Switching to tenofovir vs continuing entecavir for hepatitis B virus with partial virologic response to entecavir: a randomized controlled trial

摘要

Summary Entecavir 0.5?mg ( ETV ) is widely used among treatment‐na?ve chronic hepatitis B ( CHB ) patients. However, 10%‐30% of patients show partial virologic response ( PVR ) to the drug. If the hepatitis B virus ( HBV ) continues to replicate, the underlying liver disease may progress. Herein, we compared the efficacy of switching to tenofovir disoproxil fumarate ( TDF ) with that of continuing ETV in CHB patients with PVR to ETV . This was an open‐label randomized controlled trial including CHB patients who had been receiving 0.5?mg of ETV for 12?months, but who still had detectable HBV DNA levels of 60? IU / mL without known resistance to ETV . Sixty patients were enrolled and 45 qualified for the study: Twenty‐two patients were randomly assigned into the TDF group and 23 into the ETV group. After 12?months of treatment, the virologic response rate ( HBV DNA 20? IU / mL ) was significantly higher in the TDF group than in the ETV group, as measured using per‐protocol analysis (55% vs 20%; P? = ? .022) and intention‐to‐treat analysis (50% vs 17.4%; P? = ? .020). The reduction in HBV DNA was greater (?1.13 vs ?0.67 log 10 IU / mL ; P? = ? .024), and the mean HBV DNA level was lower (1.54 vs 2.01 log 10 IU / mL ; P? = ? .011) in the TDF group than in the ETV group. In conclusion, to achieve optimal response in CHB patients with PVR to ETV , switching to TDF would be a better strategy than continuing ETV . Appropriate modification of therapy would further improve the outcome of chronic HBV infection.