1Department of Internal Medicine, Healthcare Research Institute, Gangnam Healthcare Center, Seoul National University Hospital, Seoul, Korea.
2Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.
3Department of Gastroenterology and Hepatology, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.
4Department of Internal Medicine, Kangwon National University Hospital, Chuncheon, Korea.
5Department of Internal Medicine, CHA Gangnam Medical Center, CHA University, Seoul, Korea.
6Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Korea.
7Department of Internal Medicine, Ewha Womans University School of Medicine Liver Center, Ewha Womans University Mokdong Hospital, Ewha Womans University School of Medicine, Seoul, Korea.
8INSERM Unité 1052, Cancer Research Center of Lyon, Hospices Civils de Lyon, Lyon University, Lyon, France.
AbstractBackground/Aims: A recent study reported that entecavir had inferior efficacy in nucleos(t)ide analogue (NA)-experienced chronic hepatitis B (CHB) patients compared to NA-naïve patients. We sought to compare the efficacy of tenofovir disoproxil fumarate (TDF) in NA-experienced and NA-naïve CHB patients.
Methods: We retrospectively enrolled 252 consecutive patients who had a serum hepatitis B virus (HBV) DNA level greater than 2,000 IU/mL at the initiation of TDF treatment and who received TDF for at least 6 months. Complete virologic suppression (CVS) was defined as undetectable serum HBV DNA. We generated a multivariate Cox proportional-hazard model to examine predictive factors that were independently associated with time to CVS.
Results: The mean age of patients was 48.2 years, and the cohort included 181 NA-naïve patients and 71 NA-experienced patients. The median duration of TDF treatment was 14.4 (interquartile range, 9.5-17.8) months. A total of 167 (92.3%) of 181 NA-naïve patients achieved CVS, and 60 (84.5%) of 71 NA-exposed patients achieved CVS. Forty-nine (89.1%) of 55 patients who previously took an NA aside from adefovir and 11 (68.8%) of 16 adefovir-experienced patients achieved CVS. In multivariable analysis, previous adefovir exposure significantly influenced time to CVS (hazard ratio, 0.37; 95% confidence interval, 0.19-0.72; P=0.003), after adjusting for HBeAg positivity, baseline HBV DNA level and cirrhosis.
Conclusions: Tenofovir had inferior efficacy in adefovir-experienced CHB patients compared to NA-naïve patients. The response of patients with previous adefovir exposure to TDF monotherapy should be monitored closely.