The Effect of Naïve Tenofovir Dipivoxil Fumarate Monotherapy in Patients with Chronic Hepatitis B: 2-Year Results of a Real-world Single-center Study / 대한내과학회지

ABSTRACT

BACKGROUND/AIMS: An incomplete virological response has been observed to tenofovir dipivoxil fumarate (TDF) in nucleos(t)ide analogue (NA)-experienced chronic hepatitis B (CHB) patients. This study investigated the efficacy of TDF in NA-naïve CHB patients 96 weeks after treatment. METHODS: CHB patients treated with TDF were enrolled retrospectively between November 2012 and January 2016. We assessed virological and biochemical parameters. RESULTS: The study enrolled 179 NA-naïve patients with a median follow-up duration of 59.6 weeks. The serum hepatitis B virus (HBV) DNA level decreased significantly during treatment. The complete virological response (CVR) rate was 83.21% at week 96. In univariate analyses, the predictors of a CVR at 96 weeks were the baseline HBV DNA level (CVR vs. no-CVR, HBV DNA log10 mean value 7.34 vs. 7.86, 95% confidential interval [CI]: -7.89 to -7.37; p < 0.001) and male sex (CVR vs. no-CVR, 49.1% vs. 81.3%, odds ratio [OR] 0.22, 95% CI: 0.06 to 0.87; p = 0.025). In the multivariate analysis, male sex predicted a CVR at week 96. The CVR was significantly lower in males than in females (OR 0.12, 95% CI: 0.02 to 0.96; p = 0.046). CONCLUSIONS: TDF was effective for treating CHB for more than 2 years in NA-naïve patients.