Efficacy of tenofovir disoproxil fumarate therapy in C C hinese chronic hepatitis B B patients after multiple antiviral failures

摘要

Aim In this prospective study, we aimed to evaluate the efficacy and safety of tenofovir disoproxil fumarate ( TDF ) in C hinese chronic hepatitis B ( CHB ) patients after multiple nucleoside/nucleotide analog ( NA ) treatment failures. Methods A total of 115 C hinese CHB patients with suboptimal response to two or more NA treatments were included in this study. All patients were changed to TDF (300?mg/day, oral administration) antiviral treatment for at least 72 weeks. Hepatitis B virus ( HBV ) polymerase ( P ) gene mutation screening for each patient was performed. In addition, virological, biochemical responses and estimated glomerular filtration rate ( eGFR ) of each patient at weeks 12, 24, 48 and 72 of TDF treatment were evaluated. Results Seventy‐six out of 115 patients had drug‐resistance mutations ( R + ), including 27 with adefovir ( ADV )‐associated mutations (35.5%) and 49 with lamivudine ( LMV )‐associated mutations (64.5%). For all included patients, complete viral response ( CVR ) of HBV DNA (100?IU/mL) was 57.4%, 69.6%, 74.8% and 86.1% at weeks 12, 24, 48 and 72 of TDF treatment, respectively. Alanine aminotransferase normalization and hepatitis B e‐antigen seroclearance occurred in 77.3% and 23.2%, respectively, after 72‐week TDF treatment. CVR at weeks 12, 24 and 48 was observed more commonly in patients with baseline HBV DNA of less than 10 6 ? IU /mL. There was no significant reduction of eGFR induced by the TDF treatment. Conclusion Seventy‐two‐week treatment with TDF in Chinese CHB patients with previously multiple NA treatment failures exhibited effective and safe outcomes, which were independent of baseline mutations conferring ADV or LMV resistance.