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KMID : 1040620150210010041
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Clinical and Molecular Hepatology
2015 Volume.21 No. 1 p.41 ~ p.48
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Tenofovir disoproxil fumarate monotherapy for nucleos(t)ide analogue-naive and nucleos(t)ide analogue-experienced chronic hepatitis B patients
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Jung Sang-Kyung
Kim Kyung-Ah
Ha So-Young
Lee Hyun-Kyo
Kim Young-Doo
Lee Bu-Hyun
Paik Woo-Hyun
Kim Jong-Wook
Bae Won-Ki
Kim Nam-Hoon
Lee June-Sung
Jwa Yoon-Jung
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Abstract
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Background/Aims: This study investigated the antiviral effects of tenofovir disoproxil fumarate (TDF) monotherapy in nucleos(t)ide analogue (NA)-naive and NA-experienced chronic hepatitis B (CHB) patients.
Methods: CHB patients treated with TDF monotherapy (300 mg/day) for ≥12 weeks between December 2012 and July 2014 at a single center were retrospectively enrolled. Clinical, biochemical, and virological parameters were assessed every 12 weeks.
Results: In total, 136 patients (median age 49 years, 96 males, 94 HBeAg positive, and 51 with liver cirrhosis) were included. Sixty-two patients were nucleos(t)ide (NA)-naive, and 74 patients had prior NA therapy (NA-exp group), and 31 patients in the NA-exp group had lamivudine (LAM)-resistance (LAM-R group). The baseline serum hepatitis B virus (HBV) DNA level was 4.9±2.3 log IU/mL (mean±SD ), and was higher in the NA-naive group than in the NA-exp and LAM-R groups (5.9±2.0 log IU/mL vs 3.9±2.0 log IU/mL vs 4.2±1.7 log IU/mL, P<0.01). The complete virological response (CVR) rate at week 48 in the NA-naive group (71.4%) did not differ significantly from those in the NA-exp (71.3%) and LAM-R (66.1%) groups. In multivariate analysis, baseline serum HBV DNA was the only predictive factor for a CVR at week 48 (hazard ratio, 0.809; 95% confidence interval, 0.729?0.898), while the CVR rate did not differ with the NA experience.
Conclusions: TDF monotherapy was effective for CHB treatment irrespective of prior NA treatment or LAM resistance. Baseline serum HBV DNA was the independent predictive factor for a CVR.
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KEYWORD
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Chronic Hepatitis B, Tenofovir, Nucleos(t)ide analogue-experienced, Lamivudine-resistant
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