract infection and blood creatine phosphokinase increase; 8.5% patients experienced study drug-related AEs; 9.4% patients experienced serious AEs (none were TDF-related). Among renal safety parameters, overall trend of mean serum phosphorous level remained stable, while mean estimated glomerular filtration rate increased slightly.

Conclusions

TDF monotherapy is efficacious in CHB patients with multiple NAs treatment failure with no new safety findings.