Tenofovir disoproxil fumarate monotherapy for nucleos(t)ide-naive chronic hepatitis B patients in Korea: data from the clinical practice setting in a singlecenter cohort
Korean Journal of Hepatology 2014³â 20±Ç 3È£ p.261 ~ p.266
¾È¼º¼ö(Ahn Sung-Soo) - Yonsei University College of Medicine Department of Internal Medicine
Àü¿µÀº(Chon Young-Eun) - Yonsei University College of Medicine Department of Internal Medicine
±è¹ü°æ(Kim Beom-Kyung) - Yonsei University College of Medicine Department of Internal Medicine
±è½Â¾÷(Kim Seung-Up) - Yonsei University College of Medicine Department of Internal Medicine
±èµµ¿µ(Kim Do-Young) - Yonsei University College of Medicine Department of Internal Medicine
¾È»óÈÆ(Ahn Sang-Hoon) - Yonsei University College of Medicine Department of Internal Medicine
Çѱ¤Çù(Han Kwang-Hyub) - Yonsei University College of Medicine Department of Internal Medicine
¹ÚÁØ¿ë(Park Jun-Yong) - Yonsei University College of Medicine Department of Internal Medicine
Abstract
Background/Aims: This study assessed the antiviral efficacy and safety of tenofovir disoproxil fumarate (TDF) for up to 12 months in Korean treatment-naive chronic hepatitis B (CHB) patients.
Methods: A total of 411 treatment-naive CHB patients who had been treated with TDF for at least 3 months (median 5.6) were consecutively enrolled. Clinical, biochemical, virological parameters and treatment adherence were routinely assessed every 3 months.
Results: The median age was 51.3 years, 63.0% of the patients were male, 49.6% were HBeAg (+), and 210 patients had liver cirrhosis. The median baseline HBV DNA was 5.98 (SD 1.68) log10 IU/mL. Among the patients completing week 48, 83.3% had a complete virologic response (CVR, <12 IU/mL by HBV PCR assay), and 88.2% had normalized levels of alanine aminotransferase (ALT). The cumulative probabilities of CVR at 3, 6, 9 and 12 months were 22.8 %, 53.1%, 69.3% and 85.0%. During the follow-up period, 9.8% patients achieved HBeAg loss and 7.8% patients achieved HBeAg seroconversion. There was no virological breakthrough after initiating TDF. The most common TDF-related adverse event was gastrointestinal upset, and three patients discontinued TDF therapy. However, no serious life-threatening side effect was noted.
Conclusions: In a clinical practice setting, TDF was safe and highly effective when administered for 12 months to Korean treatment-naive CHB patients.
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Chronic hepatitis B, Tenofovir, Korean, Real-life
KMID :
1103920140200030261
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